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Mailing hepatitis c tests home could reach people who avoid clinics

NCT ID NCT04961723

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 in Georgia are testing whether mailing hepatitis C self-tests to people who inject drugs and men who have sex with men increases how many get tested. The trial enrolls 1,250 adults in Tbilisi and Batumi who do not know their hepatitis C status. Half receive a self-test kit at home through an online platform, and half receive standard care. The study compares testing rates and how many people learn their result.

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, a rapid oral-fluid test for hepatitis C antibodies
What this could lead to
If home delivery works, health programs could reach more people who avoid clinics and help them learn their hepatitis C status earlier.
What could go wrong
Self-tests can be misread or used incorrectly, and a positive result still needs a clinic visit to confirm. The trial measures testing rates, not whether treatment or cure follows.

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

1,250 people

The number who actually took part.

Started

Dec 2021

Finished

Aug 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 * Able and eligible to access services on selftest.ge * Self-identify as a PWID and or MSM * Living in Batumi or Tbilisi * Able to understand the scope of the study and provide informed consent through online platform. * Able to read and understand Georgian * Unknown HCV serology status (i.e., never tested for HCV or tested HCV ab- in a most recent test performed no later than 6 months before enrolment) Exclusion Criteria: * Self-reported previously confirmed positive HCV status (either Ab or RNA) * Un-eligible for Georgian National Hepatitis Elimination program

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Conditions

The condition(s) this trial relates to.

hepatitis C virus infection Homosexuality

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

  • Center for Information and Counselling on Reproductive Health-Tanadgoma

    Batumi, Georgia

  • Center for Information and Counselling on Reproductive Health-Tanadgoma

    Tbilisi, Georgia

  • Equality Movement

    Batumi, Georgia

  • Equality Movement

    Tbilisi, Georgia

  • Imedi Harm Reduction Site

    Batumi, Georgia

  • Tbilisi New Way Harm Reduction Site

    Tbilisi, Georgia

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