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Implementation of an Efficacious Intervention for High Risk Women in Mexico
This study has been completed.
Sponsor:
University of California, San Diego
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Thomas L. Patterson, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01465607
First received: November 2, 2011
Last updated: May 26, 2015
Last verified: May 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| HIV Syphilis Gonorrhea Chlamydia | Behavioral: Mujer Segura Behavioral: CENSIDA counseling program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Implementation of an Efficacious Intervention for High Risk Women in Mexico |
Resource links provided by NLM:
Further study details as provided by Thomas L. Patterson, University of California, San Diego:
Primary Outcome Measures:
- Reduction in HIV and STI incidence relative to control group [ Time Frame: 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 [ Time Frame: 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:
- Fidelity to Mujer Segura intervention model [ Time Frame: 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.
| Enrollment: | 1228 |
| Study Start Date: | November 2011 |
| Study Completion Date: | April 2015 |
| Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: 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).
|
|
Active Comparator: 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.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01465607
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465607
Locations
| Mexico | |
| Centro de Servicios Medicos (CSM) Revolucion | |
| Mexico City, D.f., Mexico, 06080 | |
| CSM Guadalajara | |
| Guadalajara, Jalisco, Mexico, 44270 | |
| CSM Naranjos | |
| Naranjos, Veracruz, Mexico, 92300 | |
| CSM Veracruz | |
| Veracruz, Mexico, 91910 | |
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Investigators
| Principal Investigator: | Thomas L Patterson, Ph.D. | University of California, San Diego |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Thomas L. Patterson, Principal Investigator, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01465607 History of Changes |
| Other Study ID Numbers: |
R01MH087054 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | November 2, 2011 |
| Last Updated: | May 26, 2015 |
Keywords provided by Thomas L. Patterson, University of California, San Diego:
|
Condom use |
Additional relevant MeSH terms:
|
Gonorrhea Syphilis Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial |
Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female Treponemal Infections Spirochaetales Infections |
ClinicalTrials.gov processed this record on June 23, 2017