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Author Notes:

Correspondence: E. Jennifer Edelman, MD, Yale School of Medicine, 367 Cedar Street, ESH A, New Haven, CT 06510, phone 203.737.7115 fax 203.737.3306, ejennifer.edelman@yale.edu

Author contributions: EJE helped design the study and obtain grant funding. She oversaw all aspects of the study, interpreted findings, and led the writing and editing of this manuscript. She had full access to study data and takes full responsibility for the decision to submit this manuscript for publication. SAM, NHB, CJC, LEF, and PGO were responsible for the development and implementation of intervention procedures.

JPT contributed to study design, implementation, data conceptualization, and management. YD and JD conducted all analyses. RB, CLG, VCM, DR, MRB, MSS were responsible for overseeing implementation of study procedures at each of their sites. ACJ and KB contributed to the design of the study and provided oversight to study implementation.

DAF designed the study, obtained the grant funding to conduct this study, oversaw conduct of the study, interpreted the data and contributed to the editing of the manuscript.

All authors contributed to interpretation of the findings and editing of the manuscript. We would like to acknowledge Ms. Laura Simone for her efforts in development and design of data tracking system, Ms. Melissa Skanderson for their efforts in data management and Ms. Elizabeth Porter for her efforts in coordinating and implementing this research.

The authors would like to thank the patients and providers who participated in this research.

Disclosures: The authors have no conflicts of interest.

Subjects:

Research Funding:

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:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Immunology
  • Infectious Diseases
  • Extended release naltrexone
  • Behavioral interventions
  • Clinical trials
  • Care
  • Drinking
  • Dependence
  • Mortality
  • Knowledge

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

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Journal Title:

The Lancet HIV

Volume:

Volume 6, Number 8

Publisher:

, Pages E509-E517

Type of Work:

Article | Post-print: After Peer Review

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.

Copyright information:

© 2019 Elsevier Ltd. All rights reserved.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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