[Federal Register Volume 63, Number 131 (Thursday, July 9, 1998)]
[Notices]
[Pages 37121-37124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18200]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement Number 98097]


Behavioral Intervention Research on The Prevention of Sexual 
Transmission of HIV By HIV-Seropositive Men Who Have Sex With Men

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1998 funds for a cooperative agreement 
program for the prevention of HIV transmission by HIV-seropositive men. 
This program addresses the ``Healthy People 2000'' priority area Human 
Immunodeficiency Virus (HIV) Infection.
    The purpose of this program is to support research evaluating the 
outcome of interventions based on formative research that reduce the 
spread of HIV by men who have sex with men who know they are HIV 
seropositive. Consistent with this goal, funding under this program 
will support a randomized controlled trial to evaluate the 
effectiveness of intervention activities designed to motivate and 
support HIV-seropositive men who have sex with men in sustaining sexual 
practices that reduce the risk and prevent HIV transmission to partners 
who are sero-negative or of unknown serostatus.
    The intervention proposed for the trial must be based on formative 
research, behavioral theory, and results of prior pilot evaluations. 
Because of the differential impact of HIV on men of color, both the 
prior formative research and the proposed intervention trial must be 
based on samples in which the majority of participants are men of 
color. The ultimate goal of this research is the identification of 
successful intervention strategies for HIV-seropositive men who have 
sex with men 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 community settings.

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. 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.

1. Funding Preference

    This announcement is for behavioral intervention studies that build 
upon formative research findings regarding transmission risk among HIV-
seropositive men who have sex with men. Because of the differential 
impact of HIV among men of color, preference will be given to 
applicants with documented ability to recruit research samples of HIV-
seropositive men who have sex with men in which the majority of 
participants are men of color. In order to ensure the success of the 
proposed project, it is essential that applicants have access to 
sufficient numbers of HIV-seropositive men who have sex with men. 
Therefore, preference will also be given to applications from 
metropolitan areas having a 1997 AIDS incidence rate exceeding 50 per 
100,000.

2. Funding Priorities

    This announcement is for behavioral intervention studies that build 
upon research findings regarding transmission risk among HIV-
seropositive men who have sex with men. This announcement will support 
behavioral intervention studies that build upon research findings 
regarding transmission risk among HIV-seropositive men from formative 
studies. This new research initiative will lead to the development of 
effective, feasible, and sustainable interventions that reduce the 
spread of HIV by men who know they are HIV seropositive. Consistent 
with this goal, funding under this program will support a randomized 
controlled trial to evaluate the effectiveness of intervention 
activities designed to motivate and support HIV-seropositive men who 
have sex with men in sustaining sexual practices that reduce the risk 
and prevent HIV transmission to partners who are sero-negative or of 
unknown serostatus.

C. Availability of Funds

    Approximately $800,000 is available in FY 1998 to fund two awards. 
It is expected that the average award will be $400,000. Awards are 
expected to begin on or about September 30, 1998, and

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will be made for a 12-month budget period within a project period of up 
to three years. The funding estimate is subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.

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 below and CDC will be responsible for the 
activities identified under CDC Activities below:

Recipient Activities

    a. Develop research and intervention protocols and data collection 
instruments appropriate to conduct a randomized controlled intervention 
trial.
    b. Establish procedures to maintain the rights and confidentiality 
of all study participants, including review of research activities by 
recipient's and CDC's Institutional Review Board (IRB).
    c. Identify, recruit, obtain informed consent, and enroll an 
adequate number of research participants according to procedures 
specified in the study protocol.
    d. Conduct intervention sessions, interviews, and other assessments 
according to the research protocol.
    e. Summarize data and conduct data analyses.
    f. Disseminate research findings in peer-reviewed journals and at 
professional meetings.

CDC Activities

    a. Provide scientific and technical assistance in the design and 
development of the research, and evaluation protocols, selection of 
measures and instruments, operational plans and objectives, and data 
analysis strategies.
    b. Provide scientific and technical coordination of the general 
operation of the research project, including data management support.
    c. Participate in the analysis of data gathered from program 
activities and the reporting of results.
    d. Conduct site visits to assess program progress.
    e. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.

E. Application Content

    The application may not exceed 30 double-spaced pages in length, 
excluding appendices (The appendices are the appropriate location for 
intervention protocols, references, 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 index to the application and its appendices. Submit 
the original and each copy 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. Ability To Recruit HIV-Seropositive Men

    a. Describe methods previously used to recruit community-based 
research samples of HIV seropositive men who have sex with men;
    b. Describe the differential success of various recruitment 
strategies;
    c. Describe the ethnic/racial background of participants in the 
research sample(s).

2. Formative Research With HIV-Seropositive Men

    a. Describe methods used to collect qualitative and quantitative 
formative data regarding the HIV transmission risk and its determinants 
among HIV-seropositive men who have sex with men;
    b. Summarize findings from the formative research phase, 
highlighting those with special relevance for the design of HIV 
prevention efforts;
    c. Attach copies of all abstracts, presentations, and manuscripts 
that describe findings from the formative research phase;
    d. Discuss ways in which HIV-seropositive men and their advocates 
or service providers were involved in the formative research phase.

3. Intervention Research Plan

    a. Describe the hypotheses and outcomes that will be addressed as 
part of the intervention trial;
    b. Describe the characteristics of HIV-seropositive men who have 
sex with men in the proposed study population and define the specific 
subgroups of HIV-seropositive men that will be the primary focus of the 
proposed research. Using available data, provide a rationale for any 
focus on specific population subgroups. Document ability to recruit 
sufficient numbers of men from the proposed target population;
    c. Describe the research design and methods that will be employed 
in the intervention trial. Include information about randomization 
procedures, statistical power to detect hypothesized differences, 
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);
    d. Provide a detailed description of all intervention and 
comparison conditions that are proposed for the trial and give a 
rationale for each. Clearly specify the way in which proposed 
intervention activities are based on findings from the formative 
research and behavioral theory (include the intervention curriculum in 
the Appendix;
    e. Describe procedures for involving the target population and 
their advocates or service providers in the design of research and 
intervention activities;
    (1) State whether the plans for recruitment and outreach for study 
participants include the process of establishing partnerships with 
communities and recognition of mutual benefits will be documented.
    (2) Describe the proposed plan for the inclusion of racial and 
ethnic minority populations for appropriate representation.
    f. Describe procedures for obtaining informed consent and 
maintaining participant confidentiality and;
    g. Describe plans to develop specific documents necessary to 
replicate the intervention and to disseminate study findings to 
community and scientific audiences.

4. Research and Intervention Capability

    a. Describe the research team and organizational setting;
    b. Describe the professional training and relevant research 
experience of all staff;
    c. Include in the appendix, memoranda of agreement that clearly and 
specifically document activities to be performed by any external 
experts, consultants, or collaborating agencies under the cooperative 
agreement.

5. 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 support activities such as project oversight or data 
management that will contribute to the completion of all research 
activities;

[[Page 37123]]

    c. Describe existing facilities, equipment, computer software, and 
data processing capacity;
    d. Describe the procedures to ensure the security of research data 
and;
    e. Provide a time line for the completion of the proposed research.

6. 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 24, 1998, submit the application to: Julia 
Valentine, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Announcement 98097, Centers for Disease 
Control and Prevention (CDC), Room 300, 255 East Paces Ferry Road, NE, 
M/S E15, Atlanta, Georgia 30305-2209.
    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. Ability To Recruit HIV-Seropositive Men Who Have Sex With Men (20 
points)

    a. Quality and diversity of methods used to recruit community-based 
sample(s) of HIV-seropositive men who have sex with men;
    b. Ability of applicant to provide data regarding the relative 
effectiveness of various strategies to recruit community-based samples 
of HIV-seropositive men who have sex with men;
    c. Documented ability to recruit a research sample of HIV-
seropositive men who have sex with men in which the majority of 
participants are men of color.

2. Familiarity With And Access to HIV-Seropositive Men (35 points)

    a. Quality of the description of methods used to collect 
qualitative and quantitative data during formative research phase, 
including the documented ability to recruit adequate numbers of study 
participants;
    b. Extent to which findings from the applicant's formative research 
demonstrates an in-depth understanding of the formative data regarding 
the HIV transmission risk, factors influencing risk taking behaviors, 
as well as the intervention and service needs of the proposed study 
population;
    c. Extent to which the applicant has disseminated formative 
research findings regarding HIV-seropositive men who have sex with men 
to appropriate scientific and community audiences;
    d. Quality and depth of the strategies used to involve and solicit 
input from a diverse group of HIV-seropositive men, their advocates, or 
service providers.

3. Intervention Research Plan (30 points)

    a. Appropriateness of the proposed research hypotheses and 
intervention outcome measures;
    b. Suitability of the proposed intervention subgroups and 
documented ability to recruit sufficient numbers of men who have sex 
with men from the proposed study population;
    c. Quality and scientific rigor of the research design and methods 
that will be employed in the intervention trial;
    d. Quality of the rationale and curricula for the intervention and 
comparison conditions, including the extent to which the proposed 
intervention activities are based on findings from the formative 
research and behavioral theory;
    e. Extent to which the target population, their advocates, or 
service providers will be involved in the design of research and 
intervention activities;
    f. Adequacy of procedures for obtaining informed consent and 
maintaining participant confidentiality and;
    g. Quality of plans to develop appropriate materials for 
intervention replication and to disseminate study findings to community 
and scientific audiences.

4. Research and Intervention Capability (5 points)

    a. Applicant's ability to carry out the proposed research as 
demonstrated by the training and experience of the proposed research 
team and organizational setting;
    b. Ability of the applicant to conduct the proposed research as 
reflected in the training, research, and behavioral intervention 
experience of staff members and;
    c. Extent to which services to be provided by external experts, 
consultants, or collaborating agencies are documented by memoranda of 
agreement in the appendix.

5. 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. Clarity of the described duties and responsibilities of project 
personnel;
    c. Adequacy of the facilities, equipment, data management 
resources, and systems for ensuring data security and;
    d. Specificity and reasonableness of time line.

6. The Degree to Which the Applicant Has Met the CDC Policy 
Requirements Regarding the Inclusion of Ethnic and Racial Groups in the 
Proposed Research (5 points)

    This includes:
    a. The proposed plan for the inclusion of racial and ethnic 
minority populations for appropriate representation;
    b. The proposed justification when representation is limited or 
absent;
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted;
    d. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with communities and recognition of mutual benefits.

7. Does the Application Adequately Address the Requirements of Title 45 
CFR Part 46 For The Protection of Human Subjects?

    ____ YES ____ No
    Comments: ____________

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.

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    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    Send all reports to: Julia Valentine, Grants Management Specialist, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry 
Road, NE, M/S E-15, Atlanta, GA 30305-2209.
    4. The following additional requirements are applicable to this 
program. For a complete description of each, see Attachments.

AR98-1  Human Subjects Requirements
AR98-2  Requirements for Inclusion of Racial and Ethnic Minorities 
in Research
AR98-4  HIV/AIDS Confidentiality Provisions
AR98-5  HIV Program Review Panel Requirements
AR98-9  Paperwork Reduction Act Requirements
AR98-10  Smoke-Free Workplace Requirements
AR98-11  Healthy People 2000
AR98-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under Section 301 and 317(k)(2), of the 
Public Health Service Act (42 U.S.C. 241 and 247b(k)(2)) as amended. 
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.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Julia Valentine, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE, Room 300, Mailstop E-
15, Atlanta, GA 30305, telephone: (404) 842-6871; Email [email protected].
    Programmatic technical assistance may be obtained from: Robert 
Kohmescher Division of HIV/AIDS Prevention, National Center for HIV/
STD/TB Prevention, Centers for Disease Control and Prevention (CDC), 
1600 Clifton Road, NE, Mailstop E-44, Atlanta, GA 30333, telephone 
(404) 639-8302 Email [email protected].
    This announcement will be available on CDC's home page at http://
www.cdc.gov.
John L. Williams,
Director, Procurement and Grants Office.
[FR Doc. 98-18200 Filed 7-8-98; 8:45 am]
BILLING CODE 4163-18-P