E Jennifer Edelman1, Stephen A Maisto2, Nathan B Hansen3, Christopher J Cutter4, James Dziura5, Yanhong Deng5, Lynn E Fiellin6, Patrick G O'Connor4, Roger Bedimo7, Cynthia L Gibert8, Vincent C Marconi9, David Rimland9, Maria C Rodriguez-Barradas10, Michael S Simberkoff11, Janet P Tate4, Amy C Justice12, Kendall J Bryant13, David A Fiellin6. 1. Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America. Electronic address: ejennifer.edelman@yale.edu. 2. Syracuse University, Syracuse, NY 13244, United States of America. 3. Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America; College of Public Health, University of Georgia, Athens, GA 30602, United States of America. 4. Yale School of Medicine, New Haven, CT 06510, United States of America. 5. Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America. 6. Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America. 7. Veterans Affairs North Texas Health Care System, UT Southwestern, Dallas, TX 75216, United States of America. 8. D.C. VAMC, George Washington University School of Medicine and Health Sciences, Washington, DC 20422, United States of America. 9. Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America. 10. Michael E. DeBakey VAMC, Baylor College of Medicine, Houston, TX 77030, United States of America. 11. VA NY Harbor Healthcare System, New York University School of Medicine, New York, NY 10010, United States of America. 12. Yale School of Medicine, New Haven, CT 06510, United States of America; VA Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT 06516, United States of America. 13. National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD 20892-7003, United States of America.
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.
RCT Entities:
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 ISATparticipants, 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.
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