title: The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients.
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 StartingTreatment forEthanol inPrimary 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 24weeks, 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.
authors.affiliation: Yale University School of Medicine, New Haven, CT 06510, United States; Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, CT 06510, United States. Electronic address: ejennifer.edelman@yale.edu.
authors.forename: E Jennifer
authors.initials: EJ
authors.lastname: Edelman
authors.affiliation: Syracuse University, Syracuse, NY 13244, United States.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Maisto
authors.affiliation: Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, CT 06510, United States; College of Public Health, University of Georgia, Athens, GA 30602, United States.
authors.forename: Nathan B
authors.initials: NB
authors.lastname: Hansen
authors.affiliation: Yale University School of Medicine, New Haven, CT 06510, United States.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Cutter
authors.affiliation: Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT 06511, United States.
authors.forename: James
authors.initials: J
authors.lastname: Dziura
authors.affiliation: Yale University School of Medicine, New Haven, CT 06510, United States; Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, CT 06510, United States.
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Fiellin
authors.affiliation: Yale University School of Medicine, New Haven, CT 06510, United States.
authors.forename: Patrick G
authors.initials: PG
authors.lastname: O'Connor
authors.affiliation: Veterans Affairs North Texas Health Care System and UT Southwestern, Dallas, TX 75216, United States.
authors.forename: Roger
authors.initials: R
authors.lastname: Bedimo
authors.affiliation: D.C. Veterans Affairs Medical Center and George Washington University School of Medicine and Health Sciences, Washington, D.C. 20422, United States.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Gibert
authors.affiliation: Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Decatur, GA 30033, United States.
authors.forename: Vincent C
authors.initials: VC
authors.lastname: Marconi
authors.affiliation: Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Decatur, GA 30033, United States.
authors.forename: David
authors.initials: D
authors.lastname: Rimland
authors.affiliation: Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas Houston, TX 77030, United States.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Rodriguez-Barradas
authors.affiliation: VA NY Harbor Healthcare System and New York University School of Medicine, New York, NY 10010, United States.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Simberkoff
authors.affiliation: Yale University School of Medicine, New Haven, CT 06510, United States; VA Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT 06516, United States.
authors.forename: Amy C
authors.initials: AC
authors.lastname: Justice
authors.affiliation: National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD 20892-7003, United States.
authors.forename: Kendall J
authors.initials: KJ
authors.lastname: Bryant
authors.affiliation: Yale University School of Medicine, New Haven, CT 06510, United States; Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, CT 06510, United States.
authors.forename: David A
authors.initials: DA
authors.lastname: Fiellin
mesh_terms: D000428:Alcohol Drinking / Q000628:therapy*; D019973:Alcohol-Related Disorders / Q000150:complications / Q000628:therapy; D000437:Alcoholism / Q000150:complications / Q000628:therapy*; D000465:Algorithms; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D062405:Motivational Interviewing / Q000379:methods*; D011320:Primary Health Care / Q000379:methods*; D013689:Telephone; D016896:Treatment Outcome
keywords: Alcohol; Algorithms; HIV; Multicenter study; Randomized controlled trial