Follow-up or Secondary Analysis of HIV Behavioral Intervention Research Studies

Federal RegisterJun 10, 1996

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Announcement 626]

Follow-up or Secondary Analysis of HIV Behavioral Intervention

Research Studies

Introduction

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

availability of fiscal year (FY) 1996 funds for a grant program for

conducting follow-up or secondary analysis of data from HIV behavioral

intervention research studies. This announcement provides funds for two

types of activities:

Activity 1 Follow-up or secondary analysis of outcome, process, or

economic data from existing HIV behavioral intervention data sets, and;

Activity 2 Secondary analysis of existing behavioral intervention

data with methodological implications for how to conduct, analyze, or

interpret research findings from behavioral intervention studies.

The 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), of the

Public Health Service Act [42 U.S.C. 241 and 247b], 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.

Eligible applicants must have access to data sets of outcome,

process, or economic data collected during efficacy or effectiveness

studies of HIV behavioral interventions in the United States.

Applicants may submit applications for both Activity 1 (follow-up

or secondary analysis) and Activity 2 (analysis with methodological

implications) but must submit them as separate applications.

Applications must state the activity type of the proposal in the

application's title.

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 $600,000 is available in FY 1996 to fund a total of

approximately six awards under Activities 1 and 2. It is expected that

the average award will range from $80,000 to $120,000, depending on the

number of analyses proposed. 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 one year. Funding estimates may vary and are

subject to change based on availability of funds. Grant funds are to be

applied to analyses of existing behavioral intervention data and cannot

be used for the collection of new or supplemental data, secondary

analyses of behavioral survey data, data entry, purchase of furniture,

software, computers, rental of facilities, equipment or support of

interventions.

Purpose

These awards will expand the knowledge of HIV behavioral risk

prevention by conducting further analyses of data sets from completed

research on HIV behavioral interventions. Proposals are sought for the

following activities:

Activity 1 Follow-up or secondary analysis of existing data sets

collected during efficacy or effectiveness trials of theory-based HIV

behavioral interventions.

Activity 2 Secondary analysis of existing behavioral intervention

data with methodological implications for how to conduct, analyze, or

interpret research findings from behavioral intervention studies.

Examples of analyses include methods to assess the reliability or

validity of behavioral measures, implementation and evaluation of

intervention methods, the relationship between behavioral and

biological outcome measures (including STD and HIV transmission),

comparisons of data collection or sampling methods, methods to identify

social networks, methods to determine cost-benefit or cost-

effectiveness, and the use of behavioral intervention data to model

transmission trends.

These awards also have the goal of obtaining information on diverse

populations, on populations for whom there is little information on

intervention effectiveness, on interventions conducted in geographic

areas or venue types on which there is little intervention information,

and on

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the creativity and appropriateness of the intervention for the targeted

population.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the following activities:

1. Secure access to the data set. The recipient will secure access

to the completed outcome, process, and/or economic data set from the

current manager of the data set with sufficient time to complete the

proposed analysis.

2. Prepare the data set. The recipient will finish cleaning the

data and debugging computer programs, if relevant.

3. Ensure completion of the project by sustaining analytic

capability. Throughout the course of the project, the recipient has the

responsibility to sustain and continue the level of analytic capability

which was presented in their application, particularly:

a. The skills to analyze the data and to design, oversee, and

evaluate the results of the follow-up or secondary analyses;

b. Adequate and appropriate technical and support services for the

proposed project;

c. Adequate computer and data management systems for the proposed

analyses; and

d. Plan and capacity for storing the data securely and

confidentially.

4. Conduct the proposed analyses. The recipient will:

a. Conduct the:

(1) Follow-up or secondary analysis of outcome, process, or

economic data from the data set (Activity 1); or

(2) Analysis of the data set for methodological implications

(Activity 2);

b. Apply appropriate statistical methods; and

c. Adhere to the proposed timeline for completion.

5. Disseminate results. The recipient is expected to publish the

results of the funded analyses in a peer-reviewed journal and to

prepare a report on the implication of those results for improving HIV

prevention programs or future behavioral research.

Evaluation Criteria

Applications for Activities 1 and 2 will be reviewed and evaluated

according to the following criteria:

1. Description of the Behavioral Intervention (15 points).

Thoroughness of the description of the intervention that generated

the proposed data set, including completion and evaluation. Clarity of

the goal of the intervention. Quality of the intervention design,

components, and methods. Appropriateness of the theoretical basis for

the target population and intervention method. Appropriateness of the

intervention methods for the target population.

2. Quality of the Proposed Data Set (20 points).

Detailed description of the proposed data set, including contents,

quality, size, integrity, and format. Statement whether the data are

process, outcome, or economic. Description of previous analyses on the

data set. Presence of required reprints. Demonstrated possession of or

access to the data set.

3. Quality of the Research Question(s) (20 points).

Appropriateness of the research question(s) for the data set and

the data collection design. Contribution toward improving HIV

prevention programs and HIV behavioral intervention research and its

effectiveness. Uniqueness of the research question(s) and proposed

analysis for the data set. Adequacy of justification for the proposed

analysis and for additional funding if more than one analysis is

proposed.

4. Adequacy of the Analysis Plan (20 points).

Thoroughness of analysis plan. Reasonableness and appropriateness

to the data set, including demonstration that the data set is large

enough to have the statistical power for the proposed analyses.

Statistical rigor and complexity. Adequacy of time line.

5. Analytic Capability (25 points).

Overall ability of the applicant to perform the proposed analysis

as reflected in staff qualifications, experience, demonstrated

familiarity with HIV behavioral interventions, and statistical

expertise. Clarity of the described duties and responsibilities of

project personnel. The extent to which staff time commitments for the

conduct of the analysis are realistic and sufficient. Quality of

applicant's previous statistical and methodologic work. Adequacy of the

facilities, equipment, and plans for the administration of the project.

Quality of data processing and analysis capacity. Appropriate data

management, software, and statistical packages for the proposed

analysis. Adequacy of systems for the management of data security.

Presence of required documentation.

6. Budget (not scored).

Extent to which the budget is reasonable, itemized, clearly

justified, and consistent with the intended use of the funds.

Funding Priorities

It is the intention of this announcement to solicit proposals to

fund further analyses of data sets from completed HIV behavioral

intervention research. For Activity 1, priority will be given to

proposals requesting funds to conduct quantitative analysis of outcome,

process, or economic data collected during HIV intervention studies.

Outcome (dependent) variables may include both behavioral and

biological markers. Analysis of qualitative data or analysis of

behavioral determinants may also be included if such data were

collected during the implementation phase of intervention studies and

are relevant to understanding the impact of a specific intervention.

For Activity 2, priority will be given to proposals to conduct

secondary analysis of existing behavioral intervention data with

methodological implications for how to conduct, analyze, or interpret

research findings from behavioral intervention studies.

Interested persons are invited to comment on the proposed funding

priorities. All comments received on or before July 15, 1996, will be

considered before the final funding priority is established. If the

funding priorities should change as a result of any comments received,

revised applications will be accepted prior to the final selection of

awards.

Written comments should be addressed 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.

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

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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

Catalog of Federal Domestic Assistance number is 93.941.

Other Requirements

HIV/AIDS Requirements

Recipients must comply with the document entitled Content of AIDS-

Related Written Materials, Pictorials, Audiovisuals, Questionnaires,

Survey Instruments, and Educational Sessions (June 1992) (a copy is in

the application kit). To meet the requirements for a program review

panel, recipients are encouraged to use an existing program review

panel, such as the one created by the State health department's HIV/

AIDS prevention program. If the recipient forms its own program review

panel, at least one member must be an employee (or designated

representative) of a State or local health department. The names of the

review panel members must be listed on the Assurance of Compliance for

CDC 0.1113, which is also included in the application kit. The

recipient must submit the program review panel's report that indicates

all materials have been reviewed and approved.

Application Submission and Deadlines

1. Preapplication Letter of Intent

A non-binding letter of intent-to-apply is required from potential

applicants. An original and two copies of the letter should be

submitted to the Grants Management Branch, CDC (see ``Applications''

for the address). It should be postmarked no later than July 15, 1996.

The letter should identify the announcement number, name of principal

investigator, and specify the activity(ies) to be addressed by the

proposed project. The letter of intent does not influence review or

funding decisions, but it will enable CDC to plan the review more

efficiently, and will ensure that each applicant receives timely and

relevant information prior to application submission.

2. Applications

An 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 (CDC), 255 East Paces Ferry

Road, NE., Room 300, Mailstop E-15, Atlanta, GA 30305, on or before

August 15, 1996.

3. Deadlines

A. Applications shall be considered as meeting the deadline if they

are either:

(1) Received on or before the deadline date; or

(2) Sent on or before the deadline date and received in time for

submission to the objective review group. (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 shall not be acceptable as proof of timely mailing.)

B. Applications that do not meet the criteria in 3.A.(1) or 3.A.(2)

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 information call (404) 332-4561. You will be

asked to leave your name, address, and phone number and will need to

refer to Announcement 626. 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:

[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]>.

Please refer to Announcement 626 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.

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Internet Home Page

The announcement will be available on one of two Internet sites on

the publication date: CDC's home page at http://www.cdc.gov>, or at

the Government Printing Office home page (including free access to the

Federal Register) at http://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 applicants use Internet, follow all instructions in this

announcement, and leave messages on the contact person's voice mail for