Duke Global Health Institute, Duke University, Box 90392, Durham, NC 27708-0392, USA; Duke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA.
Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, CB# 7584, Chapel Hill, NC 27599-7584, United States.
Contemp Clin Trials. 2018 Sep;72:73-85. doi: 10.1016/j.cct.2018.07.003. Epub 2018 Jul 10.
Among patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders.
This pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV.
Patients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores were randomly assigned to enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention. All patients received enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling. The Hep ART intervention combined enhanced TAU with up to six months of integrated co-located individual and/or group therapy that provided motivational, cognitive, and behavioral strategies to reduce alcohol consumption. The Timeline Followback (TLFB) Method was used to evaluate alcohol use at baseline, 3, 6, and 12 months. Primary outcomes are alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed.
This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.
在丙型肝炎病毒（HCV）感染者中，酒精会协同增加肝硬化、肝细胞癌和死亡的风险。已推荐对 HCV-酒精治疗的综合模式进行随机对照试验，但仅在有严重酒精使用障碍的患者中进行。
本实用随机对照试验旨在比较综合酒精治疗与增强治疗（TAU）对既往感染 HCV 的患者的酒精消耗和经济结果的临床效果和成本效益。
从三个肝脏中心招募的符合条件的慢性 HCV 且有酒精筛查评分的患者被随机分配到增强 TAU 或丙型肝炎酒精减少治疗（HepART）干预组。所有患者均接受增强 TAU，包括患者自行进行的酒精筛查以及接受经过筛查、简短干预和转介治疗（SBIRT）培训的医疗提供者的护理，包括简短动机访谈咨询。HepART 干预结合了增强 TAU 和最多六个月的综合同地个体和/或小组治疗，提供减少酒精摄入的动机、认知和行为策略。时间线回溯（TLFB）方法用于评估基线、3、6 和 12 个月时的酒精使用情况。主要结局是酒精戒断和更少的重度饮酒天数，对于成本效益分析，包括消耗的酒精克数。
本研究将确定 HepART，一种为期六个月的综合酒精治疗，与增强 TAU 相比，在有 HCV 和酒精使用共病史的患者中是否具有临床效果和成本效益。
