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NCT05713136From ClinicalTrials.govRecruiting

The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset

The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection - HCV Antibody Testing Minimal Dataset

  • Hepatitis C

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Kirby Institute
Enrolment target
40,000
Started
23 February 2023
Main results due
June 2029
Study sites
13
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Provide informed consent
* ≥ 18 years of age.

Exclusion Criteria:

* Is unable or unwilling to provide informed consent

What this study is about

In the sponsor’s own words, from the registry.

The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is:

What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis?

Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit.

No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.

Study sites(13)

  • ACT Justice Health

    Canberra, Australian Capital Territory, Australia

    Not yet recruiting

  • Justice Health and Forensic Mental Health Network

    Sydney, New South Wales, Australia

    Recruiting

  • Queensland Injectors Health Network Ltd

    Bowen Hills, Queensland, Australia

    Active, not recruiting

  • West Moreton Hospital and Health Service

    Brisbane, Queensland, Australia

    Recruiting

  • Lotus Glen Correctional Centre

    Cairns, Queensland, Australia

    Recruiting

  • Townsville Correctional Centre

    Townsville, Queensland, Australia

    Not yet recruiting

  • Woodford Correctional Centre

    Woodford, Queensland, Australia

    Recruiting

  • South Australian Prison Health Service

    Adelaide, South Australia, Australia

    Not yet recruiting

  • Hepatitis South Australia

    Hackney, South Australia, Australia

    Not yet recruiting

  • Tasmanian Prison Service

    Hobart, Tasmania, Australia

    Not yet recruiting

  • St Vincent's Hospital (Melbourne)

    Melbourne, Victoria, Australia

    Recruiting

  • Acacia Prison

    Beechina, Western Australia, Australia

    Recruiting

  • WA Department of Justice

    Perth, Western Australia, Australia

    Not yet recruiting

Showing 13 of 13 sites. 6 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05713136. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset | Trialion