Hepatitis C Treatment in Underserved Populations
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.
研究概览
简要总结
The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.
详细描述
This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years or older
- •Used heroin, cocaine, or injected other drugs for at least 1 year
- •Have used heroin, cocaine and/or methamphetamine within the last 30 days
- •Test positive for HCV antibody
- •Are interested in being evaluated for HCV treatment
排除标准
- •Persons who are obviously intoxicated, incoherent or otherwise unable to give informed consent are excluded from participation. Such persons may participate in the study if they return at a later date and are capable of providing informed consent.
结局指标
主要结局
Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.
时间窗: 24 weeks after completion of antiviral treatment
SVR is measured 24 weeks after completion of antiviral treatment
次要结局
- completion of medical and psychiatric evaluation for antiviral therapy(Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.)
- initiation of antiviral therapy(Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.)
- adherence to antiviral therapy(Weekly up to 48 weeks)
- completion of antiviral therapy(Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.))
- levels of alcohol and illicit drug use(Weekly up to 96 weeks)
- entry into treatment for substance use(Monthly up to 24 months)
- entry into treatment for another unaddressed medical or psychiatric condition(Monthly up to 24 months)
- neuropsychiatric side effects, including depression and hostility/irritability(Monthly up to 72 weeks)
- treatment-limiting systemic, hematologic, or other side effects(Weekly up to 72 weeks)
- other adverse events or adverse effects(Monthly up to 72 weeks)
- reinfection(Quarterly up to 10 years)
研究者
Brian Edlin
Associate Professor of Medicine and Public Health
Weill Medical College of Cornell University