Evidence map›Paper›PMID 27876616›Full record

ArticleContemporary clinical trials2017

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.

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 and 6 more

Erratum issued Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Contemporary clinical trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01410123 (Integrated Stepped Care for Unhealthy Alcohol Use in HIV), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01410123 nacompletednot on this map

Integrated Stepped Care for Unhealthy Alcohol Use in HIV

TypeinterventionalSponsorYale UniversityRan2013 to 2018Enrolled319ConditionsLiver Diseases, Alcoholic, Alcoholism, HIV, Hepatitis CArmsIntegrated Stepped Care (ISC), Treatment as Usual
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 29 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

E Jennifer EdelmanYale 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.
Stephen A MaistoSyracuse University, Syracuse, NY 13244, United States.
Nathan B HansenCenter 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.
Christopher J CutterYale University School of Medicine, New Haven, CT 06510, United States.
James DziuraYale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT 06511, United States.
Lynn E FiellinYale 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.
Patrick G O'ConnorYale University School of Medicine, New Haven, CT 06510, United States.
Roger BedimoVeterans Affairs North Texas Health Care System and UT Southwestern, Dallas, TX 75216, United States.
Cynthia GibertD.C. Veterans Affairs Medical Center and George Washington University School of Medicine and Health Sciences, Washington, D.C. 20422, United States.
Vincent C MarconiAtlanta Veterans Affairs Medical Center and Emory University School of Medicine, Decatur, GA 30033, United States.
David RimlandAtlanta Veterans Affairs Medical Center and Emory University School of Medicine, Decatur, GA 30033, United States.
Maria C Rodriguez-BarradasMichael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas Houston, TX 77030, United States.
Michael S SimberkoffVA NY Harbor Healthcare System and New York University School of Medicine, New York, NY 10010, United States.
Amy C JusticeYale University School of Medicine, New Haven, CT 06510, United States; VA Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT 06516, United States.
Kendall J BryantNational Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD 20892-7003, United States.
David A FiellinYale 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.
Yale University · USEmory University · USGeorge Washington University · USMichael E. DeBakey VA Medical Center · USNational Institute on Alcohol Abuse and Alcoholism · USNew York University · USSyracuse University · USUniversity of Georgia · USVA North Texas Health Care System · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Alcohol and Multisubstance Use in the Veterans Aging Cohort StudyU01AA020790 · NIAAA · YALE UNIVERSITY · PI JUSTICE, AMY CAROLINE · 2011 to 2020
$7.7M
Yale Drug use, Addiction and HIV Research Scholars (DAHRS)K12DA033312 · NIDA · YALE UNIVERSITY · PI Gail D'Onofrio, Patrick O'Connor · 2013 to 2026
$7.2M
Integrated Stepped Care for Unhealthy Alcohol Use in HIVU01AA020795 · NIAAA · YALE UNIVERSITY · PI FIELLIN, DAVID · 2011 to 2020
$5.2M
CHAART Consortia Scientific MeetingsU13AA022864 · NIAAA · YALE UNIVERSITY · PI JUSTICE, AMY CAROLINE · 2014 to 2016
$222k
NCATS NIH HHS UL1 TR001863NIAAA NIH HHS U01 AA020790NIAAA NIH HHS U01 AA020795NIAAA NIH HHS U13 AA022864NIDA NIH HHS K12 DA033312
6 · The paper itself

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.

Indexed as

Alcohol DrinkingAlcoholismAlcohol-Related DisordersAlgorithmsHIV InfectionsHumansMotivational InterviewingPrimary Health CareTelephoneTreatment OutcomeAlcoholAlgorithmsHIVMulticenter studyRandomized controlled trial

Identifiers

PMID27876616
PMCPMC5253227
OpenAlexW2555560091

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.