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Lancet HIV. 2019 Aug;6(8):e509-e517. doi: 10.1016/S2352-3018(19)30076-1. Epub 2019 May 17.

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

Author information

1
Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA. Electronic address: ejennifer.edelman@yale.edu.
2
Syracuse University, Syracuse, NY, USA.
3
Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA; College of Public Health, University of Georgia, Athens, GA, USA.
4
Yale School of Medicine, New Haven, CT, USA.
5
Yale School of Medicine, New Haven, CT, USA; Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA.
6
Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA.
7
Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA.
8
Veterans Affairs North Texas Health Care System and UT Southwestern, Dallas, TX, USA.
9
Washington DC Veterans Affairs Medical Center and George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
10
Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Atlanta, GA, USA.
11
Michael E DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX, USA.
12
Veterans Affairs NY Harbor Healthcare System and New York University School of Medicine, New York, NY, USA.
13
Yale School of Medicine, New Haven, CT, USA; Veterans Affairs Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT, USA.
14
Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA; Veterans Affairs Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT, USA.
15
National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD, USA.

Abstract

BACKGROUND:

We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among patients living with HIV and alcohol use disorder.

METHODS:

In this multisite, randomised controlled trial, conducted in five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment. Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence. Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study. Using a web-based clinical trial management system, we randomly assigned participants (1:1) to receive ISAT or treatment as usual; patients, investigators, and clinicians were unmasked to allocation. ISAT involved three steps: step 1, addiction physician management, comprising eight sessions; step 2, addiction physician management plus motivational enhancement therapy, comprising four sessions; and step 3, specialty referral. Participants were stepped up at weeks 4 and 12 if they exceeded a priori drinking criteria. Treatment as usual involved referral to substance use treatment services. The primary outcome was number of drinks per week over the past 30 days at week 24 by use of the timeline followback method, assessed in the intention-to-treat population. Adverse events were tracked throughout the study period in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, number NCT01410123.

FINDINGS:

Between Jan 28, 2013, and July 14, 2017, 128 of 351 patients assessed for eligibility were eligible and randomly assigned to receive ISAT (n=63) or treatment as usual (n=65). Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black. 25 (20%) were lost to follow-up. In the ISAT group, of 57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3. 32 (51%) of 63 participants assigned to ISAT versus 17 (26%) of 65 assigned to treatment as usual received at least one alcohol treatment medication (p=0·004). Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11). One adverse event occurred that was possibly related to treatment occurred in the ISAT group (headache).

INTERPRETATION:

ISAT increases the receipt of alcohol treatment medications and counselling without changes in drinking at week 24. Strategies to implement and enhance ISAT are needed. Future efforts should focus on promoting ISAT with attention to enhancing patient engagement and retention in alcohol-related care.

FUNDING:

US National Institute on Alcohol Abuse and Alcoholism.

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