Implementation of an Efficacious Intervention for High Risk Women in Mexico

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT01465607
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 1,228
• Locations: 4
• Arms: 2
• Duration (Months): 41
• Patients Per Site: 307
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV; Syphilis; Gonorrhea; Chlamydia	Behavioral: Mujer Segura; Behavioral: CENSIDA counseling program	N/A

Study Design

• Study Type: Interventional
• 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: Nov 1, 2011
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

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.	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.

Outcome Measures

Primary Outcome Measures

1. Reduction in HIV and STI incidence relative to control group [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).

2. Reduction in number of unprotected sex acts relative to control group [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

1. Fidelity to Mujer Segura intervention model [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Servicios Medicos (CSM) Revolucion	Mexico City	D.f.	Mexico	06080
2	CSM Guadalajara	Guadalajara	Jalisco	Mexico	44270
3	CSM Naranjos	Naranjos	Veracruz	Mexico	92300
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas L. Patterson, Principal Investigator, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01465607
• Other Study ID Numbers: R01MH087054; R01MH087054
• First Posted: Nov 6, 2011
• Last Update Posted: May 27, 2015
• Last Verified: May 1, 2015

• Keywords provided by Thomas L. Patterson, Principal Investigator, University of California, San Diego: Condom use
• Additional relevant MeSH terms: Gonorrhea; Syphilis

Study Results

No Results Posted as of May 27, 2015