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Implementation of an Efficacious Intervention for High Risk Women in Mexico

This study is currently recruiting participants.
Verified September 2012 by University of California, San Diego
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Thomas L. Patterson, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01465607
First received: November 2, 2011
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
HIV
Syphilis
Gonorrhea
Chlamydia
 Behavioral: Mujer Segura
Behavioral: CENSIDA counseling program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Implementation of an Efficacious Intervention for High Risk Women in Mexico

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Reduction in HIV and STI incidence relative to control group [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • Fidelity to Mujer Segura intervention model [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1080
Study Start Date: November 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465607

Contacts
Contact: Claudia Chavarin, M.D. 619-543-0195 cchavarin@ucsd.edu
Contact: Brian R Kelly, M.A. 858-534-3354 brkelly@ucsd.edu

Locations
Mexico
Centro de Servicios Medicos (CSM) Revolucion Active, not recruiting
Mexico City, D.f., Mexico, 06080
CSM Guadalajara Recruiting
Guadalajara, Jalisco, Mexico, 44270
CSM Naranjos Recruiting
Naranjos, Veracruz, Mexico, 92300
CSM Veracruz Recruiting
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
  More Information

No publications provided by University of California, San Diego

Additional 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, R01MH087054
Study First Received: November 2, 2011
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Condom use

Additional relevant MeSH terms:
Chlamydia Infections
Gonorrhea
Syphilis
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
 Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Treponemal Infections
Spirochaetales Infections

ClinicalTrials.gov processed this record on May 16, 2013