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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

November 2, 2011
September 27, 2012
November 2011
April 2016   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01465607 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Implementation of an Efficacious Intervention for High Risk Women in Mexico
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV
  • Syphilis
  • Gonorrhea
  • Chlamydia
  • 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).
  • 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.
  • 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.
    Intervention: Behavioral: Mujer Segura
  • 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.
    Intervention: Behavioral: CENSIDA counseling program
Patterson TL, Semple SJ, Chavarin CV, Mendoza DV, Santos LE, Chaffin M, Palinkas LA, Strathdee SA, Aarons GA. Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors. Implement Sci. 2012 Oct 29;7:105. doi: 10.1186/1748-5908-7-105.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1080
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Claudia Chavarin, M.D. 619-543-0195 cchavarin@ucsd.edu
Contact: Brian R Kelly, M.A. 858-534-3354 brkelly@ucsd.edu
Mexico
 
NCT01465607
R01MH087054, R01MH087054
No
Thomas L. Patterson, University of California, San Diego
University of California, San Diego
National Institute of Mental Health (NIMH)
Principal Investigator: Thomas L Patterson, Ph.D. University of California, San Diego
University of California, San Diego
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP