HIV Prevention Within High-Risk Social Networks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,292
- 试验地点
- 4
- 主要终点
- Target effect of at least 30% consistent condom use among the experimental intervention group at 15-month followup.
研究概览
简要总结
This grant involves 24 social networks of young men who have sex with men, Roma, and young high-risk heterosexual adult men and women living in Hungary, Bulgaria and Russia.
详细描述
For over 4 years, our international collaborative research team has carried out a social network HIV prevention intervention trial with community populations of young men who have sex with men (YMSM), disadvantaged ethnic minority Roma (Gypsies), and high-risk heterosexual adult (YHA) women and men in Hungary, Bulgaria and Russia. Eastern Europe has seen a sharp increase in HIV incidence, and social network interventions are high in cultural relevance because post-communist populations have a long history of trusting and relying upon their personal networks more than their governments. Across the three countries represented in our research during the past funding period, we enrolled social networks of YMSM, Roma, and YHAs. This study will renew our international collaboration to extend this network intervention approach. Our study, to date, has worked with very small independent friendship groups (usually composed of 5-6 people) as "egocentric" social networks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Members of a friendship group will be eligible for enrollment if they are of legal age to independently consent to participate in this study. In its review and approval of this protocol, the IRB at BotkinHospital, St. Petersburg, Russia verified and confirmed in writing to us that the age of research participation consent is
- •In its review and approval of this protocol, the IRB at the Health and Social Development Foundation determined that the age of research participation consent in Bulgaria is
- •In Hungary, the IRB at the Institute of Sociology at the Hungarian Academy of Sciences determined that the age of independent consent to participate in this study is
排除标准
- •Individuals will be excluded from enrollment into the study if they are below the age for providing independent consent or are not capable of providing informed consent based on impairment due to the presence of sever psychopatology, substance use, or similar conditions observed at the time of informed consent. Social networks will be excluded from the study if: (1) more than 33% of named network members do not agree to participate; (2) fewer than 50% of members report occurrence of unprotected intercourse during the past 3 months at baseline; or (3) more than 10% of a network's members are also members of another network enrolled in the study.
结局指标
主要结局
Target effect of at least 30% consistent condom use among the experimental intervention group at 15-month followup.
时间窗: August 2015
次要结局
- 15-month cumulative STD incidence rate of 20% among the control group compared 10% or less among the experimental group.(August 2015)
研究者
Jeffrey Kelly
Professor of Psychiatry and Behavioral Medicine
Medical College of Wisconsin