01-18864. Human Immunodeficiency Virus (HIV) Prevention Intervention Research Studies-Routinely Recommending HIV and Sexually Transmitted Disease (STD) Counseling and Testing in Ambulatory Care Clinics and Emergency Rooms; Notice of Availability of ...

A notice announcing the availability of Fiscal Year 2001 funds for HIV Intervention Research Studies—Routinely Recommending HIV and STD Counseling and Testing in Ambulatory Care Clinics and Emergency Rooms was published in the Federal Register on July 20, 2001, (Vol. 66, No. 140, pages 37966-37969). The notice is amended as follows:

On page 37967, First Column, under Section B. Eligible Applicants, add the following paragraph immediately following paragraph number one:

Additional Eligibility Criteria

1. Demonstrate ability to do testing for chlamydia, gonorrhea, and HIV by including a letter from a contract laboratory or facility administrator.

2. Provide evidence of adequate available space for the testing program in the form of a letter from the responsible facility administrator.

3. Provide evidence that at least 500 HIV-infected persons per year visit the ambulatory care facility or emergency room.

On page 37967, 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 independent review group appointed by CDC.

1. Background and Objectives (10 points): Demonstrate that the proposed study will identify persons who do not know they are infected with HIV.

The application should include:

a. A detailed review of the scientific literature pertinent to testing in ambulatory care clinics and emergency rooms;

b. Clearly stated goals and objectives for the research; and

c. A description of how the intervention would impact HIV and STD prevention in the community.

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

The application should include a description of:

a. The current magnitude and characteristics of the HIV epidemic;

b. STD disease burden;

c. The number of persons served by the clinics; and

d. The expected number of newly-identified HIV infections that will be detected.

Letters of support from cooperating organizations should be included which clearly describe the nature and extent of such cooperation.

3. Methods (30 points): Appropriateness of methods for implementing and evaluating the testing program.

The application should describe the potential intervention and how it might impact on HIV and STD incidence in the study area. It should specify potential barriers to implementing the intervention and how they will be overcome. The methods for assessing the increase in number of persons tested, as well as the number of infected persons identified and successfully referred for treatment, should also be addressed. (25 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 other similar research collaboration with State and local health departments and availability of qualified and experienced personnel.

The application should describe the capacity and experience of the research team and should include curriculum vitae and position descriptions for key staff. The percentage-time commitments, duties, and responsibilities of project personnel and involvement of state and local health department personnel should be sufficient to operationalize the proposed methodology. Letters of support from key collaborators, community groups, State and local health departments, should be included. The application should document that there is sufficient space available in the ambulatory care clinic or emergency room for the addition of the testing program.

5. Sustainability of the intervention (15 points): Evidence of the health department and community planning group's commitment to sustain this program beyond the end of the project period and funding support, if it finds more infected persons at a lower cost than other existing outreach programs. Evidence includes letters of support from the community planning group and the health department, and the applicant's plan for encouraging the continuation of program activities.

6. 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 increase in number of persons tested, the number of new infections identified, and the number of persons who access treatment.

7. 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).

8. 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).