Implementation of an Efficacious Intervention for High Risk Women in Mexico - Full Text View

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:

MedlinePlus related topics: Gonorrhea HIV/AIDS

Genetic and Rare Diseases Information Center resources: Treponema Infection

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.


Enrollment:	1228
Study Start Date:	November 2011
Study Completion Date:	April 2015
Primary Completion Date:	April 2015 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465607

Locations


Mexico
Centro de Servicios Medicos (CSM) Revolucion
Mexico City, D.f., Mexico, 06080
CSM Guadalajara
Guadalajara, Jalisco, Mexico, 44270
CSM Naranjos
Naranjos, Veracruz, Mexico, 92300
CSM Veracruz
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Thomas L. Patterson, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier:	NCT01465607 History of Changes
Other Study ID Numbers:	R01MH087054
Study First Received:	November 2, 2011
Last Updated:	May 26, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:


Condom use

Additional relevant MeSH terms:


Gonorrhea Syphilis Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial	Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female Treponemal Infections Spirochaetales Infections

ClinicalTrials.gov processed this record on September 30, 2016