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NCT05042544From ClinicalTrials.govRecruiting

The Australian HCV Point-of-Care Testing Program

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

  • Hepatitis C

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Kirby Institute
Enrolment target
60,000
Started
23 February 2022
Main results due
30 June 2029
Study sites
69
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:

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.

What this study is about

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

The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). Participants will attend a single visit to have their HCV RNA status tested and complete a self-administered survey. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.

Study sites(69)

  • Hepatitis ACT

    Canberra, Australian Capital Territory, Australia

    Recruiting

  • Western NSW LHD

    Bathurst, New South Wales, Australia

    Recruiting

  • Far West LHD

    Broken Hill, New South Wales, Australia

    Not yet recruiting

  • Maari Ma Health Aboriginal Corporation

    Broken Hill, New South Wales, Australia

    Completed

  • Galambila Aboriginal Health Service

    Coffs Harbour, New South Wales, Australia

    Completed

  • Central Coast LHD

    Gosford, New South Wales, Australia

    Recruiting

  • Armajun Health Service Aboriginal Corporation

    Inverell, New South Wales, Australia

    Completed

  • Rekindling the Spirit Health Service

    Lismore, New South Wales, Australia

    Completed

  • Asylum Seeker Centre

    Newtown, New South Wales, Australia

    Not yet recruiting

  • Nepean Blue Mountains LHD

    Penrith, New South Wales, Australia

    Recruiting

  • North and Mid North Coast LHD

    Port Macquarie, New South Wales, Australia

    Recruiting

  • Walhallow Aboriginal Corporation

    Quirindi, New South Wales, Australia

    Completed

  • Bulgarr Ngaru Medical Aboriginal Corporation

    South Grafton, New South Wales, Australia

    Completed

  • Kirketon Road Centre

    Sydney, New South Wales, Australia

    Recruiting

  • NSLHD

    Sydney, New South Wales, Australia

    Recruiting

  • WSLHD Drug Health

    Sydney, New South Wales, Australia

    Recruiting

  • South West Sydney LHD

    Sydney, New South Wales, Australia

    Completed

  • 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

  • Cairns Sexual Health Service

    Cairns, Queensland, Australia

    Completed

  • 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

  • Ipswich Sexual Health and BBV Service, West Moreton Health

    Ipswich, Queensland, Australia

    Terminated

  • 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

  • Pangula Mannamurna Aboriginal Corporation

    Mount Gambier, South Australia, Australia

    Completed

  • Tasmanian Sexual Health Service - Clinic 60

    Hobart, Tasmania, Australia

    Recruiting

  • Moreton Group Rural Health

    New Town, Tasmania, Australia

    Withdrawn

  • Ascot Vale Pharmacy

    Ascot Vale, Victoria, Australia

    Completed

  • 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

Showing 60 of 69 sites — filter to narrow it down. 52 of the 69 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 NCT05042544. 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 Australian HCV Point-of-Care Testing Program | Trialion