228943 Perceived and reported social impacts of participation in preventive HIV vaccine clinical trials

Wednesday, November 10, 2010

Nina Berkowitz, BS , Vaccine Research Center, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Rockville, MD
Kathy Zephir, RN , Vaccine Research Center, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, MD
Sandra Sitar, MS , Vaccine Research Center, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Rockville, MD
Brittany Jackson, BA , Vaccine Research Center, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, MD
Laura Novik, RN, MA, CCRC , Vaccine Research Center, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, MD
Diane Johnson, MPH , Vaccine Research Center, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Bethesda, MD
Ingelise Gordon, RN, CCRC , Vaccine Research Center, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, MD
Mary Enama, MA, PA-C , Vaccine Research Center, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, MD
Barney Graham, MD, PhD , Vaccine Research Center, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, MD
Julie Ledgerwood, DO , Vaccine Research Center, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, MD
BACKGROUND Preventive HIV vaccines have been evaluated in clinical trials since 1987, with participation by more than 30,000 individuals worldwide. To ethically and efficiently enroll vaccine trials, barriers to participation must be considered.

METHODS The clinic has conducted HIV vaccine studies since 2002. Pre-screening and screening data through September 2009 were reviewed for specific reasons for declining to participate. Actual social impacts of participation as experienced by enrolled volunteers were collected through a social impact assessment survey.

RESULTS 1570 contacts have declined to screen after demonstrating initial interest. Of 521 volunteers who stated a specific reason for declining, 79 (15%) cited reasons related to social impacts such as lack of social support, fear others would learn of their participation, or potential for vaccine-induced seropositivity (VISP). Of 801 individuals who consented to be screened for a study, 225 withdrew and 29 cited reasons such as lack of social support and fear of insurance and travel problems. Of 240 enrolled volunteers who completed social impact assessments, 51 (21%) reported a social impact; 46 of which related to “personal relationship” problems due to clinical trial participation.

DISCUSSION Concerns about participating in HIV vaccine clinical trials are common and justified based on social harms experienced by clinical trials participants. Strategies to mitigate the social impact of study participation include greater investment in public education on clinical research and HIV vaccine development, building social support for study participants, documentation of resolved travel and insurance issues, and developing more discriminating HIV diagnostics.

Learning Areas:
Public health or related research

Learning Objectives:
1. Explain barriers to participation in preventive HIV vaccine clinical trials 2. Identify negative social impacts feared by possible volunteers and experienced by enrolled volunteers 3. Discuss possible remedies to barriers to and impacts of participation in HIV vaccine clinical trials

Keywords: Clinical Trials, HIV/AIDS

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: This presentation references investigational preventive HIV vaccines used in approved vaccine clinical trials.

Qualified on the content I am responsible for because: I am qualified to present because I have worked for over 1.5 years as a Community Outreach and Recruitment Specialist for preventive HIV and other biological re-emerging infectious disease vaccine clinical trials.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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