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

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