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

E. Jennifer Edelman, James Dziura, Yanhong Deng, Dominick DePhilippis, Lisa M. Fucito, Tekeda Ferguson, Roger Bedimo, Sheldon Brown, Vincent C. Marconi, Matthew Bidwell Goetz, Maria C. Rodriguez-Barradas, Michael S. Simberkoff, Patricia E. Molina, Amy C. Weintrob, Stephen A. Maisto, Manuel Paris, Amy C. Justice, Kendall J. Bryant, David A. Fiellin

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article number107242
JournalContemporary Clinical Trials
Volume131
DOIs
StatePublished - Aug 2023
Externally publishedYes

Keywords

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

ASJC Scopus subject areas

  • Pharmacology (medical)

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