Hepatitis Care Coordination in Methadone Treatment

描述(申请人提供)：静脉注射吸毒者病毒性肝炎的发病率极高，包括甲型肝炎(HAV)、乙型肝炎(乙肝)和丙型肝炎(丙型肝炎)，是丙型肝炎在美国传播的主要媒介。虽然丙型肝炎的医疗治疗有了很大改善，但吸毒者在预防和护理服务方面遇到了巨大的障碍。将肝炎预防和保健服务整合到药物滥用治疗计划中，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与标准测试、教育和咨询(TEC)相比，检验肝炎护理协调(HCC)战略的有效性，该战略包括为阿片类药物使用者提供美沙酮维持治疗的测试、教育、咨询和疫苗接种。在肝细胞癌模型中，肝炎筛查和甲型和乙型肝炎疫苗接种将在现场进行，参与者将在现场接受基于理论的肝炎教育、咨询和病例管理，以促进遵守丙型肝炎评估；而在TEC模型中，肝炎筛查是在现场进行的，但疫苗接种和医疗护理将通过非现场转诊提供。主要研究目的是评估肝细胞癌干预对遵守甲型肝炎和乙肝疫苗接种以及初次与丙型肝炎病毒护理提供者预约就诊的影响。次要目标包括检查干预对肝炎、高风险注射药物使用和性行为、酒精使用的影响；对丙型肝炎护理的后期阶段进行跟踪；确定干预结果的心理调节因素；以及估计肝细胞癌干预的增量成本，以便在被证明有效的情况下对干预进行更全面的经济评估。参与者将是460名美沙酮维持性患者(两个地点各230人)。他们将被随机分配到HCC或TEC。我们假设，那些在现场接受肝细胞癌治疗的患者将更有可能：a)坚持接种甲型肝炎和/或乙肝疫苗，如所示；以及b)对于那些检测出丙型肝炎病毒阳性的患者，比起TEC组，坚持转诊到丙型肝炎病毒提供者的初步诊断评估。评估将在基线、3个月、9个月和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，增加研究的普适性。这项研究的结果将对卫生政策规划者具有巨大的价值，并将为改善针对吸毒者的肝炎服务的倡议的实施提供信息。

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.