Yuva Sath: A Peer-led Behavioral Intervention to Support Substance Use Treatment and HIV Prevention Among Young People Who Inject Drugs in India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Feasibility of the Yuva Sath Intervention: Peer counselor fidelity
研究概览
简要总结
The goal of this pilot randomized controlled trial is to learn if Yuva Sath, a youth-tailored peer-led behavioral intervention, can support substance use treatment engagement and HIV prevention among young people who inject drugs in India. The main questions it aims to answer are:
- Is Yuva Sath feasible and is it acceptable to young people who inject drugs in India ?
- Can Yuva Sath improve engagement in substance use treatment, increase use of HIV prevention services and decrease substance use and risk behaviors among young people who inject drugs in India ?
Researchers will compare participants who receive the Yuva Sath behavioral intervention to participants who do not to see if the behavioral intervention improves substance use treatment engagement and HIV prevention.
Participants will:
- Receive a total of 6 one-on-one sessions, and weekly phone text check-ins from peer counselors over a course of 6 months.
- Complete monthly random urine drug screens
- Complete in-person study questionnaires every 3 months
- Report substance use and risk behaviors weekly to peer counselors through a brief phone text message survey
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-29 years;
- •Receiving medications for opioid use disorder (MOUD) for at least 3 months and receipt frequency < 2 times a week
排除标准
- •Receiving medications for opioid use disorder (MOUD) for less than 3 months and receipt frequency >= 2 times a week
- •Requiring urgent medical attention
- •Inability to provide informed consent
结局指标
主要结局
Feasibility of the Yuva Sath Intervention: Peer counselor fidelity
时间窗: 6 months.
Feasibility of the Yuva Sath intervention as measured by peer counselor fidelity to the intervention protocol will be determined by independent observer fidelity checklists. The checklist will score content delivery on a 3-point ordinal scale (1=no key content covered to 3=all key content covered), and peer-navigator actions (i.e., identification of barriers; generation of solutions) on a 5-point Likert scale (1=not at all to 5=very much). The intervention will be deemed to be feasible if 80% of the sessions addressed key Life-Steps module content and employed flexible problem-solving
Feasibility of the Yuva Sath Intervention: Attendance in the first four sessions
时间窗: 6 months
Feasibility of the Yuva Sath intervention as measured by attendance in the first four sessions will be calculated as a proportion: participants who completed the first four sessions of the total 6 sessions of the intervention/ All participants in the intervention arm. The intervention will be deemed to be feasible if at least 75% of participants completed the first four sessions
Feasibility of the Yuva Sath Intervention: Completion of the 3 month assessment
时间窗: 3 months
Feasibility of the Yuva Sath intervention as measured by completion of the 3 month session will be calculated as a proportion: participants who completed the 3 month assessment / All participants in the intervention arm. The intervention will be deemed feasible if at least 60% of participants completed the 3-month assessment
Acceptability of the Yuva Sath Intervention
时间窗: 6 months
Acceptability of the intervention as measured by the overall satisfaction of participants rated on a 5-point Likert scale (1=not at all to 5=very much). The intervention will be deemed acceptable if at least 75% of the participants rate \>=4 on overall satisfaction
次要结局
- Substance use: monthly random point-of-care urinalysis(6 months)
- Needle sharing: Self report at 3-month assessment(3 months)
- Substance use: Self report at 3-month assessment(3 months)
- Needle sharing: self report at 6-month assessment(6 months)
- Substance use: Self report at 6-month assessment(6 months)
- Condomless sex: self report at 3-month assessment.(3 months)
- Substance use treatment engagement: the number of MOUD visits each month(6 months)
- Substance use treatment engagement: the number of weeks of MOUD receipt at >2 times a week(6 months)
- Substance use treatment engagement: retention in MOUD at 6 months(6 months)
- HIV testing receipt(6 months)
- Condomless sex: self report at 6-month assessment.(6 months)
研究者
Lakshmi Ganapathi
Physician-Investigator
Massachusetts General Hospital