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Clinical Trials/NCT01465607
NCT01465607
Completed
Not Applicable

Implementation of an Efficacious Intervention for High Risk Women in Mexico

University of California, San Diego4 sites in 1 country1,228 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of California, San Diego
Enrollment
1228
Locations
4
Primary Endpoint
Reduction in number of unprotected sex acts relative to control group
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas L. Patterson

Principal Investigator

University of California, San Diego

Eligibility 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

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • Fidelity to Mujer Segura intervention model(6 months)

Study Sites (4)

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