Expanded Use of Rapid HIV Testing, and Barriers to HIV Testing; Notice of Availability of Funds

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 98101]

Expanded Use of Rapid HIV Testing, and Barriers to HIV Testing;

Notice of Availability of Funds

A. Purpose

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

availability of fiscal Year (FY) 1998

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funds for a cooperative agreement program on the Expanded Use of Rapid

HIV Testing, and Barriers to HIV Testing. This program addresses the

``Healthy People 2000'' priority area of HIV Infection.

The purpose of these studies is to evaluate barriers to HIV testing

among persons at high risk for HIV, and to evaluate the expanded use of

rapid HIV testing in a variety of public and private settings.

Applications in BOTH or EITHER of the following research areas may

be submitted:

1. Studies evaluating the barriers to HIV testing among persons at

high risk for HIV.

The purpose of these studies is to learn more about the use of HIV

testing in personal prevention plans by interviewing persons at high

risk for HIV infection who have not been tested for HIV, or persons who

have not been tested recently despite ongoing risk. Of special interest

are persons who may not access the health care system. These should

include persons of various racial/ethnic backgrounds found by outreach

to high-risk settings, or persons on the streets in areas with known

high prevalence of HIV infection. The sample should be representative

of all persons who are not getting tested even though they are at high

risk. The study should be designed to address the following research

questions:

a. What are the determinants of and barriers to getting tested for

the high risk population? How can this population be segmented? What

can be done to increase their likelihood of getting tested?

b. What will the preferences for different testing options be when

the high risk population is offered: clinic-based counseling and

testing; home collection kits with counseling and testing; and home

test kits? What are the profiles of the segments which prefer each

alternative?

2. Studies evaluating the expanded use of rapid HIV testing,

including investigational tests, in a variety of public or private

settings.

The purpose of these studies is to learn more about how individuals

might use rapid HIV testing to prevent HIV infection and how programs

might use rapid HIV testing to identify infected persons and refer them

for care. This study should demonstrate that rapid HIV testing is

reaching high-risk persons who might not otherwise be reached by

existing testing services and that it is increasing the number of

persons who learn their HIV serostatus.*

*For more information on the availability of licensed or

candidate investigational rapid HIV tests, contact CDC at (404) 639-

2090.

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.

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.

Applicants are encouraged to collaborate with other organizations,

such as State health departments, colleges, universities, research

institutions, hospitals, correctional facilities, community

organizations, and other public and private organizations (e.g.,

managed care organizations), to carry out project activities.

C. Availability of Funds

Approximately $1.1 million is available in FY 98 to fund

approximately 4-6 awards. It is expected that the average award will be

$200,000, ranging from $100,000 to $300,000. It is expected that the

awards will begin on or about September 30, 1998 and will be made for a

12-month budget period within a project period of up to two years.

Funding estimates may change.

Continuation awards within an approved project period will be made

on the basis of satisfactory progress as evidenced by required reports

and the availability of funds.

Funding Preference

Preference will be given to areas with high HIV prevalence and

incidence. Geographic and population risk group diversity will also be

considered.

D. Program Requirements

In conducting activities to achieve the purposes of the cooperative

agreement, the recipient shall be responsible for the activities listed

under 1. (Recipient Activities), and CDC shall be responsible for

conducting activities listed under 2. (CDC Activities).

1. Recipient Activities

a. Develop the research study protocol and data collection forms.

b. Plan and conduct project activities and where appropriate, with

the participation of state and local professional associations and

health care providers and institutions serving, diagnosing, or

providing treatment and care for persons with HIV/AIDS.

c. Promote the use of rapid HIV testing for HIV prevention and for

linkage to care for infected persons by: (1) providing data and ongoing

assistance to community planning groups; (2) disseminating data through

publications and presentations.

d. Participate in project planning and implementation meetings with

CDC and other collaborators, when appropriate.

e. Establish procedures to maintain the rights and confidentiality

of all study participants.

f. Identify, recruit, obtain informed consent from participants

(when appropriate), and enroll an adequate number of study participants

as determined by study protocol and the program requirements.

g. Perform laboratory tests (when appropriate) and data analysis as

determined in the study protocol.

h. Share data and specimens (when appropriate) with other

collaborators to answer specific research questions.

i. Participate in multi-site data analysis and presentation and

publication of research findings with collaborators, when appropriate.

j. Provide HIV counseling, appropriate to the risk of the

population being studied, including referrals to needed services.

2. CDC Activities

a. Provide technical assistance in the design and conduct of the

research. Provide technical assistance in the development of study

protocols, consent forms, and data collection forms.

b. Assist in designing a data management system.

c. Assist in performance of selected laboratory tests.

d. Coordinate research activities among the different sites, when

appropriate.

e. Assist in the analysis of research information and the

presentation and publication of research findings.

E. Application Content

Use the information in the Program Requirements, Other

Requirements, and Evaluation Criteria sections to develop the

application content. For those applying for more than one research area

described in the ``Purpose'' section above, applicants should submit a

separate application for each research area proposed. Each application

will be evaluated based on the evaluation criteria listed below, so it

is important to follow them in laying out your

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program plan. The narrative should be no more than 10 double-spaced

pages, printed on one side, and with one inch margins. Applicants

should include an annualized, justified budget for the current (FY98)

project period.

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 23, 1998 submit the application to: Juanita

Crowder, Grants Management Specialist, Grants Management Branch,

Procurement and Grants Office, Announcement Number 98101, Centers for

Disease Control and Prevention (CDC), Room 300, 255 East Paces Ferry

Road, NE., Mailstop E-15, 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 reviewer group appointed by CDC.

1. Scientific Significance (15 Points)

Demonstrated scientific significance of the proposed study in that

it provides data not otherwise available, and if appropriate, provides

unique opportunities for evaluating the use of rapid HIV testing in

various settings. Application should include a detailed review of the

scientific literature pertinent to the study being proposed and

specific research questions that will guide the research, goals and

objectives for the project, and how findings can be used to guide

prevention and control efforts.

2. Research Design (10 Points)

Appropriateness of the research design for addressing the specified

research questions.

3. Capacity to Access (25 Points)

The extent to which the applicant demonstrates the capacity to

access the relevant study population; ability to enroll appropriate

number of study participants who are at high risk for HIV infection;

ability to enroll a study population outside of the health care

systems; extent to which size and characteristics of the study

population proposed for enrollment are appropriate; investigator's

experience in enrolling such persons in a culturally and linguistically

appropriate manner; and letters of support from cooperating

organizations that detail the nature and extent of such cooperation.

4. Experience (15 Points)

Experience in similar HIV prevention research, availability of

qualified and experienced personnel, percentage-time commitments,

duties, responsibilities of project personnel, and evidence of adequate

facilities, equipment and plans for administration of the project.

5. Ability to Operationalize Proposed Study Methodology (Maximum of 30

Points for a and b, Below)

a. Application should include appropriate outcome measures;

appropriate sampling schemes, sample size calculations, and handling of

sampling biases; and plan for data collection; specific quantitative

and qualitative analytic techniques to be used to answer the research

questions. Where applicable, application should demonstrate capacity to

obtain specimens and conduct testing, using appropriate quality

assurance mechanisms. (15 points)

b. Comprehensive schedule for accomplishing the activities of the

research and an evaluation plan that identifies methods and instruments

for evaluating progress in designing and implementing the research

objectives. Application should include time-phased and measurable

objectives. (15 points)

6. Inclusion of Women, Ethnic, and Racial Groups (5 Points)

The quality of the plans to develop and implement the study,

including 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 inclusion of both sexes and 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 community(ies) and recognition of mutual benefits.

7. Human Subjects (not Scored)

Does the application adequately address the requirements of 45 CFR

Part 46 for the protection of human subjects? (not scored)

____ YES ____ NO

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

8. Budget (not Scored)

Budgets will be reviewed to determine the extent to which they are

reasonable, clearly justified, consistent with the intended use of the

funds, and allowable. All budget categories should be itemized.

H. Other Requirements

Technical Reporting Requirements Provide CDC with original plus two

copies of

1. quarterly progress reports;

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

the budget period; and

3. final financial status report and performance report, no more

than 90 days after the end of the project period.

Send all reports to: Juanita Crowder, 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., Mailstop E-15, Atlanta, GA 30305-2209.

The following additional requirements are applicable to this

program. A complete description of each is included in the application

kit.

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 Sections 301(a) and 317(k)(2) of

the Public Health Service Act [42 U.S.C. 241(a) and 247b(k)(2)],as

amended. The Catalog of Federal Domestic Assistance Number is 93.941.

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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 98101.

If you have questions after reviewing the contents of all the

documents, business management technical assistance may be obtained

from Juanita Crowder, Grants Management Specialist, Grants Management

Branch, Centers for Disease Control and Prevention (CDC), Procurement

and Grants Office, 255 East Paces Ferry Road, NE., Room 300, Mailstop,

E-15, Atlanta, GA 30305-2209, telephone (404), 842-6577, or E-mail

address: [email protected].

See also the CDC home page on the Internet: http://www.cdc.gov

For program technical assistance, contact Kay Lawton, Deputy Chief,

Prevention Services Research Branch, National Center for HIV, STD, and

TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton

Rd., Mailstop E-46, Atlanta, GA 30333, telephone (404) 639-2090, E-mail

address: [email protected].

Dated: July 17, 1998.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98-19618 Filed 7-22-98; 8:45 am]

BILLING CODE 4163-18-P