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

NCT01280838 | Completed DMC

• 1 other identifier: DA029008
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• HIV status

  12 months

• STI status

  12 months

Study Arms (2)

Theory-based behavioral intervention

EXPERIMENTAL

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.

Behavioral: Hombre Seguro

Didactic attention-control condition

ACTIVE COMPARATOR

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.

Behavioral: Didactic attention-control condition

Interventions

Hombre Seguro BEHAVIORAL

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.

Theory-based behavioral intervention

Didactic attention-control condition BEHAVIORAL

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.

Didactic attention-control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Comisión de Salud Fronteriza México-Estados Unidos

Tijuana, Estado de Baja California, 22320, Mexico

Location

Related Publications (1)

• 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.

  PMID: 24885949 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas L Patterson, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Carlos Magis Rodriguez, MD, MPH

  Comisión de Salud Fronteriza Mexico-Estados Unidos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 21, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

ME (1)