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, Nazrila Hairizan Bt Nasir, Stefano Ongarello, Elena Ivanova Reipold, Muhammad Radzi Abu Hassan, Sonjelle Shilton, Xiaohui Sem, Huan-Keat Chan, Han Yang Chung, Anu Karunanithy, Jessica Markby, Po-Lin Chan, Niklas Luhmann, Cheryl Johnson, Pamela Nabeta, Nazrila Hairizan Bt Nasir, Stefano Ongarello, Elena Ivanova Reipold, Muhammad Radzi Abu Hassan

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.

Keywords: Hepatitis C; Key populations; Linkage to care; Malaysia; Self-testing; Testing uptake.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow diagram
Fig. 2
Fig. 2
Social harms community stakeholder group

References

    1. Organization WH . Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021. Geneva: World Health Organization; 2021.
    1. Samarasekera U. Urgent action needed to eliminate viral hepatitis by 2030. Lancet Gastroenterol Hepatol. 2021;6(8):611. doi: 10.1016/S2468-1253(21)00218-1.
    1. WHO . Recommendations and guidance on hepatitis C virus self-testing. Geneva: WHO; 2021.
    1. Guise A, Witzel TC, Mandal S, Sabin C, Rhodes T, Nardone A, Harris M. A qualitative assessment of the acceptability of hepatitis C remote self-testing and self-sampling amongst people who use drugs in London, UK. BMC Infect Dis. 2018;18(1):281. doi: 10.1186/s12879-018-3185-7.
    1. Nguyen LT, Nguyen VTT, Le Ai KA, Truong MB, Tran TTM, Jamil MS, et al. Acceptability and usability of HCV self-testing in high risk populations in Vietnam. Diagnostics (Basel) 2021;11(2):377. doi: 10.3390/diagnostics11020377.
    1. Martínez-Pérez GZ, Nikitin DS, Bessonova A, et al. Values and preferences for hepatitis C self-testing among people who inject drugs in Kyrgyzstan. BMC Infect Dis. 2021;21:609. 10.1186/s12879-021-06332-z.
    1. Majam M, Fischer A, Ivanova Reipold E, Rhagnath N, Msolomba V, Lalla-Edward ST. A lay-user assessment of hepatitis C virus self-testing device usability and interpretation in Johannesburg, South Africa. Diagnostics (Basel) 2021;11(3):463. doi: 10.3390/diagnostics11030463.
    1. Reipold EI, Farahat A, Elbeeh A, Soliman R, Aza EB, Jamil MS, Johnson CC, Shiha G, Easterbrook P. Usability and acceptability of self-testing for hepatitis C virus infection among the general population in the Nile Delta region of Egypt. BMC Public Health. 2021;21(1):1188. doi: 10.1186/s12889-021-11169-x.
    1. Ingold H, Mwerinde O, Ross AL, Leach R, Corbett EL, Hatzold K, Johnson CC, Ncube G, Nyirenda R, Baggaley RC. The Self-Testing AfRica (STAR) Initiative: accelerating global access and scale-up of HIV self-testing. J Int AIDS Soc. 2019;22(S1):e25249. doi: 10.1002/jia2.25249.
    1. Md Said R, Mohd Zain R, Chan HK, Soelar SA, Rusli N, Nasir NH, Zakaria R, Hassan MRA. Find the missing millions: Malaysia’s experience with nationwide hepatitis C screening campaign in the general population. J Viral Hepat. 2020;27(6):638–643. doi: 10.1111/jvh.13267.
    1. Chan H, Hassali MA, MS R, AHM R. Treatment coverage and drug expenditure in hepatitis C patients from 2013 to 2019: a journey of improving treatment accessibility in Malaysia through government-led initiatives. Hepat Mon. 2020;20(9):e107372. doi: 10.5812/hepatmon.107372.
    1. Malaysia MH. National strategic plan for hepatitis B and C 2019-2023. Putrajaya: Ministry of Health Malaysia; 2019.
    1. Pannir Selvam SB, Khoo EM, Chow SY, Wong PF, Mohsin SS, Abdullah A, Choo WY. Development of a sexually transmitted disease client-friendly unit at a primary care clinic in Malaysia: lessons learnt. Sex Transm Dis. 2019;46(2):143–145. doi: 10.1097/OLQ.0000000000000918.
    1. Jumri N. Antiretroviral treatment: a powerful tool to help HIV patients to lead productive lives, prevent transmissions: UMSC; nd [Available from: .
    1. Witzel TC, Eshun-Wilson I, Jamil MS, Tilouche N, Figueroa C, Johnson CC, Reid D, Baggaley R, Siegfried N, Burns FM, Rodger AJ, Weatherburn P. Comparing the effects of HIV self-testing to standard HIV testing for key populations: a systematic review and meta-analysis. BMC Med. 2020;18(1):381. doi: 10.1186/s12916-020-01835-z.
    1. WHO, UNAIDS . A short technical update on self-testing for HIV UNAIDS. 2014.
    1. Wingrove C, Hicks J, Regan S, Wang S. Investment cases for hepatitis C: never more important. Lancet Gastroenterol Hepatol. 2021;6(5):340–341. doi: 10.1016/S2468-1253(21)00060-1.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する