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

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.