HCV Self-testing in Malaysia

NCT04982718 | Unknown

• 1 other identifier: HC021
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Linkage to care; Online self-test distribution; Self-test

Outcome Measures

Primary Outcomes (2)

• To assess the impact of home-based HCV self-testing on the uptake of HCV antibody testing

  The number and estimate of the proportion of participants who report completing the HCV antibody testing in the intervention group vs the control group.

  Time Frame: 2 weeks to 2 months after enrollment

• To assess the impact of home-based HCV self-testing on the uptake of HCV antibody testing

  To assess that the proportion of participants who report completing the HCV antibody testing in the intervention group is superior to that of the participants in the control group by a margin of 20%.

  Time Frame: 2 weeks to 2 months after enrollment

Secondary Outcomes (5)

• To assess the impact of HCV self-testing on the number of HCV antibody positive individuals who are aware of their status

  2 weeks to 2 months after enrollment

• To assess the impact of HCV self-testing on linkage and completion of HCV RNA confirmatory testing in HCV antibody positive individuals

  2 weeks to 6 months after enrollment

• To assess the impact of HCV self-testing on treatment initiation in HCV RNA positive individuals eligible to start treatment

  2 weeks to 6 months after enrollment

• To assess the acceptability and feasibility of HCV self-testing at baseline and after study participation as assessed by responses to the questionnaire at baseline and after study participation

  2 weeks to 3 months after enrollment

• To assess the cost of HCV self-testing

  entire duration of study, estimated 6 months

Study Arms (3)

Oral fluid-based HCV ST

EXPERIMENTAL

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.

Diagnostic Test: OraQuick® HCV Self-Test

Blood-based HCV ST

EXPERIMENTAL

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 next 250 participants will receive a blood-based fingerstick HCV ST.

Diagnostic Test: First Response® HCV Self-Test

Control standard of care

NO INTERVENTION

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.

Interventions

OraQuick® HCV Self-Test DIAGNOSTIC_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.

Oral fluid-based HCV ST

First Response® HCV Self-Test DIAGNOSTIC_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.

Blood-based HCV ST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Eligible to access services on the JomTest online platform
• Not known to be HCV antibody positive
• Not tested for HCV within the last 6 months
• Able to read and understand Bahasa Malaysia or English
• Able to understand the scope of the study and provide online informed consent

You may not qualify if:

• Self-reported previously confirmed positive HCV status (either antibody or RNA)

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Hospital Sultanah Bahiyah: collaborator
• Ministry of Health, Malaysia: collaborator
• Malaysian AIDS Council: collaborator

Study Sites (1)

Jom test platform

Nationally, Malaysia

RECRUITING

Related Publications (1)

• Shilton S, Sem X, Chan HK, Chung HY, Karunanithy A, Markby J, Chan PL, Luhmann N, Johnson C, Nabeta P, Nasir NHB, Ongarello S, Reipold EI, Hassan MRA. A quasi-randomised controlled trial of online distribution of home-based hepatitis C self-testing for key populations in Malaysia: a study protocol. Trials. 2022 Apr 12;23(1):304. doi: 10.1186/s13063-022-06230-y.

  PMID: 35413933 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Muhammad Radzi Abu Hassan

  Hospital Sultanah Bahiyah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonjelle Shilton

CONTACT

+41 (22) 710 05 90; Sonjelle.Shilton@finddx.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. 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

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 29, 2021
• Study Start: September 14, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 11, 2022

Record last verified: 2021-10

Locations

MY (1)