RCT of an Integrated Treatment of Persons with Co-Occuring HCV and Alcohol Abuse (HepART)

We propose conducting a randomized controlled trial that compares our six-month integrated treatment versus brief alcohol counseling in 230 HCV-infected patients with qualifying AUDIT alcohol scores at baseline. Participants in both arms will be treated at the Duke and UNC Liver Clinics and the Durham Veterans Affairs Medical Center. Outcome variables will be assessed at baseline, 3, 6, and 12 months. The aims are to 1) evaluate alcohol abstinence; 2) determine differences in secondary outcomes between study arms; and 3) conduct a cost effectiveness analysis. We hypothesize that the intervention will significantly improve alcohol abstinence rates and significantly decrease relapse rates compared to the comparison. We further hypothesize that intervention participants will report fewer drinks per week and less illicit drug use than comparison participants, have fewer positive drug screens than comparison participants, and meet the $50,000 per quality-adjusted life year gained standard established in the health economics literature.

Multiple PI mechanism, PIs: Rae Jean Proeschold-Bell and Andrew Muir (in Gastroenterology)

CHPIR staff: Christina Makarushka, Carla Mena, Heather Parnell, Donna Safley, Jia Yao

Funder: National Institutes of Health/National Institute of Alcohol Abuse and Alcoholism

Project dates: 9/5/13 – 5/31/18 with a no-cost extension planned through 1/31/2019