PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Change in HIV/STI Risk Behaviors at 6 months
研究概览
简要总结
This application proposes a 2-arm randomized controlled trial comparing the impact of PHAT Life on 350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical mediators when delivered by Youth Representatives (YR) vs. probation staff (PS). 100 facilitators will be recruited to deliver the intervention and participate in the research.
详细描述
The main objectives of the proposed study are to compare the effectiveness, cost-effectiveness, and sustainability of Youth Representative-led vs. probation staff-led PHAT Life in a real-world juvenile probation setting. The Specific Aims of this study are:
- To conduct a methodologically-rigorous 2-arm trial comparing the impact of PHAT Life on 350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical mediators when delivered by Youth Representatives (YR) vs. probation staff (PS).
- To compare the costs and cost-effectiveness of 100 YR-led vs. PS-led PHAT Life with respect to the acquisition of incident STI.
We hypothesize: (a) Compared to teens in PS-led groups, we expect teens in YR-led groups to report less risky sex and substance use at 6-month follow-up, to demonstrate greater improvement on theoretical mediators of risk, and to have fewer incident STI infections; (b) We expect YR-led PHAT Life to cost less and be more cost-effective than PS-led PHAT Life.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a) male or female gender; b) remanded to a probation program; c) 13-17 years old; d) adolescent is fluent in English; e) are not wards of the Department of Child and Family Services (DCFS); and f) they have not already received the PHAT Life intervention.
排除标准
- •a) are unable to understand the consent/assent process; b) do not speak English, because instruments are normed for English speakers; c) do not assent; d) legal guardians do not consent to teens' participation; e) are not 13 -17 years old; f) are not on probation or remanded to a probation program; g) are wards of the Department of Child and Family Services (DCFS); and h) they have already received the PHAT Life intervention.
结局指标
主要结局
Change in HIV/STI Risk Behaviors at 6 months
时间窗: Baseline and 6-months
AIDS Risk Behavior Assessment (ARBA) A computer-assisted structured interview of self-reported sexual behavior and drug use derived from five well-established measures. The outcomes include ever had sex, condom use, number of partners, sex while using drugs and/or alcohol.
次要结局
- Change in trauma symptoms and violence exposure at 6 months(Baseline and 6-months)
- Change in parental Influences at 6 months(Baseline and 6-months)
- Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6(Baseline and 6-months)
- Change in Partner Sexual Communication at 6 months(Baseline and 6-months)
- Biological Measure of T. Vaginalis Acquisition(Baseline and 6 months)
- Facilitator Characteristics(Baseline)
- Change in peer influences at 6 months(Baseline and 6-months)
- Biological Measure of N. Gonorrhoeae Acquisition(Baseline and 6 months)
- Change in mental health symptoms at 6 months(Baseline and 6-months)
- Change in Relationship dynamics at 6 months(Baseline and 6-months)
- Change in parental communication at 6 months(Baseline and 6-months)
- Biological Measure of C. Trachomatis Acquisition(Baseline and 6 months)
- Cost Effectiveness(Through study completion, an average of 2 years)
研究者
Geri Donenberg
Professor, Departments of Medicine and Psychology
University of Illinois at Chicago