Integrated vs. Separate Care for Hepatitis C, Substance Abuse, and HIV Prevention

描述(由申请人提供)：这项拟议的研究将审查针对活跃的注射吸毒者(IDU)的丙型肝炎、成瘾和艾滋病毒预防的综合护理计划的可行性、可接受性、安全性、有效性和成本，并与针对这些情况的标准单独治疗进行比较。丙型肝炎已经是美国肝功能衰竭和肝移植的主要原因，预计未来几年疾病负担和医疗费用将继续上升。注射吸毒者构成丙型肝炎流行的核心，在大多数研究中流行率为70%。但是，尽管抗病毒治疗可以根除许多患者的感染，但很少有研究报告成功地治疗了活跃的非法吸毒者的这种感染，而且很少为他们提供抗病毒治疗。我们与为南布朗克斯和东哈莱姆区的注射吸毒者提供服务的社区组织合作，开发了一个多学科的综合护理计划，发现我们可以有效地治疗从社区招募的积极使用非法药物的注射吸毒者中的丙型肝炎和药物滥用。该计划提供初级保健、丙型肝炎专科护理、精神健康服务和药物滥用治疗，使用病例经理和多学科病例会议来协调和整合来自多个地理上独立的提供者的服务。通过减少非法药物使用和提供艾滋病毒风险降低，该计划还减少了高风险注射和性艾滋病毒风险行为。这种模式的优势是，主要在吸毒者舒适地接受服务的社区环境中提供综合的、多学科的护理。此外，由于它集成了来自不同地理位置的提供者的护理，因此在大多数情况下是可以复制的，因为在这些环境中，多学科服务不可能共存。美国国立卫生研究院已将药物滥用和合并疾病的综合治疗与单独治疗进行比较的研究确定为高度优先的比较有效性研究。我们假设，对于患有成瘾和丙型肝炎的患者，综合治疗这些疾病的方法将比单独治疗每种疾病的零散方法更有效。这项研究的具体目的是评估：(1)丙型肝炎治疗的有效性，(2)丙型肝炎治疗的安全性，(3)药物滥用治疗的结果，以及(4)在社区活跃的注射吸毒者中，随机接受综合护理与单独护理的HIV危险行为的减少。在大多数西方世界，慢性丙型肝炎是慢性肝病和肝癌的头号原因。据估计，美国有100万活跃的注射吸毒者患有丙型肝炎，无法获得治疗。如果没有更好的护理模式，许多人将需要肝脏移植或死亡。丙型肝炎疫情有可能压倒为穷人服务的脆弱和支离破碎的医疗基础设施，引发一场重大的医疗危机。了解如何让活跃的注射吸毒者参与药物滥用和丙型肝炎的治疗，对于减轻这些流行病将导致的非同寻常的发病率和死亡率至关重要。

DESCRIPTION (provided by applicant): The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an integrated care program for hepatitis C, addiction, and HIV prevention in active injection drug users (IDUs), in comparison with standard, separate treatment for each of these conditions. Hepatitis C is already the leading cause of liver failure and liver transplantation in the US, and the disease burden and health care costs are expected to continue to rise in coming years. IDUs constitute the core of the hepatitis C epidemic, with prevalence rates >70% in most studies. But although antiviral treatment can eradicate the infection in many patients, few studies have reported successful treatment of this infection in active illicit drug users, and they are rarely offered antiviral treatment. In collaboration with community-based organizations providing services to IDUs in the South Bronx and East Harlem, we developed a multidisciplinary, integrated-care program and found that we could effectively treat both hepatitis C and substance abuse in IDUs recruited from community-based settings who were actively using illicit drugs. The program provided primary care, hepatitis C specialty care, mental health services, and substance abuse treatment, using Case Managers and Multidisciplinary Case Conf- erences to coordinate and integrate services from multiple, geographically separate providers. By reducing illicit drug use and providing HIV risk reduction the program reduces high-risk injection and sexual HIV risk behavior as well. This model has the advantage of delivering integrated, multidisciplinary care primarily in community-based settings where drug users are comfortable receiving services. Moreover, because it integrates care from geographically separate providers it is replicable in the vast majority of settings where co- location of multidisciplinary services is not possible. NIH has identified research comparing integrated vs. separate treatment of substance abuse and comorbid conditions as high-priority Comparative Effectiveness Research. We hypothesize that for patients suffering from addiction and hepatitis C, an integrated approach to treating these conditions together will be more effective than fragmented approaches to each condition separately. The Specific Aims of this study are to assess: (1) the effectiveness of hepatitis C treatment, (2) the safety of hepatitis C treatment, (3) substance abuse treatment outcomes, and (4) reduction in HIV risk behaviors in a community-based sample of active IDUs randomized to receive integrated vs. separate care. Chronic hepatitis C is the number one cause of chronic liver disease and liver cancer in most of the Western world. An estimated one million active IDUs in the US have hepatitis C and no access to treatment. Without better models of care, many will require liver transplants or die. The hepatitis C epidemic threatens to overwhelm the fragile and fragmented healthcare infrastructure serving the indigent, precipitating a healthcare crisis of major proportions. Understanding how to engage active IDUs in treatment for substance abuse and hepatitis C will be critical to mitigating the extraordinary morbidity and mortality these epidemics will cause.