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24 Women's Perceptions of HIV Vaccine Efficacy Trial Participation
E. McLellan*1, P. Graham2, J. Neidig3, E. Salomon4, The VaxGen Study Team5, and M. Ackers1
1CDC, Atlanta, GA, USA; 2Univ. of Illinois at Chicago, USA; 3Ohio State Univ., Columbus, USA; 4Fenway Community Hlth., Boston, MA, USA; and 5VaxGen, Inc., Brisbane, CA, USA
Background: Female participants account for only 6% of 5,418 individuals enrolled in the first US HIV vaccine efficacy trial of AIDSVAX B/B (VaxGen, Inc.). As an increasing proportion of HIV infections occur among women at heterosexual risk (WAHR), inclusion of women in trials is necessary to identify safety and efficacy measures for vaccine use among this population. However, little data exist regarding WAHR, their motivations for joining HIV vaccine efficacy studies, and their perceptions of their role in these studies.
Methods: Analysis of AIDSVAX B/B baseline data. Thematic analysis of individual and group interviews focusing on women’s trial motivations, experiences, and perceptions using AnSWR.
Results: Overall, 308 WAHR were enrolled from 38 sites representing 20 states, the District of Columbia, and Puerto Rico. The median age was 38 years; 52% completed high school and 17% completed college. African-Americans accounted for 55%, whites 29%, and Latinos 14%. Risk behaviors included: crack use (51%), multiple sex partners (44%), and HIV-positive partner(s) (41%). Forty-eight women from 3 sites completed individual or group interviews. Women reported that monetary incentives, self-protection concerns, and reducing HIV-positive partners’ anxiety motivated enrollment. Retention was maintained through appreciation of regular HIV testing, HIV education and prevention information, and access to other services. Benefits of participation included: healthcare self-advocacy and positive relationships with study staff. Few women disclosed their trial participation to others due to fears of negative repercussions for both themselves and others. WAHR strongly supported female participation and suggested that future trials should enroll adolescent women due to perceptions of increased risk behavior among this group.
Conclusions: Participation of women in HIV vaccine trials should be increased. Inclusion criteria for women should be broad to include the diverse risk behavior profiles of WAHR. A supportive staff sensitive to women’s issues improves enrollment and retention of WAHR.
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