Implementation of an Efficacious Intervention for High Risk Women in Mexico

Study Overview
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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.

Official Title
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Implementation of an Efficacious Intervention for High Risk Women in Mexico

Conditions
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HIV, Syphilis, Gonorrhea, Chlamydia

Intervention / Treatment
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* Behavioral: Mujer Segura
* Behavioral: CENSIDA counseling program


Participation Criteria
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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 Exclusion Criteria: Previous positive HIV test result

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theory-based counseling (Mujer Segura)<br>Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants. | Behavioral: Mujer Segura<br>* Brief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA).<br>|
| Active Comparator: CENSIDA counseling program (didactic)<br>Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants. | Behavioral: CENSIDA counseling program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Condom use