Hepatitis CNCT05713136
The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
An observational study of Hepatitis C, run by Kirby Institute at 13 sites in Australia.
Trial summary
The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. 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?
- Diagnostic Test: Point-of-Care Testing
- Type of treatment
- Medical device
- How many people
- 40,000 participants
- Where
- 13 sitesAustralia
- Study dates
- 23 Feb 2023to Jun 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 included 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 that approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.
Who may be able to join
- Provide informed consent
- ≥ 18 years of age.
Who cannot join
- Is unable or unwilling to provide informed consent
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Australia13 sites, 12 recruiting
- Not yet recruiting
South Australian Prison Health Service
Adelaide, South Australia
Tom Turnbull
Tom Turnbull
- Recruiting
Acacia Prison
Beechina, Western Australia, 6558
Tahlia Kinnane, (08) 9573 3300, tahlia.kinnane@serco-ap.com
- Active, not recruiting
Queensland Injectors Health Network Ltd
Bowen Hills, Queensland, 4006
- Recruiting
West Moreton Hospital and Health Service
Brisbane, Queensland
Chris Wallis, (07) 3810 1111, christopher.wallis@health.qld.gov.au
- Recruiting
Lotus Glen Correctional Centre
Cairns, Queensland
Kerry Williamson, (07) 4093 3911, Kerry.Williamson@Corrections.qld.gov.au
- Not yet recruiting
ACT Justice Health
Canberra, Australian Capital Territory
Alex Misev
Alex Misev, Dr
- Not yet recruiting
Hepatitis South Australia
Hackney, South Australia, 5069
Lisa Carter
- Not yet recruiting
Tasmanian Prison Service
Hobart, Tasmania
Deborah Siddell
Meredith Stronach
- Recruiting
St Vincent's Hospital (Melbourne)
Melbourne, Victoria
Alex Thompson
Alex Thompson, Prof
- Not yet recruiting
WA Department of Justice
Perth, Western Australia, 6000
Holly Beasley
- Recruiting
Justice Health and Forensic Mental Health Network
Sydney, New South Wales
Tracey Brown
- Not yet recruiting
Townsville Correctional Centre
Townsville, Queensland, 4810
John Morey
- Recruiting
Woodford Correctional Centre
Woodford, Queensland
Lyn Cadman, (07) 5422 5200, lyn.cadman@health.qld.gov.au
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 - HCV Antibody Testing Minimal Dataset
The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is:
What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis?
Read more
Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit.
No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.
- Conditions
- Hepatitis C
- Being tested
- Diagnostic Test: Point-of-Care Testing
- Keywords
- Point-of-Care, Rapid Diagnostic Testing, HCV
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Point-of-Care TestingDevice
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: Device: Diagnostic Test: Point-of-Care Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
HCV treatment
Measured: 12 weeks from enrolment
Secondary outcomes (9)
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Accepting testing
Measured: Recruitment phase
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Prevalence
Measured: Recruitment phase
To evaluate the HCV antibody prevalence among people tested.
Prevalence
Measured: Recruitment phase
To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
Time to treatment
Measured: 52 weeks
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.
Initiation of treatment
Measured: 52 weeks
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
Completion of treatment
Measured: 52 weeks
To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment
SVR
Measured: 52 weeks
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.
HCV negative
Measured: 52 weeks
To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care.
Cost-effectiveness
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 posted6 Feb 2023
- Study start23 Feb 2023
- Primary completionJun 2029 (estimated)
- Study completionJun 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
- 40,000 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
- NCT05713136
- Sponsor's protocol ID
- VHCRP2203
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 - HCV Antibody Testing Minimal Dataset
- ClinicalTrials.gov ID
- NCT05713136
- Acronym / sponsor ID
- VHCRP2203
- Conditions
- Hepatitis C
- Keywords
- Point-of-Care, Rapid Diagnostic Testing, HCV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Flinders University
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 6 Feb 2023 (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 goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is:
What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis?
Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit.
No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People at risk of HCV acquisition | – | Device: 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 included 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 that approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.
Key inclusion criteria (2 listed)
- Provide informed consent
- ≥ 18 years of age.
Key exclusion criteria (1 listed)
- Is unable or unwilling to provide informed consent
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 |
|---|---|---|
| Diagnostic Test: Point-of-Care TestingParticipants will be offered finger-stick point-of-care testing for HCV | Device | People at risk of HCV acquisition |
Primary outcome
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.
Time frame: 12 weeks from enrolment
HCV treatment
9 secondary outcomes
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Time frame: Recruitment phase
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Time frame: Recruitment phase
To evaluate the HCV antibody prevalence among people tested.
Time frame: Recruitment phase
To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
Time frame: 52 weeks
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.
Time frame: 52 weeks
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
Time frame: 52 weeks
To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment
Time frame: 52 weeks
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.
Time frame: 52 weeks
To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care.
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.
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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.
13 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 13 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 13 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?
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. (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.