Clinical trial Recruiting at 52 sites Observational Ages 18 and up

National program for point-of-care testing of 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

Run by Kirby Institute · NCT05042544 · Data updated 2026-11-12

This study is testing if quick finger-stick tests for Hepatitis C can help more people at risk get diagnosed and treated in places like drug clinics and prisons.

More Hepatitis C trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment60000 (estimated)
SponsorKirby Institute
Government
Locations69 sites (Canberra, Australian Capital Territory and 68 other locations)
StatusRecruiting
StartedFebruary 23, 2022
Main results expectedJune 30, 2029
Study endsJune 30, 2029
Registry record updatedSeptember 28, 2026
Trial IDNCT05042544 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 18 and older with risk factors for HCV infection or those attending services for at-risk populations.

Probably not a fit

Patients who do not have risk factors for HCV infection or are unwilling to provide informed consent 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 program aims to evaluate the effectiveness of finger-stick point-of-care testing for Hepatitis C (HCV) in increasing diagnosis and treatment rates among at-risk populations. Participants will be recruited from various settings, including drug treatment clinics and prisons, where they will undergo HCV RNA testing and complete a survey in a single visit. The study focuses on improving HCV treatment uptake to reduce the disease burden and aims to link those who test positive to standard care. The Kirby Institute, a leader in HCV research, will oversee the program.

Why it matters

Potential benefit: If successful, this program could significantly increase the diagnosis and treatment of Hepatitis C, contributing to its elimination in Australia by 2030.

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

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Provided informed consent.
2. ≥ 18 years of age.
3. Have a risk factor for the acquisition of HCV infection (including current or past injecting drug use, previous incarceration, HIV infection, receiving blood products prior to 1990, having a tattoo or piercing in an unregulated environment, a needle-stick injury, or a mother with HCV).

   OR:
4. Are attending a service caring for people with risk factors for the acquisition of HCV infection (e.g. drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, and homelessness services).

Exclusion Criteria:

a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.

Where it's running

  • Hepatitis ACT
    Canberra, Australian Capital Territory, Australia
    Recruiting
  • Western NSW LHD
    Bathurst, New South Wales, Australia
    Recruiting
  • Central Coast LHD
    Gosford, New South Wales, Australia
    Recruiting
  • Nepean Blue Mountains LHD
    Penrith, New South Wales, Australia
    Recruiting
  • North and Mid North Coast LHD
    Port Macquarie, New South Wales, Australia
    Recruiting
  • Kirketon Road Centre
    Sydney, New South Wales, Australia
    Recruiting
Show 44 more locations
  • Nslhd
    Sydney, New South Wales, Australia
    Recruiting
  • WSLHD Drug Health
    Sydney, New South Wales, Australia
    Recruiting
  • Hepatitis NSW
    Sydney, New South Wales, Australia
    Recruiting
  • NSW Users and AIDS Association
    Sydney, New South Wales, Australia
    Recruiting
  • Prince of Wales Hospital
    Sydney, New South Wales, Australia
    Recruiting
  • SESLHD Community and Mental Health POCT Allicance (SCAMPA)
    Sydney, New South Wales, Australia
    Recruiting
  • SESLHD Drug Health
    Sydney, New South Wales, Australia
    Recruiting
  • Storr Liver Clinic (Westmead Hospital)
    Sydney, New South Wales, Australia
    Recruiting
  • Sydney Local Health District
    Sydney, New South Wales, Australia
    Recruiting
  • Murrumbidgee & Southern LHD
    Wagga Wagga, New South Wales, Australia
    Recruiting
  • Hunter New England LHD
    Waratah, New South Wales, Australia
    Recruiting
  • ISLHD Drug and Alcohol Service
    Wollongong, New South Wales, Australia
    Recruiting
  • ADSCA - Alice Springs Hospital
    Alice Springs, Northern Territory, Australia
    Recruiting
  • Clinic 34
    Alice Springs, Northern Territory, Australia
    Recruiting
  • Metro North HHS (Biala and Caboolture)
    Brisbane, Queensland, Australia
    Recruiting
  • IHWH Micah Projects
    Brisbane, Queensland, Australia
    Recruiting
  • Hepatitis QLD
    Coorparoo, Queensland, Australia
    Recruiting
  • Kombi Clinic
    Inala, Queensland, Australia
    Recruiting
  • Metro South Addiction Services - Inala AODS
    Inala, Queensland, Australia
    Recruiting
  • Ipswich AODS
    Ipswich, Queensland, Australia
    Recruiting
  • OneBridge
    Maroochydore, Queensland, Australia
    Recruiting
  • North West HHS - Mount Isa ATODS
    Mount Isa, Queensland, Australia
    Recruiting
  • Sunshine Coast HHS AODS
    Nambour, Queensland, Australia
    Recruiting
  • Ethnic Communities Council of Queensland
    West End, Queensland, Australia
    Recruiting
  • Clinic H
    Adelaide, South Australia, Australia
    Recruiting
  • The Queen Elizabeth Hospital, Central Adelaide LHN
    Adelaide, South Australia, Australia
    Recruiting
  • Drug and Alcohol Services South Australia
    Adelaide, South Australia, Australia
    Recruiting
  • Lyell McEwin Hospital, North Adelaide LHN
    Adelaide, South Australia, Australia
    Recruiting
  • Flinders Medical Centre, South Adelaide LHN
    Adelaide, South Australia, Australia
    Recruiting
  • Hepatitis SA
    Hackney, South Australia, Australia
    Recruiting
  • Tasmanian Sexual Health Service - Clinic 60
    Hobart, Tasmania, Australia
    Recruiting
  • Ballarat Community Health
    Ballarat, Victoria, Australia
    Recruiting
  • Harm Reduction Victoria
    Brunswick, Victoria, Australia
    Recruiting
  • Western Health
    Footscray, Victoria, Australia
    Recruiting
  • Eastern Health
    Melbourne, Victoria, Australia
    Recruiting
  • St Vincent's Hospital (Melbourne)
    Melbourne, Victoria, Australia
    Recruiting
  • Youth Projects - The Living Room
    Melbourne, Victoria, Australia
    Recruiting
  • Latrobe Community Health Service Liited
    Morwell, Victoria, Australia
    Recruiting
  • Goulburn Valley Community Health
    Shepparton, Victoria, Australia
    Recruiting
  • Primary Care Connect
    Shepparton, Victoria, Australia
    Recruiting
  • Peer Based Harm Reduction Bunbury
    Bunbury, Western Australia, Australia
    Recruiting
  • South Terrace Clinic - Fremantle Hospital
    Fremantle, Western Australia, Australia
    Recruiting
  • Pramana Medical Centre
    Gosnells, Western Australia, Australia
    Recruiting
  • Peer Based Harm Reduction - Perth
    Perth, Western Australia, Australia
    Recruiting

+19 more sites. See ClinicalTrials.gov for the full list.

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

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    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.