[Senate Hearing 110-270]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 110-270
 
          THE NEXT PHASE OF THE GLOBAL FIGHT AGAINST HIV/AIDS

=======================================================================

                                HEARING



                               BEFORE THE



                     COMMITTEE ON FOREIGN RELATIONS
                          UNITED STATES SENATE



                       ONE HUNDRED TENTH CONGRESS



                             FIRST SESSION



                               __________

                            OCTOBER 24, 2007

                               __________



       Printed for the use of the Committee on Foreign Relations


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                     COMMITTEE ON FOREIGN RELATIONS

                JOSEPH R. BIDEN, Jr., Delaware, Chairman
CHRISTOPHER J. DODD, Connecticut     RICHARD G. LUGAR, Indiana
JOHN F. KERRY, Massachusetts         CHUCK HAGEL, Nebraska
RUSSELL D. FEINGOLD, Wisconsin       NORM COLEMAN, Minnesota
BARBARA BOXER, California            BOB CORKER, Tennessee
BILL NELSON, Florida                 JOHN E. SUNUNU, New Hampshire
BARACK OBAMA, Illinois               GEORGE V. VOINOVICH, Ohio
ROBERT MENENDEZ, New Jersey          LISA MURKOWSKI, Alaska
BENJAMIN L. CARDIN, Maryland         JIM DeMINT, South Carolina
ROBERT P. CASEY, Jr., Pennsylvania   JOHNNY ISAKSON, Georgia
JIM WEBB, Virginia                   DAVID VITTER, Louisiana
                   Antony J. Blinken, Staff Director
            Kenneth A. Myers, Jr., Republican Staff Director

                                  (ii)




                            C O N T E N T S

                              ----------                              
                                                                   Page

Biden, Hon. Joseph R., Jr., U.S. Senator from Delaware, opening 
  statement......................................................     1
Dybul, Hon. Mark R., U.S. Global AIDS Coordinator, Department of 
  State, Washington, DC..........................................     6
    Prepared statement...........................................     9
    Responses to questions submitted for the record by Senator 
      Biden......................................................    32
    Responses to questions submitted for the record by Senator 
      Menendez...................................................    45
Feingold, Hon. Russell, D., U.S. Senator from Minnesota, 
  statement......................................................    22
Lugar, Hon. Richard G., U.S. Senator from Indiana, opening 
  statement......................................................     3
Menendez, Hon. Robert, U.S. Senator from New Jersey, statement...    25

                                 (iii)




          THE NEXT PHASE OF THE GLOBAL FIGHT AGAINST HIV/AIDS

                              ----------                              


                      WEDNESDAY, OCTOBER 24, 2007

                                       U.S. Senate,
                            Committee on Foreign Relations,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2:21 p.m., in 
room SD-419, Dirksen Senate Office Building, Hon. Joseph R. 
Biden, Jr. (chairman of the committee) presiding.
    Present: Senators Biden, Feingold, Bill Nelson, Menendez, 
Cardin, Webb, Lugar, Hagel, Corker, Sununu, Murkowski, DeMint, 
Isakson, and Vitter.

        OPENING STATEMENT OF HON. JOSEPH R. BIDEN, JR.,
                   U.S. SENATOR FROM DELAWARE

    The Chairman. We now turn to a hearing on the next phase of 
the global fight against HIV/AIDS. Our witness--and we welcome 
him--is Ambassador Dybul. Welcome, sir. Thank you for being 
here.
    This is the first of several hearings this committee will 
hold to explore the critical question, which is where do we go 
next in the global fight against HIV/AIDS. According to the 
UNAIDS organization, nearly 3 million people died because of 
AIDS last year and an estimated 40 million people are living 
with HIV today, and most of them don't know because they've 
never been tested. Thousands of people will become newly 
infected today, thousands in a single day, thousands every 
single day. That is the relentless enemy that we're up against.
    We have made tremendous gains in the last 4 years in the 
fight against HIV/AIDS, but these numbers tell us just how far 
we still have to go. Four years ago Congress passed the United 
States Leadership Against HIV/AIDS, Tuberculosis, and Malaria 
Act. We authorized $15 billion to support the President's 
Emergency Plan for AIDS Relief and for the multilateral Global 
Fund to Fight AIDS, Tuberculosis, and Malaria. That legislation 
launched a 5- year battle plan in the war on AIDS, TB, and 
malaria.
    Since then the United States has created the largest public 
health program the world has ever known, and I believe history 
will record that this is one of President Bush's greatest 
accomplishments. He has helped to save millions of lives by 
leading the global fight against HIV/AIDS and by spearheading 
the new malaria initiative.
    Thanks to the international efforts led by the United 
States, over a million people with AIDS are now on 
antiretroviral treatment, or ARVs. That means over 1 million 
death sentences have been suspended. But that's still less than 
a quarter of those who need treatment in poor and middle-income 
countries. Enrolling more people into treatment programs and 
maintaining efforts already under way is a substantial 
challenge. So is helping the countries that begin to assume 
ownership of these efforts on the road to sustainability.
    Thanks to U.S. programs designed to prevent the 
transmission of HIV from mother to child, since 2003 over half 
a million pregnant and nursing women have received treatment. 
As a result, over 100,000 babies who likely would have 
contracted HIV did not. Every healthy baby today is a triumph.
    But we cannot declare victory. Far from it, because the 
disease continues to spread. Every day an extimated 1,800 
children worldwide become infected with AIDS. The vast majority 
are newborns in sub-Saharan Africa whose mothers were infected 
and lack the means to protect their children. We are not 
keeping pace with this pandemic. For every person who enrolled 
in a treatment program last year, six more became newly 
infected, according to UNAIDS.
    The United States and its partners need to devote more 
funds to this effort. But it's not just a question of more 
money; it's a question of how we spend it.
    These are the facts before us and as the committee takes up 
the reauthorization of our global HIV/AIDS, TB, and malaria 
programs these must be kept in mind. This will be a bipartisan 
effort and I look forward to working with Senator Lugar as well 
as other members of the committee and Senators Kennedy and Enzi 
on the Health, Education, and Labor and Pensions Committee.
    In thinking about reauthorization, for myself--speaking 
only for myself--I have several priorities. The first priority 
is simply this. We have to reauthorize this bill. No one--no 
one, should doubt the bipartisan commitment of this Congress to 
see the process through. It's more important we do this right 
than we do it overnight, but we will reauthorize this 
legislation.
    Second, in reauthorizing the bill we must do more on 
prevention. The math is brutally clear. We cannot keep up with 
the current pace of the epidemic through treatment programs. To 
slow its deadly progress, we have to expand and improve the 
prevention efforts.
    Third, we should follow the recommendation of the 
Government Accountability, Accounting Office, and the Institute 
of Medicine, which is part of the National Academies of 
Science. In a congressionally mandated report, the Institute of 
Medicine recommended eliminating current budget allocations or 
earmarks that limit vital flexibility.
    We currently have 15 AIDS focus countries. That means we 
are not facing a single pandemic, but rather 15 or more local 
epidemics. What works in Botswana may not work in Nigeria or 
Vietnam. We need to give those who are fighting the battle 
against HIV/AIDS the flexibility to combat their local 
epidemics. We should have targets and mechanisms to measure 
progress. But we should not divide our funding into rigid 
arbitrary categories that dictate our priorities.
    Finally, we need to listen to the people in the front lines 
of this fight. This summer Senator Lugar and I asked the staff 
of the committee to visit these countries and look at the 
programs in the dozens of focus countries to assess their 
progress and problems, to talk to care providers and patients, 
to consult with government officials and NGOs. Their findings 
will help us strengthen the program.
    My other key priorities for reauthorization are: First, to 
better integrate our HIV effort with other health and 
development programs.
    Two, build healthy capacity in Africa. The shortage of 
health care workers may be the greatest obstacle in the fight 
against HIV/AIDS in the continent of Africa.
    Third, expand our efforts to address the gender-based 
violence and other inequities. Millions of women and girls do 
not have the power to make sexual decisions. Abstinence is not 
an option when you lack the power to choose. Girls' education 
and women's empowerment in my view are critical in the fight 
against AIDS.
    Fourth, we have to improve our efforts to combat TB and 
malaria. These diseases were part of the 2003 legislation. They 
should be part of our discussion now.
    Finally, as we work to reauthorize this legislation we 
should expand funding for it. The President has called on 
Congress to pass a bill authorizing $30 billion over the next 5 
years. He has called this a doubling of our efforts. That does 
amount to double the initial authorization, but not our current 
funding. The foreign operations appropriations bill recently 
passed by the Senate includes $5.7 billion for AIDS, TB, and 
malaria for fiscal year 2008. If we divide $30 billion over the 
next 5 years, it would provide for $6 billion a year, a 
relatively small increase over our current efforts, not a 
doubling. I believe that $30 billion should be the starting 
point for discussion, not our final destination.
    The fight against HIV/AIDS, TB, and malaria is one of the 
great moral and strategic challenges of our time. Congress must 
once again rise to the challenge, building on and improving the 
legislative framework we laid out in 2003. We're in this for 
the long haul and reauthorizing this bill will be the next 
step.
    I'd like now to yield to a leader on this subject, my 
friend, Senator Lugar.

 STATEMENT OF HON. RICHARD G. LUGAR, U.S. SENATOR FROM INDIANA

    Senator Lugar. Thank you, Mr. Chairman. It's a great 
privilege to be with you in working for reauthorization.
    I would just comment that the HIV/AIDS pandemic threatens 
millions of people and is rending the socioeconomic fabric of 
communities, nations, and an entire continent and is creating a 
potential breeding ground for instability and terrorism. In the 
most heavily affected areas, communities are losing a whole 
generation of parents, teachers, laborers, health care workers, 
peacekeepers, and police.
    United Nations projections indicate that by 2020, HIV/AIDS 
will have depressed GDP by more than 20 percent in the hardest 
hit countries. Many children who have lost parents to HIV/AIDS 
are left entirely on their own, leading to an epidemic of 
orphan-headed households.
    Beyond our own national security concerns, we have a 
humanitarian duty to take action. During the last several 
years, the American people have catalyzed the world's response 
to the HIV/AIDS epidemic. It's not often that we have an 
opportunity to save lives on such a massive scale. Yet every 
American can be proud that we have seized this opportunity.
    I am grateful that the chairman has called this hearing 
today because it provides a chance to jump-start the process of 
reauthorizing the U.S. Leadership Against HIV/AIDS, 
Tuberculosis and Malaria Act of 2003, known as the Leadership 
Act. I believe that Congress should reauthorize the Leadership 
Act as soon as possible, preferably this year, rather than wait 
until it expires in September 2008. Partner governments and 
implementing organizations in the field have indicated that 
without early reauthorization of the Leadership Act they may 
not expand their programs in 2008 to meet the goals of the 
President's Emergency Plan For AIDS Relief, PEPFAR. These goals 
include providing treatment for 2 million people, preventing 7 
million new infections, and caring for 10 million AIDS victims, 
including orphans and vulnerable children.
    Many partners in the fight against HIV/AIDS want to expand 
their programs, but to do so they need assurances of a 
continued U.S. commitment beyond 2008. We may promise that a 
reauthorization of an undetermined funding level will happen 
eventually, but partners need to make their plans now if they 
are to maximize their efforts. Today they have only a 
Presidential proposal and not an enacted reauthorization bill. 
This is an important matter of perception, similar to consumer 
confidence. It may be intangible, but it will profoundly affect 
the behavior of individuals, groups, and governments engaged in 
the fight against HIV/AIDS.
    I recently received a letter from the Ministers of Health 
of 12 African focus countries receiving PEPFAR assistance. They 
wrote: ``Without an early and clear signal of the continuity of 
PEPFAR support, we're concerned that partners might not move as 
quickly as possible to fulfill the resource gap that might be 
created. Therefore, services will not reach all those who need 
them. The momentum will be much greater in 2008 if we know what 
to expect after 2008.''
    Now, the committee has also received support for early 
authorization from AIDS Action, which believes that our global 
partners need to ``be assured that the U.S. commitment and 
leadership will continue and grow.''
    We have heard from the foundation and donors interested in 
Catholic activities, which argues that early reauthorization 
will, ``encourage implementing partners to expand the number of 
patients receiving antiretrovirals in 2008 to target levels, 
rather than holding back on new services for fear of the 
program's ending or being seriously curtailed. This means more 
lives will be saved.''
    I realize that a PEPFAR reauthorization bill will face a 
crowded Senate calendar, but maintaining the momentum of PEPFAR 
during 2008 is a matter of life and death for many. Part of the 
original motivations behind PEPFAR was to use American 
leadership to leverage other resources in the global community 
and the private sector. The continuity of our efforts to combat 
this disease and the impact of our resources on the commitments 
of the rest of the world will be maximized if we act now.
    In my judgment, Congress can reach an agreement 
expeditiously on this reauthorization. Most of the Leadership 
Act's provisions are sound and do not require alteration. The 
authorities in the original bill are expansive and they are 
enabling the program to succeed in diverse nations, each with 
its own unique set of cultural, economic, and public health 
circumstances.
    With this in mind, I introduced S. 1966 after consulting 
extensively with American officials who are implementing 
PEPFAR. My bill would increase to $30 billion the authorization 
for the years 2009 through 2013, a doubling of the initial U.S. 
commitment. It would also improve the transparency of the 
Global Fund, adjust the abstinence funding mechanism, and 
maintain the directive that 10 percent of funding be devoted to 
programs for orphans and vulnerable children.
    But my bill avoids sweeping revisions of the Leadership 
Act. Officials with experience in implementing the PEPFAR 
program have told me that preserving the existing provisions of 
the bill would provide the best chance at continued success. 
Adding new restrictions to the law could limit the flexibility 
of those charged with implementing in 2009 and beyond. We don't 
know what the challenges of 2013 will be, although we can say 
with confidence the landscape will be different than it is 
today.
    This is not to say that Senators may not have good ideas 
for improvement that should be adopted. But new provisions must 
not unduly limit the flexibility of the program and Congress 
should avoid descending into time-consuming quarrels over 
provisions that are unnecessary or that have little to do with 
the core missions of the bill.
    As Senators study the record of PEPFAR to date, I believe 
they will find that the vast majority of the authorities needed 
for the next phase of our effort already are in the existing 
legislation. The PEPFAR program is dealing successfully with 
special areas of concern, including strengthening health 
systems, addressing gender issues, improving nutrition, 
expanding educational opportunities, and funding pediatric 
care.
    Five years ago, HIV was a death sentence for most 
individuals in the developing world who contracted the disease. 
Now there is hope. We should never forget that behind each 
number is a person, a life the United States can touch or even 
save.
    At the time the Leadership Act was announced, only 50,000 
people in all of sub-Saharan Africa were receiving 
antiretroviral treatment. Through March of this year, the act 
has supported treatment for more than 1.1 million men, women, 
and children in 15 PEPFAR focus countries. U.S. bilateral 
programs have supported services for more than 6 million 
pregnancies. In more than 533,000 of these pregnancies, the 
women were found to be HIV positive and received antiretroviral 
drugs, preventing an estimated 101,000 infant infections 
through March 2007. We have supported care for more than 2 
million orphans and vulnerable children, as well as 2.5 million 
people living with HIV/AIDS through September 2006. The United 
States has supported 18.7 million HIV counseling and testing 
sessions for men, women, and children.
    PEPFAR, led by Ambassador Dybul, has listened to the 
Congress and many other stakeholders. As the Institute of 
Medicine has said, the Leadership Act is a learning 
organization. We should pass a bill now that allows PEPFAR to 
expand and evolve its program implementation using the 
experience of the past 3\1/2\ years.
    I've offered S. 1966 in the hope that other Senators will 
come forward with their proposals this year. We have had a lot 
of time to study the program since 2003. I'm certain Members of 
Congress will have considerable and constructive ideas, but 
it's important to move now. We will save more lives and prevent 
more infections if we reauthorize this remarkable program this 
year.
    I thank the Chair.
    The Chairman. Thank you very much.
    Mr. Ambassador, the floor is yours.

STATEMENT OF HON. MARK R. DYBUL, U.S. GLOBAL AIDS COORDINATOR, 
              DEPARTMENT OF STATE, WASHINGTON, DC

    Ambassador Dybul. Thank you, Mr. Chairman. Mr. Chairman, 
Senator Lugar, members of the committee and staff, let me begin 
by thanking you for your leadership and commitment on global 
AIDS, for your actions in 2003 to pass the Leadership Act to 
authorize the President's Emergency Plan for AIDS Relief, or 
PEPFAR, and for your actions today and leading to today's 
hearing on the reauthorization of this historic legislation and 
program.
    President Bush and a bipartisan, bicameral Congress have 
reflected the compassion and generosity of the American people. 
In rolling out the largest international public health 
initiative in history, we have acted quickly. We have obligated 
94 percent of the funds appropriated to PEPFAR so far and 
outlaid or expended 67 percent of them.
    But success is not measured in dollars spent. It's measured 
in services provided and lives saved, and PEPFAR is well on its 
way to achieving its ambitious prevention, treatment, and care 
targets. Senator Lugar has outlined many of those results and I 
need not go through them. They're in the written testimony.
    But I did want to point out it is important that we have 
all three: Prevention, treatment, and care. Within the past 
decade the pendulum of preferred interventions has swung from 
prevention to treatment and back to prevention. Using these 
pendulum swings to determine policy and programs can be 
dangerous.
    The President and a bipartisan Congress got it right the 
first time because a comprehensive program that includes all 
three reflects public health realities. Without treatment, 
people are not motivated to be tested to learn their HIV 
status. Without testing, we cannot identify HIV-positive 
persons and so we cannot teach them safe behavior and they 
cannot protect themselves and others. Without care and 
treatment programs, we do not have regular access to HIV-
positive persons to constantly reinforce safe behaviors. 
Without testing and treatment, we cannot medicalize the 
disease, which is essential to reducing stigma and 
discrimination. Without testing and treatment, we have no hope 
of identifying discordant couples and women have no possibility 
of getting their partners tested so they can protect 
themselves. And of course, without prevention we cannot keep up 
with the ever-growing pool of people who need care and 
treatment, as you pointed out, Mr. Chairman.
    Prevention is the bedrock of an effective global AIDS 
response and also the greatest challenge in this fight. 
Changing human behavior is very difficult, but in addition to 
earlier dramatic declines in HIV prevalence in Uganda there is 
growing evidence of similar trends in other African nations and 
the Caribbean. Our best hope for generalized epidemics, such as 
those in Africa, is what's called and was created by Africans 
as ABC--or Abstain, Be Faithful, and Correct and Consistent use 
of Condoms.
    But it should be pointed out that ABC is far more 
complicated than those letters indicate. We have to reach 
children through life skills programs and other programs at an 
early age to teach them to respect themselves and others, which 
can lead them to delay sexual debut, limit their number of 
partners, and change gender norms. These are generational and 
deep cultural changes that require time and persistence.
    For older adolescents and adults who are sexually active, 
ABC includes reducing casual and multiple concurrent 
partnerships, which can rapidly spread HIV infection. We must 
also identify discordant couples in which one partner is 
positive and the other is negative and focus effective 
prevention on them.
    We also need to teach correct and consistent condom use for 
those who are sexually active and ensure a supply of condoms. 
So far the American people have provided 1.67 billion condoms 
since the Emergency Plan began. As Peter Piot of UNAIDS has 
said, more than all others combined.
    While PEPFAR is aggressively pursuing prevention, it's also 
true that we need to improve what we are doing and, in fact, we 
need to improve every area of what we are doing. We need to 
take prevention to the next level. First, you must know your 
epidemic and tailor your prevention strategies accordingly. So, 
as the chairman pointed out, that is why we have different 
approaches depending on whether a country has a concentrated or 
a generalized epidemic.
    Next, just as we need combination therapy for treatment, we 
need combination prevention that blankets geographic areas with 
various prevention modalities so that all the youth, for 
example, hear the messages and can change their behavior 
accordingly.
    We also need to create effective approaches to older 
populations, including discordant couples, and have these 
programs in the same geographic concentration as the youth 
programs. We need to link clinical approaches, such as 
prevention of mother-to-child transmission and testing and 
counseling, to behavior change programs.
    And we must rapidly incorporate the latest scientific 
advances. Recent studies have shown that medical male 
circumcision can significantly reduce the risk of HIV infection 
for men as one part of a broad prevention arsenal, and PEPFAR 
has been the most aggressive of any international partner in 
pursuing this. We are also hoping for more scientific evidence 
on preexposure prophylaxis, microbicides, and vaccines.
    Addressing the distinctive needs of women and girls is 
critical to effective prevention, as you pointed out, Mr. 
Chairman. PEPFAR has been a leader in addressing gender issues 
and has incorporated gender actions in prevention, treatment, 
and care programs.
    While HIV/AIDS remains a global emergency, we are also 
focused on building capacity for a sustainable response. Some 
wonder whether putting money into HIV/AIDS in such large levels 
is having a negative impact on health systems. Well, 
fortunately the data to date suggest the opposite. A study in 
Rwanda showed that the addition of basic HIV care into primary 
health centers contributed to an increase in utilization of 
maternal and reproductive health services, prenatal, pediatric, 
and general health care. It found statistically significant 
increases in delivery of non-HIV services in 17 of 22 
indicators.
    In Botswana, infant mortality rose and life expectancy 
dropped by one-third because of HIV/AIDS. Now, because 
President Mogae has led an all-out battle against HIV/AIDS, 
infant mortality is declining and life expectancy is 
increasing.
    It's important to remember PEPFAR works in the general 
health sector. When we improve a laboratory to provide more 
reliable HIV testing or train a nurse in clinical diagnosis of 
opportunistic infections, that benefits everyone who comes into 
contact with that clinic or nurse. A recent study of PEPFAR-
supported treatment sites in four countries found that we 
supported a median of 92 percent--92 percent--of the 
investments in the health infrastructure to provide 
comprehensive treatment and care, and more in the public than 
in the nonpublic sector.
    As effective HIV programs are implemented, hospital 
admissions plummet, easing the burden on the health care staff 
throughout the system. In Rwanda, the average monthly number of 
new hospitalizations at seven sites that have been providing 
HIV treatment for more than 2 months dropped by 21 percent, 
increasing health care capacity by 21 percent.
    The Chairman. Excuse me. Over what period? Would you repeat 
that again?
    Ambassador Dybul. Two months.
    The Chairman. Two months.
    Ambassador Dybul. Just 2 months. And this is common because 
about 50 percent of hospitalizations in many places are because 
of HIV/AIDS. So if you treat HIV/AIDS the hospitalizations go 
down.
    As the chair of the Institute of Medicine panel put it, 
``Overall PEPFAR is contributing to make health systems 
stronger.'' PEPFAR is an important part of the President's and 
the Congress's expansive development agenda. Broadly speaking, 
PEPFAR is contributing to general development in several 
important ways, which I look forward to discussing with you.
    When President Bush called for reauthorization of the 
Leadership Act, he emphasized the need to better connect the 
dots of development, as you suggested, Mr. Chairman. The 
Leadership Act provides us with expansive authorities for such 
work and we are constantly trying to improve our efforts. But 
I'd like to note that our view of the appropriate limits of 
PEPFAR's role means that when we connect the dots of 
development we cannot become USAID, MCC, PMI, or any of its 
sister initiatives, but we are
part of a larger whole and contributing to the larger 
development agenda.
    We believe Congress got this right in the original 
legislation and that it's the right position going forward. I 
think this understanding is critical in the conversation about 
reauthorization. There is no question there is a lot to discuss 
and debate. Yet the Leadership Act already has the authorities 
we need and provides the right amount of flexibility to put 
them to use.
    The Institute of Medicine called PEPFAR ``a learning 
organization,'' as Senator Lugar noted, and we've used the 
flexibilities of the original legislation to learn and to 
constantly change our approach based on the lessons learned.
    Congress enacted a good law the first time and this is 
clear from the results. While some modifications are needed, 
rather than letting the perfect be the enemy of the good, we 
believe we can move expeditiously together.
    While I was in Haiti a few weeks ago, the Minister of 
Health expressed the same concern as every country I've been 
to: Will this continue? Can we scale up or should we see what 
happens? Countries are asking for rapid action and they are 
looking to be convinced of the need of being prudent in 
significantly expanding their programs in 2008 in order to save 
the maximum number of lives. Because of this reality, President 
Bush called for early bipartisan, bicameral action.
    Mr. Chairman, Senator Lugar, and members of the committee, 
through PEPFAR and our broader development agenda, the American 
people have engaged in one of the great humanitarian efforts in 
history. Our partnerships are founded in the profound sense of 
dignity and worth of every human life and in trust and mutual 
respect between peoples. The people of many countries have a 
new window into the hearts of Americans. They know what we 
stand for and that we stand with them.
    Beyond that, as President Bush has said, this effort is 
also good for our national character and who we are as a 
people. This noble and ennobling work has only begun and we 
look forward to working with you, your committee, the other 
committees, and a bipartisan Congress to move forward in this 
noble work.
    Thank you very much.
    [The prepared statement of Ambassador Dybul follows:]

     Prepared Statement of Ambassador Mark Dybul, U.S. Global AIDS 
            Coordinator, Department of State, Washington, DC

    Mr. Chairman, Senator Lugar, members of the committee and staff, 
let me begin by thanking you for your leadership and commitment on 
global HIV/AIDS, for your actions in 2003 to pass the authorizing 
legislation for the President's Emergency Plan for AIDS Relief 
(PEPFAR), and for your actions leading to today's hearing on 
reauthorization of this historic legislation and program.
    Just 5 years ago, many wondered whether prevention, treatment, and 
care could ever successfully be provided in resource-limited settings 
where HIV was a death sentence. Only 50,000 people living with HIV in 
all of sub-Saharan Africa were receiving antiretroviral treatment.
    President Bush and a bipartisan, bicameral Congress reflected the 
compassion and generosity of the American people as together you led 
our Nation to lead the world in restoring hope by combating this 
devastating pandemic. You recognized that HIV/AIDS was and is a global 
health emergency requiring emergency action. But to respond in an 
effective way, it has been necessary to build systems and sustainable 
programs as care is rapidly provided, creating the foundation for 
further expansion of care to those in need. The success of PEPFAR is 
firmly rooted in these partnerships, in the American people supporting 
the people of the countries in which we are privileged to serve--
including governments, nongovernmental organizations including faith- 
and community-based organizations and the private sector--to build 
their systems and to empower individuals, communities, and nations to 
tackle HIV/AIDS. And in just 3\1/2\ years, it is working.
                                results
    In rolling out the largest international public health initiative 
in history, we have acted quickly. We have obligated 94 percent of the 
funds appropriated to PEPFAR so far, and outlayed or expended 67 
percent of them. But success is not measured in dollars spent; it is 
measured in services provided and lives saved.
    PEPFAR is well on the way to achieving its ambitious 5-year targets 
of supporting treatment for 2 million people, prevention of 7 million 
new infections, and care for 10 million people infected and affected by 
HIV/AIDS, including orphans and vulnerable children.
    Through September 2006, PEPFAR-supported programs reached 61 
million people with prevention messages, and the U.S. Government has 
supplied 1.67 billion condoms through this August--as Dr. Piot of 
UNAIDS has said, more than all other developed countries combined. 
PEPFAR has supported antiretroviral prophylaxis during over half a 
million pregnancies, preventing an estimated 101,000 infant HIV 
infections. In fact, five of the focus countries have greater than 50 
percent coverage of pregnant women--the goal of the President's 
International Mother and Child Prevention Initiative (which preceded 
the Emergency Plan)--and Botswana has achieved a 4-percent national 
transmission rate, which approximates that of the United States and 
Europe. With Emergency Plan support, focus countries have scaled up 
their safe blood programs, and 13 of them can now meet two-thirds of 
their collective demand for safe blood--up from just 45 percent when 
PEPFAR started. PEPFAR has supported HIV testing and counseling for 
18.6 million people, and supported care for 2.4 million adults and 2 
million orphans and vulnerable children infected and affected by HIV. 
And through March 2007, PEPFAR supported antiretroviral treatment for 
over 1.1 million men, women, and children--more than 1 million in sub-
Saharan Africa.
    Country teams will submit their annual program results data to us 
shortly, and we expect that the data will demonstrate impressive 
continued progress.
               success requires a comprehensive strategy
    When the history of public health is written, the global HIV/AIDS 
action of the American people will be remembered for its size, but also 
for its scope: The insistence that prevention, treatment, and care--all 
three components, with goals for each--are all required to turn the 
tide against HIV/AIDS.
    Within the past decade, the pendulum of preferred interventions has 
swung from prevention to treatment and back to prevention. By the way, 
care always, and tragically, seems to get lost. Using these pendulum 
swings to determine policy and programs can be dangerous--and even 
deadly.
    The President and a bipartisan Congress got it right the first 
time, because a comprehensive program that includes prevention, 
treatment, and care reflects basic public health realities:

        Without treatment, people are not motivated to be tested and 
        learn their HIV status.

        Without testing, we cannot identify HIV-positive persons and so 
        we cannot teach them safe behavior, and they cannot protect 
        others.

        Without care and treatment programs, we do not have regular 
        access to HIV-positive persons to constantly reinforce safe 
        behaviors--a key component of prevention.

        Without testing and treatment, we cannot ``medicalize'' the 
        disease, which is essential to reducing stigma and 
        discrimination--which, in turn, is essential for effective 
        prevention and compassionate care for those infected and 
        affected by HIV.

        Without testing and treatment, we have no hope of identifying 
        discordant couples, and women have no possibility of getting 
        their partners tested so that they can protect themselves.

        And, of course, without prevention, we cannot keep up with the 
        ever-growing pool of people who need care and treatment.

    Currently, we're spending 46 percent of our programmatic funds on 
treatment. When you include counseling and testing as a prevention 
intervention, as most of our international partners do, we're spending 
29 percent of our funds on prevention. The rest is going to care.
    Will that be the right mix going forward? It's impossible to know, 
because there is no way to know what the HIV/AIDS landscape will look 
like in 3 to 7 years. This is why, as we've discussed reauthorization 
with many of you and your staff, we've supported an approach to 
reauthorization that doesn't include specific directives for the 
allocation among those three broad categories.
    Part of the reasoning behind this is that we are one piece--albeit 
a very large piece--of a complex puzzle of partners engaged in 
combating HIV/AIDS. The other pieces include: The contributions of the 
countries themselves, including remarkable efforts by people living 
with HIV--families, communities, and national leaders--and which can 
include substantial financial contributions in countries such as South 
Africa, Botswana, Namibia and others; the Global Fund to Fight AIDS, 
Tuberculosis and Malaria--for which the American people provide 30 
percent of its budget and which is an important piece of our overall 
global strategy--and other multilateral organizations; other nations' 
bilateral programs; private foundations; and many others. We constantly 
adapt the shape of our bilateral programming piece to fill its place in 
this puzzle, so flexibility is needed.
                  prevention is the bedrock of pepfar
    That being said, prevention is the bedrock of an effective global 
response to HIV/AIDS. In PEPFAR's Five-Year Strategy, in each annual 
report, in nearly every public document or statement, including those 
before Congress, we have been clear that we cannot treat our way out of 
this pandemic, and that prevention is the most important piece for 
success.
    Prevention is also the greatest challenge in the fight against HIV/
AIDS. Globally, and certainly in the hardest-hit countries, which are 
in Africa, the vast majority of HIV is transmitted through sexual 
contact. Changing human behavior is very difficult--far more difficult 
than determining the right prescription of antiretroviral drugs, 
building a health system or creating a better life for orphans and 
vulnerable children.
    Not only is effective behavior change and, therefore, prevention, 
more difficult than care and treatment, measuring success is also far 
more complicated. While it is possible to rapidly and regularly report 
on numbers of people receiving care and treatment, prevention is 
evaluated every few years, with metrics and mathematical methods that 
are constantly being refined. We must currently rely on estimating 
prevalence--or the percent of HIV positive persons in a population--
rather than evaluating directly the rate of new infections, which would 
be a far better indicator of success of interventions. In addition, as 
treatment programs are scaled up, fewer people die and prevalence may 
actually go up despite successful prevention efforts. Therefore, we 
cannot provide updates on success in prevention in the same way we do 
for care and treatment
    But that does not mean that prevention has failed--as some seem to 
want to say. In addition to earlier dramatic declines in HIV prevalence 
in Uganda, there is growing evidence of similar trends in other African 
nations, including Botswana, Ethiopia, Kenya, Tanzania, Zambia, and 
Zimbabwe. There is also evidence for stabilization or declines in the 
Caribbean, including Haiti.
    I do not mean to minimize the seriousness of disturbing increases 
that we're seeing in certain places, nor the fact that there is an 
urgent need for greater progress in every country and region. But I 
highlight these successes because the data make something very clear. 
Our best hope for generalized epidemics--the most common type of 
epidemic in Africa, which is home to more than 60 percent of the global 
epidemic and where our efforts are highly concentrated--is ABC behavior 
change: Abstain, Be faithful, and correct and consistent use of 
Condoms. Of course, bringing about these behaviors, as Uganda did 
during the 1990s, is a far more complex task than the simple letters 
suggest, because the roots of human behavior are so complex.
    ABC requires significant cultural changes. We have to reach 
children at an early age if they are to delay sexual debut and limit 
their number of partners. We must partner with children's parents and 
caregivers, supporting their efforts to teach children to respect 
themselves and each other--the only way to truly change unhealthy 
gender dynamics. We are rapidly expanding life skills programs for kids 
because of the generational impact they can have--changing a 10-year-
old's behavior is far easier than changing a 25-year-old's. Behavior 
changes due to programs for children may not immediately be apparent, 
because you're working to change their future behavior rather than 
their immediate behavior. Yet we must be patient and persistent--we are 
only 3\1/2\ years into PEPFAR's generational approach to prevention.
    For older adolescents and adults who are sexually active, ABC 
includes reducing casual and multiple concurrent partnerships, which 
can rapidly spread HIV infection through broad networks of people. We 
must also identify discordant couples, in which one partner is HIV-
positive and the other is HIV-negative--especially in countries like 
Uganda where they represent a significant contribution to the 
epidemic--and focus prevention efforts on them.
    We also need to teach correct and consistent condom use for those 
who are sexually active, and ensure a supply of condoms--and we are 
doing just that.
    ABC also includes changing gender norms. As young people are taught 
to respect themselves and respect others, they learn about gender 
equality. Through teaching delayed sexual debut, secondary abstinence, 
fidelity to a single partner, partner reduction and correct and 
consistent condom use to boys and men, ABC contributes to changing 
unhealthy cultural gender norms.
    And, of course, we need to reduce stigma against people with HIV--
and also reduce stigma against those who choose healthy lifestyles. On 
the other hand, we must identify and stigmatize transgenerational sex 
and the phenomenon of older men preying on young girls, and we must 
also prevent sexual violence. Again, life skills education--a part of 
ABC--is key.
                  taking prevention to the next level
    While PEPFAR is aggressively pursuing prevention as the bedrock of 
our efforts, it is also true that we need to improve what we are 
doing--in every area of our work. We need to take prevention to the 
next level. I'd like to share with you some of our lessons learned in 
prevention and give a glimpse of some new directions.
Know your epidemic
    First, you must know your epidemic and tailor your prevention 
strategy accordingly. While ABC behavior change must undeniably be at 
the core of prevention programs, we also recognize that one size does 
not fit all.
    This is why we take different approaches--depending on whether a 
country has a generalized and/or a concentrated epidemic. It's 
surprising how little this is understood. The existing congressional 
directive that 33 percent of prevention funding be spent on abstinence 
and faithfulness programs is applied across the focus countries 
collectively, not on a country-by-country basis--and certainly not to 
countries with concentrated epidemics.
    Even speaking of the epidemic at a country level can be misleading, 
in fact, because a country can have both a concentrated epidemic and a 
generalized one. Even in generalized epidemics, we must identify 
vulnerable groups with especially high prevalence rates, such as people 
engaged in prostitution, and tailor prevention approaches to reach 
them. On recent trips, I've seen great examples of this sort of program 
in Haiti, Cote d'Ivoire, and Ghana.
    Moreover, epidemics can shift over time. In Uganda, for example, 
ABC behavior change had such a significant impact that we now see the 
highest infection risk in discordant couples.
Combination prevention
    While much progress has been made in effective prevention, often we 
are still using prevention techniques developed 20 years ago. It is 
important for prevention activities to enter the 21st century, to use 
techniques and modalities that have been developed to change human 
behavior, especially those developed in the private sector for 
commercial marketing.
    We also need a focused and concentrated effort that mirrors 
progress in treatment. As we need combination therapy for treatment, we 
need combination prevention. Combination prevention includes using many 
different modalities to affect behavior change, but it also includes 
geographic concentration of those different modalities and adding 
existing and new clinical interventions as they become available. 
PEPFAR is supporting many extraordinary prevention programs, but they 
are not always concentrated in the same geographic area. We need to 
make sure that, wherever people are, we are there to meet them at every 
turn with appropriate knowledge and skills. For example, many youth 
listen to faith leaders, while others don't. Many youth hear prevention 
messages in church or in school, but then hang out with their friends 
and hear conflicting messages. Many have no access to either school or 
church. We need to make sure that we blanket geographic areas with 
varied prevention modalities, so that all the youth hear the messages 
and can change their behavior accordingly.
    We also need to create effective approaches to older populations, 
including discordant couples, and have them in the same geographic 
concentration as the youth programs. Effectively reaching these 
populations demands work that is outside the traditional realm of 
public health, such as gender, education, and income-generation 
programs, for example.
    We have made great strides to provide both linkages and direct 
interventions in these areas under the expansive existing authorities 
of the Leadership Act. But we also need to evaluate these combination 
programs with real science to know how best to do them. Some things 
might be good for general development, but if they don't prevent 
infections in a significant way, they are the purview of USAID and 
Millennium Challenge Corporation (MCC) development programs, not those 
of PEPFAR.
    As part of the effort to implement innovative prevention programs, 
while evaluating their impact, we are developing several exciting and 
future-leaning public-
private partnerships for combination prevention. Part of this effort 
includes ``modularizing'' successful prevention programs so that the 
components found to be most effective and easy to transfer to other 
geographic areas can be rapidly scaled up.
Integrating scientific advances
    Part of combination prevention is to rapidly incorporate the latest 
scientific, clinical advances to expand the effectiveness of behavior 
change programs. As you know, recent studies have shown that medical 
male circumcision can significantly reduce the risk of HIV transmission 
for men. PEPFAR, working closely with the Gates Foundation, has been 
the most aggressive of any international partner in pursuing 
implementation. We have to be clear that this is not a silver bullet, 
but rather one part of a broad prevention arsenal that must and will be 
used. We also need to ensure that programs demonstrate cultural 
sensitivity and incorporate ABC behavior change education.
    We need to manage rollout carefully, beginning in areas of high HIV 
prevalence and with those at greatest risk of becoming infected. For 
example, male circumcision could be very important in discordant 
couples in which the woman is HIV-positive.
    As for other promising biomedical prevention approaches, we are 
also hoping for more scientific evidence on the effectiveness of 
preexposure prophylaxis to prevent infection, which could be another 
valuable tool for most-at-risk populations. Microbicides and vaccines 
still appear to be a long way off. Yet thanks to our wide network of 
care and treatment sites, we will be able to implement these methods 
rapidly whenever they become available--demonstrating again the value 
of integrated programs.
    Along with these prevention interventions, we are also 
incorporating the latest scientific advances in evaluation. We hope to 
have markers for incidence--new infections--available in the field 
soon; they have been validated, and we are now awaiting calibration. 
These will make evaluation of prevention programs and our overall 
impact much easier, leading to program improvement and perhaps 
cushioning against pendulum swings.
                      confronting gender realities
    Addressing the distinctive needs of women and girls is critical to 
effective prevention, as well as to treatment and care. Taken as a 
whole, the Leadership Act specifies five high-priority gender 
strategies: Increasing gender equity in HIV/AIDS activities and 
services; reducing violence and coercion; addressing male norms and 
behaviors; increasing women's legal protection; and increasing women's 
access to income and productive resources.
    PEPFAR has been a leader in addressing gender issues and has 
incorporated gender across its prevention, treatment, and care 
programs. The Emergency Plan was the first international HIV/AIDS 
program to disaggregate results data by sex. Sex-disaggregated data is 
critical to understanding the extent to which women and men are reached 
by life-saving interventions, and helps implementers to better 
understand whether programs are achieving gender equity. For example, 
an estimated 61 percent of those receiving antiretroviral treatment 
through downstream U.S. Government support in fiscal year 2006 were 
women. Girls represent 51 percent of OVCs who receive care. Women 
represent 70 percent of all people who receive PEPFAR-supported 
counseling and testing services. In fiscal year 2006, across four key 
program areas, approximately 45 percent of the total prevention, 
treatment, and care budget was directed toward reaching women and 
girls.
    The Emergency Plan also annually monitors its progress on the five 
priority strategies specified in the Leadership Act. In fiscal year 
2006, a total of $442 million supported more than 830 interventions 
that included one or more of these gender strategies.
                        building health systems
    While HIV/AIDS remains a global emergency, which we are responding 
to as such, we are also focused on building capacity for a sustainable 
response. As President Bush has said, the people of host nations are 
the leaders in this fight, and our role is to support them. Eighty-five 
percent of our partners are local organizations.
    An important part of that effort is the construction and 
strengthening of health systems. Like the pendulum swing between 
prevention and treatment, discussions here sometimes reflect 
misconceptions and unsubstantiated opinions on the effect of HIV/AIDS 
programs on the capacity of health systems. Some wonder whether by 
putting money into HIV/AIDS, we're having a negative impact on other 
areas of health systems.
    Yet all the data suggest just the opposite. A peer-reviewed paper 
from Haiti showed that HIV resources are building health systems, not 
siphoning resources from them. A study in Rwanda showed that the 
addition of basic HIV care into primary health centers contributed to 
an increase in utilization of maternal and reproductive health, 
prenatal, pediatric and general health care. It found statistically 
significant increases in delivery of non-HIV services in 17 out of 22 
indicators. Effects included a 24-percent increase in outpatient 
consultations, and a rise in syphilis screenings of pregnant women from 
one test in the 6 months prior to the introduction of HIV care to 79 
tests after HIV services began. Large jumps were also seen in 
utilization of non-HIV-related lab testing, antenatal care, and family 
planning. In Botswana, infant mortality rose and life expectancy 
dropped by one-third because of HIV/AIDS despite significant increases 
in resources for child and basic health by the Government of Botswana. 
Now, because President Mogae has led an all-out battle against HIV/
AIDS, infant mortality is declining and life expectancy is increasing.
    The reasons for these improvements make sense. For one thing, 
PEPFAR works within the general health sector. When we improve a 
laboratory to provide more reliable HIV testing or train a nurse in 
clinical diagnosis of opportunistic infections of AIDS patients, that 
doesn't just benefit people with HIV--it benefits everyone else who 
comes in contact with that clinic or nurse, too.
    A recent study of PEPFAR-supported treatment sites in four 
countries found that PEPFAR supported a median of 92 percent of the 
investments in health infrastructure to provide comprehensive HIV 
treatment and associated care, including building construction and 
renovation, lab and other equipment, and training--and the support was 
higher in the public sector than the nongovernmental sector. In fact, 
many of our NGO partners are working in the public sector. In Namibia, 
the salaries of nearly all clinical staff doing treatment work and 
nearly all of those doing counseling and testing in the public sector 
are supported by PEPFAR. In Ethiopia, PEPFAR supports the government's 
program to train 30,000 health extension workers in order to place two 
of these community health workers in every rural village; 16,000 have 
already been trained. So it is clear where those broader improvements 
are coming from. We estimate that nearly $640 million dollars of fiscal 
year 2007 funding were directed toward systems-strengthening 
activities, including preservice and in-service training of health 
workers.
    Another key fact is that in the hardest-hit countries, an estimated 
50 percent of hospital admissions are due to HIV/AIDS. As effective HIV 
programs are implemented, hospital admissions plummet, easing the 
burden on health care staff throughout the system. In the Rwanda study 
I just mentioned, the average number of new hospitalizations at 7 sites 
that had been offering antiretroviral treatment for more than 2 months 
dropped by 21 percent.
    As the Chair of the Institute of Medicine panel that reviewed 
PEPFAR's implementation put it, ``[O]verall, PEPFAR is contributing to 
make health systems stronger, not weakening them.''
    We know that building health systems and workforce is fundamental 
to our work, and PEPFAR will remain focused on it. We are working to 
improve our interagency coordination on construction, and we recently 
tripled the amount of resources available for preservice training of 
health workers. We've already trained or retrained 1.7 million health 
care workers, and we need to continue to expand that number in order to 
keep scaling up our programs.
                 ``connecting the dots'' of development
    At this point, I want to step back and offer a look at a larger 
picture: The role of PEPFAR in ``connecting the dots'' of development. 
PEPFAR is an important part of the President's expansive development 
agenda, with strong bipartisan support from Congress. Together, we have 
doubled support for development, quadrupled resources for Africa, 
supported innovative programs like the MCC, President's Malaria 
Initiative (PMI), Women's Empowerment and Justice Initiative (WEJI) and 
African Education Initiative (AEI), as well as more than doubling trade 
with Africa and providing 100 percent debt relief to the poorest 
countries.
    In Haiti, for example, the Emergency Plan works with partner 
organizations to meet the food and nutrition needs of orphans and 
vulnerable children (OVCs) using a community-based approach. The kids 
participate in a school nutrition program using USAID Title II 
resources. This program is also committed to developing sustainable 
sources of food, and so the staff has aggressively supported community 
gardens primarily for OVC consumption, and also to generate revenue 
through the marketing of vegetables.
    In education, we have developed a strong partnership with the 
President's African Education Initiative, implemented through USAID. In 
Zambia, PEPFAR and AEI fund a scholarship program that helps to keep in 
school nearly 4,000 orphans in grades 10 to 12 who have lost one or 
both parents to AIDS or who are HIV-positive, in addition to pre-school 
programs and support for orphans in primary school. Similar 
partnerships exist in Uganda, where PEPFAR and AEI are working together 
to strengthen life-skills and prevention curricula in schools. This 
program, with $2 million in funding in FY 2007, targeted 4 million 
children and 5,000 teachers.
    We are also working with the President's Malaria Initiative and the 
Millennium Challenge Corporation to coordinate our activities in 
countries where there are common programs. In Zambia, by using PEPFAR's 
distribution infrastructure, known as RAPIDS, PMI will deliver more 
than 500,000 bed nets before this malaria season at a 75-percent 
savings--and the U.S. Government saved half the remaining cost of nets 
through a public-private partnership led by the Global Business 
Coalition on HIV/AIDS, Tuberculosis and Malaria. In Lesotho, PEPFAR is 
colocating our staff with that of MCC to ensure that we are jointly 
supporting the expansion of health and HIV/AIDS services.
    Broadly speaking, PEPFAR is contributing to general development in 
the following ways: (1) Leveraging an infrastructure developed for HIV/
AIDS for general health and development, as demonstrated by the data 
from Rwanda, the Zambia malaria initiative and other examples; (2) 
supporting aspects of general development activities with a direct and 
significant impact on HIV/AIDS, as demonstrated by OVC education 
programs, and in aspects of general prevention such as gender equality 
and income generation if scientific evaluations show that they impact 
significantly on HIV/AIDS; and (3) providing a piece of a larger 
approach, for example by supporting the HIV/AIDS component of 
Ethiopia's community health worker project.
    When President Bush called for reauthorization of the Leadership 
Act, he emphasized the need to better connect the dots of development. 
The Leadership Act provides us with expansive authorities for such 
work, and we are constantly trying to improve our efforts.
    But let me candidly make clear our view of the appropriate limits 
of PEPFAR's role. While we want to connect dots, PEPFAR cannot and 
should not become USAID, MCC, PMI, or any of its sister initiatives or 
agencies. Nearly every person affected by HIV/AIDS could certainly 
benefit from additional food support, greater access to education, 
economic opportunities and clean water, but so could the broader 
communities in which they live. We must integrate with other 
development programs, but we cannot, and should not, become them. 
PEPFAR is part of a larger whole. Congress got this right in the 
original legislation, and that is the right position going forward.
                   improving indicators and reporting
    As we improve the linkages between our programs and other related 
areas of development, we also need to do a better job of measuring the 
impact and outcomes of our programs. We need to know not just the 
number of people that we support on treatment, but also what impact 
that is having on morbidity and mortality. We need to know not only how 
many infections we're averting, but also how we're doing at changing 
societal norms such as the age at sexual debut, the number of multiple 
concurrent partnerships, or the status of women. To do this, we have 
instructed our technical working groups to develop a new series of 
impact indicators, in consultation with implementers and other 
interested groups. These new indicators should be completed by early 
next year, and we will then incorporate them into our planning and 
reporting systems.
    Of course, not all of the new indicators will be reported up to 
headquarters--we don't need all that information, and we don't want to 
burden our staff in the field with more reporting requirements. But we 
believe they will be useful to the country teams as they plan and 
evaluate their own programs, giving them a better idea of the impact 
they're having and where improvements can be made.
    We believe that kind of information can improve the overall quality 
of programs and potentially reduce the demands on one of our most 
valuable assets--our U.S. Government staff in the field, both American 
citizens and Locally Employed Staff. Our Staffing for Results 
initiative also seeks to ensure that we have the right people in the 
right place in each country so that we can avoid unnecessary 
duplication of work and make the best use of our extraordinary human 
resources.
                       reauthorization of pepfar
    I think the understanding that PEPFAR is essentially in the 
position it needs to be in going forward is critical in the 
conversation about reauthorization. We could spend a lot of time 
debating new authorities and new earmarks on everything from the amount 
of money we spend on operations research to the number of community 
health workers we train. Yet the bottom line is that the Leadership Act 
already has the authorities we need, and provides the right amount of 
flexibility to put them into use. None of the issues being discussed 
truly require significant changes in the law. The Institute of Medicine 
called PEPFAR a learning organization. We have used the flexibilities 
of the original legislation to learn, and to constantly change our 
approach based on the lessons learned.
    Congress enacted a good law the first time. It's not perfect, but 
it's very good--that is clear from its results. While there are some 
modifications that are needed, rather than letting the perfect be the 
enemy of the good, it should be possible to take the time that is 
needed to develop a thoughtful, solid, bipartisan bill. And the 
President has made clear the administration's desire to do just that. 
It is in no one's interest to be hasty--global HIV/AIDS is too 
important. But with a solid foundation in the first good law, it is 
possible to move expeditiously.
    And thoughtful but rapid action is important. In Haiti, a few weeks 
ago the Minister of Health expressed the same concern as every other 
country I have been to--``Will this continue? Can we scale up now or 
should we wait to see what happens?'' A recent letter from the Health 
Ministers of our focus countries conveyed this same urgency. While 
U.S.-based or local organizations experienced in the workings of the 
U.S. Government might have less concern, the policymakers who set 
standards and must decide the level of scale-up to allow in their 
countries are asking for rapid action. They need to be convinced that 
it is prudent to attempt the significant expansion in prevention, and 
especially care and treatment services, that is needed in 2008, to 
achieve our original goals and to save the maximum number of lives.
    Because of this reality, President Bush has called for early, 
bipartisan, bicameral action. He has announced the administration's 
commitment to double the initial commitment to $30 billion, along with 
setting new goals--increasing prevention from 7 to 12 million, 
treatment from 2 to 2.5 million and care from 10 to 12 million, 
including--for the first time--an OVC goal of 5 million. These goals 
reflect the need for increased focus on prevention within our 
comprehensive program--that's why our prevention goal would nearly 
double while care and treatment would see smaller increases. President 
Bush challenged the G-8 leaders to respond to the U.S. commitment, and 
in June the G-8 committed $60 billion to support HIV/AIDS, 
tuberculosis, and malaria programs over the next few years. For the 
first time, the other leaders also agreed to join us in supporting 
country-owned, national programs to meet specific, numerical goals. 
President Bush has also called for enhanced effort on connecting the 
dots of development and strengthening partnerships for greater efficacy 
and increased sustainability.
                       a noble and ennobling work
    Mr. Chairman, Senator Lugar, and members of the committee, through 
PEPFAR and our broader development agenda, the American people have 
engaged in one of the great humanitarian efforts in history. The 
foundation of that success has been true partnership, and the rejection 
of the donor/recipient mentality.
    Our partnerships are founded in the profound sense of dignity and 
worth of every human life, and in trust and mutual respect between 
peoples. These partnerships are giving individuals, communities, and 
nations great hope, and are transforming individuals, communities, 
nations, and--in the case of Africa--much of a subcontinent.
    The people of those countries have a new window into the hearts of 
Americans; they know what we stand for and that we stand with them. 
This was made clear by Presidents Mogae of Botswana and President 
Kikwete of Tanzania in their powerful statements last month.
    Beyond that, as President Bush has said, this effort is also good 
for our national character and who we are as a people. This noble and 
ennobling work has only begun. Working together to unlock the power of 
partnerships, we can and will achieve much more for others, and for 
ourselves.

    The Chairman. Thank you, Mr. Ambassador. You can assure, I 
believe, with certainty any health official in any nation that 
is benefiting from this program that it will be continued.
    Let me ask. The President's goal--target--for the next 5 
years would add 500,000 people to the original target of 
putting 2 million people on treatment by 2008. Would additional 
funding help us achieve more?
    Ambassador Dybul. I think for prevention, treatment, and 
care, resources are an important piece of the puzzle, as is 
building health capacity. I think we're all aware that as the 
President called for $30 billion for PEPFAR, the G-8 has 
committed $60 billion, but they included TB and malaria. So for 
the next 5 years, with that $30 billion we would actually be 
more than the rest of the developed world combined.
    So we think for going forward, for issues of 
sustainability, an expansion of care and treatment is 
necessary. But the goals actually for the second 5 years, as 
President has called for, are actually a little bit heavier on 
prevention. It actually calls for about a doubling of the 
prevention goal, as you pointed out, prevention being the most 
important piece, while we increase care and treatment 20 to 25 
percent.
    So I believe the answer to your question is the additional 
resources could increase, but they don't necessarily have to 
come from the American people, which is why we're turning to 
the world community as well, and we believe that about--if 
we're going to be more than half of the rest of the world, that 
puts us in about the right situation going forward.
    The Chairman. Obviously one of the controversial pieces of 
the original legislation was the abstinence piece, and it's 
still debated somewhat heavily. You pointed out that you have 
observed and tried to accommodate the cultural differences from 
country to country in how best to attack this pandemic, this 
epidemic, in their countries. In some parts of the world, there 
are some devastating statistics relative to consensual sex 
versus nonconsensual sex. Between 20 and 50 percent of women in 
the countries under consideration or that are involved indicate 
that their first sexual experience was forced. Nearly 50 
percent of all sexual assaults in these countries are committed 
against girls 15 years or younger.
    Obviously, violence puts women and girls at a higher risk 
of HIV. One study that you describe in your 2006 report to 
Congress found that in Tanzania young HIV positive women were 
10 times more likely to report violence than HIV negative 
women.
    Now, obviously we're not going to reach our goals around 
prevention, care, and treatment if--I shouldn't say 
``obviously.'' It's my view that we will not meet them if we 
don't address this: How gender-based violence is impacting on 
it.
    The President's Emergency Plan is making real strides 
forward, but you've stated obviously we have to do more. How 
much money do our programs now spend to prevent or help people 
recover from gender-based violence? Is it a focus at all?
    Ambassador Dybul. As a matter of fact--Senator--Mr. 
Chairman, it is a focus. We actually are focused on gender 
inequality in general, not just gender-based violence, because 
the gender-based violence really is a part of a culture of 
gender inequality that promotes gender violence. It also 
promotes transgenerational sex, where older men have sex with 
younger women, where younger boys prey on younger girls. So 
it's a whole deep cultural issue.
    So we're trying to address the broader issue and gender-
based violence is a piece of a multipronged approach to address 
these issues. I agree we can do more and I must admit it's 
going to be very difficult for an AIDS initiative to radically 
change all the cultural aspects, but we're trying to do our 
piece here. We dedicated around $442 million last year for 
programs that had a gender component to them.
    I think the fundamental thing, though, is changing gender 
norms. So that's why we begin with these life skills programs 
at an early age to try to change the whole dynamic, to teach 
children to respect themselves, to respect others, which 
includes respecting girls. It's a generational approach that's 
going to take time.
    At the same time we're engaged in gender-based violence, we 
work with the Women's Justice and Empowerment Initiative to 
deal with some of these issues, provide post-exposure 
prophylaxis, provide counseling and testing around gender-based 
violence. It's a very complicated approach.
    I think you're correct, in such a situation, whether it's 
violence or other gender inequality, negotiating abstinence is 
very difficult, but it's as difficult to negotiate a condom. So 
it's actually important that we address the gender norm 
overall. And it's going to take time, but we're seeing great 
success.
    I'll give you an anecdote which I think reflects it. I went 
to a high school in Botswana where we had begun these life 
skills programs to change the dynamic, to teach people to 
respect each other. This program had been going on for a little 
over a year. Now we're expanding it throughout the country, as 
we're doing in many other countries. We asked--we got a small 
group of them after and began asking some questions. The girls 
answered all of the questions and the girls talked about how 
they wanted to become doctors and engineers. That's not normal 
in an African situation. Normally the boys would dominate, the 
girls would be quiet. That's the type of thing we're trying to 
foster and change, which we then think will influence gender-
based violence.
    But also we need direct programs on gender-based violence. 
Again, I think we can improve everything we're doing. It's 
definitely a focus for us and we're doing some innovative 
programs and evaluating them to see what the greatest outcome 
is, including job creation and some other things to see if we 
can change this whole dynamic.
    But we've got to work with USAID, we've got to work with 
the Millennium Challenge Corporation, we've got to work with 
the countries themselves. That's one of the reasons going 
forward we talked about these partnership compacts, where we 
would actually work with countries to help them deal with 
gender inequality, because we agree with you, we can't tackle 
this problem if we don't deal better--
    The Chairman. The reason--I'm impressed by your answer. 
This first round is 7 minutes and my time is almost up. But let 
me just ask this question. Obviously, what I'm about to ask is 
not something that would be funded through PEPFAR. But if you 
know--if you don't know for sure, you can take an educated 
guess--what percentage of the countries that are recipients of 
this assistance have universal elementary school education that 
includes women?
    Ambassador Dybul. I'd actually have to doublecheck. Most of 
them do actually have universally available primary education. 
The problem is when they do that they have school fees or 
uniform fees, which limits the ability of kids to go. And then 
there's not much secondary schooling, so they end at primary 
school.
     We're actually developing through our orphans program with 
the African Education Initiative scholarship programs to get 
kids through secondary school. I have to get you a specific 
answer, but many of them do, but on paper might be different 
than the actual implementation.
    The Chairman. Generically, do you think that if, assuming 
we had unlimited, which we don't, unlimited money to deal with 
foreign aid, if we were to direct more of our economic aid to 
the countries in question toward building and sustaining and 
funding their elementary and secondary education systems that 
required the same treatment for young boys as young girls in 
that system, is that likely to have any positive impact on what 
we're talking about here?
    Ambassador Dybul. It's something we intend to look at. I 
don't know. You could say that it would and it very well might, 
but we're not 100 percent certain. So we want to evaluate 
that--implement programs and then evaluate it.
    I should point out that there are other players in this 
field. The United Kingdom has--
    The Chairman. Oh, I realize that. I just wondered what our 
thinking was.
    Ambassador Dybul. Right. So we want to work with all of 
these different players to basically put the pieces of the 
puzzle together and see how we can have the greatest impact.
    The Chairman. What I'm about to say--and I'm 30 seconds 
over my time already. I don't want you to respond now. What I'm 
about to suggest is not something that I would attempt to 
attach to this legislation. But I have a bill that's an 
International Violence Against Women Act, money promoting, like 
we did here domestically in the Violence Against Women Act, 
money made available to countries who would engage in certain 
activities that would, in fact, promote efforts to diminish 
violence against women in various societies.
    I'd like to, because you seem to be--and it's not in your 
wheelhouse, it's not in your secretariat. But I would like to 
maybe ask you just as a favor to give me your sense of how you 
think that--and I will send it to you--that legislation might, 
if at all, and it may not, have a positive impact on these 
larger problems, because there is a whole lot of things that 
flow from the treatment of women essentially as second class 
citizens, property, and the like.
    I have many more questions, but I thank you and I yield to 
the Senator from Indiana, Mr. Chairman.
    Senator Lugar. Thank you very much, Mr. Chairman.
    I have three questions I wanted to ask so we have as 
complete a record as possible. The first question, as I 
mentioned in my opening statement, in late August the committee 
received a letter signed by the Ministers of Health from the 12 
African PEPFAR countries asking us not to wait until next year 
to reauthorize the legislation. The letter states: ``Without an 
early and clear signal of the continuity of PEPFAR's support, 
we are concerned that partners might not move as quickly as 
possible to fill the resource gap that might be created. 
Therefore, services will not reach all those who need them, The 
momentum will be much greater in 2008 if we know what to expect 
after 2008.''
    Based on this statement, it seems to me that to delay the 
reauthorization will result in fewer people being placed on ARV 
treatment. My question to you, Ambassador: Is that correct? 
Does that mean that early reauthorization will help save more 
lives? And further, how would early reauthorization help 
leverage more funding from other donors and thus save 
additional lives?
    Ambassador Dybul. Well, Senator, I think the best way to 
answer is that just to relay the discussions I've had with 
Ministers of Health. And I think there is a big difference 
between ministers and people in-country and some of our 
partners who are very used to Washington and our U.S.-based 
partners, who understand how our system works and really don't 
see a problem in terms of the longer process.
    But in-country, the ministers and the people who are 
implementing on the ground--and 83 percent of our partners now 
are local organizations--do have some concerns here. And, Mr. 
Chairman, I must assure you that we do tell them all the time: 
Don't worry, this is coming, bipartisan support, it doesn't 
matter who the next President is, Congress has been there all 
the way.
    But it's not something that they live and breathe in terms 
of the process. So there is a real issue for them of comfort 
level, because in 2008, as much as we've done, we have a 
massive scale-up to achieve those goals. And as they're looking 
at them and saying, once I put that person in treatment, once I 
put that orphan in care, they've got to stay there, there is a 
concern, there is a discomfort with that type of scale-up in 
the absence of a sure commitment, as much as we can tell them, 
don't worry, it's coming.
    So as I speak with ministers--and every time I'm in the 
country a minister says this--I think there is this concern 
there.
    Senator Lugar. The second question is, you've mentioned in 
your testimony that the need to know your epidemic is crucial 
as each country addresses its own unique HIV/AIDS situation. 
The fact that no country's epidemic is the same as their 
neighbor's is one reason that I believe we need to keep the 
reauthorization as flexible as possible and limit the mandatory 
spending directives. We've tried to reflect this in S. 1966. 
Can you give us examples of how some of the PEPFAR countries' 
epidemics differ from one another and how greater flexibility 
would allow them to address their needs more effectively?
    Ambassador Dybul. Yes. And I think actually, Senator, the 
language you've proposed makes a lot of sense, because it 
directs programs targeting behavior change at sexual 
transmission, not the overall picture, to allow that 
flexibility to expand programs such as mother and child, 
nonbehavior change programs, so that that's taken out of the 
calculation.
    And different countries do have very different epidemics, 
which is why we've never applied the directive to each 
individual country, but to countries overall, so that we have a 
very different approach in Botswana than in Vietnam, as the 
chairman pointed out. So we believe the language that you put 
forward provides us the flexibility both to ensure that we have 
programs that will lead to long-term changes in prevention, but 
also to allow us the flexibility to have programs that are 
different in each country, with greater flexibility, and, 
importantly, to not apply behavior change directives to 
clinical and other aspects of prevention.
    Senator Lugar. The third question, on the issue of 
resources. Fiscal year 2008 money will hopefully be available 
to these countries soon. Are any of the recipients expressing 
reluctance to use the increased funding to ramp up their 
programs in light of the uncertainty of future funding pending 
a reauthorization?
    Ambassador Dybul. As I mentioned in the first answer, I do 
hear that from Ministers of Health when I travel around, that 
they're a little concerned about the massive increase in 
resources thanks to the current budgets that Congress has 
before them and the President's request and because of that 
significant increase in new people in treatment and care that's 
needed in 2008. I do hear the concern about putting that many 
more people on without knowing for sure what to expect after, 
even understanding that there will be a reauthorization.
    So I think what you said about consumer confidence gets it 
about right. It really is about perception. It's not a matter 
of fact. It's not a matter of reality. It's more a matter of 
perception that makes them uneasy, and as that uneasiness can 
cause problems in the financial markets, that uneasiness can 
lead to people not moving as quickly as they otherwise might to 
increase people, particularly in care and treatment, because 
that's something that they need to continue, which, therefore, 
might limit our ability to save the largest number of lives.
    Senator Lugar. The President has requested that our funding 
for HIV/AIDS be increased from $15 billion to $30 billion over 
the next 5 years. Some want a little less. Many want much more 
funding. What percentage of funding do you currently provide to 
focus countries versus nonfocus countries, and with additional 
funding do you anticipate increasing the number of focus 
countries or increasing assistance to nonfocus countries? Which 
nonfocus countries are in the most dire situations in relation 
to HIV/AIDS?
    Ambassador Dybul. It's interesting, Senator. When I went 
back to read the legislation it surprised me that there 
actually are no focus countries in the legislation. That's 
something that we developed. So going forward actually, when 
the President called for reauthorization he didn't talk about 
focus countries. He actually talked about using the new money 
where it can be the most effective, basically saying if we can 
save two lives with a tax dollar or one life with a tax dollar 
you're better off saving two.
    So going forward, we are going to look at the best 
opportunities to save the largest number of lives in countries 
that want to tackle their epidemic with their own resources 
where possible--many countries don't have many--but also with 
policies around gender equality and orphan protection and 
things that we know will enhance prevention of mother-to-child 
transmission, for example.
    So going forward we would look at countries--I don't know 
where for sure yet. It depends on the countries that want to 
tackle their epidemics. But we know, for example, Lesotho, 
Swaziland, Malawi, Cambodia, Ukraine--I want to be careful here 
because there are a lot of countries I could name, so I'm just 
giving you a for-example. There are many, many more, and I 
don't want to indicate in any way where we think we would want 
to move.
    But it's just an increased flexibility and thought process 
to using money where it can be most effectively utilized and 
not select countries up front this time.
    Senator Lugar. I appreciate your testimony. Thank you.
    The Chairman. Could I ask a point of clarification on that 
if I may? Senator Lugar makes a very good point about certainty 
of funding, but in this new round we are going to consider any 
increased funding not only being used in the countries that are 
focus countries, but maybe other countries. Does that create 
any uncertainty in those very countries?
     Ambassador Dybul. It's a very good question. However, we 
have said, and I think you would agree, that we would not 
reduce funding in any of those countries going forward, because 
that would be a very difficult position for us and for them.
    The Chairman. I agree. I think you should. I just wanted to 
make sure.
    Ambassador Dybul. But it does also create a sense of 
healthy competition, in a sense.
    The Chairman. No; I'm not suggesting it's bad. I just 
wanted to make sure.
    Ambassador Dybul. Yes. Because we continue, that's not an 
issue.
    The Chairman. That's good.
    Senator Feingold.

   STATEMENT OF HON. RUSSELL D. FEINGOLD, U.S. SENATOR FROM 
                           MINNESOTA

    Senator Feingold. I sincerely thank you for holding this 
hearing. It's very important and I appreciate it.
    Ambassador, it's good to see you again. As you stated, 
there has been considerable acknowledgment of the challenge of 
implementing HIV/AIDS programs in African countries that have 
inadequate or inefficient health infrastructure. The World 
Health Organization estimates that Africa has 24 percent of the 
global disease burden, but only 3 percent of the world's health 
workers, a deficit of more than 1 million doctors and nurses.
    On a recent trip to Uganda in August, I met with key 
representatives from the HIV/AIDS community and we discussed 
the importance of building national capacity so these countries 
will be increasingly able to meet the health needs of their 
citizens. Only by strengthening indigenous infrastructure will 
our global health efforts be sustainable in the long run.
    Ambassador, 2 years ago you personally testified that weak 
health infrastructure was delaying the progress of PEPFAR 
programs. What specific policies and programs have you 
introduced and what impact have they had to help address this 
problem? What other initiatives have helped strengthen national 
health infrastructure?
    Ambassador Dybul. Well, Senator, I think it's one of the 
key issues going forward. There has been a lot of debate around 
health systems versus vertical programs and that kind of thing. 
Our approach actually has been--and this was the importance of 
the focus countries--to do national expansion, which requires 
building national systems.
    So the majority of the cost actually right now, for 
example, for antiretroviral therapy goes to building systems, 
to paying salaries for doctors and nurses, to expanding or 
renovating or creating new clinics, to building a logistics 
system that will support the delivery of drugs. The same in our 
care programs and in our prevention programs.
    So right now we are dedicating, last year I believe it was, 
$640 million to what you would consider health system 
expansion, everything along that way. As I mentioned, we just 
did an evaluation on this because we thought it was important, 
to look in four countries at our care and treatment sites to 
see what we were doing for infrastructure and what the 
contributions were. On average, 92 percent of the 
infrastructure development in those sites was supported through 
PEPFAR. It was actually higher in the public sector than in the 
private sector, which is another important thing. Eighty-three 
percent of our partners are local organizations and we're 
building that capacity in-country.
    Uganda is a great example. Our biggest partners there are 
local partners, TASO and Joint Clinical Research Center and AIM 
and many others, in the communities fighting their epidemic.
    One of the interesting things, too, I think, is that many 
of our private partners are actually working in the public 
health sector building the public health infrastructure as well 
as the nonpublic health infrastructure. Very variable by 
country. I can give you an example from Namibia. In Namibia 
about 90 percent of the health care is in the public sector, 
not in the private sector, versus in Uganda or Kenya where it's 
closer to 50-50. We're supporting virtually every person doing 
care and treatment and counseling and testing in the public 
sector, but we're doing it through a contract mechanism, and we 
have a long-term plan with the Namibian Government to turn 
those people into ministerial employees over the long period 
because they just couldn't take all--it would be impossible for 
their system to take them all in immediately.
    So this is the type of thing we're working on in innovative 
and creative ways. What we fundamentally believe is we're a 
piece of the puzzle in the countries, including the Global 
Fund, World Bank, many foundations, the governments themselves, 
and we're trying to support the piece of the national program 
that we're best at, including a lot of infrastructure work.
    So we've got a lot of innovative stuff going on. Like every 
place else, we can improve this just like we can improve 
everything we're doing. We look for people's suggestions and 
opportunities, but a lot's been done and we'll continue to work 
on it.
    Senator Feingold. What do you think are the best ways to 
retain health workers in their country of origin?
    Ambassador Dybul. I think the best way to retain them is to 
provide them hope. Actually, when I was a young doctor in San 
Francisco it was the same. People were leaving every 6 months 
to a year. They just couldn't be around that much death all the 
time.
    When you talk to doctors and nurses now and you ask them 
the most important thing that's keeping them there, it's hope. 
It's the sense that they can actually do something for their 
own people.
    I would say the second most important thing is to use 
what's called task shifting to allow not only doctors and 
nurses, but medical officers and community health workers to do 
a lot of the work. The reason I mention that in response to 
your question is there is no commensurate certification in the 
United States or anywhere else to employ such people, so they 
pretty much have to stay where they are.
    They also tend to be trained in their local community 
rather than traveling for training, so they're tied in in part 
of their community. So I think those two things are very 
important.
    The third thing, and we're doing this in Namibia and 
Mozambique and Zambia, is supporting--and now in Cote d'Ivoire 
now that the north has opened up--we're supporting ministerial 
and public sector retention packages to keep professionals in 
rural areas, just as in the United States we have to do some of 
this. So it can involve housing, it can involve school fees, it 
can involve other incentive packages to keep people in rural 
areas. It's not just doctors and nurses. It's technicians and 
other types of people as well.
    Senator Feingold. In sub-Saharan Africa, health workers are 
also infected with HIV, as I understand it, at the same rate as 
the general population. In countries such as Lesotho and 
Malawi, death from HIV/AIDS is the No. 1 cause of health worker 
attrition. According to the Institute of Medicine's report, 
PEPFAR's workforce strategy does not prioritize protecting 
health workers from HIV exposure and identifying and treating 
those who are infected.
    What can PEPFAR do to keep medical staff healthy?
    Ambassador Dybul. Well, I think it's a critical point, and 
in fact a review was just done in Kenya. They thought most of 
the Kenyan nurses were leaving the country. In fact the reason 
they were losing the nurses is they were all dying.
    We are trying to engage countries in this. I have to say 
that what we're trying to do is support the national strategy, 
so we leave it to the local environment to determine 
prioritization. In many countries they do prioritize health 
care workers, they do prioritize pregnant women. For example, 
Uganda has policies around this. So we support the national 
strategy there. We are encouraging people more and more to 
support the health care workers.
    I have to say, and as a physician I know this is true, we 
can stigmatize a lot in the medical community. Some doctors and 
nurses are scared to death to say they're even positive, so we 
even have our own staff who are dying from the disease because 
they're afraid to tell. So we need to do more work on reducing 
stigma and discrimination in the medical profession as well.
    Senator Feingold. On the gender issue and its relationship 
to AIDS, what role have women's and civil society organizations 
played, both in the United States and in-country, in developing 
new strategies on gender-based violence, changing norms and 
attitudes among men and a focus on adolescent girls? And will 
these groups be involved in the implementation and evaluation 
of the ensuing program?
    Ambassador Dybul. Yes, absolutely; and they're involved 
very much now. I think--and I know, Senator, you have spent 
much time in Africa, and you've seen in many places it's the 
women who are doing the work in the care and treatment sites 
and everywhere else. And if they're not engaged we're not going 
to be able to tackle this epidemic sufficiently.
    Senator Biden asked a great deal about this. Working on 
gender issues we believe is one of the fundamental aspects, 
because we can't have effective prevention if you're not 
teaching young boys not to prey on young girls. If you're not 
teaching older men not to prey on young girls, we can't 
overcome this epidemic. So gender equality is going to affect 
our ability to have effective prevention programs, and engaging 
women's groups is critical. Men's groups, too.
    One of the problems is we don't have a lot of men who are 
engaged in the activities, and we're learning how to do this 
better. I'd be happy to describe--time's running short, so I 
don't want to go into too many programs. But we are now 
targeting men and girls separately and then bringing them 
together and finding that's far more effective, or doing 
couples counseling and testing, for example, and doing testing 
in the afternoon or on Saturdays, which will draw couples in to 
bring the men in as well.
    I want to point out one thing here, which is unless you 
have treatment you'll never get a man to get engaged at all. 
One of the reasons we're getting men to come for testing now, 
particularly in discordant couples, is because they know 
treatment's available. So it's radically changing the dynamic 
between men and women, and women can now convince their 
partners to come get tested because there's an opportunity for 
treatment.
    So it all fits together. It's a complicated picture, a 
highly complicated picture. We've got a lot more to do, a lot 
more to learn. But we've found a lot of progress in these 
areas.
    Senator Feingold. Thank you very much, Ambassador.
    The Chairman. Thank you.
    Senator Menendez.

STATEMENT OF HON. ROBERT MENENDEZ, U.S. SENATOR FROM NEW JERSEY

    Senator Menendez. Thank you, Mr. Chairman.
    Ambassador, there are currently 15 PEPFAR focus countries, 
12 in Africa, 2 in the Caribbean, and 1 in Asia. While the 
urgency and support concerning the AIDS epidemic in Africa has 
increased significantly in the past year, the awareness of 
Latin America's growing AIDS crisis remains lower. As of 2005, 
this hidden crisis affects more than 1.8 million people in the 
region. So if PEPFAR is truly to be a global initiative to 
address this issue, why aren't we paying more attention to 
Latin America, a region in which we have the movement of people 
within this own continent?
    Ambassador Dybul. I think it's a very good question and one 
that goes back to some things which were discussed earlier 
about focus countries and going forward. It is the reason that 
we have Haiti and Guyana as focus countries, because it needs 
to be a global response. At the time they were selected, Haiti 
and Guyana had the highest prevalence of the countries in the 
region.
    Great success in Haiti; I just got back from there. In the 
midst of some of the most difficult time periods, they've 
expanded care and treatment programs. Across the island on 
Hispaniola, we actually have been expanding our program in the 
Dominican Republic as well and are doing more cross-border.
    We're also looking at the region as a whole. As you point 
out, particularly in the Caribbean, people move a great deal 
from country to country. We have some Caribbeanwide training. 
We actually have increased resources, not only in those two 
countries, but more broadly for the Caribbean region, and also 
some in Latin America, in particular in Central America.
    So we do see them as opportunities. I think we also need to 
be very congratulatory of what the work the people themselves 
have done in that region and the commitments of the governments 
themselves. The Caribbean as a region has seen stabilization or 
decline in their epidemic and as a whole Latin America and the 
Caribbean are actually meeting the international standards for 
access to treatment in one of the most aggressive ways. But we 
do see opportunities there. We do see opportunities for these 
partnership arrangements. But it is the reason that Haiti and 
Guyana were focus countries.
    Senator Menendez. I appreciate that. My concern is the rest 
of the hemisphere and its increasing numbers.
    Let me ask you this. You have mentioned in recent times the 
possibility of graduating certain countries, like South Africa 
or Botswana. If those graduations take place, is there going to 
be a reattribution of those resources?
    Ambassador Dybul. Yes.
    Senator Menendez. And if so, how will that be distributed?
    Ambassador Dybul. I think graduation as we understand 
development might be too strong a term. It's quite likely we'll 
need to be engaged in those countries going forward. It's just 
the level of resource commitment could decline over time as 
those countries do more and more. South Africa this year is 
committing $800 million of their own dollars. Botswana is 
around $150 million.
    So we see and have spoken with the countries about 
gradually working with them to have them--and their national 
plans already do this--take up more of the resources. That 
would be part of our approach toward the next phase, which is 
these partnership compacts utilizing the entire pool of money, 
working in countries that want to tackle their epidemics, which 
would include the opportunity for other countries to be 
engaged. And Latin America and the Caribbean region in 
particular is one area that we would look at.
    I think the criteria are still being worked out. We have a 
lot of work to do on this. We look forward to working with 
Members of Congress and the staff on thinking through some of 
this. But certainly a couple criteria would be prevalence rate 
and whether or not we already have a strong bilateral program. 
Going into a country and reestablishing a new bilateral program 
might not be the right role for us. Maybe the Global Fund or 
another should do this.
    So we need to think together about them, but Latin America, 
in particular the Caribbean region, offers some opportunities.
    Senator Menendez. Let me ask you two final questions. As 
the leading killer of people living with HIV/AIDS, tuberculosis 
is inextricably linked to the epidemic. Given the high rates of 
TB/HIV coinfection in the 12 PEPFAR focus countries in Africa, 
TB programs present an opportunity to identify additional HIV 
positive individuals who are eligible for treatment.
    Given these opportunities, should addressing TB/HIV by 
increasing integration and coordination among programs, should 
it be a greater focus in PEPFAR's reauthorization?
    Ambassador Dybul. Absolutely, Senator. But I don't think we 
need to wait for reauthorization. In fact, for most of these 
issues we need to do this now, which is why we've increased our 
resources for HIV/TB activities from--we increased it by $50 
million last year and we're going to do it again this year. We 
are heavily targeting this issue. We're working with the World 
Health Organization. Great successes. We actually worked with 
the World Health Organization to pick a couple of countries and 
see how we'd most effectively do this, including Rwanda and 
Kenya.
    We are now up to 86 percent testing for TB in HIV-positive 
patients across the way and 75 percent or so in coinfection 
treatment. We're working the same in Kenya. So we know how to 
do it. Since that time we have brought together more countries 
to learn from those lessons, to see how we can expand those 
care and treatment programs, integrating HIV and TB, because 
you're absolutely right, TB is the No. 1 killer for these 
patients. Also, with the advent of extremely drug-resistant 
tuberculosis, we need to be paying more and more attention, in 
particular in deep sub-Saharan Africa, and we've increased our 
resources for laboratory and other means around tuberculosis so 
we can get a better understanding of that extremely concerning 
disease.
    So I don't think we need to wait for reauthorization. We're 
doing it now.
    Senator Menendez. One final question. Regular testing of 
the CD4 counts of those diagnosed with HIV is the standard of 
care in the developed world. It's critical to appropriately 
stage care from a clinical perspective. It's also important 
from a program perspective as it is a means to effectively use 
the resources available to buy antiretrovirals. Has the program 
sufficiently integrated CD4 testing into the program and into 
the national health systems in our target countries?
    Ambassador Dybul. We are working hard on that and it's part 
of our guidance to do just that. Now, we haven't held up 
treatment for the CD4 cell count because you don't always need 
it. If someone's coming in with an opportunistic infection or a 
clinical way to diagnose AIDS, you don't need to wait for a CD4 
cell capability to begin treatment. But that's actually what 
we're doing, and we're trying to scale up national CD4 cell 
counts. We're integrating transport systems because it's 
difficult to get them everywhere. For example, in northern 
Kenya--I was there about a year ago and we actually developed a 
system so that all of the satellite facilities in an area could 
send their CD4 cell counts in and send the results back out so 
we could use them in the system.
    So we are moving rapidly toward use of CD4 cell counts. To 
be honest, I think we're overusing them in some places, too. 
Getting one every 6 months isn't going to change what you do 
clinically. It's nice for the clinician to have it, but it's 
not going to change. So we're working with countries to come up 
with, and the World Health Organization, to come up with the 
best approach. But you certainly need it for diagnosis.
    One of the most exciting things is--what we're starting to 
see is people coming in at time of diagnosis have a higher CD4 
cell count, which means they're healthier, which is exactly 
what you want. That's why care is so important, so that you 
have people in a care system and you can monitor them so you 
know when to most effectively begin treatment. So this is where 
we're evolving tools as rapidly as we can, because that's going 
to be the most effective use of resources. It takes time. We've 
only been at this for 3 years and have scaled up dramatically. 
But these are the things we are trying to put into all of our 
programs.
    Senator Menendez. Mr. Chairman, I have a series of other 
questions I'll submit for the record. And I appreciate your 
answers, sir.
    The Chairman. Thank you, Senator.
    Dr. Dybul, I'm impressed with your--not only your 
knowledge, but your commitment to making this program work. Let 
me ask you--I have a number of questions as well, probably a 
half a dozen I'm going to submit in writing. But I'd like to 
conclude by asking you to talk to me about how you envision the 
coordination between the rest of the world getting into this 
fight and this program?
    I mean, in other words, how much interfacing is there 
between you and your colleagues in Europe? The decision is made 
to put X number of dollars in Country Y. Is that coordinated in 
any way with the Europeans? Talk to me about that for just a 
few moments on the record.
    Ambassador Dybul. Yes; I think that's a great question. I 
can begin by saying this morning I met with the junior Minister 
from DIFD to talk about some of these issues. Two weeks ago I 
was in Haiti with the head of the Global Fund. We've taken two 
joint missions together, Cote d'Ivoire and Haiti. He speaks 
French, I don't, so I was at a significant disadvantage in two 
French-speaking countries.
    But we are trying to do exactly that, and I think we've 
seen great successes. Now, there are two pieces of that. One is 
the global interaction together, and we actually have called a 
meeting between the head of the Global Fund, myself, the people 
in the United Kingdom, the head of the World Bank for these 
programs, and others in December or January to talk more about 
how we can do this.
    But the real key is in-country. The real key is how are we 
coordinating our programs so that we are supporting one 
national strategy. I think we've got some great successes over 
the last few years. If you look in Ethiopia, if you look in 
Rwanda, what you see is the Global Fund, for example, PEPFAR, 
and the World Bank jointly coordinated to support the national 
strategy, where we each do pieces of the puzzle to expand the 
national program.
    That's the thing we need to do more and more of and get 
better and better at. So I think we've made great strides both 
at the headquarters level and at the country level. But it's 
one of our principal focuses going forward, because otherwise 
we're duplicating effort. Otherwise we're not effectively 
supporting the national strategy. So there are opportunities 
here.
    To be honest, for the American taxpayer this is a great way 
to do it, because we're all in it together. We're all in it 
supporting together, not one piece being the most essential or 
pieces that we can't sustain over the long term.
    The Chairman. Too many countries in the beginning of this 
whole initiative responded slowly. As a matter of fact, 10 
years ago when we started discussing this, one of the 
difficulties was the willing suspension of disbelief in some 
countries, where there were some countries, which I'm not going 
to name because it will cause controversies again, who either 
denied the existence of the problem in their country, were slow 
to react to it, or when they reacted to it, reacted to it in a 
less than helpful way.
    You say countries have national strategies. I imagine a 
number of the countries, some of which you already mentioned, 
need some guidance in developing their national strategy. Is 
there a go-to agency that countries are inclined to, once they 
have reached, they have crossed the Rubicon that they have a 
problem or they have an obligation to deal with it?
    I mean, how and if--do you and how do you try to help 
develop national strategies, or do you? I don't mean you alone. 
I mean--
    Ambassador Dybul. Absolutely. I have to say there is no one 
particular go-to. There are a lot of international guidance and 
documents to help direct people, but each country does it 
differently, and they tend to pool everyone together to come 
together to develop one national strategy. South Africa 
actually just put forward a great national strategy. Ethiopia 
has a new one, Kenya has a new one.
    So they evolve over time and they're getting better all the 
time. So that is a principal part of our work, to work with our 
other partners in-country to build a national strategy that 
ultimately is owned by that government and that country. So it 
is a principal part of what we do, and they're improving all 
the time. Again, we've only been at it for 3 years, but it's 
getting better.
    The Chairman. I realize that. Look, I'm a fan. I think 
you're doing a very good job. As I said, I'm impressed.
    One of the things I'd like you to submit for the record, if 
you would--I'm not looking to make unnecessary work for you 
here, but if you could lay out for us what is the informal, if 
not formal, coordinated process that goes on for all the 
countries and the Global Fund and this fund for attacking 
basically the same problem. There's slightly--there's nuanced 
differences in approach.
    It would be a useful tool for us, for those of us who have 
been so supportive of this effort, to be able to have to make 
the case to our colleagues. And I'm not asking you to do my 
work for me. I'm asking you to help me lay out the most 
persuasive document to--it need not be a document--the most 
persuasive paper to indicate that we are multiplying, in 
effect, our dollars; we are not duplicating the dollars.
    Would you be willing to try to take a shot at that?
    Ambassador Dybul. Absolutely, Mr. Chairman. Your work is 
our work, so we're happy to do that.
    [The written information submitted by Ambassador Dybul 
follows:]

    A key difference between PEPFAR and the Global Fund, and an 
important reason for U.S. support to both programs, is that while 
PEPFAR mobilizes U.S. diplomatic leadership, technical expertise, and 
financial resources to work at the country level, the Global Fund is, 
in its own words, a ``simplified, rapid, innovative process [to] 
attract, manage, and disburse additional resources.'' The Global Fund 
is a financing mechanism, which boosts funding and political leadership 
around the world. It does not have field staff, and does not develop 
specific implementing strategies. The Global Fund relies on 
implementing partners--both host country organizations and 
international development partners--to manage the funds and build the 
programs at the country level.
    U.S. missions use their PEPFAR resources to support Global Fund 
grants and ``make the money work'' in a variety of ways. In focus 
countries, implementers supported by PEPFAR and the Global Fund work 
closely to deliver a comprehensive program under one national plan and 
strategy, which uses one system of monitoring and evaluation. This 
effort is consistent with the commitment of both agencies to the 
``Three Ones'' principle, which calls on all international partners to 
support in each country: (1) One agreed HIV/AIDS Action Framework that 
provides the basis for coordinating the work of all partners; (2) one 
National AIDS Coordinating Authority, with a broad-based multisectoral 
mandate; and (3) one agreed country-level Monitoring and Evaluation 
System.
    For example, in Uganda, all operational costs of TB/HIV sites are 
financed by the Global Fund, and PEPFAR supports the personnel, 
training, and quality assurance at these sites. Similarly, in many 
countries, PEPFAR country teams have arranged for the Global Fund to 
supply antiretroviral drugs and commodities to PEPFAR-supported HIV 
treatment sites, where PEPFAR supports personnel, training, 
infrastructure improvement, operations, and quality assurance.
    The Global Fund's 2005 progress report cites Tanzania as another 
example. ``[P]artners are now refocusing their resources to support 
implementation after the slow start to programs financed in early 
rounds. A key area of collaboration has been through USAID funding of 
Management Sciences for Health (MSH) for assistance to the Tanzania 
Commission for AIDS (TACAIDS). TACAIDS is responsible for coordinating 
the implementation of most HIV/AIDS-related activities in Tanzania. MSH 
provides capacity to support the development of work plans, and 
procurement and supply management.''
    In other countries with USG bilateral programs, where the Global 
Fund is often the largest international partner on HIV/AIDS, PEPFAR 
works to maximize the impact of Global Fund resources and to fill gaps 
in support of a comprehensive HIV/AIDS program. At the request of 
Global Fund Country Coordinating Mechanisms (CCMs), PEPFAR provides 
technical assistance to Global Fund grantees, helping them overcome 
bottlenecks, expand access to services, and resolve major issues that 
can cause grant failure in areas such as program management; governance 
and transparency; procurement and supply-chain management; and 
monitoring and evaluation.
    Of all countries that completed PEPFAR country operational plans 
(COPs) and minicountry operational plans (Mini-COPs) \1\ for FY08, 48 
percent are planning for Global Fund technical assistance in their 
annual budgets, totaling over $11 million for calendar year 2008. 
Additionally, in the past 3 years PEPFAR has provided over $35 million 
for targeted assistance using funds withheld from the U.S. contribution 
to the Global Fund, within the legislatively authorized 5 percent 
ceiling. These funds support Management Sciences for Health (a USG 
contractor), Roll Back Malaria, UNAIDS technical support facilities, 
the WHO Green Light Committee, and the WHO Stop TB initiative in order 
to provide specialized technical assistance to Global Fund grants.
    One of the most important ways PEPFAR coordinates with the Global 
Fund at the country level is by participating in the Global Fund CCMs. 
A CCM is the national planning and oversight body for the 
implementation of Global Fund resources in a given country; these 
bodies are multisectoral, and involve top leadership from all areas of 
the government. In 2007, 87 percent of countries that completed PEPFAR 
COPs and Mini-COPs had PEPFAR representation on the CCMs. As regular 
members of the CCMs, PEPFAR personnel contribute significantly to the 
design of national Global Fund grant proposals, selection of 
interventions, and oversight of implementation.
    In Ghana, the Global Fund's 2005 progress report notes that PEPFAR 
participation has been ``integral to changes made to streamline and 
strengthen the CCM. In the past the CCM was largely seen as an 
impediment to the smooth functioning of grants in Ghana. Key members of 
the CCM led by the PEPFAR representative advocated for a change in the 
size of the CCM as well as for the election of the chair and vice chair 
and the selection of members by their constituencies . . . The 
bilateral and multilateral partners deserve credit for keeping the 
issue on the table throughout the last year and for assuring that it 
was brought to resolution . . . The CCM has been streamlined and 
members are now elected by the constituencies they represent.''
    To further promote coordination, PEPFAR has entered into Memoranda 
of Understanding (MOUs) with the Ministries of Health and the Global 
Fund in several countries. These documents help clarify collaboration 
and partnership activities in such areas as antiretroviral treatment 
(ART) provision. For example, the critical relationship between PEPFAR 
and the Global Fund in Ethiopia was formalized on February 7, 2006, 
when the Minister of Health and the Charge d'Affaires at the U.S. 
Embassy signed a Global Fund-PEPFAR Ethiopia MOU. Through this MOU, 
PEPFAR, and Ethiopia's HIV/AIDS Prevention and Control Office (HAPCO) 
within the Ministry of Health, which operates with Global Fund support, 
engage in joint planning to support one national HIV/AIDS program; to 
use resources effectively according to comparative advantages; and to 
share programmatic, financial, and institutional information in order 
to identify and minimize programmatic gaps and overlaps.
    Specific coordination mechanisms within this MOU include a weekly 
PEPFAR-HAPCO management meeting to address planning and operation 
issues; a monthly PEPFAR-Ministry of Health meeting to address policy 
issues; and a Global Fund-PEPFAR liaison position to strengthen and 
lead coordination efforts in planning, implementation, and monitoring 
and evaluation of HIV/AIDS activities among the large international 
partners.
    Close PEPFAR-Global Fund coordination is also reflected in the 
PEPFAR Country Operational Plans (COPs). In Rwanda, PEPFAR focuses on 
strengthening aspects of the national health system that will enhance 
Global Fund implementation, as well as directly further the objectives 
of the national government and PEPFAR in addressing HIV/AIDS and public 
health. For example, PEPFAR:

   Provides training, infrastructure and logistics support of 
        the National Reference Lab and district and site laboratories, 
        which are also used by Global Fund-supported activities;
   Strengthens the capacity of the local authority--the 
        Treatment Research and AIDS Center (TRAC)--which oversees all 
        HIV/AIDS planning and implementation nationwide;
   Provides technical assistance for a coordinated supply chain 
        between donors for harmonized quantification, procurement, and 
        distribution of antiretroviral (ARV) drugs, laboratory 
        commodities, and other consumables.
   Supports broad-based quality initiatives to enhance 
        synchronization of Global Fund- and PEPFAR-supported packages 
        of service;
   Helps procure commodities for Global Fund-supported 
        Voluntary Counseling Testing (VCT) and Prevention of Mother-to-
        Child Transmission (PMTCT) sites;
   Supports national monitoring activities through TRACnet, an 
        innovative telephone and Web interface system to connect every 
        Rwandan health facility that provides ARV treatment and related 
        services, including Global Fund sites; and
   Participates in the CCM, such as by serving as chair of the 
        HIV/AIDS, TB, and orphans technical advisory committees.

    In Thailand, the PEPFAR team oversees technical assistance to 
Global Fund projects that is provided through UNAIDS with USG funding. 
Current funding supports:

   Building the CCM's capacity to provide technical and 
        programmatic oversight to Global Fund grants, and strengthening 
        the role of civil society in the CCM;
   Assessing needs to improve financial and programmatic 
        monitoring and reporting, and providing training and technical 
        assistance to address these needs; and
   Developing and disseminating strategic information briefs to 
        promote policies supportive of Global Fund-supported HIV 
        programs.

    Additional planned technical assistance will support capacity-
building for local government and Global Fund subrecipients and sub-
subrecipients, to improve their capacity to design and implement 
effective HIV programming at the local level. The resulting local 
policy and capacity development guidelines will be disseminated 
throughout Thailand.
    Malawi has been approved to receive large amounts of Global Fund 
resources, but lack of local capacity has impeded rapid disbursement 
and use of the funds. The PEPFAR team dedicates substantial efforts and 
resources toward helping the Global Fund grants work in Malawi. 
PEPFAR's model of long-term technical assistance to support national 
scale-up of HIV/AIDS interventions in Malawi has been very successful. 
As of June 2007, Malawi had 114,375 people on ART, and wide usage of 
counseling and testing services nationwide. However, despite these 
tremendous achievements, local capacity has not grown as well as was 
intended. The PEPFAR team is currently examining what future models of 
support will bring long-term sustainability. In 2008, PEPFAR will move 
further into supporting the scale up of PMTCT and, through the new 
Community Care Advisor, provide assistance to facilitate improved 
implementation of the Global Fund Round Five Orphans and Vulnerable 
Children (OVC) grant.
    Effective coordination at the country level also requires 
leadership and collaboration at the headquarters level. The Global AIDS 
Coordinator serves as the Chair of the Global Fund Finance and Audit 
Committee, providing a critical leadership role in budget oversight and 
management. Senior PEPFAR officials also represent the USG on the 
Global Fund Policy and Strategy committee. In addition to top-level 
leadership, a PEPFAR interagency ``Global Fund core group'' reviews 
Global Fund country programs and grant requests, communicates with USG 
field staff familiar with the strengths and challenges of Global Fund 
programs, and engages in other activities to help the Global Fund 
successfully meet the requirements of performance-based funding. This 
core group also helps to coordinate Global Fund and PEPFAR activities 
on an international level. Last, the United States, through PEPFAR, is 
the largest contributor to the Global Fund, having provided nearly one-
third of total Global Fund resources, or a total of $2.5 billion, to 
date.

------------
    \1\ Generally, countries receiving more than $10 million per fiscal 
year from PEPFAR are required to submit a full country operational plan 
(COP). Those receiving between $5 and $10 million are required to 
submit a shorter, minicountry operational plan (mini-COP). Countries 
that do not submit COPs or Mini-COPs do not report funding for Global 
Fund technical assistance.

    The Chairman. All right. Well, thank you very much. I 
appreciate your time and your commitment.
    The hearing is adjourned.
    [Whereupon, at 3:46 p.m., the hearing was adjourned.]
                              ----------                              


              Additional Material Submitted for the Record


 Responses of Ambassador Mark Dybul to Questions Submitted by Senator 
                          Joseph R. Biden, Jr.

                         prevention of hiv/aids
    Question. As Congress undertakes reauthorization, how do we most 
effectively elevate prevention as a strategic authority?

    Answer. PEPFAR has supported a balanced portfolio of prevention, 
care, and treatment, identified in its authorizing legislation. PEPFAR 
recognizes that prevention is the bedrock of an effective global 
response to HIV/AIDS. In PEPFAR's Five-Year Strategy, in each annual 
report, and in nearly every other public document, PEPFAR has clearly 
stated that we cannot treat our way out of this pandemic, and that 
prevention is the most important component for success. Counting 
counseling and testing as part of prevention, in fiscal year 2007 
prevention received 29 percent of program resources.
    We believe that goals are a key determinant of programs. The first 
phase of PEPFAR included a goal of preventing 7 million new infections. 
In the next phase of PEPFAR, the President has proposed nearly doubling 
that prevention target, seeking to prevent 12 million new infections. 
Care and treatment goals in this next phase are also increased, but 
more modestly. Countries will need to make a significant scale-up in 
prevention activities to meet this ambitious target, while continuing 
support for care and treatment interventions.
    Additionally, PEPFAR has more experience with and evidence about 
``what works'' in prevention than ever before. Evidence from Kenya, 
Zimbabwe, and a number of other countries demonstrates that HIV 
prevalence declines when young people delay sexual debut, sexually 
active persons reduce their number of partners, and people engaging in 
risky sexual activity increase condom use. In addition, PEPFAR promotes 
interventions that address gender issues (including gender-based 
violence), cross-generational and transactional sex, substitution 
therapy for injecting drug users, and prevention for those already HIV-
positive to prevent secondary infections.
    Scaling up prevention of mother-to-child HIV transmission (PMTCT) 
is also an important priority for PEPFAR. In Botswana, PEPFAR support 
for PMTCT has contributed to Botswana's success in reducing the rate of 
HIV transmission from mother to infant to just 4 percent, and the 
infant mortality rate in general is on the decline. PEPFAR is 
disseminating programmatic lessons learned from successes like the 
promising PMTCT model in Botswana to other countries.
    A promising prevention breakthrough made with PEPFAR support is 
male circumcision, which randomized control trails have shown can 
reduce a man's likelihood of contracting HIV by 60 percent. PEPFAR now 
supports male circumcision programs, including the development of 
policies, training, implementation and quality assurance in several 
countries, by host government request.
    PEPFAR also quickly adapts and supports international normative 
guidelines in prevention, such as the scale-up of WHO-approved 
provider-initiated testing and counseling in antenatal, TB, and HIV 
clinics, and in other in- and out-patient settings. Testing uptake 
under this ``opt-out'' model has been 90 percent and above in several 
settings, and expanding it will significantly increase the number of 
people who know their status and who can take measures to avoid 
contracting it themselves, or further spreading the disease.
    This progress has been achieved under the current authorities of 
the Leadership Act. The success PEPFAR has experienced thus far has 
been largely driven by the President's 2-7-10 goals. With an even more 
ambitious goal for the next phase of PEPFAR--support for prevention of 
12 million infections--and supported with more evidence, knowledge, and 
experience than ever before, we believe country teams will respond with 
a significantly greater focus on prevention interventions over the next 
5 years.

    Question. In the next phase of programs to combat HIV/AIDS, what 
are the most appropriate measures to determine the effectiveness of 
prevention programs so that we are maximizing our opportunity to build 
on and expand programs with proven impact?

    Answer. PEPFAR is currently revisiting indicators across all 
program areas. We anticipate moving toward outcome indicators that 
reflect behavioral change, rather than relying solely on output 
indicators which provide simple service delivery and utilization 
counts. This shift has important implications for prevention programs, 
as measurement of behavioral changes provides first-level evidence of 
programmatic effectiveness. PEPFAR will use this data to identify 
programs with proven impact, so that they can be scaled up and shared 
with other countries.
    As part of our strategy to strengthen and refine monitoring and 
evaluation, PEPFAR is also supporting the increased use of ``bio-
markers''--which test for a particular disease state--in tandem with 
behavioral studies that collect health knowledge, attitudes, and 
behaviors. This approach links an individual's and population's health 
outcomes (e.g., HIV status) with reported behaviors (e.g., number of 
concurrent sexual partners), thereby presenting stronger evidence of 
program success or failure and contributing to the science of behavior 
change. Similarly, these data help ensure more focused program 
alignment with those communities where HIV infections occur most often.
    Advanced technology now allows us to collect HIV incidence data for 
surveyed populations, which provides ``real-time'' documentation of the 
loci of new HIV infections and helps assess the impact of prevention 
programs over time. These efforts to better understand program impact, 
the relationship between behaviors and HIV incidence, and HIV incidence 
in particular communities are all challenging. However, the information 
gathered will allow for better mid-course adaptation and improvement of 
prevention activities, strengthening the PEPFAR program overall.
                          pediatric treatment
    Question. While children account for almost 14 percent of all new 
HIV infections, they reportedly make up only 9 percent of those on 
treatment under the President's Emergency Plan for AIDS Relief 
(PEPFAR).
    What are the barriers to increasing the access of HIV-positive 
children to life-saving treatment?
    What steps do you believe should be taken in PEPFAR reauthorization 
to reduce these disparities, so that children are accessing treatment 
at the same rate as adults?

    Answer. PEPFAR supports treatment services for over approximately 
1,101,000 men, women, and children in its focus countries alone, and 
care for over 2 million orphans and vulnerable children. However, a 
number of challenges remain to scaling up these services to all the 
children who need them.
Barrier 1: HIV diagnostic testing
    Most pediatric HIV infections worldwide are attributable to mother-
to-child transmission, with transmission occurring during pregnancy, 
around the time of birth, or through breastfeeding. Barriers to testing 
infants and children for HIV infection lead to a delay in diagnosis, 
and many infants and young children die before HIV is diagnosed or 
treatment can be given. It is estimated that 50 percent of HIV-positive 
children will die before the age of 2 years if they are not treated.
    For adults and children older than 18 months, diagnosis of HIV 
infection is made by identification of antibodies to HIV in serum. 
However, because of the transfer of maternal HIV antibodies to the 
infant, newborn infants, and children younger than 18 months will often 
test positive for the presence of anti-HIV antibodies even in the 
absence of true infection. Therefore, definitive diagnosis of HIV 
infection among infants and children younger than 18 months often 
requires the use of special infant diagnostic tests (i.e., HIV-specific 
RNA or DNA) to detect the virus itself, instead of the inexpensive and 
readily available antibody tests that can be used in adults and 
children older than 18 months. These special tests are more complex to 
perform and more expensive, and are not available in many resource-
constrained areas of the world in which the risk of HIV infection in 
infancy is highest.
    PEPFAR's existing authorities have allowed it to respond to this 
challenge. PEPFAR supported the development of the innovative dried 
blood spot polymerase chain reaction (PCR) test, for HIV-specific RNA 
or DNA, improving the rate of accurate and timely HIV diagnosis in 
infants under 18 months. PEPFAR is now supporting a significant scale-
up of this new testing technology in Botswana, Rwanda, South Africa, 
Uganda, Namibia, Zambia, Kenya, Mozambique, Ethiopia, Cote d'Ivoire, 
Nigeria, Malawi, and China, through the establishment of national 
guidelines, training of personnel, and implementation support. This 
effort will help to identify more quickly HIV-positive infants under 18 
months and to link them to care and treatment programs.
    PEPFAR also helped develop guidelines for the use of HIV rapid 
tests that have been disseminated to PEPFAR countries to support a 
systematic scale-up of rapid HIV counseling and testing for children, 
adolescents, and adults. PEPFAR is further supporting policy 
development and program implementation to hire thousands of lay 
counselors to implement quality HIV counseling and rapid testing 
throughout PEPFAR focus countries, including among infants and children 
over 18 months. A priority for such counseling and testing activities 
is to establish adequate linkages for infants and children to care and 
treatment services.
    An important component of the scale-up of infant diagnosis will be 
the expansion of sites where infants at risk of HIV can be identified 
and tested. Prevention of mother-to-child HIV transmission (PMTCT) 
programs at antenatal care sites provide excellence access to infants 
at risk of HIV. PEPFAR is substantially increasing its support for the 
national scale-up of PMTCT programs through the development of national 
PMTCT policies, strategies, and program plans; provision of training, 
infrastructure support, and assistance for monitoring and evaluation 
activities; development of key reference PMTCT tools for program 
implementation and country adaptation; and collaboration with 
multilateral partners, including WHO and UNICEF.
    Last, the foundational component of PEPFAR's scale-up of infant 
diagnosis is PEPFAR's continued strengthening of national-tiered 
laboratory networks that have the capacity for accurate and timely 
infant diagnostics. This includes training and mentoring laboratory 
personnel, establishing standard laboratory operating procedures for 
HIV and TB diagnostics, providing a reliable supply of test kits and 
laboratory reagents, renovating and constructing laboratories, and 
developing quality assurance mechanisms, among other activities. In 
fiscal year 2007, PEPFAR invested over $160 million in strengthening 
laboratory systems.
    Scaling up infant diagnostic testing, rapid HIV testing, laboratory 
strengthening, and linkages from testing to infant and child care and 
treatment will continue to be priorities for PEPFAR in the next phase.
Barrier 2: Clinicians to Provide Care for Children With HIV
    Even where appropriate HIV diagnostic testing is available and 
drugs for treatment of HIV infection and prophylaxis for HIV-associated 
infections are accessible, lack of personnel trained in treatment of 
children with HIV severely limits access to treatment for large numbers 
of children. In many areas of the world, medical care is provided by 
physicians, nurses, and other clinicians with training and experience 
in the management of adult, but not pediatric, patients. Additional 
efforts are needed to expand the availability of clinicians who are 
skilled in pediatric HIV care in resource-limited areas of the world.
    Under existing authorities, PEPFAR has made sizeable investments in 
building the health workforce capacity in PEPFAR countries to provide 
pediatric care and treatment, and will continue to do so in the next 
phase. First, PEPFAR provides partial and full salary support for 
physicians, clinical officers, and nurses providing HIV care and 
treatment for infants and children across national HIV/AIDS programs.
    Second, PEPFAR strengthens preservice training institutions, such 
as schools of medicine, nursing, and pharmacy, to produce more 
qualified graduates that can work in pediatric HIV care and treatment. 
Activities include developing curricula, hiring and training faculty, 
and providing scholarships for students to attend school within or 
outside their countries. In the case of Namibia, no schools of medicine 
or pharmacy exist, so an ongoing scholarship program supported by 
PEPFAR has successfully subsidized students to study in South Africa, 
with the agreement to serve in the public health system for 2 years 
upon completion of their degree.
    Third, PEPFAR has supported the on-going training and mentorship of 
thousands of medical providers, nurses, and pharmacists in pediatric 
care and treatment services. Notably, PEPFAR has been promoting and 
supporting a standardized model of pediatric care and treatment in the 
focus countries. This 10-Point Package for Comprehensive Care of an 
exposed infected child includes: (1) Early infant diagnosis; (2) growth 
and development monitoring; (3) routine health maintenance; (4) 
prophylaxis for opportunistic infections; (5) early diagnosis and 
treatment of infections; (6) nutrition counseling; (7) HIV disease 
staging; (8) ART for eligible children; (9) psychosocial support to the 
child and family; and (10) referral for additional care. Providing a 
standardized model of care ensures PEPFAR countries are providing 
quality care for infants and children in a systematic manner.
    Fourth, PEPFAR has further supported the development of ``centers 
of pediatric treatment excellence,'' which establish best practices and 
facilitate training and skills-building among pediatric providers in 
multiple PEPFAR countries. PEPFAR will continue to leverage the current 
rapid expansion of care and treatment services for people living with 
HIV/AIDS to expand pediatric access beyond centers of excellence to 
community-based health facilities. In Zambia, for example, with support 
from PEPFAR and the Global Fund, the government expanded antiretroviral 
treatment to children at primary health care centers, using a model led 
by nurses and clinical officers. The program resulted in strong health 
outcomes, providing further evidence for the PEPFAR-supported model of 
``task-shifting,'' or the shifting of care responsibilities from more 
specialized providers to less specialized.
    Last, a WHO-PEPFAR collaboration on task-shifting in seven 
countries will further map the provision of pediatric care and 
treatment services by all levels of providers, and will contribute to 
the establishment of WHO guidelines on task-shifting for HIV 
prevention, care, and treatment. These guidelines will help countries 
scale up pediatric and adult care and treatment more rapidly, by making 
strategic use of their existing health workforce.
Barrier 3: ARV formulations
    Assuming that appropriate HIV diagnostic testing is available, and 
the necessary clinical personnel are available to provide care and 
treatment to HIV-infected children, appropriate formulations of 
antiretroviral drug (ARV) agents for children are also necessary. 
However, pediatric formulations may cost up to four times as much as 
adult formulations, and the regimens are complex and difficult to 
follow. Lack of availability of appropriate ARV formulations that are 
inexpensive and easily usable is a major impediment to access for 
children with HIV.
    PEPFAR's existing authorities have allowed it to respond to this 
challenge. Most notably, PEPFAR has announced an unprecedented public-
private partnership to promote scientific and technical solutions for 
pediatric HIV treatment, formulations, and access. This partnership 
seeks to capitalize on the current strengths and resources of: 
Innovator pharmaceutical companies in developing, producing, and 
distributing new and improved pediatric ARV preparations; generic 
pharmaceutical companies that manufacture pediatric ARVs or have 
pediatric drug development programs; the U.S. Government in expediting 
regulatory review of new pediatric ARV preparations and supporting 
programs to address structural barriers to delivering ART to children; 
and civil society/multilateral organizations to provide their expertise 
to support the success of the partnership.
    The partners will work to identify scientific obstacles to 
treatment for children that the cooperative relationship could address. 
They will also take practical steps and share best practices on the 
scientific issues surrounding dosing of ARVs for pediatric 
applications. Finally, the partners will develop systems for clinical 
and technical support to facilitate rapid regulatory review, approval, 
manufacturing and availability of pediatric ARV formulations.
Barrier 4: Appropriate dosing of ARVs in children
    Even when appropriate formulations of ARV agents are available for 
children, pharmacokinetic data may be insufficient to appropriately 
guide drug dosing, especially in the youngest children (who metabolize 
these drugs differently) but also in adolescents, who may need higher 
than the ``maximum adult dose'' for adequate drug exposure. Earlier 
evaluation of ARV safety and pharmacokinetics in children is needed so 
that when new ARV formulations are approved for use in adults, there 
are also preparations available for children; enough information about 
drug pharmacokinetics in children is available to allow rational dosing 
recommendations. Appropriate dosing of drugs in pediatric patients 
requires measurement of weight and height and the complex calculation 
of body surface area. The requirement for different doses according to 
age, weight, and body surface area may put accurate prescribing and 
safe dispensing of ARVs and other drugs to pediatric patients beyond 
the reach of many of the front-line health care professionals who treat 
children with HIV.
    Under existing authorities, PEPFAR has supported the development 
and implementation of WHO simplified dosing guides, which are readily 
available to clinicians who care for children and adolescents with HIV 
infection in resource-limited settings (available at www.who.int/hiv/
paediatric/en/index.html). These guides will increase the accuracy of 
dosing and dispensing ARV medications to children. The PEPFAR pediatric 
technical working group has also assisted in the development of the 
``Handbook for Pediatric AIDS in Africa,'' which provides instructions 
and job aids on simplified dosing and quality services in pediatric 
care and treatment.
    Moreover, through a fast-track approval process developed under 
PEPFAR, FDA recently approved the first-ever fixed-dose pediatric 
formulation, which simplifies dosing of, and adherence to, a triple 
combination of pediatric ARV innovator drugs for use in children under 
12 years old. This formulation is one of 51 HIV/AIDS drugs approved or 
tentatively approved for purchase under PEPFAR by the FDA. Further, 
through an existing agreement with the WHO, this FDA-approved 
formulation is added automatically to the WHO prequalification list, 
which will expedite the regulatory processing of this formulation at 
the national level across PEPFAR countries.
                    counseling and testing: opt-out
    Question. Voluntary counseling and testing is an important tool in 
efforts to prevent and treat HIV/AIDS and to better understand and thus 
respond to the dynamics of local epidemics. As you know, the World 
Health Organization endorses the principle of opt-out testing for HIV 
in countries with generalized epidemics. Several focus countries, 
including Botswana, Kenya, and Uganda, have developed opt-out programs.
    What is the extent of opt-out or provider-initiated testing in 
PEPFAR focus countries?
    In countries where it has been implemented, does it apply only as 
part of prenatal care or is it practiced in more general health care 
settings?
    What are the critical components of effective counseling associated 
with initial testing?

    Answer. In varying degrees, every PEPFAR focus country is promoting 
the delivery of provider-initiated testing and counseling (PITC), 
including through developing appropriate policy and training 
mechanisms. PITC is being implemented in prenatal care, STD, TB, and 
ART settings, and is being extended to more general in- and out-patient 
care settings, depending on local capacity and epidemiology. To 
encourage this substantial scale-up of PITC, country teams are 
supporting the increased use of rapid HIV tests (that produce results 
in one clinical visit), as well as the training and deployment of lay 
counselors to conduct the testing and counseling for the medical 
provider. There is still a mix of opt-in and opt-out methods, and the 
specifics are difficult to determine from country operational plans.
    We are planning a public health evaluation study on the issue of 
effective components of counseling, which will provide additional 
information. In the meantime, some preliminary evidence and experience 
shows that lay counselors can provide quality counseling and testing, 
including rapid testing, where the policy environment enables them to 
do so. This is an important aspect of task-shifting to maximize use of 
available workforce. Evidence has also demonstrated that group pretest 
counseling is effective in terms of high acceptance rates for opt-out 
counseling and testing. We have also learned that a conducive space 
and/or environment is important for counseling and testing, and this 
continues to be a major need in our focus countries.

    Question. Voluntary counseling and testing is an important tool in 
efforts to prevent and treat HIV/AIDS and to better understand and thus 
respond to the dynamics of local epidemics. As you know, the World 
Health Organization endorses the principle of opt-out testing for HIV 
in countries with generalized epidemics. Several focus countries, 
including Botswana, Kenya, and Uganda, have developed opt-out programs.
    What are the barriers to countries accepting and implementing opt-
out testing? What are we doing to help overcome those obstacles?

    Answer. As care and treatment services are scaled up in countries 
through PEPFAR support, more people who are tested and diagnosed as 
HIV-positive can be connected to ongoing care and treatment. This 
reduces many barriers to acceptance of the opt-out model of counseling 
and testing. The remaining obstacles are more issues of policy and 
capacity, such as the following:
    Policies support the traditional VCT model. The PEPFAR HIV 
counseling and testing interagency technical working group is 
addressing this by assisting countries with revising national policies, 
in particular by adapting the new WHO provider-initiated testing and 
counseling (PITC) guidelines. In addition to this policy work, we are 
specifically working to offer a PEPFAR-sponsored HIV counseling and 
testing workshop in Zambia in January 2008, to Ministry of Health 
representatives from a variety of countries.
    Training of health care workers. PEPFAR is addressing this by 
developing curricula and supporting training of nurses and lay 
counselors in opt-out testing and counseling. Recently, the PEPFAR-
developed counseling and testing curriculum was approved and adopted by 
the WHO. A PITC training package was further developed by PEPFAR, in 
collaboration by WHO, and will be disseminated to Ministry of Health 
staff for use in their countries, during the counseling and testing 
meeting in Zambia.
    Number of health care workers. The critical shortages of health 
care workers in PEPFAR countries pose a significant barrier. In 
response, PEPFAR focus countries engaged in large-scale activities in 
FY 2007 (continuing in FY 2008) to support the scale-up of qualified 
nurses and lay counselors to provide HIV counseling and testing. PEPFAR 
activities in this area include: Direct salary support for thousands of 
nurses and counselors, preservice and in-service training (including 
development of job aids); supervision and mentorship programs; 
coordination at facility, district, and regional levels; and training 
and support for national-level leadership in scaling up testing and 
counseling plans. Further methods for task shifting of counseling and 
testing will be discussed during the January 2008 meeting.
    Procurement and quality assurance of rapid test kits. PEPFAR is 
ramping up efforts across its 15 focus countries through its main 
supply chain management partner, the Supply Chain Management System, to 
strengthen procurement and quality assurance mechanisms for rapid HIV 
test kits in order to meet the anticipated growth in the demand and 
capacity for counseling and testing services.
                                 gender
    Question. What are the targets and indicators for gender in PEPFAR 
programs?

    Answer. PEPFAR addresses gender as a set of issues that cut across 
all programs, and measures progress with the following two approaches:
    1. Gender mainstreaming. At the beginning of PEPFAR, priority 
gender issues that impact PEPFAR goals were identified, and criteria 
were developed for gender programming in each program area. These 
``technical review criteria'' are updated annually and are used to 
evaluate the quality of gender activities in PEPFAR programs. Two 
primary evaluation methods are used: (1) Technical reviews of the 
Country Operational Plans by the PEPFAR Gender technical working group, 
and (2) assessments by the country teams (using a structured tool based 
on the criteria) of their own programs.
    2. Gender strategies. PEPFAR annually tracks programming on five 
priority gender strategies that were highlighted in the Leadership Act. 
These are: (1) Increasing gender equity in HIV/AIDS activities and 
services; (2) reducing violence and coercion; (3) addressing male norms 
and behaviors; (4) increasing women's legal protection; and (5) 
increasing women's access to income and productive resources. The 
number of country program activities that include one or more of these 
strategies is tallied and reported on in the PEPFAR Annual Report. The 
level of funding associated with these activities is also reported. 
Additionally, PEPFAR was the first international HIV/AIDS program to 
establish primary indicators for prevention, care, and treatment that 
are disaggregated by sex, providing data for monitoring gender equity 
in programs and services.
    Also, in 2006, PEPFAR launched three gender special initiatives in 
nine focus countries, involving: (1) Scaling up programs to address 
male norms and behaviors; (2) strengthening services for victims of 
sexual violence; and (3) confronting adolescent girls' vulnerability to 
HIV/AIDS. Evaluation methodologies for each initiative will be 
developed that can be applied across all country programs. For example, 
under the sexual violence initiative, standardized program indicators 
are being piloted to monitor uptake, delivery, and quality of clinical 
and other services for sexual violence victims, including HIV post-
exposure prophylaxis to prevent HIV infection.
    PEPFAR is currently developing second generation indicators that 
will not only strengthen our ability to report but also will improve 
the monitoring at the individual, clinic/facility and program level. 
Each technical working group (TWG), including Gender, will develop a 
set of these indicators in consultation with country teams and 
international experts. Many organizations that play a leading role in 
Gender and HIV programming have already begun discussions to identify 
meaningful indicators, and the PEFPAR Gender TWG will work with these 
groups during the indicator development process.
                                compacts
    Question. You have previously discussed the potential role that 
compacts could play in the next phase of our global HIV/AIDS programs.
    Please provide the committee with a detailed description of the 
compact approach, including an analysis of the authorities under which 
this program will operate, a framework for the proposed compacts, and a 
timetable for implementation.
    How will these compacts be similar to or differ from Millennium 
Challenge compacts?
    How do you foresee implementation of actions for noncompliance with 
the terms of the compacts short of cutting off funding for essential 
HIV/AIDS programs?
    Would such compacts allow for the direct transfer of funds to 
governments in support of national strategies?

    Answer. In terms of authorities, the Leadership Act gives the 
Coordinator broad authority to oversee the U.S. Government's 
international HIV/AIDS programs, and this authority is sufficient for 
the establishment of compacts. Specifically, the Leadership Act assigns 
the Coordinator the duty of ``pursuing coordination with other 
countries and international organizations'' and ``establishing due 
diligence criteria for all recipients of funds and all activities 
subject to the coordination and appropriate monitoring, evaluation, and 
audits carried out by the Coordinator necessary to assess the 
measurable outcomes of such activities.'' [Sec. 102] Moreover, the 
Leadership Act stipulates that ``the President is authorized to furnish 
assistance, on such terms and conditions as the President may 
determine, for HIV/AIDS, including to prevent, treat, and monitor HIV/
AIDS, and to carry out related activities, in countries in sub-Saharan 
Africa, the Caribbean, and other countries and areas.'' [Sec. 301]
    The following is a current description of the compact framework. 
Compacts will be pursued with countries with significant HIV/AIDS 
burdens in which the U.S. Government (USG) has a well-established on-
the-ground presence and where USG resources would play a substantial 
role and have a comparative advantage in the fight against HIV/AIDS. 
Compacts will serve as a framework for moving forward together to save 
as many lives as possible with the resources that are available. 
Compacts will be structured to promote deeper integration of HIV/AIDS 
services into health systems, seeking to promote sustainability by 
ensuring that HIV/AIDS programs build capacity and benefit health 
systems overall.
    Compacts must be tailored to local circumstances, so their 
development will be led by USG country personnel, who have 
relationships with key stakeholders. Compacts are anticipated in both 
PEPFAR's current focus countries and in additional countries, and will 
link new USG resources to host country commitments in two key areas:
1. Financial commitment
    Resources differ dramatically from country to country, based on 
each nation's level of development. Almost every nation severely 
affected by HIV/AIDS can do more. For example, in the 2001 Abuja 
Declaration, African governments committed themselves to devote at 
least 15 percent of their budgets to health; only a few have reached 
this level. Several current focus countries have significant resource 
allocations to HIV/AIDS, yet nearly all can do more. In some countries, 
``more'' can be measured in hundreds of thousands of dollars, in others 
millions, tens of millions, or more. It is important that resources for 
HIV/AIDS do not offset other health or development areas, and this will 
be reflected in the compacts.
2. Policy commitment
    Policy changes can create an environment conducive to an effective 
health and HIV/AIDS response, ensuring that available resources are 
optimally used to save as many lives as possible. While agreements 
would vary from one country to another, key issues addressed might 
include:

   Workforce: Regulations and policies that allow effective 
        task-shifting for health care workers.
   Gender: Regulations and policies to stop gender-based 
        violence and discrimination, prevent transgenerational sex, and 
        protect women's inheritance rights.
   Orphans: Regulations and policies to protect the inheritance 
        rights of children.
   HIV-specific: Regulations and policies that promote 
        diagnostic counseling and testing, pediatric diagnosis, rapid 
        tariff-free regulatory procedures for drugs and commodities, 
        and full inclusion of people living with HIV/AIDS in a 
        multisectoral national response.

    A timetable for implementation has yet to be determined. A 
consultative process to gather input from USG field and headquarters 
personnel and other stakeholders on this and other issues is underway.
    A key distinction between MCC compacts and PEPFAR compacts will be 
their focus issues. PEPFAR compacts will focus on the HIV/AIDS policy 
issues described above, rather than broader criteria relating to 
governance and the economy. MCC staff are being included in the 
consultative process described above, in order for PEPFAR to learn more 
about MCC's approach and possible areas of similarity and difference 
for compacts under the two initiatives. USG staff with relevant 
experience with models other than MCC are also being consulted.
    Options for noncompliance have yet to be determined. A consultative 
process to gather input from USG field and agency personnel and other 
stakeholders on this is under way.
    As with current PEPFAR programs, additional PEPFAR resources under 
compacts will be provided in support of multisectoral national HIV/AIDS 
plans. As at present, there will likely be some transfers of funds to 
governments as implementing partners for specific programs, but there 
are no plans for general budget support of governments.
           operations research and monitoring and evaluation
    Question. How much does PEPFAR currently spend on operations 
research and evaluation?

    Answer. PEPFAR dedicated approximately $72 million to operations 
research and evaluation in FY07, including approved spending for COP-
funded public health evaluations, centrally funded public health 
evaluations, and other operations research activities. Of this, $54.5 
million was directed toward operations research in priority prevention 
activities, including those associated with gender-based violence, male 
circumcision, prevention with positives, adolescent and young girls, 
and men as partners.
    PEPFAR further spends over $135 million on strategic information in 
all countries, including monitoring and evaluation activities that may 
include operational research. Lastly, some monitoring and evaluation 
activities are budgeted by countries under prevention, care, and 
treatment categories; while these amounts cannot clearly be identified, 
the total investment in operational research is larger than the $72 
million set aside for operations research in 2007.

    Question. Do you agree that more resources should be put toward 
evaluating PEPFAR programs through operations research, so that we are 
maximizing every dollar spent?

    Answer. Operations research and evaluation, including public health 
evaluations, are integral to guiding program implementation and 
improvement under PEPFAR, and significant resources are dedicated to 
this area. Guidance to country teams in PEPFAR focus countries suggests 
1-4 percent as a reasonable spending range to support public health 
evaluations in the COP planning process. This level of spending is 
appropriate and compares to that provided under the Ryan White Care 
Act, which provides a useful domestic benchmark for the PEPFAR program.
    PEPFAR approved over $72 million for operations research in 2007, 
and further invested $135 million on strategic information, of which an 
important component is monitoring and evaluation. Combining these 
investments with additional studies that may be supported through other 
budget categories, PEPFAR believes the current level of funding for 
operations research is appropriate, and in balance with competing 
priorities of prevention, care, and treatment activities.

    Question. What are the opportunities to enhance the role of NIH and 
CDC in improving and expanding operations research?

    Answer. Within PEPFAR, operations research and evaluation 
activities have been led by CDC and USAID and their implementing 
partners to guide program implementation and on-going improvement 
efforts. NIH has focused on biomedical research and other 
investigational trials to develop new interventions, rather than on 
operations research on existing interventions. We believe that the 
agency contributions in their respective areas of expertise meet the 
needs of PEPFAR to guide program implementation and improvement, and 
that the scale and scope of these operations research efforts are 
appropriate.

    Question. How can monitoring and evaluation be most effectively 
elevated as one of PEPFAR's functions?

    Answer. Monitoring and evaluation (M&E) is a vitally important 
component of PEPFAR's program and its continued success. Indeed, 
PEPFAR's intensive focus on measuring progress, establishing evidence, 
and adapting to experience prompted the Institute of Medicine to label 
it a ``learning organization'' in its congressionally mandated 
assessment in 2006. PEPFAR guidance for country operational plans 
states that PEPFAR country teams should spend approximately 7 percent 
of their budget on strategic information, including M&E. M&E projects 
can be found throughout Country Operational Plans in every intervention 
area.
    One of the most useful ways to improve the impact of monitoring and 
evaluation in the next phase of PEPFAR is through the previously 
mentioned initiative to improve the quality of PEPFAR program 
indicators. PEPFAR is developing outcome-based indicators for programs 
in addition to its existing output indicators, which have centered on 
the number of people trained or served. These second generation 
indicators will help us improve reporting on programs having a positive 
or negative impact on the outcomes we care about, such as risk behavior 
in youth, and also help strengthen monitoring at the individual, 
clinic/facility and program level. Monitoring and evaluation, 
therefore, will have a continued strategic role in assessing program 
effectiveness. Each technical working group (TWG) will develop a set of 
these indicators in consultation with country teams and international 
experts.
    Additionally, in 2007, PEPFAR developed the Public Health 
Evaluation (PHE) Framework to provide strategic coordination of 
evaluation activities. This framework monitors and supports country 
evaluation activities to help reduce redundancy and to share 
information across programs. More importantly, this framework supports 
broader strategic operations research that measures the effectiveness 
of programmatic interventions across populations and even countries, 
aiming to answer some of the most critical programmatic questions 
PEPFAR faces. All PHE activities are guided by interagency committees 
of strategic information experts, and successful evaluation activities 
are shared at the annual ``Implementers' Meeting'' to disseminate 
program results to attending PEPFAR and partner staff and thereby 
strengthen PEPFAR programs. The PHE framework will increase the impact, 
use, and dissemination of evaluation studies conducted in PEPFAR 
countries throughout the next phase.
    Last, the role of monitoring and evaluation will be enhanced 
through PEPFAR's continued support for the UNAIDS ``Three Ones'' 
principle; one agreed HIV/AIDS Action Framework that provides the basis 
for coordinating the work of all partners; one National AIDS 
Coordinating Authority, with a broad-based multisectoral mandate; and 
one agreed country-level M&E System. This commitment means that PEPFAR 
coordinates at a national level to support patient monitoring, program 
evaluation, and quality assurance activities, among others. PEPFAR has 
been a leader in building national capacity in the Ministries of Health 
and important civil society partners to manage the M&E portfolio. These 
efforts have included building surveillance and patient monitoring 
systems, and training staff in the analysis and use of data for 
programmatic decisionmaking. In these efforts, PEPFAR must not be the 
sole M&E provider but part of a team, working in coordination with 
other partners to ensure sustained country ownership, the continued 
support of other international partners, and ultimately, the 
sustainability of the national M&E program.
                              coordination
    Question. Please elaborate on what kind of coordination takes place 
within the PEPFAR program (including OGAC, CDC, NIH, and USAID) and 
with other programs (USAID maternal and child health programs for 
example). Would you support a joint interagency review of Country 
Operational Plans to foster strengthened collaboration and coordination 
for more effective wraparound service programs?

    Answer. First, PEPFAR is built upon a model of interagency 
coordination to achieve shared HIV prevention, care, and treatment 
goals. Collaboration among agencies occurs at the planning, 
implementation, and evaluation stages of HIV activities, as well as at 
the decisionmaking level.
    In each country that receives PEPFAR support, a USG country team 
including representatives from USG agencies in-country (e.g., USAID, 
CDC, Peace Corps, and Department of Defense (DOD)) works together to 
plan HIV/AIDS activities, in coordination with the host government and 
civil society. This process requires agencies to consider comparative 
strengths, avoid duplication, and provide technical coordination and 
support to one another to deliver one HIV/AIDS program with a shared 
set of targets at the country level. An ongoing ``staffing for 
results'' effort has further strengthened the concept of one 
interagency country team to achieve common targets, by profiling the 
expertise and function of each agency staff member and making sure she 
or he fits efficiently into one USG country team, without unnecessary 
overlaps between agencies. After planning, these USG country teams 
continue to work closely together to make sure that they achieve their 
shared targets. This includes regular technical and operational 
meetings, site monitoring, and evaluation visits.
    The country operational plans (COPs) and results of each country 
program are assessed through a rigorous series of technical and 
programmatic reviews, which are conducted by working groups with 
participation from USAID, NIH, Department of State, Department of 
Health and Human Services, Health Resources and Services 
Administration, CDC, Department of Labor, Department of Commerce, Peace 
Corps, and Department of Defense. These interagency COP reviews form a 
complex and labor-intensive process that takes approximately 3 months. 
Further, PEPFAR's principals and deputy principals committees are 
interagency bodies that provide senior policy and implementation 
leadership. These committees meet regularly to make collaborative 
decisions on operational, technical, and policy issues.
    Collaborations with other agencies/offices of the USG also occur 
continuously to integrate HIV/AIDS activities with programs such as 
maternal and child health, education, family planning, and food and 
nutrition. Substantial dialogue takes place at the headquarters level 
to strategize coordinated efforts to address linkages between HIV/AIDS 
and family planning, nutrition, and education in particular. PEPFAR's 
own Public-Private Partnership section works closely with USAID's 
Global Development Alliance (GDA) to further integrate public-private 
partnerships in these and other areas.
    At the headquarters level, PEPFAR collaborates with other agencies 
through technical bodies such as the ``HIV/Food and nutrition working 
group,'' comprised of USAID Food for Peace and PEPFAR technical 
advisors that establish policy guidance on integrated HIV/food and 
nutrition activities. Further integration takes place through joint 
programming in-country, where country teams ``wraparound'' HIV 
prevention, care, and treatment activities with non-HIV activities. 
Every year, countries show increasing investment in these models of 
service integration.
    PEPFAR welcomes further dialogue and coordination at the 
headquarters level to share information, develop improved field 
guidance, and plan special initiatives. At the same time, decisions on 
the delivery of integrated and/or wraparound programs will continue to 
take place at the country level, to make sure that interventions are 
appropriate to local needs. For this reason, PEPFAR reaches out on a 
continuous basis to other agencies and offices so they can strengthen 
wraparound programs by supporting PEPFAR field teams--such as through 
site visits and technical assistance during the COP planning season. 
Rather than making recommendations at headquarters during COP review, 
ongoing contact between programs in each country throughout the 
planning cycle is essential for wraparound partners to have their input 
fully reflected in the COP document.

    Question. Please explain the coordination between PEPFAR programs 
and the President's Malaria Initiative.

    Answer. HIV/AIDS and malaria are dual epidemics that cause illness, 
suffering, and death among many of the same communities in the same 
areas of the world. This reality demands that HIV/AIDS and malaria 
programs coordinate to: Avoid duplication of efforts; capitalize on 
opportunities to extend essential interventions to populations at risk 
of both diseases, such as pregnant women and children under the age of 
five; and ensure that there is efficient use of resources, commodities, 
and personnel.
    The President's Malaria Initiative (PMI) and the President's 
Emergency Plan for AIDS Relief (PEPFAR) share seven common focus 
countries: Ethiopia, Kenya, Mozambique, Rwanda, Tanzania, Uganda, and 
Zambia. PMI and PEPFAR have developed a collaborative framework for 
action in these countries that will avoid duplication, ensure safety, 
maintain appropriate and efficient funding streams, and result in an 
overall increase in coverage of key interventions.
    PEPFAR and PMI have agreed to hold quarterly headquarters meetings 
to discuss the status of current collaborations, and may also hold 
``calls home'' from the field to both collect and distribute 
information about collaborative best-practices. Additionally, several 
of PEPFAR's technical working groups, including those on laboratory, 
blood safety, care and pediatrics, are organizing program-specific 
meetings with PMI staff. Field personnel are also sharing annual 
operational plans between HIV/AIDS and malaria programs to rationalize 
the use of USG resources.
    In all shared focus countries, PEPFAR supports strengthening health 
systems--such as laboratory and commodities capacity--as well as the 
health workforce, which can be leveraged to deliver malaria 
interventions. Several recent examples of successful collaborations 
between PMI and PEPFAR programs in the field include:
    (1) PEPFAR's outreach to increase the percentage of pregnant women 
attending antenatal clinics (ANCs) for prevention of mother-to-child 
HIV transmission (PMTCT) has allowed malaria programs working in ANCs 
to reach more of a key target population.
    (2) In Zambia, approximately 1 million people are receiving the 
benefits of insecticide-treated bed nets through a $2.5 million public-
private partnership among PEPFAR, PMI, and the Global Business 
Coalition on HIV/AIDS, Tuberculosis and Malaria (GBC). PMI is 
distributing the mosquito nets through PEPFAR's existing home-based 
care network in Zambia, RAPIDS, which reaches more than 154,000 
households. This allows PMI to reach the most vulnerable populations 
while decreasing its distribution costs. Find more information on this 
initiative at: http://www.pepfar.gov/c22130.htm.
    (3) Insecticide-treated bed nets are also distributed to HIV-
positive persons in Uganda and Kenya as part of a basic HIV care 
package, which seeks to keep HIV-positive people healthy and delay the 
need for antiretroviral treatment.
    (4) In Uganda and Kenya, PEPFAR procurement of microscopes for 
clinics in order to diagnose tuberculosis also enables improved 
diagnosis of malaria.
    (5) In Mozambique, supply-chain coordination for malaria and HIV/
AIDS commodities has been streamlined under one manager, decreasing 
overhead costs and ensuring coordination.
    (6) In Tanzania, the upcoming PEPFAR-supported HIV Indicator Survey 
will also function as a Malaria Indicator Survey, reducing the costs of 
essential epidemiological surveillance.
    PEPFAR will continue to explore ways to leverage infrastructure, 
personnel, and resources in partnership with PMI, host country 
governments, and multilateral organizations to increase coverage with 
both programs.

    Question. As we discussed, please provide us with an overview of 
coordination between PEPFAR, the Global Fund, and other major donors 
such as the World Bank.

    Answer. PEPFAR plays an important role in convening, supporting, 
and participating in partnerships with the Global Fund to Fight HIV/
AIDS, TB, and Malaria (the Global Fund), the WHO, UNAIDS, the World 
Bank, and others. In 2007, PEPFAR, the World Bank, WHO, the Global 
Fund, and UNAIDS introduced the first jointly-convened Implementers' 
Meeting to bring together the headquarters and field staff of PEPFAR 
and other major implementing partners. Many sessions focused on ways to 
improve partnership at the country level, and representatives of the 
various implementing organizations held numerous ad-hoc meetings to 
discuss collaboration more informally. Additionally, PEPFAR guidance 
for Country Operational Plans stresses the importance of field 
coordination with other partners--particularly the Global Fund--around 
shared activities, targets, and goals, and provides guidelines for this 
coordination.
The Global Fund
    The United States, through PEPFAR, is the largest contributor to 
the Global Fund, having provided nearly one-third of total resources, 
or a total of $2.5 billion, to date. A PEPFAR interagency ``core 
group'' reviews Global Fund country programs and grant requests, 
communicates with USG field staff familiar with the strengths and 
challenges of Global Fund programs, and engages in other activities to 
help the Global Fund successfully meet the requirements of performance-
based funding. This core group also helps to coordinate Global Fund and 
PEPFAR activities on an international level. Further strengthening the 
partnership of PEPFAR and the Global Fund, the Global AIDS Coordinator 
serves as the Chair of the Global Fund Finance and Audit Committee, and 
the USG is also represented on the Policy and Strategy committee. 
Additionally, USG field personnel sit on a majority of national-level 
Global Fund country coordinating mechanisms (CCMs), contributing to the 
development and selection of proposals and oversight of implementation.
    In PEPFAR focus countries, field personnel from PEPFAR and the 
Global Fund leverage the resources of both programs to deliver a 
comprehensive program that meets shared objectives. For example, in 
Uganda, all the operational costs of TB/HIV sites are supported by the 
Global Fund, and PEPFAR supports the personnel, training, and quality 
assurance costs at these sites. Similarly, in many countries, PEPFAR 
country teams have arranged for the Global Fund to supply 
antiretroviral drugs and commodities to HIV treatment sites, while 
PEPFAR supports the personnel, training, infrastructure improvement, 
operations, and quality assurance of these sites. As the two largest 
international partners in most PEPFAR focus countries, the Global Fund 
and PEPFAR work together under one national plan and strategy, 
consistent with the UNAIDS ``Three Ones'' principles.
    In other PEPFAR countries, where the Global Fund is often the 
largest international partner on HIV/AIDS, PEPFAR works to maximize the 
impact of Global Fund resources and to fill gaps in support of a 
comprehensive HIV/AIDS program. At the request of Global Fund Country 
Coordinating Mechanisms, PEPFAR provides technical assistance to Global 
Fund grantees, helping them overcome bottlenecks, expand access to 
services, and resolve major issues that can cause grant failure in 
areas such as program management; governance and transparency; 
procurement and supply-chain management; and monitoring and evaluation.
    To further promote coordination, PEPFAR has entered into Memoranda 
of Understanding (MOUs) with the Ministries of Health and the Global 
Fund in several countries. These documents help clarify collaboration 
and partnership activities in such areas as antiretroviral treatment 
(ART) provision.
The United Nations
    Working with U.N. partners strengthens PEPFAR's response to HIV/
AIDS. A visible example of the advantages of working through the U.N. 
emerged in 2006 at the U.N. General Assembly High Level Meeting on 
AIDS, where First Lady Laura Bush called for an International Voluntary 
HIV Counseling and Testing Day. After a successful feasibility study by 
UNAIDS, the USG and 24 other governments from Africa, the Americas, and 
Asia proposed a decision calling on all U.N. Member States to observe 
an International Voluntary HIV Counseling and Testing Day in 2007, and 
this decision was adopted by consensus at the U.N. General Assembly. 
PEPFAR now is working with WHO and UNAIDS to support countries in 
holding successful Testing Day events.
    PEPFAR also actively supports the work of UNAIDS, and provided over 
$30 million in funding in 2007. The previously mentioned ``Three Ones'' 
agreement, of which PEPFAR has been a key supporter, was also developed 
under the auspices of UNAIDS. PEPFAR also participates on the Global 
Task Team on Improving AIDS Coordination Among Multilateral 
Institutions and International Donors (GTT), which was created in 2005 
to help implement the Three Ones. The GTT has made specific 
recommendations for partner coordination under the Three Ones, 
particularly within the multilateral system, resolving areas of 
duplication and gaps in the global response to HIV/AIDS.
    PEPFAR's strategic information team has worked intensively with 
UNAIDS and other international partners to implement the GTT's 
recommendations in the monitoring and evaluation area. One result has 
been the close partnership between PEPFAR and the WHO to develop 
patient monitoring guidelines, which are an important step toward a 
standardized approach to monitoring patients on ART. At the country 
level, the Global Fund, Millennium Challenge Corporation, non-PEPFAR 
USG agencies and offices, and PEPFAR country teams cosponsor 
Demographic Health Surveys, which provide one set of national 
behavioral and health data for each country.
    Additionally, PEPFAR technical experts participate in U.N.-led 
joint reviews of TB and HIV/AIDS programs and collaborate closely with 
WHO experts to support the development of normative WHO guidelines in 
areas such as treating children with TB and managing smear-negative TB. 
PEPFAR country teams also work in partnership with UNICEF to help 
deliver care and support services for orphans and vulnerable children 
across PEPFAR countries, using a 6-point strategy.
The World Health Organization
    As a WHO Member State with considerable expertise in HIV/AIDS, the 
United States plays a key role in formulating HIV/AIDS-related policy 
and guidelines. The USG actively participates in the World Health 
Assembly--where Emergency Plan policy often informs the discussion--and 
partners with WHO and host country governments to adapt and implement 
such policies at the country level. PEPFAR also seconds a number of 
senior USG technical experts to WHO each year to further establish 
technical coordination and program integration.
    PEPFAR cooperation with WHO is especially important in several 
areas, including rolling out male circumcision, prevention of mother-
to-child HIV transmission, safe blood programs, and fighting TB/HIV 
coinfection. For example, PEPFAR supports a roughly $2 million, 2-year 
PEPFAR-WHO collaboration that is conducting innovative TB/HIV work in 
Ethiopia, Kenya, and Rwanda. This project provides HIV counseling and 
testing for clients attending TB clinics, as well as linkages between 
TB and HIV/AIDS programs, in order to improve access to ART for TB 
patients or suspects. PEPFAR also supports WHO's Green Light Committee 
and the international partnership STOP-TB in their country efforts to 
prevent and treat TB, including drug-resistant TB.
    A second major PEPFAR-WHO partnership addresses the chronic 
shortage of adequately trained health care workers in PEPFAR countries. 
A PEPFAR-WHO joint effort addresses the constraints countries face in 
promoting effective ``task-shifting'' from physicians and nurses to 
less highly skilled health care workers. The joint project focuses on 
three activities: (1) Identification and documentation of best 
practices; (2) standardization of training and certification criteria; 
and (3) definition of the policy, legal, financial, and social 
framework for task-shifting. To accomplish these three activities, 
research would be conducted and methods piloted in a targeted but 
diverse group of countries which includes Ethiopia, Haiti, Malawi, 
Mozambique, Rwanda, and Uganda.
    National-level partnerships between PEPFAR and the WHO further 
implement these international-level initiatives. For example, Namibia 
has adopted WHO clinical care guidelines that are based on a task-
shifted model of integrated HIV and primary health care. PEPFAR and WHO 
staff in Namibia work together to coordinate policy development, 
operations support, quality assurance, and the training and oversight 
of the health workforce at the sites implementing these guidelines.
    Additionally, PEPFAR and WHO are working together to make essential 
antiretroviral drugs (ARVs) more rapidly available in countries where 
they are most urgently needed. HHS/FDA and the WHO Prequalification 
Program have established a confidentiality agreement by which, with 
company permission, the two organizations share dossier information 
regarding reviews and inspections. As a result, generic ARVs which have 
been HHS/FDA approved or tentatively approved can be added rapidly to 
the WHO prequalification list. The rapid WHO prequalification of these 
medications hastens in-country drug regulatory review and, 
consequently, the availability of lower cost, high-quality ARVs in-
country.
    Last, together with UNICEF and WHO, PEPFAR has launched a public-
private partnership to promote scientific and technical discussions on 
solutions for pediatric HIV treatment, formulations, and access. This 
partnership brings together the resources of innovator and generic 
pharmaceutical companies, civil society organizations--such as the 
Elizabeth Glaser Pediatric AIDS Foundation and the Clinton Foundation--
and the U.N. system, to maximize the utility of currently available 
pediatric formulations and to accelerate children's access to 
treatment.
                         gender-based violence
    Question. As I mentioned during the hearing, I will soon be 
introducing, along with Senator Lugar, a comprehensive piece of 
legislation which will address violence against women and girls 
internationally. How, generally speaking, can increased programming and 
training to prevent and respond to violence against women and girls 
impact the work and initiatives of your office, particularly with 
respect to gender-based violence and the transmission of HIV?

    Answer. Gender-based violence (GBV) is a critical factor in the 
spread of HIV/AIDS and challenges the health and well-being of women 
and girls worldwide. PEPFAR has invested significantly in programming 
to address the intersection of GBV and HIV/AIDS and welcomes broader 
USG involvement to prevent and respond to violence against women and 
girls globally. As a general matter, increased efforts to address the 
societal issues of violence against women and girls will support HIV/
AIDS efforts, because GBV is a driver of HIV/AIDS transmission. 
Effective efforts to address male norms, alcohol, and other drivers of 
GBV can thus have a positive, secondary effect on HIV/AIDS programs.
    PEPFAR's strategic investments in GBV related to HIV/AIDS impact 
the HIV/AIDS pandemic, while also contributing to a broader USG mission 
to combat GBV globally. PEPFAR investment in GBV has increased each 
year, and in FY 2007, this support rose to over $188 million, an 80-
percent increase from FY 2006, and included more than 313 activities in 
the 15 focus countries. GBV interventions supported through PEPFAR are 
programmed both as ``stand-alone'' activities (where addressing GBV is 
a primary objective) and ``integrated'' activities (where addressing 
GBV is a secondary objective within a broader program). In FY 2007 
PEPFAR launched three Gender Special Initiatives, one of which responds 
to victims of sexual violence, rape, and assault in clinical settings. 
Implemented in three focus countries (South Africa, Rwanda, and 
Uganda), this intervention will develop and test optimal models of 
service delivery for victims, including post-exposure prophylaxis (PEP) 
and linkages to police and judicial support. Lessons from these 
initiatives will then be shared across all countries.
    PEPFAR is committed to leveraging existing comprehensive programs 
to deliver GBV activities. The Women's Justice and Empowerment 
Initiative (WJEI) is an example of this leveraging; PEPFAR funds will 
support PEP and other HIV/AIDS-related GBV activities, while WJEI 
addresses other needs, including capacity-building for police and 
access to legal services. Additionally, PEPFAR works in the following 
program areas to reduce GBV and its effects globally:
    Services for victims of sexual violence. Examples include clinical 
management supported by psychosocial/trauma counseling, linkages to 
legal assistance, emergency shelter and social support, and longer term 
community reintegration. PEPFAR is also working to develop 
``wraparound'' activities, such as with WJEI, on policy and legal 
reform, justice system strengthening, capacity-building of police, 
access to legal services, economic empowerment activities, and 
temporary shelter.
    Screening and counseling for GBV within PMTCT, HIV counseling and 
testing, and other HIV/AIDS services. PEPFAR supports GBV screening and 
counseling in health care settings, expanding the reach of existing GBV 
programs and strengthening local NGOs (including faith- and community-
based organizations) to fill gaps in social support services, 
supplement efforts in the health sector.
    Empowering girls and women to prevent, identify, and leave abusive 
relationships. PEPFAR activities support women and girls in avoiding or 
stepping out of violent situations through life-skills and income-
generating activities, among others.
    Working with men to prevent violence against women and girls. 
PEPFAR supports HIV prevention programs that work with young men and 
boys to change male norms associated with HIV infection, including 
behaviors that lead to sexual violence. PEPFAR will continue to expand 
these efforts, which serve as a promising area for potential future 
collaborations to promote effective interventions for rehabilitation 
and prevention among perpetrators.
    Changing community and social norms that condone or facilitate GBV. 
PEPFAR supports intensified and coordinated public education campaigns 
and awareness-raising about GBV that utilize a variety of community-
based and media strategies.
    Strengthening policy and legal frameworks. PEPFAR supports efforts 
in host nations to develop and enforce stronger laws against GBV, as 
well as policies that reduce GBV indirectly, such as codification of 
women's inheritance rights.
    PEPFAR will continue to work collaboratively to respond to the 
intersection of GBV and HIV/AIDS.
                                 ______
                                 

 Responses of Ambassador Mark Dybul to Questions Submitted by Senator 
                            Robert Menendez

                      health system strengthening
    Question. We have heard from various stakeholders that although 
PEPFAR has shown some real success, there is a concern about the 
sustainability of the program at the country level due to the great 
need to strengthen developing country health systems. We all know that 
effective HIV care requires more than treatment. It also requires 
laboratory capacity to perform CD4 testing, to diagnose tuberculosis 
and treat opportunistic infections.

   Will PEPFAR be taking these issues into account in the next 
        phase of the program?

    Answer. PEPFAR has significantly invested in sustainable 
improvements to national health systems, and plans to continue to do 
so. PEPFAR's core approach is based on strengthening the network model 
of care in national health systems by investing in central referral 
centers, provincial and district facilities, primary health care 
centers, and ultimately, communities. While PEPFAR's focus has been to 
strengthen HIV/AIDS efforts, the use of this model has resulted in much 
broader impact across health care systems. In FYs 2004-06 in the 15 
focus countries, the Emergency Plan supported the training or 
retraining of more than 1.6 million health care providers and provided 
infrastructural improvements, technical assistance, and/or operations 
support for over 25,100 service delivery sites. These trained health 
care workers not only deliver better services, improving the quality of 
care across the entire system, but also can free up other health care 
workers for additional tasks.
    Some have expressed concern that a significant expansion of HIV/
AIDS programs could draw resources and personnel from other health 
fields. However, the data do not support that view. In recent decades, 
child mortality increased in Botswana due to HIV/AIDS despite a 
significant increase in government resources for child survival and 
health. Now that investments in HIV/AIDS programs have scaled up 
significantly, infant mortality is declining again. In a study in 
Rwanda of 22 non-HIV/AIDS indicators, 17 showed statistically 
significant increases after the introduction of basic HIV care. In 
addition, in many countries, 50 percent of hospital admissions are due 
to HIV/AIDS. As effective HIV care and treatment programs are 
implemented, hospital admissions plummet, easing the burden on health 
care staff throughout the system.
    Further, PEPFAR supports the salaries of tens of thousands of 
health care workers. In Namibia, PEFPAR-supported clinical staff 
provide the vast majority of HIV treatment in the entire country. These 
health care workers, though trained in HIV treatment, are also trained 
and supported to provide health services to HIV and non-HIV patients. 
PEPFAR further strengthens preservice training institutions, through 
infrastructure, curriculum, and faculty development, which 
significantly increase the number of health care workers available to 
the health system each year.
    PEPFAR also builds and renovates clinics, pharmacies, and 
laboratories, which offer patient care for HIV- and non-HIV-related 
needs. Additionally, PEPFAR supports ongoing training, mentoring, and 
other support to Ministries of Health and indigenous partners in key 
areas of HIV/AIDS programming, such as policy development, health 
systems planning, program implementation, and monitoring and 
evaluation. As a measure of this commitment, over 80 percent of PEPFAR 
partners are indigenous organizations. Overall, PEPFAR estimates its FY 
2007 investment in network development, human resources, and local 
organizational capacity development and training at approximately $638 
million, or approximately one-quarter of total PEPFAR program 
resources.
    Moreover, PEPFAR support for the development of sustainable 
strategic information systems to measure PEPFAR's progress toward its 
prevention, care, and treatment targets has directly resulted in the 
strengthening of country health monitoring, reporting, surveillance and 
evaluation systems, all of which lead to improved programming. The 
surveillance, patient record, and country reporting systems that are 
either in place or being created are leading to improved methods of 
disease tracking.
Laboratory capacity
    Laboratory capacity is an essential component of PEPFAR support. In 
every focus country, PEPFAR supports the establishment of national, 
tiered laboratory networks, built upon an accredited national reference 
laboratory. In 2007, PEPFAR invested approximately $160 million in 
strengthening laboratory networks, through activities such as 
construction and renovation of laboratories, training of laboratory 
personnel, strengthening laboratory supply chains, and building of 
quality assurance programs. The increased laboratory capacity supported 
by PEPFAR to provide HIV/AIDS services also provides essential lab 
tests that benefit a wide range of patients in addition to those with 
HIV.
    Similarly, PEPFAR works with host countries through its Supply 
Chain Management System to build transparent and accountable 
procurement and supply systems that ensure an uninterrupted supply of 
high-quality and low-cost drugs, lab equipment, testing kits, condoms, 
and other critical commodities. Along with HIV/AIDS commodities, these 
supply chains can deliver medicines and supplies for malaria, 
tuberculosis, and other diseases.
    In 2007 PEPFAR launched a pioneering, $18 million public-private 
partnership with Becton, Dickenson, and Company, an international 
global medical technology firm, to build laboratory capacity in several 
PEPFAR focus countries that are severely affected by HIV and TB. The 5-
year partnership will support host governments and partners to develop 
integrated laboratory systems, services, and quality-improvement 
strategies; improve the quality of laboratory diagnostics for HIV and 
TB; implement quality-control and quality-assurance guidelines and 
supervisory tools for hematology, chemistry, CD4 testing and rapid HIV 
testing; and strengthen TB reference sites to serve as centralized 
training facilities. The partnership will increase laboratory capacity 
in target countries by 15-20 percent in its first year.
    Overall, PEPFAR investment has created a self-reinforcing ripple 
effect of positive change in national health systems. Building the 
capacity of leadership and infrastructure to plan and address the 
health conditions associated with HIV/AIDS increases capability and 
confidence to address planning and service delivery in other health 
issues. Instead of any negative impact on health systems, the data from 
PEPFAR sites has demonstrated increases in the uptake of services in 
family planning, care, maternal and child health, and STD services, 
after HIV/AIDS investments were made.
    PEPFAR will continue to support health systems and capacity-
building initiatives to further advance these capabilities, and will 
continue to work to foster increased financial commitment and needed 
policy change by host governments. PEPFAR will also deepen existing 
relationships to other international partners and USG programs to 
strengthen joint efforts to address related issues that impact people 
living with HIV, such as nutrition, education, and gender.
                        safe injection practices
    Question. One of the prevention initiatives that has been proven to 
be both highly effective and cost-effective is integrating safe 
injection practices and the use of safe injection devices into the 
practice of medicine. This phase of PEPFAR does not include a line item 
for these programs.

   Nonetheless, is it correct that the program will continue 
        these efforts in light of their effectiveness in preventing 
        transmission?

    Answer. According to UNAIDS, unsafe injections in health care 
settings account for approximately 2.5 percent of new infections in 
sub-Saharan Africa. In FY 2007 PEPFAR invested over $12.4 million in 
promoting injection safety, and plans to continue to support 
interventions for safe injection practices in the next phase of the 
Emergency Plan. Ongoing activities include improving injection safety 
practices through training and capacity-building; ensuring the safe 
management of sharps and waste; and reducing unnecessary injections 
through the development and implementation of targeted advocacy and 
behavior-change strategies.
                         tuberculosis diagnosis
    Question. For a number of years, HIV and infectious disease experts 
have recognized that linking tuberculosis diagnosis and care and HIV 
diagnosis and care are critical to effectively managing care for people 
living with HIV/AIDS. The Global AIDS Roundtable has recommended that 
PEPFAR allocate at least 10 percent of its funding to diagnosing and 
treating TB in HIV-infected patients.

   Will the program integrate this recommendation into its 
        strategic plan?

    Answer. The coinfection of TB and HIV is a serious threat to the 
public health progress of many countries supported by the Emergency 
Plan. The Emergency Plan has invested significant resources in 
combating the coinfection of TB and HIV, leading a unified U.S. 
Government (USG) response to fully integrate HIV prevention, treatment, 
and care with TB services at the country level in Emergency Plan 
countries. PEPFAR is the largest bilateral supporter of TB programs in 
the world, investing resources in three primary ways.
    First, for FY 2007, the Emergency Plan has dedicated over $131 
million to TB/HIV activities. Funding supports providing HIV testing 
for people with TB and TB diagnostics for people living with HIV; 
ensuring eligible TB patients receive HIV/AIDS prevention, treatment, 
and care; implementing the WHO-recommended TB treatment protocol, 
Directly Observed Therapy--Short Course (DOTS); bolstering surveillance 
and infection control activities; strengthening laboratory capacity and 
supply chain management; and working with the U.S. Federal TB Task 
Force to coordinate the USG response.
    Second, the USG is the largest contributor to our most significant 
partner in the prevention and control of TB--the Global Fund to Fight 
AIDS, Tuberculosis, and Malaria. The United States Government, through 
PEPFAR, contributed $724 million in 2007, representing nearly one-third 
of the fund's contributions from all sources. With these resources, the 
Global Fund has committed roughly 17 percent of its funding to national 
TB programs around the world. As a result, $123.1 million of Global 
Fund TB activities can be considered as coming from PEPFAR's 2007 
ontribution. [This figure was estimated by multiplying PEPFAR's annual 
contribution to the Global Fund by 17%, which represents annual PEPFAR 
funding that supports Global Fund TB activities.] This support includes 
technical assistance to the Global Fund country coordinating mechanisms 
to strengthen the planning, implementation, and evaluation of TB grant 
activities. PEPFAR is also involved in the oversight and management of 
the Global Fund, with high-level representation on the Board and 
several Global Fund committees, to ensure effective program delivery.
    Third, the Emergency Plan invests additional resources for TB 
globally through strategic partnerships with the World Health 
Organization, and the STOP TB Partnership. The Emergency Plan works 
closely with the WHO to implement a 2-year collaborative effort to 
support scale-up of TB/HIV services in Rwanda, Kenya, and Ethiopia. 
With the STOP TB Partnership, the Emergency Plan provides technical 
assistance for the Advocacy, Communication and Social Mobilization 
(ACM) components of Global Fund TB grant programs to stimulate demand 
for TB services.
    Through these three major mechanisms for reducing TB globally--(1) 
direct funding for PEPFAR TB/HIV activities, (2) financial and 
technical support for the Global Fund TB activities, and (3) financial 
and technical support for other major international TB partnerships--
PEPFAR is a leader in global contributions to international TB efforts. 
The Emergency Plan will continue its efforts to control the spread of 
TB/HIV in the next phase.

    Question. As a leading killer of people living with HIV/AIDS, 
tuberculosis is inextricably linked to the HIV/AIDS epidemic. Given the 
high rates of TB-HIV coinfection in the 12 PEPFAR focus countries in 
Africa, TB programs present an opportunity to identify additional HIV-
positive individuals who are eligible for treatment. Similarly, HIV 
clinics provide an opportunity to screen for TB.

   Given these opportunities, should addressing TB-HIV by 
        increasing integration and coordination among programs should 
        be a greater focus in PEPFAR reauthorization?

    Answer. PEPFAR is already investing significantly in the 
integration and coordination of HIV/AIDS and TB programs in clinical 
and laboratory facilities, as well as at the level of policy, 
surveillance, and monitoring and evaluation systems. PEPFAR support for 
HIV care and treatment provides an extensive platform for intensified 
TB case finding. This includes routine screening for signs and symptoms 
of TB disease and rapid initiation of appropriate treatment. This 
effort also has the important effect of interrupting secondary 
infection of TB in susceptible individuals--including people living 
with HIV--and the community at large.
    As noted, for FY 2007, the Emergency Plan has dedicated over $131 
million to TB/HIV activities, which include support for: Providing HIV 
testing for people with TB and TB diagnostics for people living with 
HIV, including cross-referrals to care; ensuring eligible TB patients 
receive HIV/AIDS prevention, treatment, and care; bolstering integrated 
surveillance activities; and strengthening integrated laboratory 
capacity and supply chain management to address HIV- and TB-related 
equipment and commodities. Country teams are working closely with 
Ministries of Health to develop national HIV/TB integration policies 
and plans, including integrated service delivery and monitoring and 
evaluation.
    As described in the response to question 3, PEPFAR is also a major 
contributor of funding, technical assistance, and strategic leadership 
to the most significant international partners on TB efforts, including 
the Global Fund, the WHO, and the STOP TB Partnership. PEPFAR 
involvement in the TB/HIV activities of these partners supports scale-
up and integration of TB activities within PEPFAR country programs and 
beyond.
    As country capacity and programming expands, PEPFAR will continue 
to focus on the TB/HIV nexus in its bilateral programs and in its 
collaboration with other USG TB efforts, the Global Fund, and host 
nations.

    Question. Drug-resistant forms of TB, including ``extensively drug 
resistant'' or ``XDR''-TB, threaten to undermine progress in reducing 
AIDS-related mortality. A well-publicized 2006 outbreak of XDR-TB in 
South Africa among 53 patients resulted in death in all but one 
patient. All those tested for HIV were found to be positive and 15 of 
the patients who died were on antiretroviral (ARV) treatment for HIV, 
indicating that ARVs were not protective against this form of TB. The 
threat of XDR-TB moving beyond Southern Africa to the rest the 
continent could have dire consequences.

   How can the threat of drug-resistant TB be comprehensively 
        addressed in HIV/AIDS programming?

    Answer. Drug-resistant tuberculosis, including multidrug resistant 
(MDR-TB) and extensively drug resistant (XDR-TB) strains, is a threat 
to people living with HIV. In many high-HIV prevalence countries, TB is 
the leading cause of mortality in people living with HIV/AIDS, and in 
some PEPFAR countries, 80 percent of individuals with TB are also 
infected with HIV. The HIV/AIDS pandemic has also severely compromised 
TB control efforts internationally.
    One week after the WHO issued a global alert over emerging strains 
of XDR-TB, PEPFAR attended an emergency experts meeting with TB 
officials from 11 Southern African countries and others in 
Johannesburg, South Africa, in September, 2006. During this meeting, a 
seven-point emergency action plan for a coordinated global response to 
XDR-TB was established. PEPFAR supports the global task force on XDR-TB 
in conducting the following activities: (1) Developing national 
emergency response plans for MDR and XDR-TB in line with national TB 
control plans that strengthen basic TB control and the proper use of 
second-line drugs; (2) conducting rapid surveys of MDR-TB and XDR-TB; 
(3) enhancing current laboratory capacity; (4) implementing urgent 
infection control precautions in health care facilities, especially 
those providing care for people living with HIV; (5) establishing and 
improving technical capacity of clinical and public health managers to 
effectively respond to MDR-TB and XDR-TB; (6) making antiretroviral 
treatment available to HIV-positive TB patients through joint TB/HIV 
activities; and (7) increasing research and support for rapid 
diagnostic tests and anti-TB drug development.
    Examples of PEPFAR activities in this effort include: Support for 
improved TB case finding; enhanced access to TB culture and drug 
susceptibility testing; environmental assessments to prevent nosocomial 
transmission of TB; and rapid initiation of appropriate drug treatment. 
PEPFAR is also providing resources for development of policies, 
guidelines, and implementation of TB infection control activities 
focused on HIV care and treatment settings and TB programs to prevent 
TB transmission to health care workers, patients, and visitors.
    The Emergency Plan is also supporting rapid TB testing, drug 
resistance surveillance, and other activities that specifically help 
prevent and control MDR- and XDR-TB, and working closely with the 
United States Federal TB Task Force to coordinate the USG response. The 
Emergency Plan also provides technical assistance funding to the WHO-
coordinated Green Light Committee (GLC) to assist Global Fund Grant 
recipient countries in improving their capacity to provide treatment 
for MDR-TB.
    PEPFAR support to develop basic infrastructure and capacity for 
addressing nondrug-resistant TB establishes the foundation upon which 
investments in more advanced capabilities for MDR- and XDR-TB can 
occur. In this way, all of PEPFAR's FY 2007 investment of approximately 
$131 million in TB/HIV activities--described in an earlier response--
contributes to the global effort to combat drug-
resistant TB.

                                  
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