FY 1995 Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement Number 529]

RIN 0905-ZA95

FY 1995 Epidemiologic Research Studies of Acquired

Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV)

Infection

Introduction

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

program for competitive fiscal year (FY) 1995 grant or cooperative

agreement applications to conduct epidemiologic and behavioral research

studies of AIDS and HIV infection. These include studies to evaluate

the implementation and effectiveness of policies to reduce mother-to-

child HIV transmission, to examine factors related to mother-to-child

HIV transmission, and to evaluate factors associated with healthy,

long-term HIV- seropositive persons. The study of these research areas

as they pertain to minority populations (defined as Black, Hispanic,

Asian and Pacific Islander, and American Indian), is encouraged because

minorities constitute over 50 percent of all reported cases of AIDS and

approximately 76 percent of all women and children with AIDS.

The Public Health Service (PHS) is committed to achieving the

health promotion and disease prevention objectives of ``Healthy People

2000,'' a PHS-led national activity to reduce morbidity and mortality

and improve the quality of life. This announcement is related to the

priority area of HIV Infection. (To order a copy of ``Healthy People

2000,'' see the section WHERE TO OBTAIN ADDITIONAL INFORMATION.)

Authority

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. Applicable program regulations are set forth in 42 CFR Part

52, entitled ``Grants for Research Projects.''

Smoke Free Workplace

The Public Health Service strongly encourages all grant recipients

to provide a smoke-free workplace and promote the non-use of all

tobacco products. 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. This is consistent with

the PHS mission to protect and advance the physical and mental health

of American people.

Eligible Applicants

Eligible applicants include all public and private, nonprofit and

for-profit organizations and governments and their agencies. Thus,

universities, colleges, research institutions, hospitals, and other

public and private organizations, State and local governments or their

bonafide agents, federally recognized Indian tribal governments, Indian

tribes or Indian tribal organizations, and small, minority- and/or

women-owned businesses are eligible to apply.

Availability of Funds

Approximately $3,900,000 will be available in FY 1995 to fund

approximately eight awards. It is expected that the average award will

be approximately $375,000, ranging from $350,000 to $400,000. It is

expected that about 5 new and 3 competing renewal awards will be made

and that awards will begin on or about September 30, 1995. Awards will

be funded for a 12-month budget period within a project period of up to

3 years. Funding estimates may vary and are subject to change.

Continuation awards within the project period will be made on the basis

of satisfactory programmatic progress and the availability of funds.

Purpose

The purpose of these awards is to conduct epidemiologic and

behavioral research studies of AIDS and HIV infection. These include

studies to evaluate the implementation and effectiveness of policies to

reduce mother-to-child HIV transmission, to examine factors related to

mother-to-child HIV transmission, and to evaluate factors associated

with healthy long-term HIV- seropositive persons. The study of these

research areas as they pertain to minority populations (defined as

Black, Hispanic, Asian and Pacific Islander, and American Indian), is

encouraged because minorities constitute over 50 percent of all

reported cases of AIDS and

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approximately 76 percent of all women and children with AIDS.

Program Requirements

In conducting activities to achieve the purpose of this program,

the applicant should follow the procedures set forth below.

Research Issues

Three research issues of programmatic interest to the health care

community and to CDC for FY 1995 are listed below and are considered to

be of significant importance in gaining a greater understanding of the

epidemiology of AIDS and HIV infection. However, applications submitted

by organizations that examine additional important HIV-related

epidemiologic research issues will also be accepted and considered for

funding.

A. Evaluating the Implementation of Policies to Reduce Mother-to-Child

Transmission

Studies should be designed to evaluate the implementation and

effectiveness of guidelines for universal counseling and voluntary HIV

testing of pregnant women, for offering zidovudine (ZDV) to HIV-

infected pregnant women to reduce mother-to-child HIV transmission, and

for providing needed health and social services for HIV-infected women

and their children. Specifically, proposals are sought which will

address the following objectives:

1. To describe the extent to which current prenatal HIV counseling,

testing, and intervention practices reflect full implementation of

local and/or national guidelines (i.e., the United States PHS

Recommendations for HIV Counseling and Testing for Pregnant Women) in a

well-defined population.

2. To identify and quantify determinants of success or failure to

implement guidelines for offering HIV counseling and testing among

pregnant women and to identify and quantify determinants of accepting

HIV testing by pregnant women.

3. To identify and quantify determinants of the acceptance of and

adherence to preventive ZDV therapy, and the receipt of needed HIV-

related services by HIV-infected pregnant women and their children.

4. To identify and quantify social and psychological effects of

being diagnosed with HIV, in particular potential adverse social and

psychological consequences of HIV testing of pregnant women including

discrimination, domestic violence, and loss of social and family

supports. Preference will be given to applicants who address two or

more of the above objectives and are able to document their ability to

enroll an adequate number of pregnant women and HIV-infected pregnant

women. Applicants must be willing to participate collaboratively with

CDC and other researchers in the development, implementation, and

analysis of data from the proposed study.

B. Mother-to-Child HIV Transmission Studies

Studies should be designed to identify HIV-infected women during

pregnancy or at delivery and enroll the women and their infants in a

prospective follow-up study to examine factors related to mother-to-

child HIV transmission, early diagnosis of infant infection, and

disease progression, particularly in infants. Studies designed to

examine the effect of interventions to prevent mother-to-child HIV

transmission are of particular interest. Preference will be given to

studies in which mother-infant pairs are already being systematically

identified and followed, and which have the ability to perform

virologic and immunologic assays. Applicants must demonstrate that they

can provide adequate rates of follow-up of both mothers and infants,

including collection of laboratory specimens at periodic intervals

(particularly within the first 48 hours of birth and during the first 6

months of life), and long-term follow-up of infants, including those

placed in foster care. Applicants must be willing to participate in

collaborative studies with other CDC-sponsored mother-to-child HIV

transmission projects, including use of common data collection

instruments and study design where warranted. Applicants must

demonstrate cost-efficient data management and statistical capability

or provide explicit plans for data management by CDC or an outside

group. Applicants must demonstrate the ability to enroll and follow at

least 30 HIV-positive mother-infant pairs per year at each study site.

C. Prospective Evaluation of Healthy, Long-Term HIV-Seropositive

Persons

Studies should be designed to assess virologic and host factors in

which the HIV-infected persons remain disease- free or asymptomatic for

prolonged periods (usually, for 10 or more years after HIV infection).

Preference will be given to studies in which cohorts of long-term

healthy HIV-seropositive persons with characterized dates of

seroconversion and high CD4+ lymphocyte counts (e.g., >500 cells/

mm3) have been established. Studies should be designed to try to

identify virologic and immunologic factors that may modulate the

clinical course of HIV infection. Applicants should demonstrate a

willingness to collaborate, or have a proven collaborative

relationship, with virologic and immunologic laboratories, CDC, and

providers of care to HIV-infected persons.

Research Project Grants

A research project grant is one in which substantial programmatic

involvement by CDC is not anticipated by the recipient during the

project period. Applicants for grants must demonstrate an ability to

conduct the proposed research with minimal assistance, other than

financial support, from CDC. This would include possessing sufficient

resources for clinical, laboratory and data management services, and a

level of scientific expertise to achieve the objectives described in

their research proposal without substantial technical assistance from

CDC.

Cooperative Agreements

A cooperative agreement implies that CDC will assist the

collaborator in conducting the epidemiologic research of AIDS and HIV

infection described in the PURPOSE section of this announcement. The

application should be presented in a manner that demonstrates the

applicant's ability to address the research problem in a collaborative

manner with CDC.

In conducting activities to achieve the purpose of this program,

the recipient shall be responsible for the activities under A., below,

and CDC shall be responsible for conducting activities under B., below:

A. Recipient Activities

1. Develop the research study protocol and the interview instrument

in collaboration with CDC;

2. Identify, recruit, obtain informed consent, and enroll an

adequate number of study participants as determined by the study

protocol and the program requirements, where applicable;

3. Continue to follow study participants as determined by the study

protocol;

4. Establish procedures to maintain the rights and confidentiality

of all study participants;

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

determined in the study protocol;

6. Collaborate and share data and specimens (when appropriate) with

CDC and other collaborators to answer specific research questions; and

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7. Conduct data analysis with CDC and other collaborators as well

as present research findings.

B. CDC Activities

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

research;

2. Provide technical guidance in the development of study

protocols, consent forms and questionnaires;

3. Assist in designing a data management system;

4. Perform selected laboratory tests;

5. Coordinate research activities among the different sites; and

6. Participate in the analysis of research information and the

presentation of research findings.

Determination of Which Instrument to Use

Applicants must specify the type of award for which they are

applying, either project grant or cooperative agreement. CDC will

review the applications in accordance with the evaluation criteria.

Before issuing awards, CDC will determine whether a grant or

cooperative agreement is the appropriate instrument based upon the need

for substantial Federal involvement in the project.

Evaluation Criteria

Applications will be reviewed and evaluated based on the evidence

submitted, which specifically describes the applicants' abilities to

meet the following criteria:

A. The inclusion of a detailed review of the scientific literature

pertinent to the study being proposed and specific research questions

and/or hypotheses that will guide the research. (25 points)

B. The originality and need for the proposed research and the

extent to which it does not replicate past or present research efforts.

(25 points)

C. The plans to develop and implement the study describing how

study participants (including racial/ethnic minority populations) will

be identified, enrolled, tested and followed. (25 points)

D. The ability to enroll and follow an adequate number of eligible

study participants to assure proper conduct of the study. This includes

both demonstration of the availability of HIV-infected potential study

participants and the experience of the investigator in enrolling and

following such persons in a culturally and linguistically appropriate

manner. (25 points)

E. The applicant's current activities in AIDS and HIV or related

research and how they will be applied to achieving the objectives of

the study. Letters of support from cooperating organizations which

demonstrate the nature and extent of such cooperation should be

included. (20 points)

F. The applicant's understanding of the research objectives and

their ability, willingness and/or need to collaborate with CDC and

researchers from other study sites in study design and analysis,

including use of common forms, and sharing of specimens (when

appropriate) and data. (25 points)

G. The plan to protect the rights and confidentiality of all

participants. (25 points)

H. The size, qualifications and time allocation of the proposed

staff and the availability of facilities to be used during the research

study. Description of how the project will be administered to assure

the proper management of the daily activities of the program. (10

points)

I. The proposed schedule for accomplishing the activities of the

research, including time-frames. (10 points)

J. A detailed evaluation plan which specifies methods and

instruments to be used to evaluate the progress made in attaining

research objectives. (10 points) (A maximum of 200 cumulative points

can be awarded.)

The budget will be reviewed to determine the extent to which it is

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

funds. All budget categories should be itemized.

Funding Priorities

Priority will be given to competing continuation applications from

satisfactorily performing projects over applications for projects not

already receiving support under the program. Projects to evaluate the

implementation of policies to reduce mother-to-child transmission will

be awarded so that the composite of projects represents the geographic

and demographic characteristics of HIV-infected childbearing women.

Public comments are not being solicited regarding the funding

priority because time does not permit solicitation and review prior to

the funding date.

Executive Order 12372 Review

Applications are not subject to review under Executive Order 12372,

Intergovernmental Review of Federal Programs.

Public Health System Reporting Requirements

This program is not subject to the Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance Number is 93.943,

Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome

(AIDS) and Human Immunodeficiency Virus (HIV) Infection in Selected

Population Groups.

Other Requirements

A. 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.

B. Human Subjects

This program involves research on human subjects. Therefore, all

applicants 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 or

activity will be subject to initial and continuing review by an

appropriate institutional review committee. The applicant will be

responsible for providing assurance in accordance with the appropriate

guidelines and form provided in the application kit.

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.

C. HIV Program Review Panel

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 a designated

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

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

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

recipient must submit the program

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review panel's report that indicates all materials have been reviewed

and approved.

D. Patient Care

Applicants should provide assurance that all HIV-infected patients

enrolled in their studies will be linked to an appropriate local HIV

care system that can address their specific needs such as medical care,

counseling, social services and therapy. Details of the HIV care system

should be provided, describing how patients will be linked to the

system. Funds will not be made available to support the provision of

direct care for study participants.

Application Submission and Deadline

The original and five copies of the completed application Form PHS-

398 (OMB No. 0925-0001) must be submitted to Clara Jenkins, Grants

Management Officer, Grants Management Branch, Procurement and Grants

Office, Centers for Disease Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 320, Mail Stop E-15, Atlanta, Georgia

30305, on or before August 11, 1995. States and local governments may

use Form PHS-5161-1 (OMB No. 0937-0189); however, Form PHS-398 is

preferred. If using Form PHS-5161-1, submit an original and two copies

to the address stated above.

1. Deadline

Applications shall be considered as meeting the deadline if they

are either:

(a) Received on or before the stated deadline date; or

(b) 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 accepted as proof of timely mailing.)

2. Late Applications

Applications which 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

A complete program description, information on application

procedures, an application package and business or financial management

technical assistance may be obtained from Kevin G. Moore, Grants

Management Specialist, Grants Management Branch, Procurement and Grants

Office, Centers for Disease Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 320, Mail Stop E-15, Atlanta, Georgia

30305, telephone (404) 842-6550. The announcement is available through

the CDC homepage on the Internet. The address for the CDC homepage is

http://www.cdc.gov.

Programmatic technical assistance may be obtained from Jeff Efird,

Division of HIV/AIDS, National Center for Infectious Diseases, Centers

for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Mail

Stop E-45, Atlanta, Georgia 30333, telephone (404) 639-6130. Eligible

applicants are encouraged to call prior to the development and

submission of their application. Please refer to Announcement Number

529 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 from the Superintendent of Documents, Government Printing

Office, Washington, DC 20402-9325, telephone (202) 512-1800.

Dated: June 30, 1995.

Joseph R. Carter,

Acting Associate Director for Management,Management and Operations

Centers for Disease Control and Prevention (CDC).

[FR Doc. 95-16688 Filed 7-6-95; 8:45 am]

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