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

描述（由申请人提供）：慢性丙型肝炎病毒（HCV）感染、药物依赖和精神疾病的共同发生是监禁人口面临的最大公共卫生挑战之一。HCV本身可导致精神损害，药物使用和精神症状是拒绝或停止聚乙二醇干扰素（pegIFN）联合利巴韦林（RBV）治疗的主要原因。同事们和我们已经证明，在监狱里治疗丙型肝炎病毒是安全和有效的囚犯长期服刑，但大多数囚犯被监禁不到一年。因此，需要建立一个行为健康和HCV治疗的综合模型，以连接从监狱到社区的过渡，以促进大部分HCV感染的囚犯的稳定和治疗，这些囚犯具有高风险，易受聚乙二醇干扰素/RBV的精神副作用影响。因此，这项研究将适应和试点测试之间的连续性照顾模式的监狱和社区设置感染HCV基因型1或4谁有吸毒史的囚犯;终身情绪或焦虑障碍的DSM-IV标准或目前的抑郁/焦虑症状，并有6至15个月的剩余刑期。在为期六个月的“磨合”阶段，56名囚犯将接受评估，然后在监狱中开始药物滥用、心理健康和HCV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）将在社区治疗阶段以2：1的比例随机分配。干预受试者（N=30）将接受详细的过渡性出院计划，强化治疗病例管理，并与成瘾，心理健康，福利和社会服务，生活技能培训以及长达9个月的陪同HCV诊所访视联系起来。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的承诺，常规出院计划和现有病例管理机构的转介。两组都将接受每周监督的peglFN，HCV支持小组和研究提供者的精神护理。主要结局将是HCV治疗完成和与药物使用或抑郁/焦虑症状相关的抗病毒治疗中止。次要结果是非法药物使用，累犯，抑郁/焦虑症状的水平，以及治疗结束时病毒学应答率。对于HCV感染的囚犯，监狱提供了一个受控的环境，以稳定药物使用和心理健康，并评估pegIFN/RBV的耐受性和反应。这一拟议的重返社会方案将有助于稳定和治疗大多数有可能中止peglFN/RBV的囚犯。结果将允许更大的CJ-DATS多中心试验的样本量估计。如果安全性和有效性可以建立，大量的丙型肝炎病毒的囚犯，谁是目前没有候选人聚乙二醇干扰素/RBV，可以获得所需的抗病毒治疗。增加获得治疗的机会将有利于公共卫生和公共安全。

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.