Human Immunodeficiency Virus (HIV) Prevention Intervention Research Studies: Social and Environmental Interventions to Prevent HIV; Notice of Availability of Funds Amendment

A notice announcing the availability of Fiscal Year 2001 funds for HIV Research Studies—Social and Environmental Interventions to Prevent HIV was published in the Federal Register on July 20, 2001, (Vol. 66, No. 140, pages 37969-37971). The notice is amended as follows:

On page 37970, First Column, under section G. Evaluation Criteria, change to read:

Section G. Evaluation Criteria

The quality of each application will be evaluated individually against the following criteria by an independent review group appointed by CDC.

1. Background and Objectives (10 points): Demonstrate the proposed study will provide data for publication that's not otherwise available concerning social and environmental interventions to reduce HIV incidence.

The application should include a detailed review of the scientific literature pertinent to the study being proposed, with evidence for the relationship of social and environmental factors to the incidence of HIV. This literature review and a review of conditions in the study community should suggest specific research questions that will guide the research. The goals and objectives for the research should be clearly stated along with how the intervention would impact one of the underlying factors determining HIV incidence in the community.

2. Site Selection (15 points): Demonstrate high prevalence of HIV or AIDS in the study area. Demonstrate ability to work in the community or communities.

The application should include a description of the size and characteristics of the communities proposed for study. Describe the prevalence and estimated incidence of HIV infection in the study community. Include the age, gender, race/ethnicity, and HIV-risks of persons with HIV in the community where the intervention will be implemented. Describe the likely acceptability of the intervention by persons in the community. Letters of support from cooperating organizations should be included which detail the nature and extent of such cooperation.

3. Methods (45 points): Appropriateness of methods for implementing and evaluating the social and environmental interventions to reduce HIV incidence and assessing the potential impact of the intervention within a community or geographic area.

The application should describe the social-environmental issue that the recipient wants to address, how the potential intervention will influence the issue, and how the intervention might impact on HIV incidence in the study area. It should specify potential barriers to implementing the intervention and how barriers will be overcome. The potential impact on HIV reduction should be clear. The intervention should be new and sustainable in the future without ongoing CDC funding. (40 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. Research Capacity (20 points): Experience in similar social interventions, human rights evaluations, and HIV prevention research; and availability of qualified and experienced personnel.

The application should describe the capacity and experience of the research team and should include curriculum vitaes and position descriptions for key staff and project participants. The percentage-time commitments, duties, and responsibilities of project personnel should be sufficient to operationalize the proposed methodology. Letters of support from key collaborators and community groups should be included.

5. Evaluation Plan (10 points): Appropriateness and comprehensiveness of:

a. the schedule for accomplishing the activities of the research;

b. an evaluation plan that identifies methods and instruments for evaluating progress in implementing the research objectives; and

c. a proposal to complete and submit for publication, a report of research findings.

The application should include time-phased and measurable objectives. The proposed report of research findings should document the process of identifying and implementing the intervention and the acceptability and estimated impact within the community.

6. 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 four members of the study team to meet with CDC staff and other investigators).

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