Abstract

Background

Malaysia 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.

Methods

We 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 registration

ClinicalTrials.gov NCT04982718

Details

Title
A quasi-randomised controlled trial of online distribution of home-based hepatitis C self-testing for key populations in Malaysia: a study protocol
Author
Shilton, Sonjelle 1   VIAFID ORCID Logo  ; Sem, Xiaohui 1 ; Chan, Huan-Keat 2 ; Chung, Han Yang 3 ; Karunanithy, Anu 4 ; Markby, Jessica 1 ; Chan, Po-Lin 5 ; Luhmann, Niklas 6 ; Johnson, Cheryl 6 ; Nabeta, Pamela 1 ; Nasir, Nazrila Hairizan Bt 7 ; Ongarello, Stefano 1 ; Reipold, Elena Ivanova 1 ; Hassan, Muhammad Radzi Abu 2 

1  FIND, Geneva, Switzerland (GRID:grid.452485.a) (ISNI:0000 0001 1507 3147) 
2  Hospital Sultanah Bahiyah, Clinical Research Centre, Alor Setar, Malaysia (GRID:grid.452819.3) (ISNI:0000 0004 0411 5999) 
3  Drugs for Neglected Diseases initiative South-East Asia Regional Office, Kuala Lumpur, Malaysia (GRID:grid.452819.3) 
4  Malaysian AIDS Council, Kuala Lumpur, Malaysia (GRID:grid.452819.3) 
5  World Health Organization Regional Office for Western Pacific, Manila, Philippines (GRID:grid.483407.c) (ISNI:0000 0001 1088 4864) 
6  World Health Organization, Global HIV, Hepatitis & STI Programmes, Geneva, Switzerland (GRID:grid.3575.4) (ISNI:0000000121633745) 
7  Ministry of Health, Family Health Development Division, Putrajaya, Malaysia (GRID:grid.415759.b) (ISNI:0000 0001 0690 5255) 
Pages
304
Publication year
2022
Publication date
Dec 2022
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-022-06230-y
ProQuest document ID
2730331012
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.