Accessible Care Intervention for Engaging People who Inject Illicit Drugs (PWID) in Hepatitis C Care

 描述（由申请人提供）：拟议的研究将检查可行性，可接受性，安全性，有效性和成本的可接受的护理干预措施，使注射非法药物（PWID）的人参与丙型肝炎护理。在美国，丙型肝炎的流行率是艾滋病毒感染的四倍，已经是肝衰竭和肝移植的主要原因， 在未来几十年，疾病负担和卫生保健费用将继续上升。150 - 200万PWID构成了美国丙型肝炎流行的核心，在大多数研究中患病率>70%。新的全口服抗病毒治疗方案可以根除几乎100%以前未经治疗的患者的HCV。尽管如此，很少有研究报告成功治疗这种感染的活动性PWID -没有一个新的全口服方案-他们很少提供抗病毒治疗。随着越来越多的丙型肝炎患者获得治疗并治愈，丙型肝炎结果的健康差异将加剧。 对残疾人的可接受护理是在专门为残疾人设计的方案中提供的低门槛护理，在社区地点，他们可以舒适地获得护理，而不必担心羞耻或耻辱。拟议的研究将比较可持续护理与社区护理（转介到现有服务）在促进PWID在丙型肝炎、成瘾和艾滋病毒预防护理中的联系、参与和保留方面的有效性。我们的主要结果是持续的病毒学应答（SVR），这构成了病毒学治愈。物质使用和HIV和HCV风险行为是次要结果。本研究的具体目的是比较主动PWID接受可持续护理或家庭护理的以下结果：1。丙型肝炎结局：（1a）丙型肝炎护理的联系和参与，（1b）成功的丙型肝炎治疗，（1c）丙型肝炎治疗的安全性，（1d）再感染率。2.物质使用结果：（2a）物质滥用治疗的进入和保留，以及（2b）物质使用的减少。3.减少自我报告的HIV和HCV风险行为。由于所有口服方案可用于不注射药物的患者，丙型肝炎已经明显的实质性健康差异将变得更糟，因为富人被治愈而穷人没有。需要有关于有效方法的数据，以便向受这一流行病影响的核心人口-目前正在使用非法药物的人-提供成功的抗病毒治疗，使他们也能受益。治疗还可以通过防止进一步传播来帮助结束HCV流行-治疗即预防-但前提是我们必须有有效的模式为积极注射毒品的人提供治疗。

 DESCRIPTION (provided by applicant): The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Four times as prevalent in the US as HIV infection, hepatitis C is already the leading cause of liver failure and liver transplantation, and the disease burden and health care costs will continue to rise in the coming decades. The 1.5-2.0 million PWID constitute the core of the hepatitis C epidemic in the United States, with prevalence rates >70% in most studies. New, all-oral antiviral treatment regimens can eradicate HCV in nearly 100% of previously untreated patients. Nonetheless, few studies have reported successful treatment of this infection in active PWID - none with the new all-oral regimens - and they are rarely offered antiviral treatment. As more advantaged populations gain access to the treatments and are cured, health disparities in hepatitis C outcomes will sharpen. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID, in community-based locations where they can comfortably access care without fear of shame or stigma. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. Our primary outcome is sustained virologic response (SVR), which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes. The Specific Aims of this study are to compare active PWID receiving Accessible Care or Usual Care on the following outcomes: 1. Hepatitis C Outcomes: (1a) Linkage and engagement in hepatitis C care, (1b) Successful hepatitis C treatment, (1c) Safety of hepatitis C treatment, and (1d) Rates of reinfection. 2. Substance use outcomes: (2a) Substance abuse treatment entry and retention, and (2b) Reductions in substance use. 3. Reductions in self-reported HIV and HCV risk behaviors. As all-oral regimens become available to patients who do not inject drugs, the substantial health disparities in hepatitis C already evident will become worse, as the haves are cured and the have-nots are not. Data are needed on effective methods to provide successful antiviral therapy to the core population affected by the epidemic, persons who are currently using illicit drugs, so that they, too, may benefit. Treatment can also help end the HCV epidemic by preventing onward transmission - Treatment as Prevention - but only if we have effective models for delivering treatment to people actively injecting drugs.