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Completed

NCT Number: NCT01465607

Implementation of an Efficacious Intervention for High Risk Women in Mexico

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.

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Key information

Conditions

HIV Bacterial Infections Bacterial Infections and Mycoses Chlamydia Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Servicios Medicos (CSM) Revolucion, Mexico City, D.f., Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mujer Segura

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2011
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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