Implementation of an Efficacious Intervention for High Risk Women in Mexico

University of California, San Diego1,228 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

1,228

Conditions

HIV Syphilis Gonorrhea Chlamydia

Interventions

Mujer SeguraBEHAVIORAL

Brief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA).

CENSIDA counseling programBEHAVIORAL

Didactic HIV and STI counseling involving some personal risk assessment and presenting appropriate information on methods of transmission and for avoiding or reducing the risk of infection. Based on a counseling manual disseminated by CENSIDA, Mexico's federal HIV-AIDS prevention agency.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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, Veracruz, Mexico

Outcomes

Primary Outcomes

Reduction in HIV and STI incidence relative to control group

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).

Time frame: 6 months

Reduction in number of unprotected sex acts relative to control group

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).

Time frame: 6 months

Secondary Outcomes

Fidelity to Mujer Segura intervention model

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.

Time frame: 6 months