Implementation of an Efficacious Intervention for High Risk Women in Mexico

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Syphilis Gonorrhea Chlamydia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Theory-based counseling (Mujer Segura)

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

Group Type EXPERIMENTAL

Mujer Segura

Intervention Type BEHAVIORAL

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 program (didactic)

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

Group Type ACTIVE_COMPARATOR

CENSIDA counseling program

Intervention Type BEHAVIORAL

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.

Interventions

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Mujer Segura

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

Intervention Type BEHAVIORAL

CENSIDA counseling program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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