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Implementation of an Efficacious Intervention for High Risk Women in Mexico

Primary Purpose

HIV, Syphilis, Gonorrhea

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Mujer Segura
CENSIDA counseling program
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV focused on measuring Condom use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centro de Servicios Medicos (CSM) Revolucion
  • CSM Guadalajara
  • CSM Naranjos
  • CSM Veracruz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Theory-based counseling (Mujer Segura)

CENSIDA counseling program (didactic)

Arm Description

Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.

Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.

Outcomes

Primary Outcome Measures

Reduction in HIV and STI incidence relative to control group
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
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
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.

Full Information

First Posted
November 2, 2011
Last Updated
May 26, 2015
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01465607
Brief Title
Implementation of an Efficacious Intervention for High Risk Women in Mexico
Official Title
Implementation of an Efficacious Intervention for High Risk Women in Mexico
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Syphilis, Gonorrhea, Chlamydia
Keywords
Condom use

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theory-based counseling (Mujer Segura)
Arm Type
Experimental
Arm Description
Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.
Arm Title
CENSIDA counseling program (didactic)
Arm Type
Active Comparator
Arm Description
Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.
Intervention Type
Behavioral
Intervention Name(s)
Mujer Segura
Intervention Description
Brief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA).
Intervention Type
Behavioral
Intervention Name(s)
CENSIDA counseling program
Intervention Description
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 Outcome Measure Information:
Title
Reduction in HIV and STI incidence relative to control group
Description
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).
Time Frame
6 months
Title
Reduction in number of unprotected sex acts relative to control group
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fidelity to Mujer Segura intervention model
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L Patterson, Ph.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Servicios Medicos (CSM) Revolucion
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
06080
Country
Mexico
Facility Name
CSM Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44270
Country
Mexico
Facility Name
CSM Naranjos
City
Naranjos
State/Province
Veracruz
ZIP/Postal Code
92300
Country
Mexico
Facility Name
CSM Veracruz
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
30204761
Citation
Pitpitan EV, Semple SJ, Aarons GA, Palinkas LA, Chavarin CV, Mendoza DV, Magis-Rodriguez C, Staines H, Patterson TL. Factors associated with program effectiveness in the implementation of a sexual risk reduction intervention for female sex workers across Mexico: Results from a randomized trial. PLoS One. 2018 Sep 11;13(9):e0201954. doi: 10.1371/journal.pone.0201954. eCollection 2018.
Results Reference
derived
PubMed Identifier
23107285
Citation
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.
Results Reference
derived

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Implementation of an Efficacious Intervention for High Risk Women in Mexico

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