Strengthening HIV/AIDS and STD Prevention Through Use of Behavioral Data in Programmatic Decision Making; Notice of Availability of Funds

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 99098]

Strengthening HIV/AIDS and STD Prevention Through Use of

Behavioral Data in Programmatic Decision Making; Notice of Availability

of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1999 funds for competitive cooperative

agreement awards to (1) Better understand state and local decision-

making processes that involve the use of HIV- and STD-related

behavioral data, and (2) enhance the availability and utilization of

high-quality HIV/STD behavioral data for meeting the needs of HIV/AIDS

and STD prevention program planners. Use of scientifically credible

behavioral data is expected to strengthen HIV/AIDS/STD prevention by

enhancing decision makers' ability to target priority populations,

precisely design programs that address local HIV risk factors, and

respond quickly to changing prevention needs within their

jurisdictions. This Program Announcement addresses the Healthy People

2000 priority areas of (18) HIV infection, (19) Sexually Transmitted

Diseases, and (22) Surveillance and Data Systems.

Effective HIV/AIDS and STD prevention programs include the

development, implementation, and evaluation of HIV behavioral risk-

reduction interventions that address the specific needs of at-risk

populations within their communities. To help achieve these objectives,

public health decision makers need accurate, timely, and relevant data

about HIV/STD risk behaviors and their determinants for groups within

their jurisdictions. However, in some jurisdictions, HIV/STD behavioral

risk data may be incomplete, unavailable, of poor quality, or out of

date. In other areas, useful data are available but may not be

effectively used in HIV and STD prevention program planning.

This process is intended to support research to answer several

overarching questions: (1) How are HIV/AIDS/STD prevention decisions

made? (2) How do behavioral data currently inform these decisions? (3)

What gaps currently exist with respect to the match between available

behavioral data and current decision-making needs? (4) What data and

analyses can address key program decisions for setting community HIV/

STD prevention priorities? (5) How can decision makers make better use

of existing data? (6) In what measurable ways can HIV/STD prevention

programs be improved by enhancements in the capacity of local decision

makers to use behavioral data?

B. Eligible Applicants

Assistance will be provided only to the health departments of

States or their bona fide agents, including the District of Columbia,

the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth

of the Northern Mariana Islands, American Samoa, Guam, federally

recognized Indian tribal governments, the Federated States of

Micronesia, the Republic of the Marshall Islands, and the Republic of

Palau. In consultation with States, assistance may be provided to

political subdivisions of States.

C. Availability of Funds

Approximately $600,000 is available in FY 1999 to make up to 3

awards. CDC anticipates that the average award amount will range from

$180,000 to $220,000 for the first year of the project. An application

requesting more than $220,000 (including indirect costs) will not be

considered for review and will be returned to the applicant. Awards are

expected to begin on or about September 30, 1999. Initial awards will

be made for a 12-month budget period, with support anticipated for a

project period of up to 4 years. Limited funds are anticipated to be

available for the fourth year to support dissemination. These estimates

may vary and are subject to change. 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.

Use of Funds

Funds may not be used to support laboratory testing; salary for

medical personnel to perform clinical services; pharmaceuticals; or

facility rental.

D. Program Requirements

In conducting activities to achieve the purpose of this Program

Announcement, recipients will be responsible for activities under

``Recipient Activities,'' and CDC will be responsible for the

activities under ``CDC Activities'' listed below.

1. Recipient Activities

a. Phase I: Baseline Study Phase: Design and conduct a baseline

study that systematically describes current HIV and STD prevention

program decision-making processes in your jurisdiction, with specific

attention to behavioral data. Focus should be on decision making by

health departments and associated community planning groups and on the

data used to support these purposes. Include evaluation of the data for

decision making purposes in terms of its availability, scientific

quality, and utility. Note gaps in data quality, availability, or

interpretability that constrain decision making.

b. Meetings and Collaboration: Meet and collaborate with other

recipients and CDC staff in the design, revision, and implementation of

all aspects of the

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project. Meetings will occur twice yearly.

c. Phase II: Intervention Activities: Design and implement

activities to address the quality, availability, interpretation, or

application of behavioral data with respect to the jurisdiction's HIV/

STD prevention needs. Activities should address data gaps or barriers

to data utilization identified in the baseline study.

d. Evaluation: Evaluate the effects of intervention activities on

jurisdictional HIV/STD program decision making and associated outcomes,

including changes in policy, service delivery, resource allocation, or

risk behavior monitoring.

e. Dissemination of Findings: Disseminate findings of the baseline

and intervention studies in peer-reviewed scientific journals and at

professional and community meetings.

f. Obtain Permissions and Consent: Obtain all needed permissions,

consent, and reviews for carrying out project activities, including

Institutional Review Board (IRB) clearances at the local level and

provide documentation and materials necessary for review and approval

by CDC IRB.

2. CDC Activities

a. Assist recipients in the design, revision, and implementation of

all project protocols:

(1) Host an initial meeting to review and coordinate proposals and

conduct subsequent follow up meetings.

(2) Conduct site visits, as needed, for each recipient. Monitor

site activities and progress toward meeting project objectives.

(3) Work with recipient staff, as needed, to resolve research and

implementation issues related to project protocols. This includes the

provision of technical assistance during the baseline study and the

intervention phase.

b. Provide general project oversight:

(1) Review and assist with or provide guidance on behavioral

surveys, sampling, questionnaire design, rapid assessment

methodologies, data analysis techniques, and ethnographic

methodologies, as well as other elements of protocol design or methods.

(2) Participate in analysis of data gathered from program

activities; assist in reporting and disseminating results.

(3) Conduct site visits, as needed, to assess program progress and

evaluate progress reports to ensure that objectives are being

accomplished and terms and conditions of the award are being met.

(4) Assist in development of research protocols resulting from this

project that are subject to 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 an annual

basis until the research project is completed.

E. Application Content

Submit a proposal that includes plans for addressing all activities

outlined in the program requirements section. The application may not

exceed 30 double-spaced pages, excluding table of contents, abstract,

and appendices (appendices are the appropriate location for references,

publications, resumes, MOA, sample reports, and other supportive

documents). Print all materials double-spaced, in a 12 point or larger

font size, on one side of 8\1/2\'' by 11'' paper with at least 1''

margins. Number each page. Submit your application unbound and

unstapled. Applications that exceed the 30-page limit, excluding

attachments, will not be reviewed and will be returned to the

applicant.

Achieving the main objectives of this project will require

participation from HIV community planning groups and may benefit from

the participation of academic researchers, particularly in areas such

as decision making models, development of new data systems, and

specialized data management or analysis functions. Therefore,

applicants should demonstrate evidence of strong collaborative

partnerships among these parties. Memoranda of agreement (MOA) showing

existence of, or intent to collaborate with the applicant must

accompany the proposal for funding. MOA should delineate the specific

roles and activities to be performed by the collaborating partners.

Use the following outline to organize their proposals:

1. Title and Abstract: The title and abstract should be a clear 1-

page summary of the applicant's proposal.

2. Background: Describe the HIV/AIDS epidemic in your jurisdiction,

recent STD epidemiology, and the programmatic responses, i.e., funding

priorities and prevention efforts. Whenever possible, cite specific

data and sources referenced, e.g., epidemiologic characteristics,

behavioral risk factors, or documented community conditions that place

groups at elevated HIV/STD risk within the jurisdiction. Note changes

in HIV/STD prevalence and incidence rates, with special attention to

populations that have recently emerged as a major focus of programmatic

intervention. Finally, describe the characteristics of HIV and STD

prevention programs developed over the past 5 to 10 years within the

jurisdiction.

3. Assessment of Existing Data: Describe current content, utility,

adequacy, and scientific merit (e.g., reliability, validity, sampling

methodology) of behavioral data available to the applicant. Also

describe uses of these data in HIV program decision making. Provide

similar descriptions for relevant sources of biomedical or other

epidemiological data for use in local HIV and STD prevention decision

making. Relevant CDC-sponsored data sources, as well as data from

academic sources, vital statistics registries, census data, or case

data from other public agencies should be included, as appropriate.

4. Phase I: Baseline Study Phase: Describe:

a. The proposed baseline study to examine HIV and STD prevention

program decision making, with particular attention given to the current

use of behavioral data, as well as other data types. For the purposes

of this study, ``decision making'' is defined as those activities that

involve program planning, development, monitoring, and evaluation, as

well as allocation of financial, personnel, and material resources.

Similarly, ``decision makers'' include those individuals or groups

within the jurisdiction who have authority for determining how these

actions are carried out in HIV and STD prevention programs. Describe

who the key decision makers are in the locality and provide a summary

of their responsibilities within their respective groups or

organizations.

b. Key decision making factors and how they will be measured.

c. The overall research design to be used for the baseline study.

d. Approaches for identifying the role behavioral data currently

have in decision making, as well as ways to identify potential gaps or

needs related to behavioral data and HIV prevention in the

jurisdiction. If formal or theoretical models of decision making are

proposed, describe them and cite appropriate literature in the list of

references.

e. Evaluate existing sources of data, particularly behavioral data,

in terms of availability, scientific quality, timeliness, ease of

analysis and interpretation, as well as utility for prevention program

decision making.

f. Plans for using baseline study results to develop a descriptive

or empirical decision-making model for the jurisdiction that

incorporates better utilization of behavioral data.

g. All data collection methods and instruments to be used.

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h. Anticipated approaches to data management, specific analysis

techniques, and software tools.

5. Phase II: Intervention Phase: Describe:

a. The anticipated study design for addressing potential gaps or

needs identified during the baseline study, e.g., pre and post-

intervention comparison, quasi-experimental, experimental.

b. The anticipated features of the intervention activities, i.e.,

what steps are anticipated for enhancing the availability, quality, or

use of behavioral data in decision making.

c. How intervention activities are to be carried out.

d. Key decision makers.

e. Anticipated barriers and facilitators of data use.

f. All assessment or evaluation methods and instruments to be used

to assess the effects of these intervention activities on HIV and STD

prevention program decision making, e.g., sampling, procedures for

review of archival documents, key informant interviews, ethnographic

observation, surveys, or other methods.

g. How changes in key-decision making variables will be measured in

relation to anticipated changes in the quality, availability, or use of

behavioral data.

h. Plans for data management, specific analysis techniques, and

software tools.

i. How the methods, variables, and instruments used during the

intervention (including evaluation) will provide comparability with

methods, variables, and instruments used in the baseline study.

6. Staffing Plan and Organizational Commitment: The application

should:

a. Explain the proposed staffing plan and organizational commitment

for the baseline and the intervention phases, including the percentage

of time each staff member will commit to the project.

b. Provide evidence that the proposed staff have the capacity and

experience to conduct all the proposed activities.

c. Include copies of curriculum vitae for the staff in the appendix

of the proposal.

d. Include copies of previous staff publications in the appendix,

if relevant.

e. Provide evidence of strong collaborative partnerships between

HIV prevention program decision makers, community planning groups, and

academic researchers. Describe collaborations in detail, and provide

signed and dated copies of MOA and letters of support between

participating partners.

7. Dissemination Plan: Describe plans for disseminating findings

from the baseline study and the intervention through peer-reviewed

scientific journals and presentation to appropriate professional and

community audiences. Meetings such as the CDC-sponsored HIV Prevention

Summit, as well as more academic meetings, should be considered.

8. Time Line: Provide a detailed time line for completion of all

the proposed activities, including anticipated meetings with other

recipients and CDC staff. It is expected that the baseline study will

require 9-12 months, while implementation, evaluation, and

dissemination of the intervention activities and associated findings

will require the remainder of the 4-year project period.

9. Permissions and Human Subjects: Describe plans for obtaining all

formal permissions and reviews needed for carrying out project

activities, including human subjects protection (Institutional Review

Board) plans, as well as procedures for safeguarding data collected

during the project. Application adequately addresses the requirements

of 45 CFR part 46 for the protection of human subjects. Policy

requirements regarding the inclusion of women, ethnic, and racial

groups in the proposed research are met. Documentation of study design

adequacy measure group differences is present. Documentation of

recruitment and outreach plans for study participants includes the

process of establishing partnerships with community(ies) and

recognition of mutual benefits.

10. Budget: Provide a detailed, line-item budget for carrying out

all proposed activities, including travel expenses for meetings with

other recipients and CDC staff and a budget narrative that justifies

each line item.

F. Submission and Deadline

Submit the original and two copies of the complete application

along with Form PHS 5161-1 (OMB Number 0937-0189). On or before July

20, 1999, submit the application to: Brenda Hayes, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Centers for Disease Control and Prevention, 2920 Brandywine Road, Room

3000, Mail Stop E-15, Atlanta, GA 30341-4146.

Applications shall be considered as meeting the deadline if they

are either received on or before the deadline date or 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 as proof of timely mailing.) Applications that

do not meet these criteria are considered to be late, will not be

considered, and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated individually against the

following criteria by an independent review group appointed by CDC.

1. Background (10 Points)

a. Quality, completeness, and specificity of the description of

HIV/AIDS and STD epidemiology within the applicant's jurisdiction.

b. Quality, completeness, and specificity of the description of

programmatic response to prevention needs over the past 5 to 10 years.

c. Adequacy of appropriate supporting data and reference citations.

2. Assessment of Existing Data (10 Points)

Quality, completeness, and specificity of the description of the

content, utility, and adequacy of existing behavioral data for the

applicant's jurisdiction, along with known uses of these data in

current HIV program decision making. Similar descriptions of other

data, such as biomedical or epidemiological information used in HIV and

STD program decision making. Appropriate sources should be cited in the

references.

3. Phase I: Baseline Study Plans (25 Points)

a. Clarity, completeness, and scientific quality of the plans to

conduct a baseline study on how behavioral and other types of data are

used in local HIV and STD prevention program decision making.

b. Clarity, scientific credibility, and feasibility of plans for

all baseline study components including overall research design;

sampling plan; methods and data collection protocols and instruments;

description and measurement of key variables related to decision

making, as well as potential barriers and facilitators that may

contribute to the quality, availability, and use of data in HIV and STD

prevention programs; data management and analysis plans; and

appropriate software tools.

c. Quality of the explanation of how results will be used to

develop a model of decision making for the jurisdiction; the model will

delineate the role of behavioral data relative to other factors

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that might influence HIV and STD program decision making.

d. Quality of plans to identify specific needs and gaps related to

behavioral data important for HIV and STD program decision making,

including the extent to which needs and gaps related to women and

racial and ethnic minority populations are addressed.

4. Phase II: Intervention Plans (30 Points)

a. Clarity, completeness, and scientific quality of the plans to

conduct and evaluate an intervention to address the gaps identified in

the baseline study. Intervention activities should focus on enhancing

data quality, availability, or utilization as they relate to HIV and

STD prevention decision making.

b. Clarity, scientific credibility, and feasibility of plans for

all intervention components, including overall intervention design;

anticipated types of intervention activities; methods and data

collection protocols, variables, and instruments needed for evaluating

the intervention; sampling, data management and analysis plans; and

appropriate software tools.

c. Comparability of evaluation methods and data used during

intervention phase with those used during the baseline study.

d. Likelihood that the intervention will improve the quality and

availability of behavioral data, promote their use in decision-making

and improve the overall quality and effectiveness of the local HIV

prevention programs.

e. Likelihood that the evaluation plans and methods can accurately

document these improvements in a scientifically credible manner.

5. Staffing Plan and Organizational Commitment (10 Points)

Clarity of proposed staffing plan. Participating staff and

organizations are qualified, committed, and available for carrying out

the proposed activities. Strong evidence is provided that documents

relevant staff experience and capabilities. Copies of curriculum vitae

or resumes are included in an appendix. Roles of participating

individuals and organizations are clearly described and are adequate

for completing the proposed work. Detailed and dated memoranda of

agreement or letters of support, written on appropriate institutional

letterhead, are provided in an appendix. Evidence is included of past

collaboration between the participating organizations or individual

staff. Applicant describes a strong commitment to collaborate with

other recipients and CDC staff involved with the project.

6. Dissemination Plans (5 Points)

Quality, completeness, and specificity of plans for disseminating

findings from the baseline and intervention phases of the project.

Include plans for written publications in peer-reviewed scientific

journals and presentation to appropriate professional and community

audiences.

7. Time Line (5 Points)

A detailed, clear, complete, and feasible time line is provided.

Time line includes plans for participating in meetings with other

recipients and CDC staff, as described in the Recipient Activities

section of this Program Announcement.

8. Permissions and Human Subjects (5 Points)

Includes plans for human subject review (Institutional Review Board

[IRB]) as well as procedures for safeguarding data and other

information or records gathered during the project.

Clear and appropriate plans are provided for obtaining all formal

permissions and reviews needed for the project at all levels (i.e,

applicable local IRBs; provide necessary documentation for review by

CDC IRB).

Does the application adequately address the requirements of 45 CRF

part 46 for the protection of human subjects?

____ Yes ____No

Comments:--------------------------------------------------------------

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:

1. The proposed plan for the inclusion of both sexes and racial and

ethnic minority populations 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.

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

9. Budget (Not Scored)

A detailed line item budget is provided. Budget expenditures are

well-justified and appropriate. Budget includes line-items for

attending project meetings described in the Recipient Activities

section of this Program Announcement. Travel for these meetings should

be budgeted with Atlanta as the destination for all meetings, although

the location may rotate among sites.

H. Other Requirements

1. Technical Reporting Requirements.

Provide CDC with original plus two copies of semiannual progress

reports, 30 days after the end of each reporting period. The progress

reports must include the following for each program, function, or

activity involved:

a. Progress in achieving stated goals.

b. Reasons that any goals were not met.

c. A description of steps taken to overcome barriers to

accomplishing the goals for the period.

2. Financial status report, no more than 90 days after the end of

the budget period.

3. Final financial status and performance reports, no more than 90

days after the end of the project period.

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 Women and Racial and Ethnic

Minorities in Research

AR98-4 HIV/AIDS Confidentiality Provisions

AR98-5 HIV Program Review Panel Requirements

AR98-7 Executive Order 12372 Review

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 (99098). You may view or download this

and other CDC/ATSDR Program Announcements, and download application

forms, at the following web site: HTTP://WWW.CDC.GOV

If you have questions after reviewing the contents of all the

documents, business management technical

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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, Atlanta, Georgia 30341-4146, Telephone: (770) 488-2720,

Email: [email protected].

Programmatic technical assistance can be obtained from: Robert

Kohmescher, Behavioral Intervention Research Branch, Division of HIV/

AIDS Prevention, Centers for Disease Control and Prevention (CDC), 1600

Clifton Road, NE, Mailstop E-37, Atlanta, GA 30333, Telephone: 404-639-

1900, Fax: 404-639-1950, Email: [email protected].

See also the CDC home page on the Internet: HTTP://WWW.CDC.GOV.

Dated: June 1, 1999.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 99-14281 Filed 6-4-99; 8:45 am]

BILLING CODE 4163-18-P