Implementation of an Efficacious Intervention for High Risk Women in Mexico

University of California San Diego

Status: Completed

Conditions: Gonorrhea; Syphilis; Chlamydia; HIV

Treatments: Behavioral: CENSIDA counseling program; Behavioral: Mujer Segura

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01465607

R01MH087054 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,228 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,228 participants in 2 patient groups

Theory-based counseling (Mujer Segura)

Experimental group

Description:

Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.

Treatment:

Behavioral: Mujer Segura

CENSIDA counseling program (didactic)

Active Comparator group

Description:

Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.

Treatment:

Behavioral: CENSIDA counseling program