Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients

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

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Unhealthy alcohol use is common among HIV-positive patients, yet effective evidence-based treatments are rarely provided in clinical settings providing HIV care. Further, given patient variability in response to initial treatments, stepped care approaches may be beneficial. We describe the rationale, aims and study design for the current Starting Treatment for Ethanol in Primary care Trials (STEP Trials); three parallel randomized controlled effectiveness trials being conducted in five Infectious Disease Clinics. Participants meeting criteria for: 1) at-risk drinking, 2) moderate alcohol use with liver disease (MALD), or 3) alcohol use disorder (AUD) are randomized to integrated stepped care versus treatment as usual. For those with at-risk drinking or MALD, integrated stepped care starts with a one session brief intervention and follow-up 2-week telephone booster. Based on pre-specified nonresponse criteria, participants may be “stepped up” at week 4 to receive four sessions of motivational enhancement therapy (MET) and “stepped up” again at week 12 for addiction physician management (APM) and consideration of alcohol pharmacotherapy. For those with AUD, integrated stepped care begins with APM. Non-responders may be “stepped up” at week 4 to receive MET and again at week 12 for a higher level of care (e.g. intensive outpatient program). The primary outcome is alcohol consumption assessed at 24 weeks, and secondary outcome is the VACS Index, a validated measure of HIV morbidity and mortality risk. Results from the STEP Trials should inform future research and the implementation of interventions to address unhealthy alcohol use among HIV-positive individuals.

Original languageEnglish (US)
Pages (from-to)80-90
Number of pages11
JournalContemporary Clinical Trials
Volume52
DOIs
StatePublished - Jan 1 2017

Fingerprint

Alcohols
HIV
Therapeutics
Drinking
Liver Diseases
Primary Health Care
Ethanol
Physicians
Critical Care
Telephone
Alcohol Drinking
Communicable Diseases
Outpatients
Randomized Controlled Trials
Morbidity
Drug Therapy
Mortality

Keywords

  • Alcohol
  • Algorithms
  • HIV
  • Multicenter study
  • Randomized controlled trial

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

Edelman, E. J., Maisto, S. A., Hansen, N. B., Cutter, C. J., Dziura, J., Fiellin, L. E., ... Fiellin, D. A. (2017). Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients. Contemporary Clinical Trials, 52, 80-90. https://doi.org/10.1016/j.cct.2016.11.008

Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients. / Edelman, E. Jennifer; Maisto, Stephen A.; Hansen, Nathan B.; Cutter, Christopher J.; Dziura, James; Fiellin, Lynn E.; O'Connor, Patrick G.; Bedimo, Roger; Gibert, Cynthia; Marconi, Vincent C.; Rimland, David; Rodriguez-Barradas, Maria C.; Simberkoff, Michael S.; Justice, Amy C.; Bryant, Kendall J.; Fiellin, David A.

In: Contemporary Clinical Trials, Vol. 52, 01.01.2017, p. 80-90.

Research output: Contribution to journalArticle

Edelman, EJ, Maisto, SA, Hansen, NB, Cutter, CJ, Dziura, J, Fiellin, LE, O'Connor, PG, Bedimo, R, Gibert, C, Marconi, VC, Rimland, D, Rodriguez-Barradas, MC, Simberkoff, MS, Justice, AC, Bryant, KJ & Fiellin, DA 2017, 'Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients', Contemporary Clinical Trials, vol. 52, pp. 80-90. https://doi.org/10.1016/j.cct.2016.11.008
Edelman, E. Jennifer ; Maisto, Stephen A. ; Hansen, Nathan B. ; Cutter, Christopher J. ; Dziura, James ; Fiellin, Lynn E. ; O'Connor, Patrick G. ; Bedimo, Roger ; Gibert, Cynthia ; Marconi, Vincent C. ; Rimland, David ; Rodriguez-Barradas, Maria C. ; Simberkoff, Michael S. ; Justice, Amy C. ; Bryant, Kendall J. ; Fiellin, David A. / Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients. In: Contemporary Clinical Trials. 2017 ; Vol. 52. pp. 80-90.
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