Share Safer Sex Counseling Program for Changing Sexual Risk Behaviors in Mexican Female Sex Workers

NCT00338845 | Completed Phase 2

• 2 other identifiers: R01MH065849DAHBR 9A-ASI
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of the Share Safer Sex Program in reducing sexual risk behaviors among female sex workers in four Mexican cities close to the U.S. border.

Conditions

HIV Infections; Sexually Transmitted Diseases

Keywords

STDs

Outcome Measures

Primary Outcomes (1)

• Frequency of unprotected vaginal, oral, and anal sex with clients and spouse or steady partner

  Measured at Month 6 post-treatment

Secondary Outcomes (2)

• STD incidence

  Measured at Month 6 post-treatment

• Knowledge, self-efficacy, and positive outcome expectancies re: condom use

  Measured at Month 6 post-treatment

Study Arms (2)

1

EXPERIMENTAL

Participants will receive the Share Safer Sex counseling program

Behavioral: Share Safer Sex program

2

ACTIVE COMPARATOR

Participants will receive a standard didactic safer-sex counseling session

Behavioral: Standard didactic safer-sex counseling program

Interventions

Share Safer Sex program BEHAVIORAL

The Share Safer Sex intervention will consist of a single, 30 to 40 minute, one-on-one counseling session designed to increase personal awareness of the participant's current unsafe behaviors and the associated risks, help her understand her motivation to change, and increase her knowledge about how to practice safe sex. Demonstrations and practice exercises will be used to improve participants' attitudes about, as well as intentions to practice, condom use. The counseling session will include the following activities: assessing readiness for change; building motivation for change; and performing exercises in decisional balance, identification of problem and problem-solving, and knowledge and skill-building.

1

Standard didactic safer-sex counseling program BEHAVIORAL

The standard counseling program will be based on a sexual risk reduction counseling program developed by the Centers for Disease Control and Prevention, and will focus on personal risk assessment and strategies for risk reduction. Additionally, it will incorporate risk reduction materials provided by CENSIDA, Mexico's National Center for AIDS Studies.

2

Eligibility Criteria

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

You may qualify if:

• Reports having had unprotected vaginal, oral, or anal sex at least once within 2 weeks prior to study entry

You may not qualify if:

• Consistent use of condoms or dental dams for vaginal, oral, and anal sex with all clients within 2 weeks prior to study entry
• Duration of employment as an FSW is less than 2 weeks

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Study outreach clinic

Tijuana, B.c., Mexico

Location

Related Publications (5)

• Patterson TL, Mausbach B, Lozada R, Staines-Orozco H, Semple SJ, Fraga-Vallejo M, Orozovich P, Abramovitz D, de la Torre A, Amaro H, Martinez G, Magis-Rodriguez C, Strathdee SA. Efficacy of a brief behavioral intervention to promote condom use among female sex workers in Tijuana and Ciudad Juarez, Mexico. Am J Public Health. 2008 Nov;98(11):2051-7. doi: 10.2105/AJPH.2007.130096. Epub 2008 Sep 17.

  PMID: 18799768 RESULT

• Strathdee SA, Lozada R, Semple SJ, Orozovich P, Pu M, Staines-Orozco H, Fraga-Vallejo M, Amaro H, Delatorre A, Magis-Rodriguez C, Patterson TL. Characteristics of female sex workers with US clients in two Mexico-US border cities. Sex Transm Dis. 2008 Mar;35(3):263-8. doi: 10.1097/OLQ.0b013e31815b0.

  PMID: 18032996 RESULT

• Patterson TL, Semple SJ, Staines H, Lozada R, Orozovich P, Bucardo J, Philbin MM, Pu M, Fraga M, Amaro H, Torre Ade L, Martinez G, Magis-Rodriguez C, Strathdee SA. Prevalence and correlates of HIV infection among female sex workers in 2 Mexico-US border cities. J Infect Dis. 2008 Mar 1;197(5):728-32. doi: 10.1086/527379.

  PMID: 18260766 RESULT

• Burgos JL, Gaebler JA, Strathdee SA, Lozada R, Staines H, Patterson TL. Cost-effectiveness of an intervention to reduce HIV/STI incidence and promote condom use among female sex workers in the Mexico-US border region. PLoS One. 2010 Jun 30;5(6):e11413. doi: 10.1371/journal.pone.0011413.

  PMID: 20617193 DERIVED

• Loza O, Patterson TL, Rusch M, Martinez GA, Lozada R, Staines-Orozco H, Magis-Rodriguez C, Strathdee SA; Proyecto Mujer Segura. Drug-related behaviors independently associated with syphilis infection among female sex workers in two Mexico-US border cities. Addiction. 2010 Aug;105(8):1448-56. doi: 10.1111/j.1360-0443.2010.02985.x. Epub 2010 Apr 27.

  PMID: 20456292 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas L. Patterson, PhD

  Dept. of Psychiatry, University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: December 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

ME (1)