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

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Share Safer Sex program
Standard didactic safer-sex counseling program
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring STDs

Eligibility Criteria

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

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

Sites / Locations

  • Study outreach clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive the Share Safer Sex counseling program

Participants will receive a standard didactic safer-sex counseling session

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2006
Last Updated
April 9, 2013
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00338845
Brief Title
Share Safer Sex Counseling Program for Changing Sexual Risk Behaviors in Mexican Female Sex Workers
Official Title
Safer Sex Intervention for At-risk Women in Mexico
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (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

5. Study Description

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.
Detailed Description
Mexican female sex workers (FSWs) represent a large portion of the reported cases of AIDS and other sexually transmitted diseases (STDs) in Mexico. Despite the imbalance in the distribution of reported cases, there have been few efforts to change high-risk sexual behaviors in this population. There has been a dramatic increase in HIV and other STDs over the past decade, especially in Mexican cities along the United States border. Border cities often have a thriving sex trade industry, and some are considered "sexual tourist" destinations. FSWs in these border cities, however, often do not know how to practice safe sex. A previous study showed that a culturally sensitive risk reduction counseling program was effective in reducing sexual risk behavior in FSWs in Tijuana, Mexico. It may therefore be possible to implement the same program, with similar efficacy, in other Mexican cities near the U.S. border. This study will evaluate the effectiveness of the Share Safer Sex Program versus a standard counseling program in reducing sexual risk behaviors among FSWs in the Mexican cities of Tijuana, Ciudad Juarez, Nuevo Laredo, and Matamoros. Participants in this open label study will be randomly assigned to either the Share Safer Sex Program or a standard counseling program. Both programs will last for 6 months and will consist of a single counseling session lasting between 35 and 40 minutes. All participants will undergo blood collection and a gynecological exam upon study entry and 6 months later. 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. The Share Safer Sex Program will be tailored to the needs, values, beliefs, and behaviors of the participants, and will take into account gender and cultural differences. Counselors will work with participants to increase personal awareness of their current unsafe behaviors and the associated risks, help them understand their motivation to change, and increase their 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. Outcomes for both treatment groups will be assessed after 6 months. Participants in the standard counseling program will be offered an opportunity to participate in the Share Safer Sex Program upon completion of the study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive the Share Safer Sex counseling program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive a standard didactic safer-sex counseling session
Intervention Type
Behavioral
Intervention Name(s)
Share Safer Sex program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard didactic safer-sex counseling program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of unprotected vaginal, oral, and anal sex with clients and spouse or steady partner
Time Frame
Measured at Month 6 post-treatment
Secondary Outcome Measure Information:
Title
STD incidence
Time Frame
Measured at Month 6 post-treatment
Title
Knowledge, self-efficacy, and positive outcome expectancies re: condom use
Time Frame
Measured at Month 6 post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Reports having had unprotected vaginal, oral, or anal sex at least once within 2 weeks prior to study entry Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L. Patterson, PhD
Organizational Affiliation
Dept. of Psychiatry, University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Study outreach clinic
City
Tijuana
State/Province
B.c.
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
18799768
Citation
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.
Results Reference
result
PubMed Identifier
18032996
Citation
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.
Results Reference
result
PubMed Identifier
18260766
Citation
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.
Results Reference
result
PubMed Identifier
20617193
Citation
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.
Results Reference
derived
PubMed Identifier
20456292
Citation
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.
Results Reference
derived

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

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