Evidence map›Paper›PMID 30006024›Full record

ArticleContemporary clinical trials2018

The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial.

Rae Jean Proeschold-Bell, Donna M Evon, Christina Makarushka, John B Wong, Santanu K Datta, Jia Yao, Ashwin A Patkar, Paolo Mannelli, Terra Hodge, Susanna Naggie and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02176980 (Hepatitis C Alcohol Reduction Treatment - Randomized Controlled Trial), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 25% 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.

NCT02176980 nacompletednot on this map

Hepatitis C Alcohol Reduction Treatment - Randomized Controlled Trial (Hep ART-RCT)

TypeinterventionalSponsorDuke UniversityRan2014 to 2018Enrolled182ConditionsHepatitis C, Chronic, AUDArmsBrief alcohol counseling, Group and Individual Therapy Sessions
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 3 institutions in 1 country.

Rae Jean Proeschold-BellDuke Global Health Institute, Duke University, Box 90392, Durham, NC 27708-0392, USA; Duke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA. Electronic address: Rae.jean@duke.edu.
Donna M EvonDivision of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, CB# 7584, Chapel Hill, NC 27599-7584, United States. Electronic address: Donna_evon@med.unc.edu.
Christina MakarushkaDuke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA. Electronic address: Christina.makarushka@duke.edu.
John B WongDivision of Clinical Decision Making, Tufts Medical Center, 800 Washington St #302, Boston, MA 02111, USA. Electronic address: JWong@TuftsMedicalCenter.org.
Santanu K DattaDepartment of Medicine, Duke University, 411 West Chapel Hill St, Suite 500, Durham, NC 27701, USA. Electronic address: santanu.datta@duke.edu.
Jia YaoDuke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA. Electronic address: jia.yao@duke.edu.
Ashwin A PatkarDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2213 Elba Street, Suite 165, Durham, NC 27705, United States; Department of Community and Family Medicine, Duke University Medical Center, 2213 Elba Street, Suite 165, Durham, NC 27705, United States. Electronic address: Ashwin.patkar@duke.edu.
Paolo MannelliDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2213 Elba Street, Suite 165, Durham, NC 27705, United States. Electronic address: paolo.mannelli@duke.edu.
Terra HodgeDivision of Gastroenterology, Department of Medicine, Duke University School of Medicine, DUMC 3913, Durham, NC 27710, USA. Electronic address: Terra.hodge@duke.edu.
Susanna NaggieDuke University School of Medicine, Infectious Diseases, Durham, NC 27710, USA; Duke Clinical Research Institute, 2400 Pratt Street, Rm. 0311, Terrace Level, Durham, NC 27705, USA; Durham VA Medical Center, Durham, NC 27705, USA. Electronic address: susanna.naggie@duke.edu.
Julius M WilderDivision of Gastroenterology, Department of Medicine, Duke University School of Medicine, DUMC 3913, Durham, NC 27710, USA; Duke Clinical Research Institute, 2400 Pratt Street, Rm. 0311, Terrace Level, Durham, NC 27705, USA. Electronic address: julius.wilder@duke.edu.
Michael W FriedDivision of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, CB# 7584, Chapel Hill, NC 27599-7584, United States. Electronic address: mfried@med.unc.edu.
Donna NiedzwieckiDepartment of Biostatistics and Bioinformatics, Duke University, Box 2721, Durham, NC 27710, United States. Electronic address: donna.niedzwiecki@duke.edu.
Andrew J MuirDivision of Gastroenterology, Department of Medicine, Duke University School of Medicine, DUMC 3913, Durham, NC 27710, USA; Duke Clinical Research Institute, 2400 Pratt Street, Rm. 0311, Terrace Level, Durham, NC 27705, USA. Electronic address: Andrew.muir@duke.edu.
Duke University · USUniversity of North Carolina at Chapel Hill · USTufts Medical Center · US

Funding

Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI Nwora Lance Okeke · 2005 to 2026
$50.5M
RCT of an Integrated Treatment of Persons with Co-Occurring HCV and Alcohol AbuseR01AA021133 · NIAAA · DUKE UNIVERSITY · PI MUIR, ANDREW J., PROESCHOLD-BELL, RAE JEAN ELIZABETH · 2013 to 2017
$3.5M
NIAAA NIH HHS R01 AA021133NIAID NIH HHS P30 AI064518
6 · The paper itself

Abstract

introductionAmong patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders.

objectivesThis pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV.

methodsPatients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores were randomly assigned to enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention. All patients received enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling. The Hep ART intervention combined enhanced TAU with up to six months of integrated co-located individual and/or group therapy that provided motivational, cognitive, and behavioral strategies to reduce alcohol consumption. The Timeline Followback (TLFB) Method was used to evaluate alcohol use at baseline, 3, 6, and 12 months. Primary outcomes are alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed. DISCUSSION: This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.

Indexed as

AlcoholismCognitive Behavioral TherapyHepatitis C, ChronicMotivational InterviewingAlcohol AbstinenceAlcohol DrinkingCarcinoma, HepatocellularComorbidityCost-Benefit AnalysisHumansLiver CirrhosisLiver NeoplasmsMulticenter Studies as TopicPragmatic Clinical Trials as TopicPsychotherapy, GroupQuality-Adjusted Life YearsAddictionAlcoholBehavioralHepatitis CIntegrated careTherapy

Identifiers

PMID30006024
PMCPMC6711183
OpenAlexW2874020390

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.