Directly Observed Hepatitis C Treatment in Methadone Clinics

描述（由申请人提供）：注射吸毒者（IDUs）占美国约500万丙型肝炎病毒（HCV）感染者的60%，并且大多数阿片类激动剂治疗方案的吸毒者患有HCV。尽管有有效的HCV治疗方法，但令人震惊的是，很少有吸毒者和阿片类激动剂维持患者开始HCV治疗。由于HCV的治疗过程离散，持续时间仅为24至48周，其骨干是每周一次的皮下聚乙二醇化干扰素注射，因此可能非常适合直接观察治疗（DOT）管理。为了验证这一点，我们设计了一项小型随机对照试验，将修饰DOT （mDOT）用于HCV治疗（聚乙二醇化干扰素和利巴韦林），用于阿片类激动剂治疗的吸毒者。该导师奖的目标是通过将HCV治疗与药物滥用治疗相结合的研究，提高Alain Litwin， m.d., m.p.h., m.s.的临床研究技能。Litwin博士的培训计划包括以下领域的正式指导：在阿片激动剂项目中实施全面的DOT项目，测量和分析吸毒者的依从性，为吸毒者设计行为干预，临床试验研究设计，先进的统计方法，以及社区参与性研究。该建议的具体目的是：(1)在随机试验中确定在美沙酮项目现场提供的直接观察丙型肝炎治疗（聚乙二醇化干扰素α -2a加利巴韦林）是否比自我给予丙型肝炎治疗更有效，以增强依从性；(2)确定现场HCV治疗对病毒学结果的影响，并确定HCV治疗依从性与病毒学结果之间的关系。作为一个子目标，我们还将确定mDOT在实现HCV治疗结果方面是否比自我给予HCV治疗更有效；(3)确定影响丙型肝炎治疗依从性和治疗结果的个人因素（如：活跃的药物和酒精使用、活跃的精神疾病、住房状况、社会支持、对丙型肝炎药物的信念和知识、坚持的动机、自我效能感和药物副作用）。该项目的研究结果将用于开展一项大型随机试验，研究改良直接观察丙型肝炎病毒治疗与常规现场治疗的疗效和成本效益。

DESCRIPTION (provided by applicant): Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the United States infected with hepatitis C virus (HCV), and the majority of drug users in opioid agonist treatment programs have HCV. Even though there are effective HCV treatments, alarmingly few drug users and opioid agonist maintained patients have initiated HCV treatment. Because HCV has a discrete course of treatment lasting only 24 to 48 weeks and its backbone is once-weekly subcutaneous pegylated interferon injections, it may be ideally suited for directly observed treatment (DOT) management. To test this, we have designed a small randomized controlled trial of modified DOT (mDOT) for HCV treatment (both pegylated interferon and ribavirin) in drug users enrolled in opioid agonist treatment. The goal of this mentored award is to enhance the clinical research skills of Alain Litwin, M.D., M.P.H., M.S., through research on integrating HCV treatment with substance abuse treatment. Dr. Litwin's training plan involves formal mentorship in the following areas: implementing comprehensive DOT programs in opiate agonist programs, measuring and analyzing adherence in drug users, designing behavioral interventions for drug users, clinical trial study design, advanced statistical methods, and community-based participatory research. The specific aims of this proposal are: (1) To determine in randomized trial whether modified directly observed HCV treatment (pegylated interferon alfa-2a plus ribavirin) provided on-site at a methadone program is more efficacious than self-administered HCV treatment for enhancing adherence; (2) To determine the impact of providing on-site HCV treatment on virologic outcomes, and to determine the association between HCV treatment adherence and virologic outcomes. As a sub-aim, we will also determine whether mDOT is more efficacious than self-administered HCV treatment for achieving HCV treatment outcomes; and (3) To identify individual-level factors (e.g. active drug and alcohol use, active psychiatric illness, housing status, social support, beliefs and knowledge about HCV medications, motivation to adhere, self-efficacy, and medication side effects) influencing HCV treatment adherence and HCV treatment outcomes. Findings from this project will be used to inform the development of a large randomized trial of the efficacy and cost-effectiveness of modified directly observed HCV care versus regular on-site care.