Implementation of an Efficacious Intervention for High Risk Women in Mexico
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ClinicalTrials.gov Identifier: NCT01465607 |
Recruitment Status
:
Completed
First Posted
: November 7, 2011
Last Update Posted
: May 27, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Syphilis Gonorrhea Chlamydia | Behavioral: Mujer Segura Behavioral: CENSIDA counseling program | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1228 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Implementation of an Efficacious Intervention for High Risk Women in Mexico |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
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.
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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).
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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.
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- 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).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465607
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 |
Principal Investigator: | Thomas L Patterson, Ph.D. | University of California, San Diego |
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 ( U.S. NIH Grant/Contract ) |
First Posted: | November 7, 2011 Key Record Dates |
Last Update Posted: | May 27, 2015 |
Last Verified: | May 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 |