01-16532. Human Immunodeficiency Virus (HIV) Related Applied Research; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2001 funds for a cooperative agreement program for human immunodeficiency virus (HIV) related applied research for the control and prevention of HIV. This program addresses the “Healthy People 2010” focus area of HIV. For a copy of “Healthy People 2010” visit the internet site: http://www.health.gov/​healthypeople.

The purpose of this program is to encourage new and innovative methods to further the prevention of HIV infection.

Projects that will be considered for funding are applied research for the control and prevention of HIV that address only the following Research Topics:

1. Community Interventions Among Adolescents

Funds are available to support formative research that will lead to community or structural based interventions to prevent HIV among high-risk adolescents, aged 17 or younger. High-risk adolescents is defined as youth 17 or younger who engage in activities that put them at higher risk for becoming HIV infected. Structural interventions are defined as factors that are barriers to, or facilitators of, an individual's HIV prevention behaviors. They directly or indirectly affect an individual's ability to avoid exposure to HIV and include physical, social, cultural, organizational, community, economic, legal or policy aspects of the individual's environment.

2. Demonstration Projects for the Efficient Allocation of HIV Prevention Resources

Funds are available to support research to develop decision making tools for the efficient allocation of HIV prevention resources. An efficient allocation is defined as expending resources on interventions that are cost-effective, producing an optimal outcome at the least cost. The research should fully address the data needs and requirements for the practical use of cost effectiveness analysis to allocate resources. Applicants must demonstrate the ability to either identify and evaluate models and tools currently being used by state and local health departments and community based organizations or the ability to develop, pilot and evaluate models and tools usable by state and local health departments and community based organizations. Applicants should also demonstrate a willingness to collaborate with CDC and others in the documentation and dissemination of the research findings.

3. Biologic Determinants of HIV Transmission

Funds are available to support research on biologic determinants of HIV transmission. These determinants will include the effect of antiretroviral use by source partners and other factors such as viral load, viral resistance and replication fitness, genetic factors including HLA class, and mucosal and humoral immunity. Applicants must demonstrate the potential to recruit at least 10 recently infected individuals (ie., infected less than six months) per month with their source partners and a comparison cohort of uninfected but exposed individuals and their partners. The applicants should demonstrate adequate laboratory capacity and a willingness to collaborate with the CDC laboratory.

4. HIV Testing Survey Among Asians/Pacific Islanders

Funds are available to implement the HIV testing survey (HITS) among Asians/Pacific Islanders in urban settings in geographic areas highly impacted by the HIV epidemic. HITS assesses determinants of HIV-related risk, testing and care-seeking behaviors. Applicants must demonstrate the ability to cooperate with health officials and community groups to gain access to this target population and to interview at least 300 persons during the one-year project period. Applicants should also demonstrate a willingness to collaborate with CDC in developing and disseminating findings from this survey.

5. HIV Testing Survey Among American Indians/Alaska Natives

Funds are available to implement the HIV testing survey (HITS) among American Indians/Alaska Natives in urban settings in geographic areas highly impacted by the HIV epidemic. HITS assesses determinants of HIV-related risk, testing and care-seeking behaviors. Applicants must demonstrate the ability to cooperate with health officials, community groups and/or tribal leaders to gain access to this target population and to interview at least 300 persons during the one-year project period. Applicants should also demonstrate a willingness to collaborate with CDC in developing and disseminating findings from this survey.

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, public and private non-profit organizations, State and local governments or their bona fide agents or instrumentalities, federally recognized Indian Tribal governments, Indian tribes or organizations.

Note:

Title 2 United States Code Section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

C. Availability of Funds

1. Community Interventions Among Adolescents

Approximately $200,000 is available in FY 2001 to fund approximately one to two new awards. It is expected that the award will begin September 30, 2001, and will be made for a 12 month budget period within a project period of up to four years. Funding estimates are subject to change.

2. Demonstration Projects for the Efficient Allocation of HIV Prevention Resources

Approximately $1,250,000 is available in FY 2001 to fund approximately five new awards. It is expected that the average award will be $250,000. It is expected that awards will begin September 30, 2001, and will be made for a 12 month budget period within a project period of one year. Funding estimates are subject to change.

3. Biologic Determinants of HIV Transmission

Approximately $1,000,000 is available in FY 2001 to fund approximately up to two new awards. It is expected that the average award will be $500,000, ranging from $500,000 to $1,000,000. It is expected that awards will begin September 30, 2001, and will be made for a 12 month budget period within a project period of up to five years. Funding estimates are subject to change.

4. HIV Testing Survey Among Asians/Pacific Islanders

Approximately $100,000 is available in FY 2001 to fund approximately one new award. It is expected that the award will begin September 30, 2001, and will be made for a 12 month budget period for a one year project period. Funding estimates are subject to change.

5. HIV Testing Survey Among American Indians/Alaska Natives

Approximately $100,000 is available in FY 2001 to fund approximately one new award. It is expected that the award will begin September 30, 2001, and will be made for a 12 month budget period for a one year project period. Funding estimates are subject to change.

Continued 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.

D. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. (Recipient Activities), and CDC will be responsible for the activities under 2. (CDC Activities). Recipient activities to achieve the purposes of this program will vary by project.

1. Recipient Activities

a. Develop research protocol.

b. Carry out the activities according to the approved protocol.

c. Ensure that appropriate approvals are secured for the protection of human subjects, Office of Management and Budget and Paperwork Reduction Act, privacy, confidentiality, and data security.

d. Compile and disseminate findings.

2. CDC Activities

a. Through publications and other methods, CDC will collaborate as necessary in the development of a research common protocol for 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 at least an annual basis until the research project is completed.

b. Monitor and evaluate scientific and operational accomplishments of the project through periodic site visits, frequent telephone calls, and review of technical reports and interim data analysis.

c. Assist in facilitating the planning and implementation of the necessary linkages with local or State health departments and assist with the developmental strategies for applied clinical or prevention oriented research programs, for recipients whose projects involve collaboration with a State or local health department.

d. Assist with the facilitation of the technological and methodological dissemination of successful prevention and intervention models among appropriate target groups, such as, State and local health departments, community based organizations, and other health professionals.

e. Provide technical assistance in planning and evaluating strategies and protocols, as requested.

E. Application Content

Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative, excluding the budget, should be no more than 11 doubled-spaced pages, printed on one side, with one inch margins, and unreduced font.

The application narrative should consist of:

1. Abstract (Not to exceed 1 page): An executive summary of your program covered under this announcement. Identify the Research Topic that the application addresses.

2. Program Plan (Not to exceed 10 pages): In developing the application under this announcement, please review the recipient activities and, in particular, evaluation criteria and respond concisely and completely.

3. Budget: Submit an itemized budget and supporting justification that is consistent with your proposed program plan.

F. Submission and Deadlines

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 available in the application kit and at the following Internet address: www.cdc.gov/​od/​pgo/​forminfo.htm.

On or before August 17, 2001, submit your application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Deadline: 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 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.)

Late Applications: Applications which do not meet the criteria in (1) or (2) above are considered late applications, 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. CDC will act as reviewer for these applications.

1. The inclusion of a brief review of the scientific literature pertinent to the study being proposed and specific research questions or hypotheses that will guide the research. The originality and need for the proposed research, the extent to which it does not replicate past or present research efforts, and how findings will be used to guide prevention and control efforts. (25 points)

2. The quality of the plans to develop and implement the study. 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 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 communities and recognition of mutual benefits. (25 points)

3. Extent to which proposed activities, if well executed, support attaining project objectives. (25 points)

4. Extent to which personnel involved in this project are qualified, including evidence of past achievements appropriate to the project, and realistic and sufficient time commitments. Evidence of adequacy of facilities and other resources supported to carry out the project. (25 points)

5. Other (not scored)

(a) Budget: Will be reviewed to determine the extent to which it is reasonable, clearly justified, consistent with the intended use of the funds, and allowable. All budget categories should be itemized.

(b) Human Subjects: Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. An annual progress report;

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 the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment 1 of the announcement in the application kit.

AR-1—Human Subjects Requirements

AR-2—Inclusion of Women and Racial and Ethnic Minorities in Research Requirements

AR-4—HIV/AIDS Confidentiality Provisions

AR-5—HIV Program Review Panel Requirements

AR-6—Patient Care Prohibitions

AR-9—Paperwork Reduction Act Requirements

AR-10—Smoke-Free Workplace Requirements

AR-11—Healthy People 2010

AR-12—Lobbying Restrictions

AR-22—Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under the Public Health Service Act, Section 317(k)(2) [42 U.S.C. 247b(k)(2)], as amended. The Catalog of Federal Domestic Assistance number 93.943, Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection in Selected Population Groups.

J. Where To Obtain Additional Information

This and other CDC announcements can be found on the CDC home page e-mail address www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

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.

If you have questions after reviewing the contents of all documents, business management technical 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, GA 30341-4146, telephone [phone], or facsimile at [phone], or Email address: [e-mail].

You may obtain programmatic technical assistance from: Sharon Robertson, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE, Atlanta, GA 30333, Telephone [phone], Email address: [e-mail].

Dated: June 26, 2001.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).