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Randomized Controlled Trial
. 2014 May 20:14:475.
doi: 10.1186/1471-2458-14-475.

Hombre Seguro (Safe Men): a sexual risk reduction intervention for male clients of female sex workers

Affiliations
Randomized Controlled Trial

Hombre Seguro (Safe Men): a sexual risk reduction intervention for male clients of female sex workers

Eileen V Pitpitan et al. BMC Public Health. .

Abstract

Background: Male clients of female sex workers (FSWs) are at risk of HIV and other sexually transmitted infections (STIs). We conducted a two-arm randomized controlled trial to test the efficacy of a sexual risk reduction intervention for male clients of FSWs in Tijuana, Mexico.

Methods/design: Male clients of FSWs who were at least 18, were HIV-negative at baseline, and reported recent unprotected sex with FSWs were randomized to the Hombre Seguro sexual risk reduction intervention, or a time-attention didactic control condition. Each condition lasted approximately one hour. Participants underwent interviewer-administered surveys and testing for HIV and other STIs at baseline, and at 4, 8, and 12 month follow-ups. Combined HIV/STI incidence and unprotected vaginal and anal sex acts with FSWs were the primary outcomes.

Discussion: A total of 400 participants were randomized to one of the two conditions. Analyses indicated that randomization was successful; there were no significant differences between the participants in the two conditions at baseline. Average follow-up was 84% across both conditions. This is the first study to test the efficacy of a sexual risk reduction intervention for male clients of FSWs using the rigor of a randomized controlled trial.

Trial registration: NCT01280838, Date of registration: January 19, 2011.

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Figures

Figure 1
Figure 1
Consort diagram summarizing participant flow through the study.

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