Directly Observed Hepatitis C Treatment in Methadone Clinics

美沙酮诊所直接观察的丙型肝炎治疗

• 批准号: 7883680
• 负责人: Alain Harris Litwin
• 金额: $ 18.2万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7883680
• 关键词: Abstinence; Adherence; Adverse effects; Agonist; Alcohol consumption; Area; Award; Behavior Therapy; Belief; Caring; Characteristics; Clinical Research; Clinical Trials; Communicable Diseases; Consensus; Data; Development; Directly Observed Therapy; Disease; Doctor of Medicine; Dose; Drug usage; Drug user; Enrollment; Goals; Guidelines; HIV; Hepatitis C; Hepatitis C virus; Highly Active Antiretroviral Therapy; Home environment; Housing; Individual; Injecting drug user; Injection of therapeutic agent; Interferons; Intervention; Knowledge; Master of Public Health; Measures; Mental Depression; Mentors; Mentorship; Methadone; Modeling; Motivation; NIH Consensus Development Conferences; Opiates; Opioid; Outcome; Patient Self-Report; Patients; Perception; Pharmaceutical Preparations; Provider; Randomized; Randomized Controlled Trials; Regimen; Research; Research Design; Ribavirin; Risk; Self Administration; Self Efficacy; Self-Administered; Site; Social support; Statistical Methods; Substance abuse problem; Testing; Time; Training; Treatment outcome; United States; United States National Institutes of Health; Vertebral column; Viral; active method; arm; community based participatory research; cost effectiveness; design; improved; interferon therapy; methadone clinic/center; non-drug; peginterferon alfa-2a; pill; primary outcome; programs; randomized trial; response; skills; standard of care; subcutaneous; substance abuse treatment; success; treatment adherence; treatment as usual; treatment program; treatment response; tuberculosis treatment

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.

描述（由申请人提供）：注射吸毒者（IDU）占美国大约500万人感染了丙型肝炎病毒（HCV）的60％，而阿片类激动剂治疗计划中的大多数吸毒者患有HCV。即使进行了有效的HCV治疗，但令人震惊的吸毒者和阿片类动力学维持患者的患者已经开始了HCV治疗。由于HCV的治疗方法仅持续24至48周，并且其骨架是每周一次的皮下注射干扰素注射，因此它可能非常适合直接观察到的治疗（DOT）管理。为了测试这一点，我们设计了一项针对接受阿片类药物治疗的吸毒者的HCV治疗（同性恋干扰素和利巴韦林）的修改点（MDOT）的小型随机对照试验（MDOT）。该指导奖的目标是通过将HCV治疗与药物滥用治疗相结合的研究，以提高M.D.，M.P.H.，M.P.H.，M.P.H.，M.P.H.，M.P.H.的临床研究技能。 Litwin博士的培训计划涉及以下领域的正式指导：在阿片类动力学计划中实施全面的点计划，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，高级统计方法，基于社区的参与性研究。该提案的具体目的是：（1）在随机试验中确定在美沙酮程序上提供的在现场进行的经过修改是否直接观察到的HCV治疗（Pegyped Interferon alfa-2a Plus Ribavirin）是否比自我管理的HCV处理更有效，以增强依从性； （2）确定提供现场HCV治疗对病毒结局的影响，并确定HCV治疗依从性和病毒学结局之间的关联。作为一个子AIM，我们还将确定MDOT是否比自我管理的HCV治疗更有效，以实现HCV治疗结果。 （3）确定个人水平因素（例如，活跃的药物和酒精使用，活跃的精神病，住房状况，社会支持，信念和有关HCV药物的知识，依从性，自我效能感和药物副作用）影响HCV治疗治疗依从性和HCV治疗量。该项目的发现将用于告知开发一项大型随机试验，该试验的疗效和成本效益直接观察到的HCV护理与常规现场护理。