Contingency management with stepped care for unhealthy alcohol use among individuals with HIV: Protocol for a randomized controlled trial

E Jennifer Edelman, Program in Addiction Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Yale Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA. Electronic address: ejennifer.edelman@yale.edu.
James Dziura, Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA; Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.
Yanhong Deng, Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA.
Dominick DePhilippis, Veterans Affairs Office of Mental Health and Suicide Prevention, US Department of Veterans Affairs, Washington, DC, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Lisa M. Fucito, Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.
Tekeda Ferguson, Department of Epidemiology, Louisiana State University School of Public Health, New Orleans, LA, USA; Comprehensive Alcohol-HIV/AIDS Research Center, Louisiana State University Health Sciences Center, New Orleans, LA, USA.
Roger Bedimo, Veterans Affairs North Texas Health Care System and UT Southwestern Dallas, TX, USA.
Sheldon Brown, James J. Peters Veterans Affairs Medical Center and Manhattan VA Medical Center and Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Vincent C. Marconi, Atlanta VAMC, Emory University School of Medicine, Rollins School of Public Health, Atlanta, GA, USA.
Matthew Bidwell Goetz, VA Greater Los Angeles Healthcare System, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
Maria C. Rodriguez-Barradas, Michael E DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX, USA.
Michael S. Simberkoff, VA NY Harbor Healthcare System and New York University Grossman School of Medicine, New York, NY, USA.
Patricia E. Molina, Comprehensive Alcohol-HIV/AIDS Research Center, Louisiana State University Health Sciences Center, New Orleans, LA, USA; Department of Physiology, School of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA, USA.
Amy C. Weintrob, Washington D.C. Veterans Affairs Medical Center and George Washington University, Washington, DC, USA.
Stephen A. Maisto, Department of Psychology, Syracuse University, Syracuse, NY, USA.
Manuel Paris, Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.
Amy C. Justice, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; VA Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT, USA.
Kendall J. Bryant, National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD, USA.
David A. Fiellin, Program in Addiction Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Yale Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA; Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.

Document Type

Journal Article

Publication Date

5-23-2023

Journal

Contemporary clinical trials

DOI

10.1016/j.cct.2023.107242

Keywords

Alcohol; Algorithms; Contingency management; HIV; Motivational enhancement therapy; Multicenter study; Randomized controlled trial

Abstract

BACKGROUND: Although unhealthy alcohol use is associated with increased morbidity and mortality among people with HIV (PWH), many are ambivalent about engaging in treatment and experience variable responses to treatment. We describe the rationale, aims, and study design for the Financial Incentives, Randomization, with Stepped Treatment (FIRST) Trial, a multi-site randomized controlled efficacy trial. METHODS: PWH in care recruited from clinics across the United States who reported unhealthy alcohol use, had a phosphatidylethanol (PEth) >20 ng/mL, and were not engaged in formal alcohol treatment were randomized to integrated contingency management with stepped care versus treatment as usual. The intervention involved two steps; Step 1: Contingency management (n = 5 sessions) with potential rewards based on 1) short-term abstinence; 2) longer-term abstinence; and 3) completion of healthy activities to promote progress in addressing alcohol consumption or conditions potentially impacted by alcohol; Step 2: Addiction physician management (n = 6 sessions) plus motivational enhancement therapy (n = 4 sessions). Participants' treatment was stepped up at week 12 if they lacked evidence of longer-term abstinence. Primary outcome was abstinence at week 24. Secondary outcomes included alcohol consumption (assessed by TLFB and PEth) and the Veterans Aging Cohort Study (VACS) Index 2.0 scores; exploratory outcomes included progress in addressing medical conditions potentially impacted by alcohol. Protocol adaptations due to the COVID-19 pandemic are described. CONCLUSIONS: The FIRST Trial is anticipated to yield insights on the feasibility and preliminary efficacy of integrated contingency management with stepped care to address unhealthy alcohol use among PWH. CLINICALTRIALS: gov identifier: NCT03089320.

Department

Medicine

Link to Full Text

Share

COinS