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Can At-Home hepatitis c tests reach people clinics miss?

NCT ID NCT04982718

Diagnosis Sponsor: Foundation for Innovative New Diagnostics, Switzerland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether giving people in Malaysia a rapid hepatitis C self-test kit to use at home increases how many get tested, compared with standard clinic-based testing. The trial enrolls 750 adults who are not known to have hepatitis C and have not been tested in the past six months, including people who inject drugs and men who have sex with men. Participants in the self-testing group receive an OraQuick HCV kit through an online platform and report their results, while the control group follows usual testing pathways. The study measures whether self-testing leads to more completed tests and more people learning their hepatitis C status.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OraQuick HCV self-test kit
What this could lead to
If home self-testing raises testing rates, Malaysia could expand this approach to reach more people at risk for hepatitis C and connect those who test positive to care.
What could go wrong
The kit is not approved for self-testing in Malaysia and is labelled for research use only, so accuracy outside a clinic is uncertain. People who test at home may also fail to seek confirmatory testing or treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

750 people

The number who actually took part.

Started

Sep 2021

Finished

Jun 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: • Self-reported previously confirmed positive HCV status (either antibody or RNA)

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Conditions

The condition(s) this trial relates to.

hepatitis C virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diagnostic self evaluation Hepatitis C

Contacts and locations

Locations

  • Jom test platform

    Alor Star, Kedah, 05000, Malaysia

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