Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial

• Type of Material: Article
• Authors: E. Jennifer Edelman, Yale University; Stephen A. Maisto, Syracuse University; Nathan B. Hansen, Yale University; Christopher J. Cutter, Yale University; James Dziura, Yale University; Yanhong Deng, University of Georgia; Lynn E. Fiellin, Yale University; Patrick G. O'Connor, Yale University; Roger Bedimo, Yale University; Cynthia L. Gibert, Washington DC Veterans Affairs Medical Center; Vincent Marconi, Emory University; David Rimland, Emory University; Maria C. Rodriguez-Barradas, Michael E DeBakey VA Medical Center; Michael S. Simberkoff, Vet Affairs NY Harbor Healthcare System; Janet P. Tate, Yale University; Amy C. Justice, Yale University; Kendall J. Bryant, National Institute on Alcohol Abuse and Alcoholism; David A. Fiellin, Yale University
• Language: English
• Date: 2019-08-01
• Publisher: Elsevier Inc.
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2019 Elsevier Ltd. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/S2352-3018(19)30076-1
• Title of Journal or Parent Work: The Lancet HIV
• Volume: 6
• Issue: 8
• Start Page: E509
• End Page: E517
• Grant/Funding Information: This work was generously support by grants from the National Institute on Alcohol Abuse and Alcoholism (grant #U01AA020795, U01AA020790, U24AA020794).; EJ Edelman was supported as a Yale-Drug Abuse, HIV and Addiction Research Scholar (NIDA grant #K12DA033312) during the conduct of this work.
• Keywords: Care; Dependence; Drinking; Infectious Diseases; Life Sciences & Biomedicine; Extended release naltrexone; Science & Technology; Mortality; Knowledge; Clinical trials; Immunology; Behavioral interventions
• Research Categories: Health Sciences, Public Health; Health Sciences, Immunology; Biology, Biostatistics

Abstract

Background We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among patients living with HIV (PLWH) and alcohol use disorder (AUD). Methods In this multi-site randomized trial conducted in five Veterans Affairs-based HIV clinics , we enrolled PLWH and AUD who were not otherwise receiving formal alcohol treatment. Using a web-based clinical trial management system, participants were randomized in a 1:1 fashion to receive ISAT or treatment as usual (TAU). ISAT involved: Step 1 - Addiction Physician Management (APM), Step 2- APM plus Motivational Enhancement Therapy (MET), and Step 3 – Specialty referral. Participants were stepped up at weeks 4 and 12 if they exceeded a priori drinking criteria. Treatment as usual (TAU) involved referral. The primary outcome was drinks per week over the past 30 days at week 24 by Timeline Followback. The trial is registered at ClinicalTrials.gov, number NCT01410123. Findings Between January 28, 2013 and July 14, 2017, we randomized 128 participants to receive ISAT (n=63) and TAU (n=65). Fifty-two percent (30/57) ISAT participants advanced to Step 2 and 57% (17/30) to Step 3. Fifty one percent (32/63) in ISAT vs. 26% (17/65) in TAU received at least one alcohol medication (p=0·004). Both groups decreased alcohol consumption. At week 24 (primary outcome), we did not detect a difference between the ISAT and TAU groups in drinks per week (Least square mean (Lsmean) [SD]= 10·4 [16·5] vs. 15·6 [17·6]), adjusted mean difference [AMD] [95% CI]= −4·2 [−9·4, 0·9], p=0·11) Interpretation ISAT increases receipt of alcohol treatments without changes in drinking at week 24. Strategies to implement and enhance ISAT are needed.