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

E. Jennifer Edelman, Stephen A Maisto, Nathan B. Hansen, Christopher J. Cutter, James Dziura, Yanhong Deng, Lynn E. Fiellin, Patrick G. O'Connor, Roger Bedimo, Cynthia L. Gibert, Vincent C. Marconi, David Rimland, Maria C. Rodriguez-Barradas, Michael S. Simberkoff, Janet P. Tate, Amy C. Justice, Kendall J. Bryant, David A. Fiellin

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)97-106
Number of pages10
JournalJournal of Substance Abuse Treatment
Volume106
DOIs
StatePublished - Nov 1 2019

Fingerprint

Liver Diseases
Alcohols
HIV
Therapeutics
Odds Ratio
Alcohol Abstinence
Liver
Hepatitis C
Viral Load
Self Report
Biomarkers
Interviews
Physicians

Keywords

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

ASJC Scopus subject areas

  • Phychiatric Mental Health
  • Medicine (miscellaneous)
  • Clinical Psychology
  • Psychiatry and Mental health

Cite this

Integrated stepped alcohol treatment for patients with HIV and liver disease : A randomized trial. / Edelman, E. Jennifer; Maisto, Stephen A; Hansen, Nathan B.; Cutter, Christopher J.; Dziura, James; Deng, Yanhong; Fiellin, Lynn E.; O'Connor, Patrick G.; Bedimo, Roger; Gibert, Cynthia L.; Marconi, Vincent C.; Rimland, David; Rodriguez-Barradas, Maria C.; Simberkoff, Michael S.; Tate, Janet P.; Justice, Amy C.; Bryant, Kendall J.; Fiellin, David A.

In: Journal of Substance Abuse Treatment, Vol. 106, 01.11.2019, p. 97-106.

Research output: Contribution to journalArticle

Edelman, EJ, Maisto, SA, Hansen, NB, Cutter, CJ, Dziura, J, Deng, Y, Fiellin, LE, O'Connor, PG, Bedimo, R, Gibert, CL, Marconi, VC, Rimland, D, Rodriguez-Barradas, MC, Simberkoff, MS, Tate, JP, Justice, AC, Bryant, KJ & Fiellin, DA 2019, 'Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial', Journal of Substance Abuse Treatment, vol. 106, pp. 97-106. https://doi.org/10.1016/j.jsat.2019.08.007
Edelman, E. Jennifer ; Maisto, Stephen A ; Hansen, Nathan B. ; Cutter, Christopher J. ; Dziura, James ; Deng, Yanhong ; Fiellin, Lynn E. ; O'Connor, Patrick G. ; Bedimo, Roger ; Gibert, Cynthia L. ; Marconi, Vincent C. ; Rimland, David ; Rodriguez-Barradas, Maria C. ; Simberkoff, Michael S. ; Tate, Janet P. ; Justice, Amy C. ; Bryant, Kendall J. ; Fiellin, David A. / Integrated stepped alcohol treatment for patients with HIV and liver disease : A randomized trial. In: Journal of Substance Abuse Treatment. 2019 ; Vol. 106. pp. 97-106.
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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.",
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author = "Edelman, {E. Jennifer} and Maisto, {Stephen A} and Hansen, {Nathan B.} and Cutter, {Christopher J.} and James Dziura and Yanhong Deng and Fiellin, {Lynn E.} and O'Connor, {Patrick G.} and Roger Bedimo and Gibert, {Cynthia L.} and Marconi, {Vincent C.} and David Rimland and Rodriguez-Barradas, {Maria C.} and Simberkoff, {Michael S.} and Tate, {Janet P.} and Justice, {Amy C.} and Bryant, {Kendall J.} and Fiellin, {David A.}",
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TY - JOUR

T1 - Integrated stepped alcohol treatment for patients with HIV and liver disease

T2 - A randomized trial

AU - Edelman, E. Jennifer

AU - Maisto, Stephen A

AU - Hansen, Nathan B.

AU - Cutter, Christopher J.

AU - Dziura, James

AU - Deng, Yanhong

AU - Fiellin, Lynn E.

AU - O'Connor, Patrick G.

AU - Bedimo, Roger

AU - Gibert, Cynthia L.

AU - Marconi, Vincent C.

AU - Rimland, David

AU - Rodriguez-Barradas, Maria C.

AU - Simberkoff, Michael S.

AU - Tate, Janet P.

AU - Justice, Amy C.

AU - Bryant, Kendall J.

AU - Fiellin, David A.

PY - 2019/11/1

Y1 - 2019/11/1

N2 - 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.

AB - 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.

KW - Alcohol-related disorders

KW - Delivery of health care, integrated

KW - Hepatitis C

KW - HIV

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