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Open Access Study protocol

Mujer Mas Segura (Safer Women): a combination prevention intervention to reduce sexual and injection risks among female sex workers who inject drugs

Alicia Vera1, Daniela Abramovitz1, Remedios Lozada2, Gustavo Martinez3, M Gudelia Rangel4, Hugo Staines5, Thomas L Patterson6 and Steffanie A Strathdee17*

Author Affiliations

1 Department of Medicine, University of California, San Diego, 9500 Gilman Drive # 0507, La Jolla, CA, 92093-0507, USA

2 Instituto de Servicios de Salud Publica, Secretaria de Salud de Baja California, Calle Circuito de las Misiones Oriente 188, Parque Industrial Las Californias, Mexicali, BC, 2139, Mexico

3 Salud y desarrollo Comunitario de cuidad Juarez, Ave. Malecon e Ing. M Cardona, No. 788 Zona Centro, Cd Juarez, Chih, 32000, Mexico

4 Colegio de la Frontera Norte, Baja California, Frontera, Norte México

5 Universidad Autonoma de Ciudad Juarez, Pedro Rosales de Leon #7510-117 Colonia Las Fuentes, Cd Juarez, Chih, 32500, Mexico

6 Department of Psychiatry, University of California, San Diego, 9500 Gilman Drive # 0680, La Jolla, CA, 92093-0680, USA

7 University of California, San Diego, Institute of the Americas, 9400 Gilman Drive MC 0507, La Jolla, CA, 92093-0507, USA

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BMC Public Health 2012, 12:653  doi:10.1186/1471-2458-12-653

Published: 14 August 2012

Abstract

Background

Female sex workers who inject drugs (FSW-IDUs) are at risk of acquiring HIV, sexually transmitted infections (STI) and blood-borne infections through unprotected sex and sharing injection equipment. We conducted a 2×2 factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among FSW-IDUs in Tijuana and Ciudad Juarez, Mexico.

Methods/design

FSW-IDUs ≥18 years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule, blinding interviewer/counselors to assignment. Due to the extreme vulnerability of this population, we did not include a control group that would deny some women access to preventive information. All women received similar information regardless of group allocation; the difference was in the way the information was delivered and the extent to which women had an interactive role. Each condition was a single 60-minute session, including either an interactive or didactic version of an injection risk intervention and sexual risk intervention. Women underwent interviewer-administered surveys and testing for HIV, syphilis, gonorrhea, Chlamydia, and Trichomonas at baseline and quarterly for 12 months. Combined HIV/STI incidence will be the primary outcome. Secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients.

Discussion

Of 1,132 women, 548 (48.4%) were excluded (88.9% were ineligible; 11.1% refused to participate or did not return); 584 eligible women enrolled (284 in Tijuana; 300 in Ciudad Juarez). All 584 participants completed the baseline interview, provided biological samples and were randomized to one of the four groups. During follow-up, 17 participants (2.9%) were lost to follow-up, of whom 10 (58.8%) had died, leaving 567 participants for analysis. This study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among FSW-IDUs. The factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks, which will have direct, tangible policy implications for Mexico and potentially other resource-poor countries.

Trial registration

NCT00840658