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临床试验/NCT00338845
NCT00338845已完成2 期

Safer Sex Intervention for At-risk Women in Mexico

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2003年12月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
1,800
试验地点
1
主要终点
Frequency of unprotected vaginal, oral, and anal sex with clients and spouse or steady partner

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: Measured at Month 6 post-treatment

次要结局

  • STD incidence(Measured at Month 6 post-treatment)
  • Knowledge, self-efficacy, and positive outcome expectancies re: condom use(Measured at Month 6 post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas L. Patterson

Professor in Residence

University of California, San Diego

研究点 (1)

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