Accessible Care Intervention for Engaging People Who Inject Illicit Drugs in HCV Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider
研究概览
简要总结
The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID where they can comfortably access care without fear of shame or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle exchange program. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome is sustained virologic response, which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes.
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
- 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
- •18 years or older,
- •injected heroin, cocaine, or other drugs in the past 90 days.
- •test HCV Ab and RNA positive
- •provide written consent (including consent for researchers to examine their hepatitis C medical records)
排除标准
- •Persons already in care for hepatitis C, defined as having had at least 2 visits with a hepatitis treatment provider within the past 6 months, will be excluded.
- •People with decompensated cirrhosis will be excluded.
结局指标
主要结局
Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider
时间窗: each participant will be assessed at 1 year post entry
Proportion of patients in each arm referred to hepatitis C treatment provider by 12 months
Proportion of Patients to Achieve SVR12 at 1 Year
时间窗: each participant will be assessed at 1 year post entry
SVR12 is a sustained virologic response to HCV treatment defined as HCV RNA below the limit of quantification 12 weeks post completion of HCV treatment
Proportion of Participants in Each Arm Who Initiated Treatment
时间窗: Each participant will be assessed 1 year post entry
Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion)
The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit
时间窗: end of study (12 months)
The proportion of participants in each arm who attend an initial visit with a hepatitis treatment provider post randomization.
Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment
时间窗: each participant will be assessed at 1 year post entry
Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation
次要结局
未报告次要终点