Hepatitis Care Coordination in Methadone Treatment

描述（由申请人提供）：静脉注射吸毒者具有极高的病毒性肝炎发病率，包括甲型肝炎（HAV），乙型肝炎（HBV）和丙型肝炎（HCV），并且是HCV在美国传播的主要载体。尽管HCV的医学治疗有了很大的改善，但吸毒者在预防和护理服务方面遇到了很大的障碍。将肝炎预防和卫生保健服务纳入药物滥用治疗方案可能会增加对日益有效的医疗保健的参与和坚持。这项随机临床试验将检验肝炎护理协调（HCC）策略的有效性，包括美沙酮维持治疗中阿片类药物使用者的检测、教育、咨询和疫苗接种，与标准的检测、教育和咨询（TEC）进行比较。在HCC模型中，肝炎筛查和甲型、乙型肝炎疫苗接种将在现场进行，参与者接受基于现场理论的肝炎教育、咨询和病例管理，以促进HCV评估的依从性；而在TEC，肝炎筛查是在现场进行的，但疫苗接种和医疗保健将由现场外转诊提供。研究的主要目的是评估HCC干预对丙肝和乙肝疫苗接种依从性和初次就诊丙肝医护人员的影响。次要目的包括检查干预措施对肝炎知识、危险注射药物使用和性行为、酒精使用的影响；丙型肝炎后期护理的随访；确定干预结果的心理调节因子；并估计HCC干预的增量成本，以便在证明有效的情况下对干预进行更全面的经济评估。参与者为460例美沙酮维持患者（两个中心各230例）。他们将被随机分配到HCC或TEC。我们假设那些接受原位肝癌的患者将更有可能：a)如所述，坚持接种甲肝和/或乙肝疫苗；b)对于丙型肝炎病毒检测呈阳性的患者，坚持转诊到丙型肝炎病毒提供者进行初步诊断评估，而不是TEC组。评估将在基线、3、9和12个月进行。研究参与者将从两个地点的美沙酮维持治疗中招募，以增加研究的普遍性。这项研究的结果将对卫生政策规划者具有巨大的价值，并将为实施改善针对吸毒者的肝炎服务的举措提供信息。

DESCRIPTION (provided by applicant): Intravenous drug users have extremely high rates of viral hepatitis including hepatitis A (HAV), hepatitis B (HBV), and hepatitis C (HCV) and are the major vector of spread of HCV in the U.S. Although medical treatment of HCV has improved considerably, drug users experience significant barriers to prevention and care services. Integrating hepatitis prevention and health care services into drug abuse treatment programs may increase engagement in and adherence to increasingly effective medical care. This randomized clinical trial will examine the effectiveness of a strategy of Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for opioid users in methadone maintenance treatment compared with standard Testing, Education, and Counseling (TEC). In the HCC model, hepatitis screening and hepatitis A and B vaccination will be done on site and participants receive on site theory-based hepatitis education, counseling, and case management to promote adherence to HCV evaluation; whereas in TEC hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. Primary study aims are to assess the impact of the HCC intervention on adherence to HAV and HBV vaccination and attendance at an initial appointment with a HCV care provider. Secondary aims include examining the effect of the intervention on knowledge of hepatitis, risky injection drug use and sexual behaviors, alcohol use; follow-up with later stages of hepatitis C care; to identify psychological mediators of intervention outcomes; and to estimate the incremental cost of the HCC intervention to facilitate fuller economic evaluations of the intervention if proven effective. Participants will be 460 (230 from each of two sites) methadone maintenance patients. They will be randomly assigned to either HCC or TEC. We hypothesize that those receiving on site HCC will be more likely to: a) adhere to vaccination for HAV and/or HBV, as indicated; and b) for those who test HCV positive, to adhere to referral to an initial diagnostic evaluation with a HCV provider than the TEC group. Assessment will occur at baseline, 3, 9, and 12 months. Study participants will be recruited from methadone maintenance treatment at two sites, increasing the generalizability of the study. Findings from this study would be of immense value to health policy planners and would inform the implementation of initiatives to improve hepatitis services targeted to drug users.