NIAID Cover Letter

DATE: July 15, 2008

TO: Office of Management and Budget

THRU: Project Clearance Officer, DHHS

Project Clearance Officer, NIH

Project Clearance Liaison, NIAID

FROM: Katharine Kripke, Assistant Director

National Institute of Allergy and Infectious Disease

Division of AIDS

Vaccine Research Program

SUBJ: Pretesting of NIAID’s HIV Vaccine Research Education Initiative

(OMB No. 0925-0585; Expiration Date 2/28/11)

In accordance with the terms of the generic clearance granted by OMB to the Division of AIDS, NIAID on February 28, 2008, I have electronically attached the submission for the first individual collection requested under this generic clearance (tracking # 0925-0585-01). This collection includes in-depth interviews with key opinion leaders from three priority populations.

The National Institute of Allergy and Infectious Diseases’ (NIAID) Division of AIDS funds HIV vaccine research. In an effort to educate US populations most affected by HIV about vaccine research, NIAID has created the NIAID HIV Vaccine Research Education Initiative (NHVREI). As part of NHVREI, local and national non-governmental partner organizations have committed to share information and educational materials about HIV vaccine research. NIAID developed educational materials in 2006 to meet this need; however, major events in vaccine research have occurred since then. NIAID does not know the extent to which these materials remain effective with the target audiences. As a result, NIAID plans to conduct formative research with key opinion leaders for three priority populations: African Americans, Hispanics, and men from all racial and ethnic groups who have sex with men. This formative research includes up to 29 interviews that will gather information about existing HIV vaccine research knowledge, attitudes, and intentions to distribute supportive materials. In addition to gathering this information, NIAID also plans to ask respondents: what questions they and their communities have about HIV vaccine research; what would encourage them to be more supportive of these efforts; what are their opinions of current national and local partners; and what type of educational materials they would find useful for increasing knowledge of and support for HIV vaccine research.

Individuals from key community organizations will be recruited. NIAID would like to recruit up to 29 individuals for a total of up to 29 interviews. Thus, the total respondent burden for this effort, based on in-depth interviews averaging one hour and approximately 29 non-government employee respondents, is 29 hours. This effort will account for 0.79 percent of the total annual burden hours (3689.0) granted in our approval package.

This submission includes:

• Supporting statement;

• Generic clearance form;

• OMB burden statement;

• Interview guide; and

• Informed consent document.

Please feel free to contact me if you have any questions.

Katharine Kripke, Ph.D.