Risk behavior for HIV infection in participants in preventive HIV vaccine trials: a cautionary note.
We conducted a longitudinal study of participants in phase I and II HIV vaccine safety and immunogenicity trials to examine changes in sexual risk behavior that are associated with risk of HIV transmission. The participants were 48 HIV-negative men and women enrolled in one of two placebo-controlled HIV vaccine trials conducted at San Francisco General Hospital. There was a significant increase in insertive unprotected anal intercourse (UAI) from 9% at baseline (trial entry), to 13% at the month 6 assessment, to 20% at the month 12 assessment (p = .02). The primary predictor of either insertive or receptive UAI during the vaccine trials was having engaged in this behavior prior to entry (p = .001). Higher-risk behavior was also seen among participants who were younger and had multiple sexual partners (each, p = .06) and who indicated that one of their reasons for participation in the vaccine trial was hope of protection from HIV infection (p = .07). These findings indicate that despite instructions otherwise, participants with a history of high-risk behavior or who express hope of protection from HIV infection by enrolling in vaccine trials may be candidates for more intensive risk-behavior counseling prior to and during their participation.
Chesney
M A
MA
Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, 94105, USA. margaret_chesney@quickmail.ucsf.edu
Chambers
D B
DB
Kahn
J O
JO
D016915:AIDS Vaccines / Q000008:administration & dosage*; D000328:Adult; D018849:Controlled Clinical Trials as Topic / Q000523:psychology*; D005260:Female; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control* / Q000523:psychology*; D006679:HIV Seropositivity / Q000523:psychology; D018451:Homosexuality, Male; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D011939:Mental Recall; D010358:Patient Participation / Q000523:psychology*; D018579:Patient Selection; D012309:Risk-Taking; D012725:Sexual Behavior; D012938:Social Perception; D012959:Socioeconomic Factors; D014836:Volition
D016915:AIDS Vaccines