01-18866. Human Immunodeficiency Virus (HIV) Prevention Intervention Research Studies-Prevention for HIV-Positive Persons; Notice of Availability of Funds; Amendment

A notice announcing the availability of Fiscal Year 2001 funds for HIV Intervention Research Studies—Prevention for HIV-Positive Persons was published in the Federal Register on July 19, 2001, [Vol. 66, No. 139, pages 37694-37696]. The notice is amended as follows:

On page 37694, First Column, under section B. Eligible Applicants, add the following paragraph immediately following paragraph number one:

Additional Eligibility Criteria

Eligible applicants must have:

1. A minimum of three participating clinics in the project. Provide evidence of this by including letters from each participating clinic signed by the responsible facility administrator; and

2. Each participating clinic must be currently serving a minimum of 300 HIV infected persons. Provide a statement signed by the responsible facility administrator certifying the number of HIV infected persons served.

On page 37695, Third Column, Under Section G. Evaluation Criteria, change to read:

The quality of 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):

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.). (5 points)

2. Demonstrating the quality of proposed prevention program. (15 points)

a. Exceeds the minimum number of 900 clients served by the clinics participating in the study (minimum three (3) clinics X minimum 300 clients per clinic). One point will be given for every 200 additional HIV infected clients, up to a maximum of 5 points. (5 points)

b. 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). (5 points)

c. 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. (5 points)

3. Demonstrating the appropriateness of research design to evaluate the proposed program. (35 points)

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). (20 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)

In addition, (5 points)

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:

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.

4. Demonstrating the ability to implement the intervention and the research design. (40 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. (10 points)

5. Budget (not scored): The extent to which the budget is reasonable, clearly justified, and consistent with the intent of the announcement.

The 12 month budget should anticipate the organizational and operational needs of the study. The budget should include staff, supplies, and travel (including two trips per year for up to two members of the study team to meet with CDC staff and other investigators).

6. Human Subjects (not scored): Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects?

Dated: July 24, 2001.

John L. Williams,

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