HCV Self-testing in Malaysia

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.

Conditions

• Hepatitis C
• Diagnostic Self Evaluation

Interventions

DIAGNOSTIC_TEST

OraQuick® HCV Self-Test

Self-testing will be performed using the OraQuick® HCV Self-Test manufactured by OraSure Technologies Inc., USA. Modified IFU developed by the manufacturer will be used to adapt the below professional use kits to a self-test: the OraQuick® HCV Rapid Antibody Test is prequalified by WHO and CE marked for professional use (sensitivity 98.1%, specificity 99.6%). As it is not approved for self-test use in Malaysia, the OraQuick® HCV Self-Test kits provided to participants in the intervention group will be labelled for Research Use Only (RUO) and test results will not be used for patient management.

DIAGNOSTIC_TEST

First Response® HCV Self-Test

Self-testing will be performed using the First Response® HCV Card Test (Self Test) manufactured by Premier Medical Corporation, India. Modified IFU developed by the manufacturer will be used to adapt the below professional use kits to a self-test: the First Response® HCV Card Test is CE-marked and currently under WHO review for professional use (sensitivity 100%, specificity 100%). As it is not approved for self-test use in Malaysia, the First Response® HCV Self-Test kits provided to participants in the intervention group will be labelled for Research Use Only (RUO) and test results will not be used for patient management.

Sponsors & Collaborators

• Hospital Sultanah Bahiyah

  collaborator OTHER_GOV

• Ministry of Health, Malaysia

  collaborator OTHER_GOV

• Malaysian AIDS Council

  collaborator UNKNOWN

• Foundation for Innovative New Diagnostics, Switzerland

  lead OTHER

Principal Investigators

• Muhammad Radzi Abu Hassan · Hospital Sultanah Bahiyah

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-14

Primary Completion

2022-03-31

Completion

2022-04-30

Countries

• Malaysia