The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients

• 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; Lynn E. Fiellin, Yale University; Patrick G. O'Connor, Yale University; Roger Bedimo, Veterans Affairs North Texas Health Care System and UT Southwestern; Cynthia Gibert, George Washington University; Vincent Marconi, Emory University; David Rimland, Emory University; Maria C. Rodriguez-Barradas, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine; Michael S. Simberkoff, VA NY Harbor Healthcare System and New York University School of Medicine; Amy C. Justice, Yale University; Kendall J. Bryant, National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program; David A. Fiellin, Yale University
• Language: English
• Date: 2017-01-01
• Publisher: Elsevier
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2016 Elsevier Inc. All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1016/j.cct.2016.11.008
• Title of Journal or Parent Work: Contemporary Clinical Trials
• ISSN: 1551-7144
• Volume: 52
• Start Page: 80
• End Page: 90
• Grant/Funding Information: EJ Edelman was supported as a Yale-Drug Abuse, HIV, and Addiction Research Scholar (National Institute on Drug Abuse K12DA033312-02) during this time.; This work was generously supported by funding from the National Institute on Alcohol Abuse and Alcoholism (1U01AA020795 and 2U01AA020790).
• Keywords: TREATMENT SERVICES; Medicine, Research & Experimental; Life Sciences & Biomedicine; Randomized controlled trial; Research & Experimental Medicine; HIV; PROBABILITY SAMPLE; Pharmacology & Pharmacy; HEPATITIS-C; Science & Technology; EMERGENCY-DEPARTMENT; NICOTINE DEPENDENCE; Multicenter study; RANDOMIZED CONTROLLED-TRIAL; BRIEF INTERVENTION; Alcohol; Algorithms; HARMFUL DRINKERS; MEDICATION ADHERENCE; ACTIVE ANTIRETROVIRAL THERAPY
• Research Categories: Health Sciences, Public Health; Health Sciences, Rehabilitation and Therapy

Abstract

Unhealthy alcohol use is common among HIV-positive patients, yet effective evidence-based treatments are rarely provided in clinical settings providing HIV care. Further, given patient variability in response to initial treatments, stepped care approaches may be beneficial. We describe the rationale, aims and study design for the current Starting Treatment for Ethanol in Primary care Trials (STEP Trials); three parallel randomized controlled effectiveness trials being conducted in five Infectious Disease Clinics. Participants meeting criteria for: 1) at-risk drinking, 2) moderate alcohol use with liver disease (MALD), or 3) alcohol use disorder (AUD) are randomized to integrated stepped care versus treatment as usual. For those with at-risk drinking or MALD, integrated stepped care starts with a one session brief intervention and follow-up 2-week telephone booster. Based on pre-specified nonresponse criteria, participants may be “stepped up” at week 4 to receive four sessions of motivational enhancement therapy (MET) and “stepped up” again at week 12 for addiction physician management (APM) and consideration of alcohol pharmacotherapy. For those with AUD, integrated stepped care begins with APM. Non-responders may be “stepped up” at week 4 to receive MET and again at week 12 for a higher level of care (e.g. intensive outpatient program). The primary outcome is alcohol consumption assessed at 24 weeks, and secondary outcome is the VACS Index, a validated measure of HIV morbidity and mortality risk. Results from the STEP Trials should inform future research and the implementation of interventions to address unhealthy alcohol use among HIV-positive individuals.