The Australian HCV Point-of-Care Testing Program (HCVPOCT)

March 26, 2026 updated by: Kirby Institute

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The advent of simple direct-acting antiviral hepatitis C (HCV) therapies with cure rates >95% is one of the greatest medical advances in decades, having led to a reversal in liver-related mortality. In Australia, treatment uptake has declined between 2016 (32,000 treated) and 2019/20 (2019: 11,500; 2020: 8,500).1 Progress towards HCV elimination has been impeded by COVID-19, affecting the delivery of national and state-based HCV strategies. Improving HCV treatment uptake to reduce disease burden is a key aim of global, national and state-based HCV strategies.2-4

Scale-up of HCV testing and treatment will be required to achieve elimination by 2030. Current diagnostic pathways require multiple visits to a practitioner reducing the proportion who receive a diagnosis. In Australia, 81% of people have had HCV antibody testing (indicates exposure), but only 47% have been HCV RNA tested (indicates active infection and the need for HCV treatment).5 Mathematical modelling suggests that HCV RNA testing needs to increase by at least 50% annually to achieve elimination in Australia by 2030.6

The Kirby Institute is an international leader in research evaluating the Xpert HCV assay (Grebely Lancet Gastro Hep 2017), having built a large network of Xpert platforms for HCV testing in needle and syringe programs, prisons, drug treatment clinics, tertiary hospitals, and Aboriginal Community Controlled Health Service. In Kirby-led research, point-of-care HCV testing interventions in needle and syringe programs and prisons have resulted in high HCV treatment uptake (70-90%). The Kirby Institute and Flinders University also have a strong track record of implementing point-of-care testing for STIs and COVID-19, providing an ideal foundation to scale-up Xpert HCV testing in Australia.

The Kirby Institute and Flinders University will establish the Australian National HCV Point-of-care Testing Program for the scale-up of point-of-care HCV RNA testing in services with high prevalence of HCV infection, including community health centres, drug treatment clinics, needle and syringe programs, and prisons. This program will include the development of standard operating procedures, logistics/deployment, initial set-up, an operator training program, and quality assurance and competency assessment program.

An observational cohort study that will be established to evaluate HCV treatment uptake following scale-up of point-of-care HCV testing among people with a risk factor for acquisition of HCV infection or people attending a service caring for people with risk factors for the acquisition of HCV infection. This study will also include the linkage of survey data to a range of administrative datasets which will be used to evaluate the impact of HCV testing and treatment scale-up on a range of long-term health outcomes.

Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to receive point-of-care HCV testing and complete a self-administered survey. Testing will be performed using point-of-care HCV antibody testing (results within 1-20 minutes, depending on the test) and if positive, HCV RNA testing will be performed. Participants who have previously had HCV infection or previously received HCV treatment will be tested using point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA detectable will be linked to standard of care for any other clinical assessments and treatment initiation.

Study Type

Observational

Enrollment (Estimated)

60000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2612
        • Recruiting
        • Hepatitis ACT
        • Contact:
          • Kareen Tait
        • Principal Investigator:
          • Sarah Ahmed
    • New South Wales
      • Bathurst, New South Wales, Australia, 2795
        • Recruiting
        • Western NSW LHD
        • Contact:
          • Laura Boundy
        • Principal Investigator:
          • Laura Boundy
      • Broken Hill, New South Wales, Australia
        • Not yet recruiting
        • Far West LHD
        • Contact:
          • Trevor Slattery
        • Principal Investigator:
          • Kendall Jackman
      • Broken Hill, New South Wales, Australia
        • Completed
        • Maari Ma Health Aboriginal Corporation
      • Coffs Harbour, New South Wales, Australia
        • Completed
        • Galambila Aboriginal Health Service
      • Gosford, New South Wales, Australia, 2250
        • Recruiting
        • Central Coast LHD
        • Principal Investigator:
          • Amanda Burfitt
        • Contact:
          • Amanda Burfitt
      • Inverell, New South Wales, Australia
        • Completed
        • Armajun Health Service Aboriginal Corporation
      • Lismore, New South Wales, Australia
        • Completed
        • Rekindling the Spirit Health Service
      • Newtown, New South Wales, Australia
        • Not yet recruiting
        • Asylum Seeker Centre
        • Contact:
          • Emily Cumming
        • Principal Investigator:
          • Emily Cumming
      • Penrith, New South Wales, Australia
        • Recruiting
        • Nepean Blue Mountains LHD
        • Contact:
          • Emma Phillips
        • Principal Investigator:
          • Prasun Datta
      • Port Macquarie, New South Wales, Australia, 2444
        • Recruiting
        • North and Mid North Coast LHD
        • Contact:
          • Alexandra Wade
        • Principal Investigator:
          • Alexandra Wade
      • Quirindi, New South Wales, Australia
        • Completed
        • Walhallow Aboriginal Corporation
      • South Grafton, New South Wales, Australia
        • Completed
        • Bulgarr Ngaru Medical Aboriginal Corporation
      • Sydney, New South Wales, Australia
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
          • Renier Lagundy
        • Principal Investigator:
          • Marianne Martinello
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • Kirketon Road Centre
        • Contact:
          • Phillip Read
        • Principal Investigator:
          • Phillip Read
      • Sydney, New South Wales, Australia, 2151
        • Recruiting
        • WSLHD Drug Health
        • Principal Investigator:
          • Thao Lam
        • Contact:
          • Meryem Jefferies
      • Sydney, New South Wales, Australia, 2170
        • Recruiting
        • South West Sydney LHD
        • Principal Investigator:
          • Gilbert Whitton
        • Contact:
          • Gary Keogh
      • Sydney, New South Wales, Australia
        • Recruiting
        • NSW Users and AIDS Association
        • Contact:
          • Nikkas Skelley
        • Principal Investigator:
          • Mary Harrod
      • Sydney, New South Wales, Australia
        • Recruiting
        • SESLHD Community and Mental Health POCT Allicance (SCAMPA)
        • Contact:
          • Nathan McGarry
        • Principal Investigator:
          • Amany Zekry
      • Sydney, New South Wales, Australia
        • Recruiting
        • Storr Liver Clinic (Westmead Hospital)
        • Principal Investigator:
          • Jacob George
        • Contact:
          • Kindness Bondezi
      • Sydney, New South Wales, Australia
        • Recruiting
        • Sydney Local Health District
        • Contact:
          • Sophie King
        • Principal Investigator:
          • Shih Chi Kao
      • Sydney, New South Wales, Australia, 2065
        • Recruiting
        • NSLHD
        • Contact:
          • Erica Martin
        • Principal Investigator:
          • Mark Montebello
      • Sydney, New South Wales, Australia
        • Recruiting
        • Hepatitis NSW
        • Contact:
          • Kyle Leadbeatter
        • Principal Investigator:
          • Steven Drew
      • Sydney, New South Wales, Australia
        • Recruiting
        • SESLHD Drug Health
        • Contact:
          • Arshman Sahid
        • Principal Investigator:
          • Apo Demirkol
      • Wagga Wagga, New South Wales, Australia
        • Recruiting
        • Murrumbidgee & Southern LHD
        • Contact:
          • Lauren Coelli
        • Principal Investigator:
          • Lauren Coelli
      • Waratah, New South Wales, Australia
        • Recruiting
        • Hunter New England LHD
        • Contact:
          • Melanie Kingsland
        • Principal Investigator:
          • Melanie Kingsland
      • Wollongong, New South Wales, Australia
        • Recruiting
        • ISLHD Drug and Alcohol Service
        • Principal Investigator:
          • David Reid
        • Contact:
          • Siyu Qian
    • Northern Territory
      • Alice Springs, Northern Territory, Australia
        • Recruiting
        • ADSCA - Alice Springs Hospital
        • Contact:
          • Khim Tan
        • Principal Investigator:
          • Khim Tan
      • Alice Springs, Northern Territory, Australia
        • Recruiting
        • Clinic 34
        • Contact:
          • Khim Tan
        • Principal Investigator:
          • Khim Tan
    • Queensland
      • Brisbane, Queensland, Australia, 4000
        • Recruiting
        • Metro North HHS (Biala and Caboolture)
        • Principal Investigator:
          • Jeremy Hayllar
        • Contact:
          • Kylie Page
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • IHWH Micah Projects
        • Contact:
          • Kim Rayner
        • Principal Investigator:
          • Kim Rayner
      • Cairns, Queensland, Australia, 4870
        • Completed
        • Cairns Sexual Health Service
      • Coorparoo, Queensland, Australia
        • Recruiting
        • Hepatitis QLD
        • Contact:
          • Anna Hawkes
        • Principal Investigator:
          • Anna Hawkes
      • Inala, Queensland, Australia, 4077
        • Recruiting
        • Kombi Clinic
        • Contact:
          • Mim O'Flynn
        • Principal Investigator:
          • Joss O'Loan
      • Inala, Queensland, Australia, 4077
        • Recruiting
        • Metro South Addiction Services - Inala AODS
        • Contact:
          • Joss O'Loan
        • Principal Investigator:
          • Joss O'Loan
      • Ipswich, Queensland, Australia, 4305
        • Terminated
        • Ipswich Sexual Health and BBV Service, West Moreton Health
      • Ipswich, Queensland, Australia, 4305
        • Recruiting
        • Ipswich AODS
        • Contact:
          • Lisa Ball
        • Principal Investigator:
          • Lisa Ball
      • Maroochydore, Queensland, Australia, 4560
        • Recruiting
        • OneBridge
        • Contact:
          • Jennifer Lang
        • Principal Investigator:
          • Sonia Martin
      • Mount Isa, Queensland, Australia, 4825
        • Recruiting
        • North West HHS - Mount Isa ATODS
        • Contact:
          • Georgia Steele
        • Principal Investigator:
          • Ruth Dewar
      • Nambour, Queensland, Australia, 4560
        • Recruiting
        • Sunshine Coast HHS AODS
        • Contact:
          • Matthew Reeves
        • Principal Investigator:
          • Matthew Reeves
      • West End, Queensland, Australia, 4101
        • Recruiting
        • Ethnic Communities Council of Queensland
        • Contact:
          • Zhihong Gu
        • Principal Investigator:
          • Zhihong Gu
    • South Australia
      • Adelaide, South Australia, Australia, 5069
        • Recruiting
        • Drug and Alcohol Services South Australia
        • Contact:
          • Danica Liu
        • Principal Investigator:
          • Victoria Cock
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Clinic H
        • Contact:
          • Benny Tang
        • Principal Investigator:
          • Benny Tang
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • The Queen Elizabeth Hospital, Central Adelaide LHN
        • Principal Investigator:
          • Morgyn Warner
        • Contact:
          • Jeffery Stewart
      • Adelaide, South Australia, Australia, 5112
        • Recruiting
        • Lyell McEwin Hospital, North Adelaide LHN
        • Principal Investigator:
          • Damien Harding
        • Contact:
          • Bin Chen
      • Adelaide, South Australia, Australia, 5168
        • Recruiting
        • Flinders Medical Centre, South Adelaide LHN
        • Principal Investigator:
          • Alan Wigg
        • Contact:
          • Sumudu Narayana
      • Hackney, South Australia, Australia, 5069
        • Recruiting
        • Hepatitis SA
        • Contact:
          • Lisa Carter
        • Principal Investigator:
          • Lisa Carter
      • Mount Gambier, South Australia, Australia
        • Completed
        • Pangula Mannamurna Aboriginal Corporation
    • Tasmania
      • Hobart, Tasmania, Australia
        • Recruiting
        • Tasmanian Sexual Health Service - Clinic 60
        • Contact:
          • Tina Evans
        • Principal Investigator:
          • Adriana Trujillo
      • New Town, Tasmania, Australia
        • Withdrawn
        • Moreton Group Rural Health
    • Victoria
      • Ascot Vale, Victoria, Australia, 3032
        • Recruiting
        • Ascot Vale Pharmacy
        • Contact:
          • Alice Horrigan
        • Principal Investigator:
          • Alice Horrigan
      • Ballarat, Victoria, Australia
        • Recruiting
        • Ballarat Community Health
        • Contact:
          • Ingrid Taylor
        • Principal Investigator:
          • Ingrid Taylor
      • Brunswick, Victoria, Australia, 3056
        • Recruiting
        • Harm Reduction Victoria
        • Contact:
          • Jane Dicka
        • Principal Investigator:
          • Sione Crawford
      • Footscray, Victoria, Australia, 3011
        • Recruiting
        • Western Health
        • Contact:
          • Nhung Duong
        • Principal Investigator:
          • Thileepan Naren
      • Melbourne, Victoria, Australia
        • Recruiting
        • St Vincent's Hospital (Melbourne)
        • Principal Investigator:
          • Jacinta Holmes
        • Contact:
          • Adam Pastor
      • Melbourne, Victoria, Australia, 3128
        • Recruiting
        • Eastern Health
        • Principal Investigator:
          • Rohit Sawhney
        • Contact:
          • Cathy Ngo
      • Melbourne, Victoria, Australia
        • Recruiting
        • Youth Projects - The Living Room
        • Contact:
          • Ally Sampson
        • Principal Investigator:
          • Fiona Cook
      • Morwell, Victoria, Australia, 3840
        • Recruiting
        • Latrobe Community Health Service Liited
        • Contact:
          • Neal Daly
        • Principal Investigator:
          • Naomi Taylor
      • Shepparton, Victoria, Australia, 3630
        • Recruiting
        • Goulburn Valley Community Health
        • Contact:
          • Vinay Menon
        • Principal Investigator:
          • Vinay Menon
      • Shepparton, Victoria, Australia, 3630
        • Recruiting
        • Primary Care Connect
        • Contact:
          • Lily Summers
        • Principal Investigator:
          • Lily Summers
    • Western Australia
      • Bunbury, Western Australia, Australia, 6230
        • Recruiting
        • Peer Based Harm Reduction Bunbury
        • Contact:
          • Jodie Savage
        • Principal Investigator:
          • Julie Byrne-King
      • Fremantle, Western Australia, Australia
        • Recruiting
        • South Terrace Clinic - Fremantle Hospital
        • Contact:
          • Joseph Cotter
        • Principal Investigator:
          • Joseph Cotter
      • Gosnells, Western Australia, Australia, 6110
        • Recruiting
        • Pramana Medical Centre
        • Contact:
          • Kate Fulford
        • Principal Investigator:
          • Kate Fulford
      • Mount Barker, Western Australia, Australia, 6324
        • Not yet recruiting
        • Plantagenet Medical
        • Contact:
          • Amanda Villis
        • Principal Investigator:
          • Amanda Villis
      • Perth, Western Australia, Australia
        • Not yet recruiting
        • Next Step East Perth
        • Contact:
          • Shuan Tan
      • Perth, Western Australia, Australia
        • Recruiting
        • Hepatitis WA
        • Contact:
          • Alison Lori
        • Principal Investigator:
          • Alison Lori
      • Perth, Western Australia, Australia, 6230
        • Recruiting
        • Peer Based Harm Reduction - Perth
        • Principal Investigator:
          • Julie Byrne-King
        • Contact:
          • Julie Byrne-King
      • Perth, Western Australia, Australia
        • Active, not recruiting
        • Next Step Fremantle
      • Perth, Western Australia, Australia
        • Recruiting
        • Next Step Warwick
        • Contact:
          • Michael Cao
        • Principal Investigator:
          • Wendy Lawrance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People at risk of HCV acquisition
This is an observational cohort study. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to receive point-of-care HCV testing and complete a self-administered survey. Testing will be performed using point-of-care HCV antibody testing (results within 1-20 minutes, depending on the test) and if positive, HCV RNA testing will be performed. Participants who have previously had HCV infection or previously received HCV treatment will be tested using point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA detectable will be linked to standard of care for any other clinical assessments and treatment initiation.
Diagnostic test: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following HCV RNA testing.
Time Frame: 12 Weeks from enrolment
HCV treatment
12 Weeks from enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Time Frame: Recruitment phase
Accepting testing
Recruitment phase
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Time Frame: Recruitment phase
Prevalence
Recruitment phase
To evaluate the time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing
Time Frame: 52 weeks
Time to treatment
52 weeks
To evaluate the proportion of HCV RNA detectable participants who initiate HCV treatment at 12 months (52 weeks) following detectable finger-stick point-of-care HCV RNA testing.
Time Frame: 52 weeks
Initiation of treatment
52 weeks
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.
Time Frame: 52 weeks
Completion of treatment
52 weeks
To evaluate the proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit of quantitation at post treatment week 12) following a detectable HCV RNA test result.
Time Frame: 12 weeks
SVR
12 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following a detectable HCV RNA test.
Time Frame: 52 weeks
HCV negative
52 weeks
To evaluate the cost-effectiveness of different testing strategies
Time Frame: 52 weeks
Cost-effectiveness
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Collaborators

Flinders University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP2101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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