Evidence map›Paper›PMID 31669450›Full record

ArticleContemporary clinical trials2019

Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study.

Alain H Litwin, John Jost, Katherine Wagner, Moonseong Heo, Alison Karasz, Judith Feinberg, Arthur Y Kim, Paula J Lum, Shruti H Mehta, Lynn E Taylor and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06295250 (ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
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.

NCT06295250 narecruitingnot on this mapstarted 2024, after this paper: background citation

ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women

TypeinterventionalSponsorUniversity of Massachusetts, WorcesterRan2024 to 2026Enrolled600ConditionsDepression, Economic Vulnerability, Anxiety, Culture Specific SymptomsArmsManualized Group Based Psychotherapy, Poverty Alleviation
3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Viral hepatitis: Past, present, and future.World journal of gastroenterology · 2022
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
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.

Alain H LitwinClemson University School of Health Research, Clemson, SC, USA; Department of Medicine, University of South Carolina School of Medicine, Greenville, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA. Electronic address: Alain.Litwin@prismahealth.org.
John JostDepartment of Medicine, Montefiore Medical Center, Bronx, NY, USA.
Katherine WagnerDepartment of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
Moonseong HeoDepartment of Public Health Sciences, College of Behavioral, Social, and Health Sciences, Clemson University Clemson, SC, USA.
Alison KaraszEinstein College of Medicine, Bronx, NY, USA.
Judith FeinbergDepartment of Behavioral Medicine & Psychiatry and Department of Medicine, West Virginia University, Morgantown, WV, USA.
Arthur Y KimDepartment of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Paula J LumDepartment of Medicine, University of California San Francisco, San Francisco, CA, USA.
Shruti H MehtaDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Lynn E TaylorCollege of Pharmacy, University of Rhode Island, CODAC Behavioral Health, Providence, RI, USA.
Judith I TsuiDepartment of Medicine, University of Washington, Seattle, WA, USA.
Irene Pericot-ValverdeClemson University School of Health Research, Clemson, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA.
Kimberly PageDepartment of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
HERO Study Group

Funding

West Virginia IDEA-CTRU54GM104942 · NIGMS · WEST VIRGINIA UNIVERSITY · PI JUDITH FEINBERG · 2012 to 2026
$81.0M
Development and Evaluation of Video-Based Directly Observed Therapy for Office-Based Treatment of Opioid Use Disorders with BuprenorphineR44DA044053 · NIDA · EMOCHA MOBILE HEALTH, INC. · PI SEIGUER, SEBASTIAN, TSUI, JUDITH · 2017 to 2019
$2.8M
NIDA NIH HHS R44 DA044053NIGMS NIH HHS U54 GM104942
6 · The paper itself

Abstract

backgroundAlthough people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection.

methodsThe HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT.

conclusionsThis study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.

Indexed as

Antiviral AgentsHepatitis CPatient-Centered CareSubstance Abuse, IntravenousDirectly Observed TherapyHealth Services AccessibilityHumansMedication AdherenceMulticenter Studies as TopicPatient Acceptance of Health CarePatient NavigationPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicResearch DesignSustained Virologic ResponseAntiviral AgentsAntiviral therapyHepatitis CInjection drug useSustained virologic response

Identifiers

PMID31669450
PMCPMC7261375

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.