01-18049. Human Immunodeficiency Virus (HIV) Prevention Intervention Research Studies-Prevention for HIV-Positive Persons; 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 the prevention for HIV-positive persons. This program addresses the “Healthy People 2010” focus area of HIV.

The purpose of the activity is to generate effective prevention service models designed for HIV-infected persons, to be delivered at HIV care settings.

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, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.

Note:

Title 2 of the United States Code, chapter 26, section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

C. Availability of Funds

Approximately $750,000 is available in FY 2001 to fund approximately three to five awards. It is expected that the average award will be $250,000, ranging from $150,000 to $350,000. It is expected that the awards will begin on or about September 30, 2001, and will be made for a 12-month budget period within a project period of up to three 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.

1. Use of Funds

Funds are awarded for a specifically defined purpose and may not be used for any other purpose or program. Funds may be used to support personnel and to purchase equipment, supplies, and services directly related to project activities. Funds may not be used to supplant State or local funds available for HIV Prevention. Funds may not be used to provide direct medical care.

2. Funding Preferences

Preference will be given to applicants with geographic and population risk group diversity.

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 listed under 2. (CDC Activities).

1. Recipient Activities

a. Develop the prevention intervention, research study protocol and data collection forms.

b. Plan and conduct project activities such as, enrolling care sites into comparison (or control) and intervention groups; implementing the prevention intervention; and collecting and analyzing data to evaluate the prevention intervention.

c. Where necessary, build and maintain a coalition to adequately implement the program and research design.

d. Where appropriate, obtain the participation of state and local professional associations and healthcare providers and institutions in serving, diagnosing, or providing treatment and care for persons with HIV/AIDS.

e. Promote the adoption of effective prevention services for HIV-infected persons in care settings other than those participating in the study by: (1) Providing data and ongoing assistance to community planning groups; (2) disseminating data through publications and presentations.

f. Participate in project planning and implementation meetings with other collaborators, when appropriate.

g. Establish procedures to maintain the rights and confidentiality of all study participants.

h. 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. The protocol must be submitted to the local Institutional Review Boards (IRB) for approval.

i. Share data and specimens (when appropriate) with other collaborators to answer specific research questions.

j. Participate in multi-site data analysis and presentation and publication of research findings with collaborators, when appropriate.

2. CDC Activities

a. Provide technical assistance, as needed, in refining the proposed intervention.

b. As needed, assist in designing a data management system and data analysis and dissemination of findings.

c. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

E. Application Content

Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to follow them in laying out your program plan. The narrative should be no more than 25 pages double-spaced, printed on one side, with one inch margins, and unreduced font.

The narrative should consist of, at a minimum, a Plan, Objectives, Methods, Evaluation and Budget.

F. Submission and Deadline

Submit the original and five copies of PHS form 398 (OMB Number 0925-0001) (adhere to the instructions on the Errata Instruction Sheet for PHS 398). Forms are available at the following Internet address: www.cdc.gov/​od/​pgo/​forminfo.htm

On or before August 27, 2001, submit the 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 which do not meet the criteria in 1. or 2. above 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 objective review group appointed by CDC.

1. Background, Understanding of Problem and Objectives (10 Points)

To the extent to which the applicant—

a. Demonstrates knowledge of literature pertinent to the proposed program and its goals. Demonstrates an understanding of how prevention models developed for high-risk individuals should be adapted, as suggested by theory or research, to customize the service for HIV infected persons. (5 points)

b. Provides a compelling argument for justifying the care setting in which program will be implemented (patient load, lack of available prevention services, etc.). In addition, provide information on high HIV prevalence and incidence, and opportunities for evaluating prevention services designed for HIV infected persons in various HIV care settings. (5 points)

2. Demonstrating the Quality of Proposed Prevention Program (15 Points)

To the extent to which the applicant—

a. Demonstrates adequacy of proposed program to address the purpose stated in the background section: Reduction in unprotected sex and/or needle sharing with HIV negative partners and partners of unknown status. (Disclosure of serostatus and adherence to therapy are acceptable but not required as additional outcomes). (8 points)

b. Presents a program which adequately incorporates into the prevention model organizational and personnel factors which accelerate adoption and proper implementation by the care organizations specified in the application. (7 points)

3. Demonstrating the Appropriateness of Research Design To Evaluate the Proposed Program (30 points):

To the extent to which the applicant—

a. Presents an overall research design which can generate reasonably certain conclusions about the effects of the proposed program; and which includes appropriate design elements such as: Outcome measures taken at pre-intervention, post-intervention and follow-up; process measures; control or comparison group(s). (10 points)

b. Presents reliable and valid measures to gauge effectiveness at three levels: Organizational adoption (ability and willingness of the service organization to provide sustained support); adoption by care personnel (acceptance and use by the individual service providers); reduction in risk behaviors by clients. (10 points)

c. In addition, applications will be evaluated on 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: (10 points)

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 communities and recognition of mutual benefits.

4. Demonstrating the Ability To Implement the Intervention and the Research Design (45 Points)

a. Demonstrates the extent to which the applicant has the necessary skills and resources needed for both program and research design implementation. In cases where a collaboration is necessary between different organizations, demonstrates the ability to put together the collaboration necessary for adequately implementing the program and the research design. Demonstrates the degree of commitment from non-lead organizations to the project and explains how the lead organization intends to maintain this commitment. Letters of support from all collaborating organizations are the required minimum. (10 points)

b. Identifies the technical assistance and training needs required for the proper implementation of the prevention service and the research protocol, and presents a plan that ensures that these needs will be met. (5 points)

c. Specifies methods for careful verification that the proposed intervention is actually being implemented. (5 points)

d. Specifies a plan for tracking participants and ensuring successful follow-up. (5 points)

e. Presents a plan for carrying out the program and research activities. (5 points)

f. Demonstrates experience and expertise in conducting similar prevention programs and research. (15 points)

6. Budget (Not Scored)

The extent to which the budget is reasonable, clearly justified, and consistent with the intent of the announcement.

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; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks are so inadequate as to make the entire application unacceptable.)

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original and two copies of:

1. Annual progress reports to be submitted with subsequent continuation applications;

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

3. Final financial 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 I of the announcement.

AR-1 Human Subjects Requirements

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

AR-4 HIV/AIDS Confidentiality Provisions

AR-5 HIV Program Review Panel Requirements

AR-7 Executive Order 12372 Review

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 sections 317 (42 U.S.C. 241(a) and 247b); 301 (42 U.S.C. 241); and 311 (42 U.S.C. 243), as amended. The Catalog of Federal Domestic Assistance number is 93.941.

J. Where To Obtain Additional Information

This and other CDC announcements can be found on the CDC home page Internet address http://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 the documentation, business management technical assistance may be obtained from: James Masone, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Mailstop E-15, Atlanta, GA 30341-4146 Telephone: [phone], Email address: [e-mail].

For program technical assistance, contact: Cassandra Walker, MPH, Acting Deputy Chief, Prevention Services Research Branch, Division of HIV/AIDS Prevention, Surveillance & Epidemiology, National Center for HIV, STD, TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop E-46, Atlanta, GA 30333, Telephone: [phone], Email address: [e-mail].

Dated: July 13, 2001.

John L. Williams,

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