Comunidades Positivas and Enhanced Partner Therapy in Peru
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 718
- 试验地点
- 2
- 主要终点
- Cumulative incidence of STIs
研究概览
简要总结
This study will evaluate the effectiveness of community-level behavioral and biomedical interventions, each alone and combined, in reducing sexual risk behavior and HIV/sexually transmitted infections in Peruvian men who have sex with men.
详细描述
Sexually transmitted infections (STIs), including HIV, are among the most significant public health concerns worldwide. Although common across all groups of people, STIs have had a considerable impact among men who have sex with men (MSM). Particularly, in Peru, which accounts for about 6% of the estimated HIV infections in Latin America, HIV and STIs are highly concentrated in the MSM population.
Both behavioral and biomedical interventions are needed to provide education about the health risks associated with unprotected sex and to help those with STIs seek treatment. Communidades Positivas (CPOS) (Spanish for "Positive Communities") is a behavioral intervention designed to reduce the frequency of sexual activity with nonprimary partners. Enhanced partner therapy (EPT) is a biomedical intervention designed to provide treatment to partners who may become or already are infected with an STI and to thereby reduce the rate of reinfections. When implemented individually or together at a community level, these interventions may be effective in preventing HIV/STI transmission in MSM. This study will evaluate the effectiveness of community-level CPOS and EPT, each alone and combined, in reducing sexual risk behavior and HIV/STIs in Peruvian MSM.
Participation in this study will last 18 months. A total of 24 communities will be assigned randomly to 1 of 4 different treatment groups:
- Communities in Group 1 will provide CPOS plus EPT to MSM.
- Communities in Group 2 will provide CPOS alone to MSM.
- Communities in Group 3 will provide EPT alone to MSM.
- Communities in Group 4 will provide standard care to MSM.
Within each community, a select number of MSM will be evaluated at various points during the study. The initial evaluation visit will occur prior to any treatment and will include an interview, counseling, and HIV/STI testing. The interview will involve questions about health and community, including topics such as sexual activities, views on health problems, use of alcohol and drugs, use of health care services, and attitudes about people with HIV or AIDS. Counselors will then provide information about contracting and preventing HIV/STIs and will ask questions about STI symptoms. Finally, HIV/STI testing will be conducted and throat and anal swabs will be collected. Two weeks after the initial evaluation, MSM will receive their test results, and if positive for HIV or any STIs, they will receive appropriate referrals, services, and treatments. They will also receive the specific treatment to which their community was assigned and will be asked additional questions concerning the treatment of their partners, if applicable. The remaining evaluations, which will repeat assessments from the initial evaluation, will occur at months 9 and 18.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •For MSM evaluation group:
- •Anatomically male at birth (by self-report)
- •Lives in study barrio OR works in study barrio OR socializes in study barrio (present at least 3 times per week)
- •Anal or oral sexual intercourse with another male in the 12 months before study entry
- •Stated preference for sexual relations with males
- •For CPOS group:
- •Self-identifies as a man who has sex with men
排除标准
- •For all participants:
- •Imminent plans to move away from the study barrio for the duration of the study
结局指标
主要结局
Cumulative incidence of STIs
时间窗: Measured at Month 18
次要结局
- Rates of unprotected intercourse with nonprimary partners(Measured at Month 18)
研究者
Thomas J. Coates
Professor of Medicine
University of California, Los Angeles
