[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;
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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
