HIV sexual risk behavior over 36 months of follow-up in the world's first HIV vaccine efficacy trial.
Increased risk behavior among participants in HIV vaccine efficacy trials has been a concern. This study evaluated HIV sexual risk behavior among 5095 HIV-negative men who have sex with men (MSM) and 308 women enrolled in a randomized, double-blind, placebo-controlled efficacy trial of a bivalent rgp120 vaccine at 61 sites, primarily in North America. Sexual risk behavior data were collected at baseline and semiannually for 36 months. Overall, sexual risk behavior did not exceed baseline levels during the trial. Among MSM, younger age (< or =30 years), perceived assignment to vaccine, and nonblack race were associated with an increased probability of unprotected anal sex. Among women, unprotected vaginal sex initially decreased but was statistically equivalent to baseline by 24 months, whereas unprotected vaginal sex with HIV-infected partners decreased from baseline, where it remained throughout the trial. HIV sexual risk behavior did not increase among trial participants; however, it was substantial throughout the trial. Consistently high levels of risk behavior and the association of these behaviors to perceived assignment and demographic variables underscore the need for vigilant HIV risk reduction counseling, informed consent, and educational processes in the context of HIV vaccine efficacy trials.
Bartholow
Bradford N
BN
Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. bub1@cdc.gov
Buchbinder
Susan
S
Celum
Connie
C
Goli
Vamshidar
V
Koblin
Beryl
B
Para
Michael
M
Marmor
Michael
M
Novak
Richard M
RM
Mayer
Kenneth
K
Creticos
Catherine
C
Orozco-Cronin
Patti
P
Popovic
Vladimir
V
Mastro
Timothy D
TD
D016915:AIDS Vaccines; D000328:Adult; D002170:Canada; D004522:Educational Status; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000276:immunology* / Q000635:transmission*; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D009042:Motivation; D009426:Netherlands; D010919:Placebos; D044469:Racial Groups; D012309:Risk-Taking; D012725:Sexual Behavior; D011795:Surveys and Questionnaires; D014481:United States
D016915:AIDS Vaccines; D010919:Placebos