Clinical trial Recruiting at 11 sites Observational Ages 18 and up

Evaluating point-of-care testing for Hepatitis C in Australia

Official title: 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 - Minimal Dataset

Run by Kirby Institute · NCT05248555 · Data updated 2026-11-12

This study is testing if quick finger-stick tests for Hepatitis C can help people in high-risk areas in Australia get diagnosed and treated more easily.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment80000 (estimated)
SponsorKirby Institute
Government
Locations16 sites (Sydney, New South Wales and 15 other locations)
StatusRecruiting
StartedJanuary 23, 2023
Main results expectedDecember 2029
Study endsDecember 2029
Registry record updatedSeptember 28, 2026
Trial IDNCT05248555 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this program are individuals aged 18 and older who are at risk for Hepatitis C and willing to undergo point-of-care testing.

Probably not a fit

Patients who are not at risk for Hepatitis C or those who have already been diagnosed and treated may not benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort program aims to assess the impact of finger-stick point-of-care testing on the diagnosis and treatment of Hepatitis C (HCV) infection in Australia. Participants will be recruited from various high-risk settings, including drug treatment clinics and prisons, where they will undergo HCV testing. The study will collect data on participants who test positive for HCV RNA, linking them to standard care for treatment. The initiative seeks to improve treatment uptake and contribute to the goal of HCV elimination by 2030.

Why it matters

Potential benefit: If successful, this program could significantly increase the diagnosis and treatment rates of Hepatitis C, ultimately reducing the disease burden.

How similar studies have gone: Previous studies have shown success with point-of-care testing interventions for Hepatitis C, indicating a promising approach to increasing diagnosis and treatment.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* ≥ 18 years of age.
* Received point-of-care HCV testing.

Exclusion Criteria:

* Nil

Where it's running

  • Maryborough Correctional Centre
    Aldershot, Queensland, Australia
    Recruiting
  • QuIHN
    Brisbane, Queensland, Australia
    Recruiting
  • Lotus Glen Correctional Centre
    Cairns, Queensland, Australia
    Recruiting
  • West Moreton Hospital and Health Service
    Ipswich, Queensland, Australia
    Recruiting
  • Townsville Correctional Centre
    Townsville, Queensland, Australia
    Recruiting
  • Woodford Correctional Centre
    Woodford, Queensland, Australia
    Recruiting
Show 10 more locations
  • Hepatitis SA
    Hackney, South Australia, Australia
    Recruiting
  • Mount Gambier Priosn
    Mount Gambier, South Australia, Australia
    Recruiting
  • Medically Supervised Injecting Room
    Melbourne, Victoria, Australia
    Recruiting
  • Dame Phyllis Frost Centre
    Ravenhall, Victoria, Australia
    Recruiting
  • Geo Healthcare - The Geo Group Australia Pty Ltd
    Ravenhall, Victoria, Australia
    Recruiting
  • Justice Health and Forensic Mental Health Network
    Sydney, New South Wales, Australia
    Active not recruiting
  • Hepatitis Queensland
    Coorparoo, Queensland, Australia
    Completed
  • Palen Creek Correctional Centre
    Rathdowney, Queensland, Australia
    Not yet recruiting
  • South Australian Prison Health Service
    Marden, South Australia, Australia
    Not yet recruiting
  • St Vincent's Correctional Health Services
    Fitzroy, Victoria, Australia
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Glecaprevir/pibrentasvir started during pregnancy for women with hepatitis C, with or without HIV

    This trial will test whether taking glecaprevir/pibrentasvir during pregnancy is safe and how the drug is processed in pregnant women who have hepatitis C, including those who also have HIV, and will follow their infants for 10 weeks after birth.

    Recruiting at 8 sites Phase 1/2 National Institute of Allergy and Infectious Diseases (NIAID) · Los Angeles, California and 9 other locations · NCT07040319

  • Evaluating hepatitis C treatment during pregnancy

    This study tests how well a new hepatitis C treatment works for pregnant adults with a history of drug use and looks at their experience during the treatment.

    Recruiting at 2 sites Washington University School of Medicine · St Louis, Missouri and 1 other locations · NCT06367465

  • Decentralized treatment for hepatitis C in Brazil

    This study is testing a new way to treat hepatitis C in Brazil using a medication called Epclusa to see if it helps more people get the care they need compared to traditional methods.

    Recruiting at 2 sites Phase 4 Oswaldo Cruz Foundation · Rio de Janeiro, Rio de Janeiro and 1 other locations · NCT06306300

  • Helping young people who inject drugs start treatment for Hepatitis C

    This study tests a new support program to help young adults who inject drugs start treatment for Hepatitis C and see if it works better than regular care.

    Recruiting University of California, San Francisco · San Francisco, California · NCT06179498

  • Simplified hepatitis C testing with same-day treatment for people who inject drugs in Armenia, Georgia and Tanzania

    This project will test whether a simplified pathway that starts hepatitis C treatment the same day after a quick antibody test helps people who inject drugs in Armenia, Georgia, and Tanzania get treated and cured faster than the usual antibody-plus-RNA pathway.

    Recruiting Early Phase 1 Médecins du Monde · Yerevan · NCT06159504

  • Point-of-care testing program for Hepatitis C screening

    This study is testing if quick Hepatitis C tests done during a single visit can help more at-risk adults get diagnosed and start treatment faster.

    Recruiting at 6 sites Kirby Institute · Canberra, Australian Capital Territory and 12 other locations · NCT05713136

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.