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Safer Sex Intervention for Male Clients of Female Sex Workers in Tijuana, Mexico

Primary Purpose

HIV, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Hombre Seguro
Didactic attention-control condition
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

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

Inclusion Criteria:

  • Living in either Tijuana or San Diego County
  • Reports having purchased sex for money, drugs, shelter or goods in the last 4 months
  • Reports having had unprotected vaginal or anal sex with a FSW in Tijuana at least once during the previous 4 months
  • Tests HIV-negative at baseline
  • Agrees to receive antibiotic treatment for Chlamydia, gonorrhea, and syphilis if he tests positive (to allow us to differentiate incident from prevalent cases at follow-up)

Exclusion Criteria:

  • Consistent use of condoms for vaginal and anal sex with all FSWs during the previous 4 months
  • Transgender male (i.e, biologically female)
  • Tests HIV-positive at baseline

Sites / Locations

  • Comisión de Salud Fronteriza México-Estados Unidos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Theory-based behavioral intervention

Didactic attention-control condition

Arm Description

Participants in this arm will receive a single-session, theory-based intervention (Hombre Seguro) at baseline that uses principles of behavior change derived from Social Cognitive Theory (SCT), Cognitive Behavioral Therapy (CBT), Theory of Reasoned Action (TRA), and Motivational Interviewing (MI) to increase clients' use of condoms with FSWs. The intervention lasts approximately 45 minutes.

The didactic control condition is a modified version of the CDC's revised guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). The one-session, 60-minute counseling intervention focuses on HIV and STI prevention, risk appraisal, and the development of a risk reduction plan.

Outcomes

Primary Outcome Measures

Number of unprotected vaginal or anal sex acts with a female sex worker
Participants will be asked to specify the number of unprotected sex acts they had with female sex workers, spouses, steady partners, and casual partners over the past four months. This question will be asked at baseline and at 4 months, 8 months, and 12 months post-baseline.

Secondary Outcome Measures

HIV status
Participants will be tested for the presence of HIV antibodies at baseline and at 12 months post-baseline.
STI status
Participants will be tested for syphilis, gonorrhea, and chlamydia at baseline and at 12 months post-baseline.

Full Information

First Posted
January 19, 2011
Last Updated
May 26, 2015
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01280838
Brief Title
Safer Sex Intervention for Male Clients of Female Sex Workers in Tijuana, Mexico
Official Title
Safer Sex Intervention for Male Clients of Female Sex Workers in Tijuana, Mexico
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Behavioral interventions designed to reduce risk of HIV and sexually transmitted infections (STIs) have mostly failed to consider clients of female sex workers (FSWs), who may act as a "bridge" to the general population. This study proposes to test a brief, one-hour counseling intervention with male clients in Tijuana, Mexico, to reduce their rates of unprotected sex (i.e., sex without a condom) with FSWs as well as their rates of infection with HIV and STIs. Finding an effective intervention for this population is important given the rising rates of HIV infection in Tijuana (as documented in earlier studies) and the large numbers of people crossing the border in both directions, many of them specifically to purchase sex from FSWs in Tijuana.
Detailed Description
Interventions designed to reduce STI/HIV risk have mostly failed to consider clients of FSWs, who may act as a 'bridge' to the general population. Our recent survey of U.S and Mexican clients seeking FSWs in Tijuana revealed a startling HIV prevalence rate of 4.1%. Based on qualitative and quantitative interviews with clients from Tijuana Mexico and the U.S. the investigators developed a theory-based intervention (Hombre Seguro) that uses Motivational Interviewing, active participation, and problem solving to increase clients' use of condoms with FSWs. The investigators now propose an RCT to test the efficacy of this one-hour intervention in Tijuana which will enroll 400 HIV-negative men (200 residents of San Diego County; 200 Tijuana residents) who report having unprotected sex with FSWs in the past 4 months. Our theory-based participatory intervention will be evaluated in comparison with a time and information equivalent didactic control condition. Participants will be recruited in Tijuana where they will undergo a baseline CAPI-administered interview, STI testing (HIV, syphilis, gonorrhea, Chlamydia), and intervention counseling with follow-up interviews at 4, 8, and 12 months post-baseline conducted in either Tijuana or San Diego. Our study aims are to: 1) evaluate the efficacy of Hombres Seguro to increase condom use of clients with FSWs; 2) determine if the intervention is as efficacious among U.S. versus Mexican clients; 3) determine the extent to which theoretically-based components of our intervention (e.g., self-efficacy) represent underlying mechanisms of change in primary outcomes (e.g., lower HIV/STI incidence); and 4) explore subgroup differences in efficacy of the intervention based on background characteristics (e.g., age), contextual factors (e.g., substance use before/during sex), psychosexual factors (e.g., social-sexual effectiveness), and psychosocial factors (e.g., social network influence). Our primary analytic approach will utilize a generalized linear mixed models (GLMM) approach to repeated measures analysis. This bi-national study will contribute significantly to HIV prevention research by addressing the role of male clients in the escalating HIV epidemics in Tijuana and San Diego, and could have application to other settings where HIV prevalence is high among FSWs and their clients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theory-based behavioral intervention
Arm Type
Experimental
Arm Description
Participants in this arm will receive a single-session, theory-based intervention (Hombre Seguro) at baseline that uses principles of behavior change derived from Social Cognitive Theory (SCT), Cognitive Behavioral Therapy (CBT), Theory of Reasoned Action (TRA), and Motivational Interviewing (MI) to increase clients' use of condoms with FSWs. The intervention lasts approximately 45 minutes.
Arm Title
Didactic attention-control condition
Arm Type
Active Comparator
Arm Description
The didactic control condition is a modified version of the CDC's revised guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). The one-session, 60-minute counseling intervention focuses on HIV and STI prevention, risk appraisal, and the development of a risk reduction plan.
Intervention Type
Behavioral
Intervention Name(s)
Hombre Seguro
Intervention Description
A theory-based intervention that uses principles of behavior change derived from Social Cognitive Theory (SCT), Cognitive Behavioral Therapy (CBT), Theory of Reasoned Action (TRA), and MI to increase clients' use of condoms with FSWs.
Intervention Type
Behavioral
Intervention Name(s)
Didactic attention-control condition
Intervention Description
The didactic control condition is a modified version of the CDC's revised guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). The one-session, 60-minute counseling intervention focuses on HIV and STI prevention, risk appraisal, and the development of a risk reduction plan.
Primary Outcome Measure Information:
Title
Number of unprotected vaginal or anal sex acts with a female sex worker
Description
Participants will be asked to specify the number of unprotected sex acts they had with female sex workers, spouses, steady partners, and casual partners over the past four months. This question will be asked at baseline and at 4 months, 8 months, and 12 months post-baseline.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HIV status
Description
Participants will be tested for the presence of HIV antibodies at baseline and at 12 months post-baseline.
Time Frame
12 months
Title
STI status
Description
Participants will be tested for syphilis, gonorrhea, and chlamydia at baseline and at 12 months post-baseline.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Living in either Tijuana or San Diego County Reports having purchased sex for money, drugs, shelter or goods in the last 4 months Reports having had unprotected vaginal or anal sex with a FSW in Tijuana at least once during the previous 4 months Tests HIV-negative at baseline Agrees to receive antibiotic treatment for Chlamydia, gonorrhea, and syphilis if he tests positive (to allow us to differentiate incident from prevalent cases at follow-up) Exclusion Criteria: Consistent use of condoms for vaginal and anal sex with all FSWs during the previous 4 months Transgender male (i.e, biologically female) Tests HIV-positive at baseline
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
First Name & Middle Initial & Last Name & Degree
Carlos Magis Rodriguez, MD, MPH
Organizational Affiliation
Comisión de Salud Fronteriza Mexico-Estados Unidos
Official's Role
Study Director
Facility Information:
Facility Name
Comisión de Salud Fronteriza México-Estados Unidos
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22320
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
24885949
Citation
Pitpitan EV, Chavarin CV, Semple SJ, Magis-Rodriguez C, Strathdee SA, Patterson TL. Hombre Seguro (Safe Men): a sexual risk reduction intervention for male clients of female sex workers. BMC Public Health. 2014 May 20;14:475. doi: 10.1186/1471-2458-14-475.
Results Reference
derived

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Safer Sex Intervention for Male Clients of Female Sex Workers in Tijuana, Mexico

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