Randomized Controlled Trial of a Social-network Oriented Mobile Health Based Intervention to Increase Access and Adherence to Hepatitis C Treatment and HIV Viral Suppression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Continuity in HIV care scale
研究概览
简要总结
The purpose of this study is to test an intervention designed to train persons who inject drugs (PWID) and are infected with hepatitis C (HCV) and HIV in communication skills to 1) promote new HCV treatment and care 2) risk reduction and 3) recruit their social network members for HIV and HCV testing and linkage to care.
详细描述
The investigators propose recruiting 300 HIV/HCV co-infected PWID (i.e. Index participants). Half will be randomly assigned to the experimental condition and half to the equal attention comparison. The experimental intervention will include 8 group sessions that focus on communication to social network members, medical adherence and risk reduction skills, 2 dyad sessions with network members, monthly booster sessions for 6 months, and mHealth cuing of behavior for 6 months. These Index participants will be followed for 24 months (3, 6, 12, 18, & 24 month assessments). Participants who test positive for HCV will be linked to the Johns Hopkins Viral Hepatitis clinic to assess liver function and HCV chronicity and if applicable offered HCV treatment. Additionally, 450 network members will be recruited and will be tested for HIV and HCV and followed longitudinally to examine the social diffusion and social network factors associated with adherence among the Index participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HCV antibody positive
- •HIV antibody positive
- •lifetime history of injection drug use
- •interrupted HIV care:>3 months since HIV care or detectable viral load
- •willingness to participate in group sessions and have conversations with social network members
排除标准
- •participated in a behavioral intervention in prior 2 years
研究组 & 干预措施
Peer Mentor
Individuals in this arm will be trained in communication skills to promote HIV and HCV testing to their social network members, linkage to care and risk reduction behaviors.
干预措施: Peer Mentor (Behavioral)
Neighborhood Matters
Participants in this arm will view a 15-20 minute video on issues in neighborhoods such as crime and violence, restoring communities and incarceration and discuss their reactions and thoughts.
结局指标
主要结局
Continuity in HIV care scale
时间窗: 24 months
Access to HCV care scale
时间窗: 24 months
Initiation of HCV care at a viral hepatitis clinic
次要结局
- HIV medication adherence scale(24 months)