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

https://doi.org/10.1016/j.jsat.2019.08.007Get rights and content

Highlights

  • Alcohol abstinence is recommended among patients with HIV + liver disease.

  • Patients with moderate alcohol use are rarely interested in treatment trials.

  • Stepped care promotes evidence-based care for patients.

  • Stepped care may also promote alcohol abstinence and improve liver markers.

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.

Abbreviations

HIV
Human Immunodeficiency Virus
PWH
people with HIV
ART
antiretroviral therapy
HCV
hepatitis C virus
NIAAA
National Institute of Alcohol Abuse and Alcoholism
STEP
Starting Treatment for Ethanol in Primary Care
MALD
Moderate Alcohol Use with Liver Disease
VA
Veterans Administration
AUDIT-C
Alcohol Use Disorders Identification Test
TLFB
Timeline Followback
RNA
Ribonucleic Acid
FIB-4
Fibrosis-4
SCID
Structured Clinical Interview for DSM-5 Disorders
HIPAA
Health Insurance Portability and Accountability Act
ISAT
integrated stepped alcohol treatment
TAU
treatment as usual
BNI
Brief Negotiated Interview
MET
Motivational Enhancement Therapy
APM
Addiction Physician Management
FDA
Food and Drug Administration
PEth
phosphatidylethanol
VACS (Index)
Veterans Aging Cohort Study Index
ALT
alanine aminotransferase
AST
aspartate aminotransferase
EMR
electronic medical record
ITT
intention to treat
CI
confidence interval
MSM
marginal structural model
GEE
generalized estimating equations
AOR
adjusted odds ratio
Lsmean
Least Squared Mean
AMD
adjusted mean difference

Keywords

HIV
Hepatitis C
Alcohol-related disorders
Delivery of health care, integrated

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