E9-16834. Proposed Collection; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

PROPOSED COLLECTION:

Title: Evaluation of the NIAID HIV Vaccine Research Education Initiative. Type of Information Collection Request: New. Need and Use of Information Collection: Developing a vaccine that protects against HIV infection is one of NIAID's highest priorities. To address the need for volunteers in HIV vaccine clinical trials, and enable NIAID to fulfill its Congressional mandate to prevent infectious diseases like HIV/AIDS, NIAID created the NIAID HIV Vaccine Research Education Initiative (NHVREI). The goal of NHVREI is to increase knowledge about and support for HIV vaccine research among U.S. populations most heavily affected by HIV/AIDS—in particular, African Americans, Hispanics/Latinos, men who have sex with men (MSM), women and youth, recognizing the intersection of these groups.

The NHVREI program objectives include (1) Increasing awareness of the need for an HIV vaccine in communities most affected and infected by HIV/AIDS, (2) Improving the public's knowledge of and attitudes toward HIV vaccine research, (3) Enhancing the partnership between community and HIV clinical trial researchers, and (4) Creating support for current and future HIV vaccine trials and fostering an environment that supports clinical trial volunteers.

To determine if the strategies used to meet these objectives were successful, it is necessary to measure the effectiveness of initiative elements. Specifically, the evaluation will assess (a) implementation of NHVREI (i.e., process evaluation) and (b) impact (i.e., outcomes evaluation) of NHVREI on awareness of, knowledge about, and support for HIV vaccine research among NHVREI primary audiences (i.e., partner organizations, key influencers) that work with target populations. The ultimate goal of evaluation planning and implementation is to determine what components/strategies of NHVREI are effective and impact desired outcomes, so that these components/strategies can be continued, enhanced, and/or expanded if needed.

Evaluation will be conducted through several processes including a survey and multiple focus groups. A survey will be conducted with key influencers of the NHVREI target populations to measure their level of awareness, knowledge about, and support for HIV vaccine research.

Focus groups will also be conducted with representatives of organizations receiving grants through the NHVREI Local Partnership Program (LPP) and National Partnership Program (NPP), as well as representatives from a broader group of organizations called the NHVREI Network. The LPP and NPP are organizations that are funded to raise awareness about HIV vaccine research at either the local or national level. The planned NHVREI network will be composed of leadership organizations and coalitions that are either influencers of or provide information services to the target populations. The purpose of conducting focus groups with LPP, NPP, and NHVREI Network representatives is to obtain data on their experience implementing NHVREI activities. Questions asked during the group discussions will address efforts implementing educational activities and developing materials, community partnerships developed, engagement of key influencers in program activities, and the types of media outreach and capacity building engaged in. Frequency of Response: Twice. Affected Public: Individuals. Type of Respondents: Key influencers of target populations. The annual reporting burden is shown in the table below. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Type of respondents	Form name	Estimated number of respondents	Noumber of responses per respondent	Average burden hours per response	Estimated total annual burden hours requested
	Time 1
LPP, NPP, and NHVREI Network	Focus Groups	78	1	1	78
Key Influencers	Survey	656	1	0.33	216
	Total Time 1	734			294
	Time 2
LPP, NPP, and NHVREI Network	Focus Groups	78	1	1	78
Key Influencers	Survey	590	1	0.33	195
	Total Time 2	668			273
	Total Time 1 & Time 2	1,402			567

Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Katharine Kripke, Assistant Director, Vaccine Research Program, Division of AIDS, NIAID, NIH, 6700B Rockledge Dr., Bethesda, MD 20892-7628, or call non-toll-free number 301-402-0846, or E-mail your request, including your address to [e-mail].

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

Dated: July 9, 2009.

John J. McGowan,

Deputy Director for Science Management, NIAID, National Institutes of Health.