Outcome Evaluations of HIV/AIDS Prevention Interventions

[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
[Notices]
[Pages 31128-31131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15560]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 628]


Outcome Evaluations of HIV/AIDS Prevention Interventions

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 funds for a cooperative agreement 
program to conduct outcome evaluations of existing innovative 
interventions designed to reduce the transmission of the human 
immunodeficiency virus (HIV).
    CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2000,'' a national activity 
to reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of Human Immunodeficiency 
Virus (HIV) Infection. (For ordering a copy of ``Healthy People 2000,'' 
see the section ``Where To Obtain Additional Information.'')

Authority

    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.

Smoke-Free Workplace

    CDC strongly encourages all recipients to provide a smoke-free 
workplace and to promote the nonuse of all tobacco products, and Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities that receive Federal funds in which education, library, day 
care, health care, and early childhood development services are 
provided to children.

Eligible Applicants

    Applications may be submitted by public and private, nonprofit and 
for-profit organizations and governments and their agencies. Thus, 
universities, colleges, research institutes, hospitals, other public 
and private organizations, State and local health departments or their 
bona fide agents or instrumentalities, federally recognized Indian 
tribal governments, Indian tribes or Indian tribal organizations, and 
small, minority- and/or women-owned businesses are eligible to apply.

    Note: Organizations described in section 501(c)(4) of the 
Internal Revenue Code of 1986 that engage in lobbying are not 
eligible to receive Federal grant/cooperative agreement funds.

Availability of Funds

    Approximately $500,000 is available in FY 1996 to fund 
approximately three awards each evaluating a different intervention 
strategy in a different high-risk population. It is expected that the 
average award will be $150,000, ranging from $125,000 to $175,000. 
Awards are expected to begin on or about September 30, 1996, and will 
be made for a 12-month budget period within a project period of up to 
three years. Funding estimates may vary and are subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.

Definitions

    For the purposes of this program, an Innovative HIV Prevention 
Intervention is an HIV prevention strategy that has not been 
extensively researched in the context in which it is being applied or 
one that represents a new approach to the integration of known 
prevention strategies. The terms Outcome Evaluation and Effectiveness 
Study are used somewhat interchangeably and refer to the design and 
methods used to assess the short- or long-term effects that can be 
reasonably attributed to the intervention.
    The term HIV Community Planning Priorities are priorities based 
upon the epidemiologic profile of HIV in a community as determined by 
the Community Planning Group (CPG). For example, if a CPG determined 
that there is a significant problem of HIV intravenous drug (ID) use in 
the community then the funding of HIV prevention strategy for ID use 
would be a priority for HIV community planning.

Purpose

    The purpose of this program is to support intervention 
effectiveness studies that assess social, behavioral, programmatic, and 
policy outcomes of specific innovative HIV prevention interventions. 
These outcome evaluations should assess prevention interventions that 
are innovative, have new components or involve the innovative 
application of interventions that are commonly employed (e.g. HIV 
counseling and testing) and have potentially broad relevance to the 
field of HIV prevention. These evaluation studies will use methods 
common to rigorous outcome evaluation research (e.g. comparison groups, 
individual baseline data, cohorts, cross-sectional surveys) within the 
limits of the funding available and appropriately matched to the nature 
and size of the intervention.
    This program is designed to provide evaluation resources to 
organizations that might not otherwise have the resources to determine 
the effectiveness of their programs. Funds are intended solely to 
implement the evaluation and not to support the intervention itself. 
Interventions being evaluated should target high-risk populations (e.g. 
men who have sex with men, injection drug users and their partners, 
youth in high risk situations).
    Lastly, this program is to devise practical, yet reasonably 
rigorous, outcome evaluation methods and designs that integrate both 
qualitative and quantitative data, possibly from multiple sources, in 
the analysis and interpretation of the findings.

Program Requirements

    The application should demonstrate the applicant's ability to 
design and implement the evaluation, analyze the data, and disseminate 
the findings. In conducting activities to achieve the purpose of this 
program, the recipient will be responsible for the activities under A. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under B. (CDC Activities).

A. Recipient Activities

    Recipients will be asked to attend meetings in Atlanta 
approximately twice a year to brief CDC staff on the project and 
discuss key decisions. Additionally the recipient should expect to host 
periodic (up to 4 per year) site visits by the CDC project officer.
    1. Prepare a detailed evaluation protocol, including a description 
of the intervention and how it is innovative, the study research 
questions, proposed methods, including sampling, assessment, and 
analysis plans, draft measurement instruments, and project timelines.

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    2. Develop measures to evaluate the intervention. New instruments 
should be field-tested.
    3. Develop procedures to ensure confidentiality and informed 
consent when appropriate and obtain IRB clearances as needed.
    4. Recruit study subjects and comparison groups according to the 
evaluation design.
    5. Conduct individual baseline and repeat assessments according to 
the evaluation design.
    6. Establish data management systems, analyze and interpret the 
data.
    7. Prepare a final report for CDC, including submission of a 
cleaned data set.
    8. Prepare a paper that summarizes the results and recommends 
future research and describes programmatic implications.
    9. Present the findings locally. Collaborate with other recipients 
in presenting the findings at national meetings.

B. CDC Activities

    1. Assist the recipient in planning and implementing the 
evaluation, including providing technical guidance in the development 
of the study design, data collection instruments, selection of 
comparison groups, outcome measures, data collection protocols, and 
pretesting of methods and instruments.
    2. Provide project oversight and technical assistance.
    3. Assist in analyzing the data and interpreting the results.
    4. Assist in presenting the findings.

Evaluation Criteria

    Before submitting an application, applicants will need to identify 
an innovative behavioral or social HIV prevention intervention that is 
designed to reduce risk behaviors by high-risk persons or within high-
risk communities. Communities may be defined by geopolitical boundaries 
or by relational affiliations (e.g., men who have sex with men, African 
American community, youth in high risk situations).
    Evaluation criteria are based upon the responsiveness to, and the 
quality of, specific information requested in the ``Application 
Content'' section of the program announcement included in the 
application kit.

1. Justification and Significance of the Intervention (30 Points)

    The degree to which the intervention is innovative, i.e., new or 
represents a new approach to the integration of known prevention 
strategies and has not yet been extensively evaluated in the context in 
which it is being applied. The extent to which the intervention has 
broader significance or relevance for HIV prevention. In determining 
significance, consideration will be given to the degree to which the 
selected intervention is based on behavioral or social science theory, 
public health practice or program experience and the relevant research 
literature, including a description of the social and contextual issues 
if relevant. Degree to which clear intervention goals and objectives 
are articulated. Degree to which the behavioral or social interventions 
complement other biomedical or socioenvironmental interventions. The 
degree to which the proposed activity is significant to HIV prevention. 
The degree to which the intervention is generalizable.

2. Evidence That Target Population Reflects HIV Community Planning 
Priorities (10 Points)

    Degree to which the local, regional or State HIV prevention 
community plan, especially the epidemiologic profile and behavioral 
data, were used in the selection of the intervention. The degree to 
which the target population is described clearly and concisely. 
Evidence that the intervention has access to sufficient numbers of the 
target population to show intervention effects is also important.

3. Soundness of the Evaluation Plan (30 Points)

    The extent to which the evaluation plan, including the stated 
research or evaluation question, study design and methods, comparison 
groups, data collection instruments and plans for analysis, are 
scientifically sound and capable of producing the intended results. The 
degree to which the plan is clear, complete, and includes time-related 
milestones that CDC and recipients can use to gauge progress. The 
degree to which plans for data management, analysis, and interpretation 
are appropriate and reflect the intention to collaborate with CDC. 
Reasonableness of plans for collecting and integrating qualitative and 
quantitative data from multiple sources.

4. Adequacy of the Dissemination Plan (10 Points)

    Degree to which a dissemination plan is articulated. Evidence that 
the applicant is committed to disseminating findings locally and 
collaborating with CDC in disseminating findings nationally. The degree 
to which the applicant is committed to collaborating with CDC in 
coauthoring papers.
5. Evidence of Collaboration and Capacity To Undertake the Evaluation 
(20 Points)
    Quality of supporting evidence (letters and memorandums of 
agreement) that the applicant has the full support of all specified 
collaborators. The degree to which the applicant has the scientific and 
programmatic capacity and proven track record in successfully 
designing, implementing and completing similar evaluations, either 
alone or in partnership with the proposed collaborator. The degree to 
which the affected population seems to be involved in planning the 
evaluation. (To obtain specific information on the community plan for 
your location, please contact your local health department.)
    In addition, the degree to which the applicant has met the CDC 
policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research. This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The appropriateness of the proposed justification when 
representation is limited or absent.
    c. Whether the design of the study is adequate to measure 
differences when warranted.
    d. Whether the plans for recruitment and outreach for study 
participants include the process of establishing partnerships with 
community(ies) and recognition of mutual benefits.

6. Budget (Not Scored)

    The extent to which the budget is reasonable, itemized, clearly 
justified, and consistent with intended use of funds.

Funding Preferences

    All applicants are encouraged to provide evidence of support from 
their local health departments. Preference will be given to applicants 
who collaborate with representatives of target populations at highest 
risk for HIV infection and who are served by the program being 
evaluated. Special consideration will be given to applications to 
evaluate innovative interventions to integrate or link multiple 
intervention components, for example, provision of HIV counseling and 
testing services by nongovernmental organizations (NGOs) that serve 
high-risk communities and also provide innovative behavior-change 
services.

[[Page 31130]]

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets 
up a system for State and local government review of proposed Federal 
assistance applications. Applicants (other than federally recognized 
Indian tribal governments) should contact their State Single Point of 
Contact (SPOC) as early as possible to alert them to the prospective 
applications and receive any necessary instructions on the State 
process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. A 
current list of SPOCs is included in the application kit. If SPOCs have 
any State process recommendations on applications submitted to CDC, 
they should send them to Van Malone, Grants Management Officer, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, 
Mailstop E15, Atlanta, GA 30305, no later than 30 days after the 
application deadline (the appropriation for this financial assistance 
program was received late in the fiscal year and would not allow for an 
application receipt date which would accommodate the 60-day State 
recommendation process period). The granting agency does not guarantee 
to ``accommodate or explain'' for State process recommendations it 
receives after that date.
    Indian tribes are strongly encouraged to request tribal government 
review of the proposed application. If tribal governments have any 
tribal process recommendations on applications submitted to the CDC, 
they should forward them to Van Malone, Grants Management Officer, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., 
Room 300, Mailstop E15, Atlanta, GA 30305. This should be done no later 
than 30 days after the application deadline date. The granting agency 
does not guarantee to ``accommodate or explain'' for tribal process 
recommendations it receives after that date.

Public Health System Reporting Requirements

    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based 
nongovernmental applicants must prepare and submit the items identified 
below to the head of the appropriate State and/or local health 
agency(s) in the program area(s) that may be impacted by the proposed 
project no later than the receipt date of the Federal application. The 
appropriate State and/or local health agency is determined by the 
applicant. The following information must be provided:
    A. A copy of the face page of the application (SF 424).
    B. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not exceed one page, and include the 
following:
    1. A description of the population to be served;
    2. A summary of the services to be provided; and
    3. A description of the coordination plans with the appropriate 
State and/or local health agencies.
    If the State and/or local health official should desire a copy of 
the entire application, it may be obtained from the Single Point of 
Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance number is 93.941.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations, 45 CFR Part 46, regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. In addition to other applicable 
committees, Indian Health Service (IHS) institutional review committees 
also must review the project if any component of IHS will be involved 
or will support the research. If any American Indian community is 
involved, its tribal government must also approve that portion of the 
project applicable to it. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
form provided in the application kit.

Women, Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in CDC/ATSDR-supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian, Alaskan Native, Asian, Pacific Islander, Black and 
Hispanic. Applicants shall ensure that racial and ethnic minority 
populations are appropriately represented in applications for research 
involving human subjects. Where clear and compelling rationale exist 
that inclusion is inappropriate or not feasible, this situation must be 
explained as part of the application. This policy does not apply to 
research studies when the investigator cannot control the race, 
ethnicity and/or sex of subjects. Further guidance to this policy is 
contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, 
dated Friday, September 15, 1995.

Application Submission and Deadline

    The original and two copies of the application PHS Form 5161-1 (OMB 
Number 0937-0189) must be submitted to Van Malone, Grants Management 
Officer, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention, 255 East Paces Ferry Road, 
NE., Room 300, Mailstop E-15, Atlanta, GA 30305, on or before August 5, 
1996.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either:
    a. Received on or before the deadline; or
    b. Sent on or before the deadline date and received in time for 
submission to the objective review committee. (Applicants must request 
a legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or the U.S. Postal Service. Private 
metered postmarks will not be acceptable proof of timely mailing.)
    2. Late Applications: Applications that do not meet the criteria in 
1.a. or 1.b. above are considered late applications. Late applications 
will not be considered in the current competition and will be returned 
to the applicant.

Where To Obtain Additional Information

    To receive additional written information call (404) 332-4561. You

[[Page 31131]]

will be asked to leave your name, address, and telephone number and 
will need to refer to Announcement 628. You will receive a complete 
program description, information on application procedures and 
application forms. If you have questions after reviewing the contents 
of all the documents, business management technical assistance may be 
obtained from Adrienne Brown, 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) 842-6634, 
email:. Programmatic technical assistance be 
obtained from Deborah L. Rugg, Ph.D., Program Evaluation Branch, 
Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB 
Prevention, Centers for Disease Control and Prevention, 1600 Clifton 
Road, NE., Mailstop E-59, Atlanta, GA 30333, telephone (404) 639-0952, 
FAX (404) 639-0923, e-mail: .
    Please refer to Announcement 628 when requesting information and 
submitting an application.
    Potential applicants may obtain a copy of ``Healthy People 2000,'' 
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000,'' 
(Summary Report, Stock No. 017-001-00473-1) referenced in the 
``Introduction,'' through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.
Internet Home Page
    The announcement will be available on one of two Internet sites on 
the publication date: CDC's home page at <www.cdc.gov>, or at 
the Government Printing Office home page (including free access to the 
Federal Register) at <www.access.gpo.gov.>.
    There may be delays in mail delivery and difficulty in reaching the 
CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC 
suggests using Internet, following all instructions in this 
announcement and leaving messages on the contact person's voice mail 
for more timely responses to any questions.

    Dated: June 11, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-15560 Filed 6-18-96; 8:45 am]
BILLING CODE 4163-18-P