Improving Hepatitis C Treatment in Injection Drug Users

改善注射吸毒者的丙型肝炎治疗

基本信息

批准号：
7695135
负责人：
Steven L Batki
金额：
$ 50.52万
依托单位：
NORTHERN CALIFORNIA INSTITUTE/RES/EDU
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-09-26 至 2010-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7695135
关键词：
Adherence Affect Alcohol consumption Alcohols Antiviral Agents Biological Caring Chronic Chronic Hepatitis C Clinic Cocaine Condition Control Groups Controlled Clinical Trials Diagnosis Enrollment Goals Health Health Services Research Hepatitis A Hepatitis C Hepatitis C Antibodies Hepatitis C virus Heroin Incentives Injecting drug user Knowledge Maintenance Measures Medical Methadone Modeling Morbidity - disease rate Numbers Outcome Participant Patients Pharmaceutical Preparations Phase Principal Investigator Quality of life Randomized Randomized Controlled Clinical Trials Rate Research Project Grants Series Services Site Substance abuse problem Testing Treatment Effectiveness Treatment outcome Universities Urine Vaccination Viral Work base economic value follow-up improved programs response therapy design treatment program treatment site viral RNA voucher

项目摘要

DESCRIPTION (provided by applicant): The overall goal of the proposed health services research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C virus (HCV) infection. This will be done by testing two interventions designed to improve the rates of HCV treatment completion and sustained virologic response (SVR) in IDUs. The first will increase access by integrating HCV medical care into substance abuse treatment, and the second will use voucher incentives to reduce drug and alcohol use among IDUs with HCV infection. HCV infection is endemic among IDUs, and is associated with significant medical morbidity. While antiviral treatments are improving rapidly, providing HCV medical care for IDUs remains problematic for a number of reasons. IDUs often do not have adequate access to HCV diagnosis and treatment services, and they may engage in active drug and alcohol use, making them ineligible for treatment. Continued drug and alcohol use also worsens HCV outcomes by reducing adherence to HCV treatment and reducing the effectiveness of treatment. The proposed project is a five-year program of work made up of two controlled clinical trials, studying 220 patients with HCV infection enrolled in methadone maintenance treatment (MMT). Study 1 - Integrated HCV Medical Care - is a randomized trial to test the efficacy of On-site HCV Medical Care provided at the MMT program versus Off-site care at the GI Clinic. HCV antibody positive MMT patients will be randomly assigned to receive HCV medical services either through an integrated delivery model located on-site in the MMT clinic, or through usual off-site referral to the GI Clinic. The main outcomes will be the rates of attaining SVR and completion of HCV treatment, as well as other measures of HCV related health outcomes and quality of life. Study 2 - Voucher Incentives to Reduce Drug Alcohol Use - is a randomized trial of voucher-based incentives to reduce heroin, cocaine, and alcohol use and to thereby increase the rates of completion of HCV treatment and achieving SVR. Eighty HCV antibody positive MMT patients will be randomly assigned to one of two study conditions: a) Voucher group in which participants can earn vouchers with monetary value as incentives for drug and alcohol-free urine tests, and b) No Voucher control group. The main outcomes will be completion of HCV medical treatment, SVR and other HCV-related health measures, and quality of life. These studies are expected to yield new knowledge about the efficacy of providing on-site HVC medical care in substance abuse treatment programs. They will also provide information about how HCV treatment outcomes are affected by incentives to reduce drug/alcohol use in MMT patients with chronic HCV. Finally, the studies will also provide information about the influence of active drug and alcohol use on HCV medical outcomes such as treatment completion and SVR.

描述（由申请人提供）：拟议的卫生服务研究项目的总体目标是通过丙型肝炎病毒（HCV）感染改善注射吸毒者医疗服务的结果。这将通过测试旨在提高IDU中HCV治疗完成和持续病毒反应（SVR）的两种干预措施来完成。第一个将通过将HCV医疗保健纳入药物滥用治疗中来增加通道，第二种将使用代金券激励措施减少与HCV感染的IDU中的药物和酒精使用。 HCV感染在IDU中是地方性的，并且与明显的医疗发病率有关。尽管抗病毒治疗正在迅速改善，但出于多种原因，为IDU提供HCV医疗服务仍然有问题。 IDU通常无法获得HCV诊断和治疗服务的足够访问，并且它们可能从事积极的吸毒和饮酒，因此它们没有资格进行治疗。持续的毒品和饮酒也通过降低遵守HCV治疗并降低治疗的有效性，从而使HCV结果恶化。拟议的项目是一项五年的工作计划，由两项对照临床试验组成，研究了220例接受美沙酮维持治疗（MMT）的HCV感染患者。研究1-综合HCV医疗保健 - 是一项随机试验，用于测试MMT计划与GI诊所的现场护理相对于现场护理提供的现场HCV医疗服务的功效。 HCV抗体阳性MMT患者将通过位于MMT诊所现场的集成输送模型或通过通常的异地转诊到GI诊所进行随机分配的HCV医疗服务。主要结果是获得HCV治疗的SVR和完成的率，以及HCV相关的健康结果和生活质量的其他措施。研究2-减少药物饮酒的优惠券激励措施 - 是一项基于代金券的激励措施，以减少海洛因，可卡因和饮酒，从而提高HCV治疗和实现SVR的完成率。八十种HCV抗体阳性MMT患者将被随机分配到两个研究条件之一：a）代金券组，其中参与者可以赚取货币价值作为药物和无酒精尿液测试的优惠券，而b）无凭证控制组。主要结果将是HCV医疗，SVR和其他与HCV相关的健康指标以及生活质量的完成。预计这些研究将产生有关在药物滥用治疗计划中提供现场HVC医疗服务的功效的新知识。他们还将提供有关HCV治疗结果如何受到减少慢性HCV患者药物/酒精使用的激励措施的信息。最后，研究还将提供有关活性药物和饮酒对HCV医疗结果（例如治疗完成和SVR）的影响的信息。