[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.

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    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