Implementation of an Efficacious Intervention for High Risk Women in Mexico

Not Applicable

Completed

• Conditions: Syphilis; HIV; Chlamydia; Gonorrhea
• Interventions: Behavioral: Mujer Segura; Behavioral: CENSIDA counseling program

• Registration Number: NCT01465607
• Lead Sponsor: University of California, San Diego

Brief Summary

This project seeks to determine the personal and organizational conditions that are most conducive to the widespread adoption by community-based organizations (CBOs) of effective programs for reducing the spread of HIV and other sexually transmitted infections (STIs). Taking a brief, single-session counseling program (called "Mujer Segura") that has been proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities along the U.S. border, this project will study the implementation of the program in CBOs in 12 additional cities throughout Mexico to determine how best to ensure that the program remains true to the original model and retains its effectiveness. Mexico has been chosen because HIV is a global problem that respects no international borders, and because HIV prevention programs that can be implemented in settings with limited resources are urgently needed in many parts of the world.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1228

Inclusion Criteria

• At least 18 years of age
• Self-identify as female sex worker
• Exchanged sex for money, drugs, shelter, or other benefit in last 2 months
• Had unprotected anal or vaginal sex with male client at least once in last 2 months
• Agree to be tested for HIV & STIs at baseline and 6-month follow-u0

Exclusion Criteria

• Previous positive HIV test result

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Theory-based counseling (Mujer Segura)	Mujer Segura	Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.
CENSIDA counseling program (didactic)	CENSIDA counseling program	Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.

Primary Outcome Measures

Name	Time	Method
Reduction in HIV and STI incidence relative to control group	6 months	Female sex worker (FSW) participants will be tested at baseline and 6-month follow-up for HIV, syphilis, gonorrhea, and Chlamydia. Incidence rates for all infections at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
Reduction in number of unprotected sex acts relative to control group	6 months	Female sex worker (FSW) participants will be assessed at baseline and 6-month follow-up using self-report measures of frequency of protected and unprotected sex acts with male clients. Changes in frequency at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).

Secondary Outcome Measures

Name	Time	Method
Fidelity to Mujer Segura intervention model	6 months	Counselors at each CBO will be assessed for their fidelity to the intervention protocol and assigned a numerical score. This number will be used to determine possible correlations between levels of fidelity and the efficacy of the Mujer Segura intervention at each clinic.

Trial Locations

Locations (4)

Centro de Servicios Medicos (CSM) Revolucion; 🇲🇽 Mexico City, D.f., Mexico

CSM Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico

CSM Naranjos; 🇲🇽 Naranjos, Veracruz, Mexico

CSM Veracruz; 🇲🇽 Veracruz, Mexico