Evidence map›Paper›PMID 35413933›Full record

ArticleTrials2022

A quasi-randomised controlled trial of online distribution of home-based hepatitis C self-testing for key populations in Malaysia: a study protocol.

Sonjelle Shilton, Xiaohui Sem, Huan-Keat Chan, Han Yang Chung, Anu Karunanithy, Jessica Markby, Po-Lin Chan, Niklas Luhmann, Cheryl Johnson, Pamela Nabeta and 4 more

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

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04982718 (Randomized Controlled Trial of Home-based Hepatitis C Self-testing for Key Populations in Malaysia), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 30% 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.

NCT04982718 naunknown statusnot on this map

Randomized Controlled Trial of Home-based Hepatitis C Self-testing for Key Populations in Malaysia

TypeinterventionalSponsorFoundation for Innovative New Diagnostics, SwitzerlandRan2021 to 2022Enrolled750ConditionsHepatitis C, Diagnostic Self EvaluationArmsOraQuick® HCV Self-Test, First Response® HCV Self-Test
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. 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 at 6 institutions in 3 countries.

Sonjelle ShiltonFIND, Geneva, Switzerland. sonjelle.shilton@finddx.org.ORCID http://orcid.org/0000-0003-1569-8758
Xiaohui SemFIND, Geneva, Switzerland.
Huan-Keat ChanClinical Research Centre, Hospital Sultanah Bahiyah, Alor Setar, Malaysia.
Han Yang ChungDrugs for Neglected Diseases initiative South-East Asia Regional Office, Kuala Lumpur, Malaysia.
Anu KarunanithyMalaysian AIDS Council, Kuala Lumpur, Malaysia.
Jessica MarkbyFIND, Geneva, Switzerland.
Po-Lin ChanWorld Health Organization Regional Office for Western Pacific, Manila, Philippines.
Niklas LuhmannGlobal HIV, Hepatitis & STI Programmes, World Health Organization, Geneva, Switzerland.
Cheryl JohnsonGlobal HIV, Hepatitis & STI Programmes, World Health Organization, Geneva, Switzerland.
Pamela NabetaFIND, Geneva, Switzerland.
Nazrila Hairizan Bt NasirFamily Health Development Division, Ministry of Health, Putrajaya, Malaysia.
Stefano OngarelloFIND, Geneva, Switzerland.
Elena Ivanova ReipoldFIND, Geneva, Switzerland.
Muhammad Radzi Abu HassanClinical Research Centre, Hospital Sultanah Bahiyah, Alor Setar, Malaysia.
FIND · CHHospital Sultanah Bahiyah · MYWorld Health Organization · CHMinistry of Health · MYNational Cancer Council Malaysia · MYWorld Health Organization Regional Office for the Western Pacific · PH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundMalaysia has an estimated hepatitis C virus (HCV) prevalence of 1.9% among its adult population and a history of providing HCV treatment in the public sector. In 2019, Malaysia launched a 5-year national strategic plan for viral hepatitis control and has been expanding HCV testing and treatment to the primary care and community levels, while actively engaging key populations in services for hepatitis care. The Ministry of Health (MoH) is seeking to specifically understand how to better target HCV services at men who have sex with men (MSM); HCV self-testing could increase the uptake of HCV testing among this group.

methodsWe aim to integrate HCV antibody self-testing into an existing online platform used for HIV self-testing, to evaluate the acceptability and impact of an online HCV self-testing programme in Malaysia. This is a non-blinded parallel group quasi-randomised superiority study comparing HCV self-testing via an online distribution model with the standard care, which involves attending a clinic for facility-based HCV antibody testing (control, 2:1). Participants will be randomised to either the HCV self-testing via online distribution arm, in which either an oral fluid- or blood-based HCV self-test kit will be mailed to them, or the control arm, where they will be provided with information about the nearest centre with HCV testing. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who (a) receive a positive result and are made aware of their status, (b) are referred to and complete HCV RNA confirmatory testing, and (c) start treatment. Acceptability, feasibility, attitudes around HCV testing, and cost will also be evaluated. The target sample size is 750 participants. DISCUSSION: This study is one of the first in the world to explore the real-world impact of HCV self-testing on key populations using online platforms and compare this with standard HCV testing services. The outcomes of this study will provide critical evidence about testing uptake, linkage to care, acceptability, and any social harms that may emerge due to HCV self-testing.

trial registrationClinicalTrials.gov NCT04982718.

Indexed as

Hepatitis CSexual and Gender MinoritiesAdultEquivalence Trials as TopicHepacivirusHomosexuality, MaleHumansMalaysiaMaleRandomized Controlled Trials as TopicSelf-TestingHepatitis CKey populationsLinkage to careMalaysiaSelf-testingTesting uptake

Identifiers

PMID35413933
PMCPMC9003167
OpenAlexW4223562319

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.