A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment Among Young Adult People Who Inject Drugs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Intervention efficacy
研究概览
简要总结
The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult people who inject drugs (PWID).
详细描述
After an initial ramp-up phase to ensure intervention materials and protocols meet the needs of the target population and organizational setting, we will apply a stratified randomized design to enroll 250 adult PWID with recently diagnosed HCV infection ("index") and their primary injecting partner("partner") into a randomized control efficacy trial of a two-session partner navigation intervention, compared to standard of care. The primary endpoint is starting HCV treatment. Recruitment will over sample PWID between 18-30 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self report injecting drugs in the past month
- •Self report a primary injecting partner (currently inject drugs together)
- •HCV infection identified at partnering community-based clinical site
排除标准
- 未提供
结局指标
主要结局
Intervention efficacy
时间窗: 6 months, 12 months, and 24 months after HCV infection disclosure visit.
Assessed by comparing the proportion of those enrolled in the intervention group who initiated treatment to the proportion of those enrolled in the control group who initiated treatment at 6 months, 12 months, and 24 months after HCV infection disclosure visit.
次要结局
- HCV Treatment Completion(Point of HCV treatment initiation up to 3 years)
- Change in Partner Support (Intervention mechanism)(1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit)
- Sustained Virologic Response at 12 weeks post treatment completion (SVR12)(Point of HCV treatment initiation up to 3 years)