Evidence map›Paper›PMID 34226208›Full record

ArticleBMJ open2021

Eliminating hepatitis C in a rural Appalachian county: protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C.

Jennifer R Havens, Takako Schaninger, Hannah Fraser, Michelle Lofwall, Michele Staton, April M Young, Ardis Hoven, Sharon L Walsh, Peter Vickerman

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03949764 (Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 47% 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.

NCT03949764 phase4completednot on this map

Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study

TypeinterventionalSponsorJennifer HavensRan2019 to 2025Enrolled374ConditionsHepatitis C, Opioid-Related Disorders, Injection Drug UseArmsSofosbuvir/velpatasvir (Epclusa®)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Clinical and demographic characteristics of participants in a hepatitis C treatment trial in rural Kentucky: How policies around treatment access may impact elimination efforts in the United States.The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association · 2026
    Article
  2. Article
  3. 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

9 authors at 2 institutions in 3 countries.

Jennifer R HavensBehavioral Science, University of Kentucky College of Medicine, Lexington, Kentucky, USA jhave2@uky.edu.ORCID 0000-0002-1753-7280
Takako SchaningerInfectious Diseases, University of Kentucky College of Medicine, Lexington, Kentucky, USA.
Hannah FraserPopulation Health Sciences, University of Bristol, Bristol, UK.
Michelle LofwallBehavioral Science, University of Kentucky College of Medicine, Lexington, Kentucky, USA.
Michele StatonBehavioral Science, University of Kentucky College of Medicine, Lexington, Kentucky, USA.
April M YoungEpidemiology, University of Kentucky College of Public Health, Lexington, Kentucky, USA.
Ardis HovenInfectious Diseases, University of Kentucky College of Medicine, Lexington, Kentucky, USA.
Sharon L WalshBehavioral Science, University of Kentucky College of Medicine, Lexington, Kentucky, USA.
Peter VickermanPopulation Health Sciences, University of Bristol, Bristol, UK.
University of Kentucky · USUniversity of Bristol · GB

Funding

Kentucky Center for Clinical and Translational ScienceUL1TR001998 · NCATS · UNIVERSITY OF KENTUCKY · PI HARTMANN, KATHERINE E, KERN, PHILIP A · 2016 to 2025
$34.2M
Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: the Kentucky Viral Hepatitis Treatment (KeY Treat) StudyR01DA047952 · NIDA · UNIVERSITY OF KENTUCKY · PI HAVENS, JENNIFER R · 2018 to 2023
$8.7M
NCATS NIH HHS UL1 TR001998NIDA NIH HHS R01 DA047952
6 · The paper itself

Abstract

objectivesThe overall goal of the Kentucky Viral Hepatitis Treatment Study (KeY Treat) is to eliminate hepatitis C transmission from a county in Appalachian Kentucky by removing the barriers to accessing hepatitis C virus (HCV) treatment. METHODS/ANALYSIS: KeY Treat is a phase IV, open-label, single-arm clinical trial of sofosbuvir/velpatasvir (SOF/VEL) for the treatment of viraemic HCV infections. Those eligible for KeY Treat are at least 18 years of age, viraemic and are residents of the target county. Pregnant women are not eligible. Rapid HCV RNA screening is used to determine eligibility, and those with a quantifiable viral load (VL) consenting to participate initiate SOF/VEL on the same day. All pharmacologic treatment and related medical care is provided free of charge using a non-specialist provider model. Follow-up visits occur at 2, 6 and 12 weeks during treatment to assess medication adherence (measured via VL and self-report), side effects and engagement in risk behaviours. Post-treatment visits occur at 12 weeks (sustained virologic response (SVR12) visit), 6 months and 12 months post-treatment completion to assess re-infection. A control county has also been identified, and prevalence and incidence of chronic HCV infections will be compared with the target community longitudinally. The primary outcome to assess elimination is SVR12. However, several outcomes will be measured to assess the effectiveness of removing the barriers to HCV treatment, including treatment entry, completion and re-infection. Analyses will be conducted via a generalised linear model framework that can incorporate flexible covariate adjustment and multiple outcome types with a compatible link function. Mathematical modelling will be completed assessing the impact and cost-effectiveness of the intervention. ETHICS AND DISSEMINATION: KeY Treat has been approved by the Institutional Review Board at the University of Kentucky. Results from KeY Treat will be presented at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03949764.

Indexed as

Hepatitis CHepatitis C, ChronicAntiviral AgentsBenzimidazolesBenzopyransCarbamatesClinical Trials, Phase IV as TopicDrug Therapy, CombinationFemaleGenotypeHepacivirusHeterocyclic Compounds, 4 or More RingsHumansKentuckyPregnancySofosbuvirAntiviral AgentsBenzimidazolesBenzopyransCarbamatesHeterocyclic Compounds, 4 or More RingsSofosbuvirvelpatasvirepidemiologyhepatologypublic health

Identifiers

PMID34226208
PMCPMC8258565
OpenAlexW3179738138

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.