Stabilize Addiction/Affect, Begin Inmates' Interferon for HCV of Liver (STAABIHL)

描述(申请人提供)：慢性丙型肝炎病毒(丙型肝炎病毒)感染、药物依赖和精神障碍并存是被监禁人口面临的最大公共卫生挑战之一。丙型肝炎病毒本身可导致精神损害，而药物使用和精神症状是拒绝或停止聚乙二醇化干扰素(PeglFN)和利巴韦林(RBV)治疗的主要原因。我们的同事和我们已经证明，对长期服刑的囚犯来说，监狱内的丙型肝炎病毒治疗是安全有效的，但大多数囚犯的监禁时间不到一年。因此，需要一种行为健康和丙型肝炎病毒治疗的综合模式，作为从监狱向社区过渡的桥梁，以促进稳定和治疗因聚乙二醇化干扰素/RBV的精神副作用而具有高风险的大部分丙型肝炎病毒感染的囚犯。因此，这项研究将调整和试行监狱和社区环境之间的连续性护理模式，适用于感染丙型肝炎病毒1型或4型的囚犯，这些囚犯有吸毒史；有DSM-IV标准的终生情绪或焦虑症，或目前的抑郁/焦虑症状，并还有6至15个月的刑期。在为期六个月的“磨合”阶段，56名囚犯将接受评估，然后在狱中开始药物滥用、心理健康和丙型肝炎治疗。那些在监狱中有12周早期病毒学应答而没有失代偿的患者(N=45)在社区治疗阶段将被随机分为2：1。干预对象(N=30)将接受详细的过渡性出院计划、密集的治疗病例管理以及与成瘾、心理健康、福利和社会服务、生活技能培训的联系，并陪同丙型肝炎病毒诊所就诊，最长可达9个月。对照受试者(N=15)将接受简短的动机干预，以加强他们对继续治疗、通常出院计划和现有病例管理机构转介的承诺。两组都将接受每周监督的peglFN，一个丙型肝炎病毒支持小组，以及研究提供者提供的精神护理。主要结果将是与药物使用或抑郁/焦虑症状有关的丙型肝炎病毒治疗完成和抗病毒治疗停止。次要结果是非法药物使用、复发、抑郁/焦虑症状水平和治疗结束病毒学应答率。对于感染丙型肝炎病毒的囚犯，监狱提供了一个受控的环境，在其中稳定药物使用和精神健康，并评估对peglFN/RBV的耐受性和反应。这一拟议的重新入狱方案将有助于稳定和治疗大多数面临停止peglFN/RBV的风险的囚犯。结果将使更大的CJ-DATS多站点试验的样本量估计成为可能。如果能够确定安全性和有效性，大量感染丙型肝炎病毒的囚犯可以获得所需的抗病毒治疗，他们目前不是peg-干扰素/RBV的候选对象。这种增加获得治疗的机会将有利于公共健康和公共安全。

DESCRIPTION (provided by applicant): The co-occurrence of chronic hepatitis C virus (HCV) infection, drug dependence and psychiatric disorders is one of the greatest public health challenges to the incarcerated population. HCV itself can cause psychiatric impairment, and drug use and psychiatric symptoms are leading causes of denial or discontinuation of pegylated interferon (peglFN) plus ribavirin (RBV) therapy. Colleagues and we have shown that in-prison HCV treatment is safe and effective for inmates serving long sentences, but most inmates are incarcerated for less than one year. An integrated model of behavioral health and HCV treatment that bridges the transition from prison to community is thus needed to facilitate the stabilization and treatment of the large proportion of HCV-infected inmates at high risk for psychiatric side effects from peg-IFN/RBV. This study will thus adapt and pilot test a continuity of care model between the prison and community settings for inmates infected with HCV genotype 1 or 4 who have a history of drug use; lifetime mood or anxiety disorder by DSM-IV criteria or current depressive/anxiety symptoms, and have 6 to 15 months remaining in their sentences. In a six-month "run-in" phase, 56 inmates would be assessed then initiate substance abuse, mental health and HCV treatment while in prison. Those who have a 12-week early virologic response without decompensation in prison (N=45) would be 2:1 randomized in the community treatment phase. Intervention subjects (N=30) would receive detailed transitional discharge planning, intensive therapeutic case management and linkage to addiction, mental health, benefits, and social services, life skills training and accompanied HCV clinic visits for up to 9 months. Comparison subjects (N=15) would receive a brief motivational intervention to enhance their commitment to continued treatment, usual discharge planning and referral from existing case management agencies. Both groups would receive weekly-supervised peglFN, an HCV support group and psychiatric care from the study provider. Primary outcomes will be HCV treatment completion and antiviral treatment discontinuation related to drug use or depressive/anxiety symptoms. Secondary outcomes are illicit drug use, recidivism, level of depressive/anxiety symptoms, and rates of end-of-treatment virologic response. For HCV-infected inmates, prison provides a controlled environment in which to stabilize substance use and mental health, and assess tolerability of and response to peglFN/RBV. This proposed reentry program would facilitate stabilization and treatment of the majority of inmates at risk for discontinuation of peglFN/RBV. Results would allow sample size estimation for a larger CJ-DATS multisite trial. If safety and efficacy can be established, a large number of inmates with HCV, who are not currently candidates for peg-IFN/RBV, could gain access to needed antiviral treatment. Such increased access to therapy would benefit public health and public safety.