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Open Access Study protocol

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

Eileen V Pitpitan1, Claudia V Chavarin1, Shirley J Semple1, Carlos Magis-Rodriguez2, Steffanie A Strathdee1 and Thomas L Patterson34*

Author Affiliations

1 Division of Global Public Health, Department of Medicine, University of California, San Diego, USA

2 Centro Nacional para la PrevenciĆ³n y Control del VIH/SIDA (CENSIDA), Ministry of Health, Mexico City, Mexico

3 Department of Psychiatry, University of California, San Diego, USA

4 Department of Psychiatry, University of California, 9500 Gilman Drive, La Jolla, San Diego, Mail Code 0680, CA 92093-0680, USA

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BMC Public Health 2014, 14:475  doi:10.1186/1471-2458-14-475

Published: 20 May 2014

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.