Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial

Abstract

Background: There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease.

Methods: In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat.

Results: Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [-3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = -0.2 [-0.9, 0.5]), ALT (AMD [95% CI] = -7 [-20, 7]) and AST (AMD [95% CI] = -4 [-15, 7]) at week 24 compared to TAU.

Conclusion: ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.

Keywords: Alcohol-related disorders; Delivery of health care, integrated; HIV; Hepatitis C.

Conflict of interest statement

Conflicts of Interest

The authors have no conflicts of interest to disclose.

Declaration of interests: none

Copyright © 2019 Elsevier Inc. All rights reserved.

Figures

Figure 1.. Participant Flow

Notes: a. Received allocated intervention: defined as attending at least one intervention visit over the 24 week period. b. Lost to follow-up: defined as not having any assessment at week 24 and afterwards through week 52.

Figure 2.. Visit attendance among those randomized to integrated stepped alcohol treatment*

Note: *Denominator is among those eligible for the intervention: STEP 1, n=49; Step 2, n=27; Step 3, n=19. BNI=brief negotiated interview; MET=motivational enhancement therapy; APM=addiction physician management.

Figure 3.. Drinking outcomesa

a. Random intercept and, for the continuous outcome, time effects were included for each participant with an unstructured covariance pattern for serial correlation. Abstinence was defined as no reported alcohol use on any day in the past 30 days.