CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
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Acceptability of HIV vaccine trials in high-risk heterosexual cohorts in Mombasa, Kenya.

AIDS 1995 November
OBJECTIVES: To ascertain the level of acceptance of a prophylactic HIV vaccine trial in high-risk HIV-seronegative heterosexual cohorts of men and women in Mombasa, Kenya, and to assess the anticipated effects of participation on risk behavior.

METHODS: Standardized questionnaire administered to a convenience sample of commercial sex workers and trucking company employees enrolled in prospective cohort studies.

RESULTS: Ninety-six per cent of respondents believed that HIV was a major problem in Kenya and 86% of men and 94% of women perceived themselves at risk. One hundred per cent of women and 84% of men expressed interest in participation in an HIV vaccine trial, after explanation of the experimental nature of the vaccine, double-blind placebo-controlled design, prolonged follow-up and potential change in serostatus. Seventeen per cent of men and 9% of women anticipated an increase in risk behavior as a result of participation.

CONCLUSION: The majority of individuals in two high-risk cohorts were interested in participating in Phase III efficacy trials of HIV vaccines. A significant minority anticipated an increase in risk behavior, which emphasizes the need for intensive counseling and education throughout a vaccine trial.

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