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240 Comparison of Men and Women Participating in a Phase III HIV Vaccine Efficacy Trial of AIDSVAX B/B in the US
R. Novak*1, P. Graham1, P. Brown-Peterside2, B. Koblin2, M. Lally3, K. Mayer3, and the VaxGen 0044 Study Team
1Univ. of Illinois, Chicago, USA; 2New York Blood Ctr., NY, USA; 3Brown Univ., Providence, RI, USA; and 4VaxGen, Inc., Brisbane, CA, USA
Introduction: The first phase III HIV vaccine efficacy trial will serve as a model for the future large-scale recruitment of sexually at-risk volunteers for HIV prevention research. We compared baseline characteristics of men and women in this cohort.
Methods: A total of 309 HIV-negative women and 5,109 men were randomized to AIDSVAX‚ B/B, or placebo. Enrollment criteria were heterosexual risk for women and MSM for men. Demographics, risk, and motivation assessments were collected.
Results: Women were enrolled at 38 of 61 study sites. Men were 86% white, whereas women were 55% black. Men had more education than women: 63% of men had more than college; 82% of women had less than high school education.
Risk Behaviors: Both men and women reported similar numbers of HIV+ partners (44 vs. 42%). Women reported higher frequencies of unprotected vaginal sex with HIV+ or unknown partners than unprotected receptive anal sex for men. Men reported more partners than women. Crack cocaine use was higher in women.
Motivations: Both men and women strongly agreed that they wanted to help their communities and help find a vaccine. However, women more often felt that getting money was important (43 vs. 12% of men); 25% of women agreed that study participation would get them access to medical care vs. 8% of men. When asked if they thought vaccine trial participation would protect them against HIV, 45% of men and 62% of women agreed; only 31% of men but 70% of women agreed that they participated in the study to get HIV counseling and testing.
Conclusions: Women trial participants are more often minority, less educated than the men, perceived protection against HIV infection, and valued monetary incentives more than men. These factors must be addressed in future vaccine trials designed for sexually at risk women.
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