Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04982718 |
| Other study ID # |
HC021 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 14, 2021 |
| Est. completion date |
April 2022 |
Study information
| Verified date |
October 2021 |
| Source |
Foundation for Innovative New Diagnostics, Switzerland |
| Contact |
Sonjelle Shilton |
| Phone |
+41 (22) 710 05 90 |
| Email |
Sonjelle.Shilton[@]finddx.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Self-testing with easy-to-use rapid diagnostic tests (RDTs) has been successfully used for
diseases such as HIV. The availability of self-testing has been shown to increase testing
rates and testing acceptability in diverse populations around the world, in large part due to
its convenience and privacy advantages. Self-testing has also been effectively used to reach
key populations who may not be covered by traditional healthcare programs, such as persons
who inject drugs and men who have sex with men. In Malaysia, HIV self-testing has been shown
to have moderate to high levels of acceptability, depending on the population, test used, and
test delivery framework. In the present study we aim to evaluate the acceptability and impact
of an online program enabling home-based hepatitis C virus (HCV) self-testing in Malaysia.
Description:
Malaysia is an upper middle-income country with a population of more than 32 million,
comprising thirteen states and three federal territories. It is estimated that the hepatitis
C virus (HCV) seroprevalence in the general population of Malaysia is between 0.3% and 2.5%.
In Malaysia, people who inject drugs represent just 0.24% (75 000) of the adult population;
however, they are disproportionately affected by HCV, with an overall HCV prevalence of 67.5%
to 89.9%. Other key populations in Malaysia at higher risk of HCV include 77 903 people
living with human immunodeficiency virus (HIV, 0.24%), 221 698 men who have sex with men
(0.69%), 22 000 female sex workers (0.069%), and 15 000 transgender sex workers (0.047%).
The major challenges faced by Malaysia in eliminating viral hepatitis have been
under-screening, under-diagnosis and under-treatment. A high proportion of those infected
with HCV remain undiagnosed and, until 2018, only a small proportion of those infected
received treatment each year. Up until 2017, it is estimated that just 6.1% (23 258) of
people infected with HCV were diagnosed.
Self-testing with easy-to-use rapid diagnostic tests (RDTs) has been successfully used for
diseases such as HIV. The availability of self-testing has been shown to increase testing
rates and testing acceptability in diverse populations around the world, in large part due to
its convenience and privacy advantages. In the present study we aim to evaluate the
acceptability and impact of an online program enabling home-based HCV self-testing in
Malaysia.
FIND, in conjunction with the Malaysian AIDS Council (MAC) and the Ministry of Health (MOH)
Malaysia, is evaluating HCV self-testing as a way to expand outreach, improve HCV testing
rates, and increase linkage to care among HCV-infected individuals. The ability to utilize an
existing online platform promoting HIV self-testing (JomTest) will enable us to examine how
offering home-based HCV self-testing may help identify HCV-infected individuals and link them
to care. *The online platform JomTest is currently hosting a research study with Medical
Research Ethics Committee, University Malaya Medical Center MRECID No. 202013-8135, study
title "Integrated HIV self-testing (HIVST) service delivery in Malaysia for policy and
service development: JomTest online" and aims to assess the integrated HIVST service delivery
in Malaysia for policy and service development through the platform.
This study will evaluate the impact of a home-based HCV self-testing program in Malaysia. We
aim to describe the acceptability and impact of an online platform offering home-based HCV
self-tests to key populations. Since HCV self-tests detect the presence of antibodies to HCV,
indicating exposure to HCV, any individual reporting a positive HCV self-test will be
referred to HCV RNA confirmatory testing in order to identify active HCV infection. Those
confirmed to have active HCV infection with a positive HCV RNA test will be linked to HCV
treatment and care. Rates of testing and linkage to care will be measured, along with
knowledge, attitudes, and practices around HCV testing and care.
This is a randomized controlled trial comparing an online platform providing home-delivery of
HCV self-tests to referral to standard of care community-based HCV testing sites in Malaysia.
Study participants will be recruited through an existing HIV self-testing program using an
online platform JomTest. Interested participants will sign up and proceed for study
eligibility screening and if eligible, proceed to complete an online consent form. All
consented and enrolled study participants will complete an online baseline survey collecting
demographics and knowledge and attitudes towards HCV testing.
Participants will be randomized to the intervention or control group in a 2:1 ratio. In the
intervention group, participants will receive a HCV self-test (ST) kit delivered in
non-identifiable packaging to their home or a preferred mailing address. The kit will include
the test, instructions for use, and information about additional supporting materials, such
as access to live chat and a call center for questions about testing. In order to evaluate
two sampling methods for HCV self-testing, the first 250 participants in the intervention
group will receive an oral fluid-based HCV ST, and the next 250 participants will receive a
blood-based fingerstick HCV ST. In the control group, participants will receive information
about standard of care HCV antibody testing available at local testing sites in their
community and information about additional supporting materials, such as access to live chat
and a call center for questions about testing.
As there is no quality-assured HCV self-test today, the professional use OraQuick® HCV Rapid
Antibody Test and First Response® HCV Card Test that have been repackaged and labelled with
Instructions for Use (IFU) adapted by the manufacturers for self-testing would be used in
this study. The OraQuick® HCV Rapid Antibody Test is prequalified by WHO and CE marked for
professional use (sensitivity 98.1%, specificity 99.6%); the First Response® HCV Card Test is
CE-marked and currently under WHO review for professional use (sensitivity 100%, specificity
100%). Both these professional tests are not yet registered with the Medical Device Authority
in Malaysia. The OraQuick® HCV Self-Test and First Response® HCV Self-Test kits provided to
participants in the intervention group will be labelled for Research Use Only (RUO).
All participants will be sent a reminder for online Follow-up survey #1 and the opportunity
to upload any testing result in approximately 2-4 weeks from day of enrolment. A second
online Follow-up survey #2 will be sent after the closure of the first survey. Up to 3
reminders may be sent if a survey has not been completed. Participants will receive 20
Ringgit (~5 USD) for completing Follow-up survey #1 and an additional 20 Ringgit for
completion of the Follow-up survey #2. Any participants found to be HCV antibody positive
through the study will be supported to access HCV management and care services for
confirmatory HCV testing and HCV treatment if required and be provided additional assistance
through MAC's existing peer navigation system as outlined in the organization's standard
operating procedures.
