The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial

Abstract

Introduction: 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.

Objectives: 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.

Methods: 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.

Discussion: 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.

Keywords: Addiction; Alcohol; Behavioral; Hepatitis C; Integrated care; Therapy.

Conflict of interest statement

Conflicts of interest

Dr. Evon receives research grants from Gilead, Inc.

Dr. Wong is an invited Panel Member of the American Association for the Study of Liver Disease and Infectious Diseases Society of America, Recommendations for Testing, Managing, and Treating Hepatitis C.

Dr. Mannelli has received consultation fees from Guidepoint Global and research funding from Orexo and Alkermes Inc., and served on Scientific Advisory Boards for Alkermes.

Dr. Naggie has received research grants from AbbVie, Bristol Meyers Squibb, Gilead, Janssen, Merck and Tacere.

Dr. Muir has received research grants and served on advisory boards for AbbVie, Bristol Myers Squibb, Gilead, Janssen, and Merck.

Copyright © 2018. Published by Elsevier Inc.

Figures

Figure 1.. Study flow and treatment arms

Notes: SBIRT = screening, brief intervention and referral to treatment AUDIT = Alcohol Use Disorders Identification Test (Alcohol screener) EMR = electronic medical record

Figure 2.. Hypothesized mechanisms of change for the Hep ART treatment, based on the Integrated Model

Notes: The Integrated Theoretical Model of Behavior Change contains other components (e.g., social norms) that are not included below. This figure depicts the pathways hypothesized for Hep ART. The addiction therapists facilitate change in all areas below. Shaded boxes indicate where medical providers also facilitate change.