Implementation of an Efficacious Intervention for High Risk Women in Mexico

HIV Clinical Trial

Official title:

Implementation of an Efficacious Intervention for High Risk Women in Mexico

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465607
• Other study ID #: R01MH087054
• Secondary ID: R01MH087054
• Status: Completed
• Phase: N/A
• First received: November 2, 2011
• Last updated: May 26, 2015
• Start date: November 2011
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1228
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea
• HIV
• Syphilis

Intervention

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).
• 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.

Locations

Country	Name	City	State
Mexico	CSM Guadalajara	Guadalajara	Jalisco
Mexico	Centro de Servicios Medicos (CSM) Revolucion	Mexico City	D.f.
Mexico	CSM Naranjos	Naranjos	Veracruz
Mexico	CSM Veracruz	Veracruz

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	No