Hepatitis CNCT05248555
The National Australian HCV Point-of-Care Testing Program - Minimal Dataset
An observational study of Hepatitis C, run by Kirby Institute at 16 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Point-of-Care Testing
- How many people
- 80,000 participants
- Where
- 16 sitesAustralia
- Study dates
- 23 Jan 2023to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ≥ 18 years of age.
- Received point-of-care HCV testing.
Who cannot join
- Nil
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Australia16 sites, 13 recruiting
- Recruiting
Maryborough Correctional Centre
Aldershot, Queensland, 4650
Ashley Willman, (07) 4123 7600, ashley.willmann@health.qld.gov.au
- Recruiting
QuIHN
Brisbane, Queensland, 4000
Nicholas Alexander, 3620 8111, nalexander@quihn.org
- Recruiting
Lotus Glen Correctional Centre
Cairns, Queensland
Darren Russell
Darren Russell
- Completed
Hepatitis Queensland
Coorparoo, Queensland, 4151
- Active, not recruiting
St Vincent's Correctional Health Services
Fitzroy, Victoria, 3065
- Recruiting
Hepatitis SA
Hackney, South Australia, 5069
Lisa Carter, (08) 8362 8443, lisa@hepatitissa.asn.au
- Recruiting
West Moreton Hospital and Health Service
Ipswich, Queensland
Blake Ponting
Blake Ponting
- Not yet recruiting
South Australian Prison Health Service
Marden, South Australia, 5070
Tom Turnbull
Tom Turnbull
- Recruiting
Medically Supervised Injecting Room
Melbourne, Victoria, 3000
Nathan Stam
Nathan Stam
- Recruiting
Mount Gambier Priosn
Mount Gambier, South Australia, 5290
William Galloway
William Galloway
- Not yet recruiting
Palen Creek Correctional Centre
Rathdowney, Queensland, 4287
Mike Hurley, (07) 5544 3700, mike.hurley@corrections.qld.gov.au
- Recruiting
Dame Phyllis Frost Centre
Ravenhall, Victoria, 3023
Katelyn Mannix, 1300 492 202, katelyn.mannix@wh.org.au
- Recruiting
Geo Healthcare - The Geo Group Australia Pty Ltd
Ravenhall, Victoria, 3023
David Grace
David Grace
- Active, not recruiting
Justice Health and Forensic Mental Health Network
Sydney, New South Wales
- Recruiting
Townsville Correctional Centre
Townsville, Queensland
John Morey
John Morey
- Recruiting
Woodford Correctional Centre
Woodford, Queensland
Rajendra Prakash
Rajendra Prakash
About this study
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
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). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.
Read the 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 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.
Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. All participants who undergo point-of-care HCV testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care for any other clinical assessments and treatment initiation.
- Conditions
- Hepatitis C
- Being tested
- Point-of-Care Testing
- Keywords
- Hepatitis C Virus
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care TestingDiagnostic test
Participants will be offered finger-stick point-of-care testing for HCV
| Study group | Role | What they receive |
|---|---|---|
| People at risk of HCV acquisition | Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing. Receives: Diagnostic Test: Point-of-Care Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of HCV infected participants who initiate HCV treatment at 12 weeks
To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing.
Measured: 12 Weeks from enrolment
Secondary outcomes (7)
The proportion of participants who accept point-of-care testing
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Measured: 2 years from recruitment commencement
The prevalence of HCV infection amongst study participants tested
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Measured: 2 years from recruitment commencement
To evaluate the time to HCV treatment uptake among HCV RNA positive participants
To evaluate the length of time participants take to initiate HCV treatment after diagnosis
Measured: 52 weeks
To evaluate proportion of HCV RNA positive participants who initiate HCV treatment
To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
Measured: 52 weeks
To evaluate the proportion of participants who complete HCV (DAA) treatment
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.
Measured: 52 weeks
To evaluate the proportion of participants who achieve an SVR
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).
Measured: 12 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start23 Jan 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Flinders University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248555
- Sponsor's protocol ID
- VHCRP2104
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2021
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Request to share IPD will be considered by the protocol steering committee on individual basis
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05248555
- Acronym / sponsor ID
- VHCRP2104
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C Virus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80,000 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Flinders University
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.
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 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.
Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. All participants who undergo point-of-care HCV testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care for any other clinical assessments and treatment initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People at risk of HCV acquisition | – | Diagnostic Test: Point-of-Care TestingClinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ≥ 18 years of age.
- Received point-of-care HCV testing.
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-Care TestingParticipants will be offered finger-stick point-of-care testing for HCV | Diagnostic test | People at risk of HCV acquisition |
Primary outcome
The proportion of HCV infected participants who initiate HCV treatment at 12 weeks
Time frame: 12 Weeks from enrolment
To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing.
7 secondary outcomes
The proportion of participants who accept point-of-care testing
Time frame: 2 years from recruitment commencement
The prevalence of HCV infection amongst study participants tested
Time frame: 2 years from recruitment commencement
To evaluate the time to HCV treatment uptake among HCV RNA positive participants
Time frame: 52 weeks
To evaluate proportion of HCV RNA positive participants who initiate HCV treatment
Time frame: 52 weeks
To evaluate the proportion of participants who complete HCV (DAA) treatment
Time frame: 52 weeks
To evaluate the proportion of participants who achieve an SVR
Time frame: 12 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Undecided. Request to share IPD will be considered by the protocol steering committee on individual basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Kirby Institute at 16 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Silk, BSc (+61293850900, dsilk@kirby.unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of HCV infected participants who initiate HCV treatment at 12 weeks (time frame: 12 Weeks from enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.