[Federal Register Volume 64, Number 118 (Monday, June 21, 1999)]
[Notices]
[Pages 33093-33097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15632]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 99090]
Intervention Research Addressing the Primary and Secondary
Prevention Needs of HIV-Seropositive Injection Drug Users Notice of
Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) and the Health
Resources and Services Administration (HRSA) announce the availability
of fiscal year (FY) 1999 funds for a cooperative agreement program to
support intervention research on the primary and secondary prevention
needs of HIV-seropositive injection drug users (IDUs). This
announcement addresses the ``Healthy People 2000'' priority area Human
Immunodeficiency Virus (HIV) Infection.
The purpose of this announcement is to support intervention
research for HIV-seropositive IDUs that leads to the development of
effective, feasible, and sustainable interventions having three goals:
(1) To prevent HIV transmission due to high risk sexual and drug
injection behaviors; (2) to increase access to, use of, and maintenance
in primary health care; and (3) to increase access to, use of, and
adherence to HIV treatments, including prophylaxis to prevent
opportunistic infections.
Consistent with this purpose, funding under this program will
support: (1) One year for intervention refinement and piloting of
intervention strategies and components, in collaboration with other
funded sites; (2) three years for a multi-site randomized controlled
trial to test behavioral/biomedical interventions and strategies for
this population; and (3) one year for data analysis and dissemination
of research findings.
The intervention proposed for the trial must be based on behavioral
theory as well as: (1) Prior research on sexual and drug injection
practices among IDUs that lead to HIV/STD risk; and (2) prior research
or research data on either adherence to HIV treatment or access to
health care. The ultimate goal of this research is the identification
of successful intervention strategies for HIV-seropositive IDUs, with
an emphasis on IDUs newly diagnosed as HIV seropositive (within the
past three years). It is expected that these strategies will integrate
behavioral and biomedical approaches and will lead to models that are
appropriate for implementation in community settings (e.g., local
health departments, community-based organizations, health maintenance
organizations) and that are suitable for replication in other
communities.
B. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies; that is,
universities, colleges, research institutions, hospitals, other public
and private nonprofit organizations, state and local governments or
their bona fide agents, and federally recognized Indian tribal
governments, Indian tribes, or Indian tribal organizations.
Note: Public Law 104-65 states that an organization described in
section 501(c)(4) of the Internal Revenue Code of 1986 that engages
in lobbying activities is not eligible to receive Federal funds
constituting an award, grant, cooperative agreement, contract, loan
or any other form.
C. Availability of Funds
Approximately $2,000,000 is available in FY 1999 to fund three to
five awards. It is expected that the average award for the first year
will be $500,000. An application requesting greater than $600,000,
including indirect costs, in year one will not be considered for review
and will be returned to the applicant.
Awards are expected to begin on or about September 30, 1999. Awards
will be made for a 12-month budget period within a total project period
of up to five years. It is anticipated that increased funding may be
available in years 2-4 to support the randomized controlled trial and
in year 5 to support data analysis and dissemination of research
findings. Funding estimates may vary and are subject to change based on
the availability of funds.
Continuation awards within the project period will be made on the
basis of satisfactory progress as evidenced by required reports and the
availability of funds.
Funding Preference
In order to promote research and interventions that address the
needs of diverse regions of the United States, geographic diversity may
be a factor considered in funding decisions. The recruitment area for
funded applicants may not overlap. In addition, applicants must
demonstrate that intervention programs and research studies for HIV-
seropositive IDUs that are currently being conducted in the applicant's
catchment area will not jeopardize the success of the proposed
research.
D. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities identified under
Recipient Activities and CDC and HRSA will be responsible for the
activities identified under CDC and HRSA Activities.
1. Recipient Activities
a. Refine and pilot test intervention strategies and components.
b. Develop plans for active collaboration during the entire project
with local health departments, medical service providers, members of
the affected population, their service providers, and community
organizations.
c. Develop research protocols and data collection instruments
appropriate to conduct a multi-site randomized controlled intervention
trial.
d. Develop plans to collect prospective cost data for the
intervention to allow estimates of the
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cost of replicating the intervention elsewhere.
e. Establish procedures to maintain the rights and confidentiality
of study participants.
f. Submit research protocols to the recipient's Institutional
Review Board (IRB).
g. Identify, recruit, and enroll at least 200 research participants
according to the study protocol.
h. Collect biological specimens to verify HIV serostatus and assess
the presence of sexually transmitted diseases and other blood borne
pathogens.
i. Contribute blood specimens (at least every 6-12 months depending
on the protocol requirements) for shipment and storage at a centralized
repository system at CDC.
j. Summarize the data from the intervention trial, conduct data
analyses, and disseminate findings in peer-reviewed journals and at
professional meetings.
k. Meet three or four times each year with other funded sites, CDC,
and HRSA to discuss research and intervention protocols.
l. Obtain certificate of confidentiality to protect research
records.
2. CDC and HRSA Activities
a. Provide scientific and technical assistance and coordination, as
requested, for all phases of the study.
b. As needed, participate in the analysis of data gathered from
research projects and the reporting of results.
c. Facilitate group meetings with the sites to allow for the
exchange of information and for input into the development and
refinement of the research and intervention protocol.
d. Conduct site visits to assess program progress.
e. Assist in the development a research protocol for IRB review by
each institution participating in the research project as well as the
CDC IRB. CDC IRB also will review the projects on at least an annual
basis until the research is complete.
f. Arrange meetings with the External Working Group (EWG) convened
by CDC. The EWG is an independent advisory group made up of non-CDC
experts who will provide input on the scientific, methodological, and
ethical aspects of the research and intervention protocol. The EWG will
act like a data safety monitoring board during the intervention trial.
g. Assist the sites in obtaining certificates of confidentiality to
protect research records.
E. Application Content
You must document that this proposal is consistent with the
Statewide Coordinated Statement of Need document from your area or
provide a rationale for any discrepancies. Note: This initiative is
supported, in part from funds provided under the Special Projects of
National Significance Program of the Ryan White Comprehensive AIDS
Resource Emergency Act. Section 2691(f) indicates that the Secretary
may not make a grant under this program ``unless the applicant submits
evidence that the proposed program is consistent with the Statewide
Coordinated Statement of Need, and the applicant agrees to participate
in the ongoing revision process of such statement of need.''
Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow them in laying out your program
plan. The application may not exceed 40 double-spaced pages in length,
excluding appendices. (The appendices are the appropriate location for
curriculum vitae, references, letters of support, and memoranda of
agreement documenting collaboration with other agencies.) Provide a
one-page abstract of the proposal. Number all pages clearly and
sequentially and include a complete table of contents to the
application and its appendices. Submit the original and five copies of
the application UNSTAPLED and UNBOUND. Print all material, double
spaced, in a 12-point or larger font on 8\1/2\'' by 11'' paper, with at
least 1'' margins and printed on one side only.
Use the following outline.
1. Experience With Relevant Research and Familiarity With HIV-
Seropositive Injection Drug Users
a. Describe prior research and, if appropriate, service provision
to IDUs, and particularly, HIV-seropositive IDUs. Describe methods used
to collect prior data among IDUs regarding (1) HIV transmission risk
and its correlates, AND (2) either access to, use of, and maintenance
in health care, OR, access to, use of, and adherence to HIV treatments;
b. Demonstrate familiarity with issues faced by HIV-seropositive
IDUs in coping with HIV, maintaining safer sex and injection practices,
accessing and utilizing health care, and adhering to various HIV
treatments such as antiretroviral treatment as well as medications used
to prevent opportunistic infections. Applicant should describe both its
own research experience with any of these issues as well as provide a
review of the scientific literature.
c. Describe the characteristics of HIV-seropositive IDUs in the
proposed study population, including demographic, drug taking, and
other relevant characteristics;
d. Describe procedures for involving the target population, their
advocates, or service providers in the design of research and
intervention activities:
(1) A statement as to how the plans for recruitment and outreach
for study participants include the process of establishing partnerships
with communities; and
(2) The proposed plan for the inclusion of racial and ethnic
minority populations and women for appropriate representation, and
justification when representation is limited or absent.
2. Access to a Sufficient Number of HIV-Seropositive Injection Drug
Users
a. Describe methods previously used to recruit and follow research
samples of IDUs, particularly HIV seropositive IDUs, and document the
ability to recruit and follow at least 200 HIV-seropositive injection
drug users for the proposed research activities (including at least 100
IDUs newly diagnosed as HIV seropositive within the past three years).
b. Describe linkages and relationships with organizations providing
medical and psycho social services to HIV-seropositive IDUs and how
participants will be referred to these services as needed.
c. Demonstrate knowledge of the health care system available to the
targeted population, specifically HIV outpatient medical care. Provide
detail regarding ability to access care, ability to access HIV
treatments, monitoring of adherence to medications, the process for
appointment setting and follow-up, etc.
d. In the appendix, include a table of any intervention studies and
prevention programs for HIV seropositive IDUs that you are conducting
or that you are aware of in the proposed recruitment area. In this
table, include target population; proposed activities; sites for
recruitment, intervention, or data collection activities and provide a
narrative describing potential overlap and plans to coordinate efforts
(if any) to minimize overlap.
3. Intervention Research Plan
a. Propose an integrated behavioral/biomedical intervention that
will
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promote the three primary objectives: decreasing sexual and injection
risk behavior, increasing access to and maintenance in primary health
care, and increasing adherence to HIV treatments;
b. Describe the research design and methods that are proposed for
the intervention. Include information about the research hypotheses,
randomization procedures, primary (behavioral and biological) and
secondary (relevant mediating variables) outcome measures, the
reliability and validity of measures that will be used, and procedures
for maximizing external and internal validity (e.g., sampling
strategies and retention procedures, respectively);
c. Provide a detailed description of the proposed intervention and
comparison conditions and give a rationale for each. Clearly specify
the way in which the proposed intervention activities are based on
findings from prior research and behavioral theory (include the
intervention curriculum in the Appendix);
d. Propose a method for conducting a prospective cost analysis
(excluding research costs) so the costs of the intervention will be
available for replication purposes;
e. Describe procedures for obtaining informed consent and
maintaining participant confidentiality;
f. Describe plans to develop specific documents necessary to
replicate the intervention (if effective) and to disseminate study
findings to community and scientific audiences.
4. Plan for Intervention Refinement and Piloting
Describe plans to refine and pilot the intervention to improve its
acceptability to and feasibility with the target population;
5. Research and Intervention Capability
a. Describe the research team and organizational setting;
b. Describe the professional training and relevant research
experience of all scientific staff;
c. Describe prior experience collecting biologic data (especially
from IDUs) and conducting biomedical research in a behavioral context;
d. Include in the appendix memoranda of agreement that clearly and
specifically document activities to be performed by any external
agreements, consultants, or collaborating agencies under the
cooperative agreement. Clearly indicate roles, responsibilities, and
staffing provided by these collaborators.
6. Staffing, Facilities, and Time Line
a. Explain the proposed staffing, percentage of time each staff
member commits to this and other projects, and division of duties and
responsibilities for the project;
b. Describe the arrangements that you have made for facilitating
access to primary health care for project participants;
c. Identify and describe key roles of behavioral scientists,
biomedical scientists, and other staff essential to the completion of
the project;
d. Describe support activities such as project oversight or data
management that will contribute to the completion of all research
activities;
e. Provide a statement that project staff will attend three or four
meetings each year with CDC and HRSA staff and staff from other
recipient sites;
f. Describe existing facilities (including ability to collect and
store biologic data), equipment, computer software, and data processing
capacity;
g. Describe the procedures to ensure the security of research data
(including biologic data); and
h. Provide a time line for the completion of the proposed research.
7. Budget: Provide a Detailed, Line-Item Budget for the Project and a
Budget Narrative That Justifies Each Line-Item.
F. Submission and Deadline
Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for
PHS 398). Forms are in the application kit.
On or before August 6, 1999, submit the application to the Grants
Management Specialist identified in the ``Where to Obtain Additional
Information'' section of this announcement.
Deadline: Application shall be considered as meeting the deadline
if they are either:
1. Received on or before the deadline date; or
2. Sent on or before the deadline date and received in time for
submission to the independent review group. (Applicants must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or U.S. Postal Service. Private
metered postmarks shall not be acceptable proof of timely mailing.)
Late Applications: Applications which do not meet the criteria in
(a) or (b) above are considered late applications, will not be
considered, and will be returned to the applicant.
If your application does not arrive in time for submission to the
independent review group, it will not be considered in the current
competition unless you can provide proof that you mailed it on or
before the deadline (i.e., receipt from U.S. Postal Service or a
commercial carrier; private metered postmarks are not acceptable).
G. Evaluation Criteria
Each application will be evaluated individually against the
following criteria by an independent review group appointed by CDC.
1. Experience With Relevant Research and Familiarity With HIV-
Seropositive Injection Drug Users (20 points)
a. Extent of applicant's knowledge of issues faced by HIV-
seropositive IDUs, as demonstrated by prior research and review of the
scientific literature, and applicant's experience in working with this
population;
b. Evidence of: (1) Prior research on the correlates of sexual and
injection risk behavior, and (2) research or research data on access to
medical care, or adherence to HIV treatments among HIV-seropositive
IDUs; and overall quality of research in all 3 areas;
c. Description of proposed study population and rationale for
focusing on specific subgroups, if any;
d. Feasibility of plans to involve HIV-seropositive IDUs, their
advocates, or service providers in the development of research and
intervention activities.
2. Access to a Sufficient Number of HIV-Seropositive Injection Drug
Users (20 points)
a. Quality of methods used to recruit and follow IDUs for prior
studies, and particularly the quality of methods used to recruit HIV-
seropositive IDUs and achieve high follow-up rates;
b. Evidence of ability to recruit at least 200 HIV-seropositive
IDUs, including at least 100 newly diagnosed IDUs (diagnosed with HIV
infection or AIDS in the past three years);
c. Existence of linkages to facilitate recruitment from and
referral to programs providing services for HIV-seropositive IDUs;
d. Feasibility of proposed intervention given other intervention
studies and prevention programs for HIV-seropositive IDUs being
conducted by applicant or other investigators in the same greater
metropolitan area;
3. Intervention Research Plan, and the Degree to Which the Applicant
Has Met the CDC Policy Requirements Regarding the Inclusion of Ethnic
and Racial Groups and Women in the Proposed Research (25 points)
a. Intervention Research Plan.
[[Page 33096]]
1. Quality, feasibility, and theoretical bases of the suggested
biomedical/behavioral intervention;
2. Appropriateness of proposed research hypotheses and intervention
outcome measures;
3. Quality and scientific rigor of the proposed research design and
methods for the intervention trial;
4. Quality of the rationale for the curricula for the intervention
and comparison conditions, including the extent to which intervention
activities are based on findings from prior research and behavioral
theory;
5. Ability to collect data for tracking costs (excluding research
costs) to conduct a prospective cost analysis;
6. Adequacy of procedures for obtaining informed consent and
maintaining participant confidentiality; and
7. Quality of plans to develop appropriate materials for
intervention replication and to disseminate study findings to community
and scientific audiences.
b. The degree to which the applicant has met the CDC Policy
requirements regarding the inclusion of ethnic and racial groups and
women in the proposed research.
1. The proposed plan for the inclusion of racial and ethnic
minority populations and women for appropriate representation;
2. The proposed justification when representation is limited or
absent;
3. A statement as to whether the design of the study is adequate to
measure differences when warranted; and
4. A statement as to whether the plans for recruitment and outreach
for study participants include the process of establishing partnerships
with community(ies) and recognition of mutual benefits.
4. Plan for Intervention Refinement and Piloting (10 points)
Quality of the proposed plan to refine and pilot test the proposed
intervention.
5. Research and Intervention Capability (20 points)
a. Ability of the applicant to conduct the proposed research as
reflected in the training, research, and behavioral intervention
experience of staff members;
b. Ability of the applicant to collect and monitor biologic data as
reflected in prior experience;
c. Extent to which services to be provided by external experts,
consultants, or collaborating agencies are documented by memoranda of
agreement in the appendix, including a clear indication of roles,
responsibilities, and staffing provided by these collaborators.
6. Staffing, Facilities, and Time Line (5 points)
a. Availability of qualified and experienced personnel with
sufficient time dedicated to the proposed project. Presence of
behavioral scientists in key leadership positions on the project;
b. Availability of persons with biomedical expertise on the
research staff and among other project personnel to assure competent
and appropriate collection and storage of biological specimens;
c. Clarity of the described duties and responsibilities of project
personnel, including support personnel for project oversight and data
management, as well as a clear plan for facilitating access to primary
health care for participants;
d. Stated agreement to meet three or four times each year with CDC
and HRSA staff and staff from other recipient sites to discuss and
provide input to each site throughout the 5-year project;
e. Adequacy of the facilities (including ability to collect and
store biologic data), equipment, data management resources, and systems
for ensuring data security and;
f. Specificity and reasonableness of time line.
7. Does the application adequately address the requirements of Title 45
CFR part 46 for the protection of human subjects? (not scored)
8. Budget (not scored)
Extent to which the budget is reasonable, itemized, clearly
justified, and consistent with the intended use of funds.
H. Other Requirements
1. Technical Reporting Requirements Provide CDC with original plus two
copies of
a. semi-annual progress reports, no more than 30 days after the end
of each reporting period. The progress reports must include the
following for each program, function, or activity involved:
(1) A comparison of accomplishments of the goals established for
the period;
(2) Reasons that any goals were not met and;
(3) A description of steps taken to overcome barriers to the goals
for the period.
b. financial status report, no more than 90 days after the end of
the budget period; and
c. final financial status and performance reports, no more than 90
days after the end of the project period.
Send all reports to the Grants Management Specialist identified in the
``Where to Obtain Additional Information'' section of this
announcement.
2. The following additional requirements are applicable to this
program. For a complete description of each, see Attachments.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Racial and Ethnic Minorities in
Research
AR-4 HIV/AIDS Confidentiality Provisions
AR-5 HIV Program Review Panel Requirements
AR-6 Patient Care
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2000
AR-12 Lobbying Restrictions
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under sections 301 and 317(k)(2), of the
Public Health Service Act [42 U.S.C. 241 and 247b(k)(2)], as amended.
The HRSA Special Projects of National Significance (SPNS) program is
authorized by section 2691 of the Public Health Service Act (42
U.S.C.300ff-10). The Catalog of Federal Domestic Assistance number is
93.941.
J. Where To Obtain Additional Information
To receive additional written information and to request an
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked
to leave your name and address and will be instructed to identify the
Announcement number of interest. You may also view this and all other
CDC/ATSDR competitive Program Announcements, and download application
forms, via the Internet at http://www.cdc.gov.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from:
Brenda Hayes, Grants Management Specialist, Grants Management Branch,
Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 2920 Brandywine Road, Room 3000, Mail Stop E-15,
Atlanta, GA 30341-4146, telephone: (770) 488-2720; Email: [email protected].
Programmatic technical assistance may be obtained from: Robert
Kohmescher, Centers for Disease Control and
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Prevention (CDC), 1600 Clifton Road, NE, Mail Stop E-44, Atlanta, GA
30333, telephone (404) 639-1914 Email HTTP://WWW.RNK1.CDC.GOV or
Jeff Efird, Centers for Disease Control and Prevention (CDC), 1600
Clifton Road, NE, Mail Stop E-45, Atlanta, GA 30333 telephone (404)
639-6136, Email HTTP://WWW.JLE[email protected]
Dated: June 15, 1999.
Henry S. Cassell III,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 99-15632 Filed 6-18-99; 8:45 am]
BILLING CODE 4163-18-P