Evidence map›Paper›PMID 30012192›Full record

ArticleTrials2018

Community-based provision of direct-acting antiviral therapy for hepatitis C: study protocol and challenges of a randomized controlled trial.

A J Wade, J S Doyle, E Gane, C Stedman, B Draper, D Iser, S K Roberts, W Kemp, D Petrie, N Scott and 6 more

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

Article in 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 NCT02555475 (The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

NCT02555475 nacompletednot on this map

The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital: a Randomised Trial

TypeinterventionalSponsorMacfarlane Burnet Institute for Medical Research and Public Health LtdRan2016 to 2018Enrolled140ConditionsHepatitis CArmscommunity based hepatitis C care and treatment
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 9 citations in OpenAlex.

  1. Review
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

16 authors at 7 institutions in 2 countries.

A J WadeDisease Elimination Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC, 3004, Australia. amanda.wade@burnet.edu.au.ORCID http://orcid.org/0000-0002-8499-8490
J S DoyleDisease Elimination Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC, 3004, Australia.
E GaneNew Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.
C StedmanDepartment of Gastroenterology, Christchurch Hospital, and University of Otago, Christchurch, New Zealand.
B DraperDisease Elimination Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC, 3004, Australia.
D IserDepartment of Infectious Diseases, The Alfred, Melbourne, VIC, Australia.
S K RobertsDepartment of Gastroenterology, The Alfred, Melbourne, VIC, Australia.
W KempDepartment of Gastroenterology, The Alfred, Melbourne, VIC, Australia.
D PetrieCentre for Health Economics, Monash University, Melbourne, VIC, Australia.
N ScottDisease Elimination Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC, 3004, Australia.
P HiggsDisease Elimination Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC, 3004, Australia.
P A AgiusDisease Elimination Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC, 3004, Australia.
J RoneyDepartment of Infectious Diseases, The Alfred, Melbourne, VIC, Australia.
L StothersDepartment of Gastroenterology, St Vincent's Hospital, Melbourne, VIC, Australia.
A J ThompsonDepartment of Medicine, University of Melbourne, Melbourne, VIC, Australia.
M E HellardDisease Elimination Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC, 3004, Australia.
Burnet Institute · AUThe Alfred Hospital · AUAuckland City Hospital · NZChristchurch Hospital · NZMonash University · AUSt Vincent's Hospital Melbourne · AUThe University of Melbourne · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to treatment. Direct-acting antiviral (DAA) treatment can be provided in primary healthcare services (PHCS), improving accessibility, and, potentially, retention in care. Here, we describe our protocol for assessing the effectiveness of providing DAAs in PHCS, and the impact on the HCV care cascade. In addition, we reflect on the challenges of conducting a model of care study during a period of unprecedented change in HCV care and treatment.

methodsConsenting patients with HCV infection attending 13 PHCS in Australia or New Zealand are randomized to receive DAA treatment at the local tertiary institution (standard care arm), or their PHCS (intervention arm). The primary endpoint is the proportion commenced on DAAs and cured. Treatment providers at the PHCS include: hepatology nurses, primary care practitioners, or, in two sites, a specialist physician. All PHCS offer opioid substitution therapy. DISCUSSION: The Prime Study is the first real-world, randomized, model of care study exploring the impact of community provision of DAA therapy on HCV-treatment uptake and cure. Although the study has faced challenges unique to this period of time characterized by changing treatment and service delivery, the data gained will be of critical importance in shaping health service policy that enables the elimination of HCV.

trial registrationClinicalTrials.gov , ID: NCT02555475 . Registered on 15 September 2015.

Indexed as

Community Health ServicesRandomized Controlled Trials as TopicAdultAntiviral AgentsHepatitis CHumansOutcome Assessment, Health CareSample SizeAntiviral AgentsCommunity-based careHepatitis C virusProtocolRandomized controlled trial

Identifiers

PMID30012192
PMCPMC6048874
OpenAlexW2883242398

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.