Hepatitis CHCVPOCTNCT05042544
The Australian HCV Point-of-Care Testing Program
An observational study of Hepatitis C, run by Kirby Institute at 69 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
- 60,000 participants
- Where
- 69 sitesAustralia
- Study dates
- 23 Feb 2022to 30 Jun 2029
- How long will I take part?
- 12 Months
- 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
- Provided informed consent.
- ≥ 18 years of age.
- 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:
- 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).
Who cannot join
- Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Trial locations and contacts
69 sites in 1 country. Contact the study team or a site near you to ask about taking part.
69 sites in 1 country
Australia69 sites, 56 recruiting
- Recruiting
Clinic H
Adelaide, South Australia, 5000
Benny Tang
Benny Tang
- Recruiting
The Queen Elizabeth Hospital, Central Adelaide LHN
Adelaide, South Australia, 5000
Jeffery Stewart
Morgyn Warner
- Recruiting
Drug and Alcohol Services South Australia
Adelaide, South Australia, 5069
Danica Liu
Victoria Cock
- Recruiting
Lyell McEwin Hospital, North Adelaide LHN
Adelaide, South Australia, 5112
Bin Chen
Damien Harding
- Recruiting
Flinders Medical Centre, South Adelaide LHN
Adelaide, South Australia, 5168
Sumudu Narayana
Alan Wigg
- Recruiting
ADSCA - Alice Springs Hospital
Alice Springs, Northern Territory
Khim Tan
Khim Tan
- Recruiting
Clinic 34
Alice Springs, Northern Territory
Khim Tan
Khim Tan
- Completed
Ascot Vale Pharmacy
Ascot Vale, Victoria, 3032
- Recruiting
Ballarat Community Health
Ballarat, Victoria
Ingrid Taylor
Ingrid Taylor
- Recruiting
Western NSW LHD
Bathurst, New South Wales, 2795
Laura Boundy
Laura Boundy
- Recruiting
Metro North HHS (Biala and Caboolture)
Brisbane, Queensland, 4000
Kylie Page
Jeremy Hayllar
- Recruiting
IHWH Micah Projects
Brisbane, Queensland, 4101
Kim Rayner
Kim Rayner
- Not yet recruiting
Far West LHD
Broken Hill, New South Wales
Trevor Slattery
Kendall Jackman
- Completed
Maari Ma Health Aboriginal Corporation
Broken Hill, New South Wales
- Recruiting
Harm Reduction Victoria
Brunswick, Victoria, 3056
Jane Dicka
Sione Crawford
- Recruiting
Peer Based Harm Reduction Bunbury
Bunbury, Western Australia, 6230
Jodie Savage
Julie Byrne-King
- Completed
Cairns Sexual Health Service
Cairns, Queensland, 4870
- Recruiting
Hepatitis ACT
Canberra, Australian Capital Territory, 2612
Kareen Tait
Sarah Ahmed
- Completed
Galambila Aboriginal Health Service
Coffs Harbour, New South Wales
- Recruiting
Hepatitis QLD
Coorparoo, Queensland
Anna Hawkes
Suzy McLucas
- Recruiting
Western Health
Footscray, Victoria, 3011
Nhung Duong
Thileepan Naren
- Recruiting
South Terrace Clinic - Fremantle Hospital
Fremantle, Western Australia
Joseph Cotter
Joseph Cotter
- Recruiting
Central Coast LHD
Gosford, New South Wales, 2250
Amanda Burfitt
Amanda Burfitt
- Recruiting
Pramana Medical Centre
Gosnells, Western Australia, 6110
Kate Fulford
Kate Fulford
- Recruiting
Hepatitis SA
Hackney, South Australia, 5069
Lisa Carter
Lisa Carter
- Recruiting
Tasmanian Sexual Health Service - Clinic 60
Hobart, Tasmania
Tina Evans
Adriana Trujillo
- Recruiting
Kombi Clinic
Inala, Queensland, 4077
Mim O'Flynn
Joss O'Loan
- Recruiting
Metro South Addiction Services - Inala AODS
Inala, Queensland, 4077
Joss O'Loan
Joss O'Loan
- Completed
Armajun Health Service Aboriginal Corporation
Inverell, New South Wales
- Recruiting
Ipswich AODS
Ipswich, Queensland, 4305
Lisa Ball
Lisa Ball
- Terminated
Ipswich Sexual Health and BBV Service, West Moreton Health
Ipswich, Queensland, 4305
- Completed
Rekindling the Spirit Health Service
Lismore, New South Wales
- Recruiting
OneBridge
Maroochydore, Queensland, 4560
Jennifer Lang
Sonia Martin
- Recruiting
Eastern Health
Melbourne, Victoria, 3128
Cathy Ngo
Rohit Sawhney
- Recruiting
St Vincent's Hospital (Melbourne)
Melbourne, Victoria
Adam Pastor
Jacinta Holmes
- Recruiting
Youth Projects - The Living Room
Melbourne, Victoria
Ally Sampson
Fiona Cook
- Recruiting
Latrobe Community Health Service Liited
Morwell, Victoria, 3840
Neal Daly
Naomi Taylor
- Not yet recruiting
Plantagenet Medical
Mount Barker, Western Australia, 6324
Amanda Villis
Amanda Villis
- Completed
Pangula Mannamurna Aboriginal Corporation
Mount Gambier, South Australia
- Recruiting
North West HHS - Mount Isa ATODS
Mount Isa, Queensland, 4825
Georgia Steele
Ruth Dewar
- Recruiting
Sunshine Coast HHS AODS
Nambour, Queensland, 4560
Matthew Reeves
Matthew Reeves
- Withdrawn
Moreton Group Rural Health
New Town, Tasmania
- Not yet recruiting
Asylum Seeker Centre
Newtown, New South Wales
Emily Cumming
Emily Cumming
- Recruiting
Nepean Blue Mountains LHD
Penrith, New South Wales
Emma Phillips
Prasun Datta
- Recruiting
Peer Based Harm Reduction - Perth
Perth, Western Australia, 6230
Julie Byrne-King
Julie Byrne-King
- Recruiting
Hepatitis WA
Perth, Western Australia
Alison Lori
Alison Lori
- Not yet recruiting
Next Step East Perth
Perth, Western Australia
Shuan Tan
- Active, not recruiting
Next Step Fremantle
Perth, Western Australia
- Recruiting
Next Step Warwick
Perth, Western Australia
Michael Cao
Wendy Lawrance
- Recruiting
North and Mid North Coast LHD
Port Macquarie, New South Wales, 2444
Alexandra Wade
Alexandra Wade
- Completed
Walhallow Aboriginal Corporation
Quirindi, New South Wales
- Recruiting
Goulburn Valley Community Health
Shepparton, Victoria, 3630
Vinay Menon
Vinay Menon
- Recruiting
Primary Care Connect
Shepparton, Victoria, 3630
Lily Summers
Lily Summers
- Completed
Bulgarr Ngaru Medical Aboriginal Corporation
South Grafton, New South Wales
- Recruiting
Kirketon Road Centre
Sydney, New South Wales, 2010
Phillip Read
Phillip Read
- Recruiting
NSLHD
Sydney, New South Wales, 2065
Erica Martin
Mark Montebello
- Recruiting
WSLHD Drug Health
Sydney, New South Wales, 2151
Meryem Jefferies
Thao Lam
- Completed
South West Sydney LHD
Sydney, New South Wales, 2170
- Recruiting
Hepatitis NSW
Sydney, New South Wales
Kyle Leadbeatter
Steven Drew
- Recruiting
NSW Users and AIDS Association
Sydney, New South Wales
Mary Harrod
Mary Harrod
- Recruiting
Prince of Wales Hospital
Sydney, New South Wales
Renier Lagundy
Marianne Martinello
- Recruiting
SESLHD Community and Mental Health POCT Allicance (SCAMPA)
Sydney, New South Wales
Nathan McGarry
Amany Zekry
- Recruiting
SESLHD Drug Health
Sydney, New South Wales
Arshman Sahid
Apo Demirkol
- Recruiting
Storr Liver Clinic (Westmead Hospital)
Sydney, New South Wales
Kindness Bondezi
Jacob George
- Recruiting
Sydney Local Health District
Sydney, New South Wales
Sophie King
Shih Chi Kao
- Recruiting
Murrumbidgee & Southern LHD
Wagga Wagga, New South Wales
Lauren Coelli
Lauren Coelli
- Recruiting
Hunter New England LHD
Waratah, New South Wales
Melanie Kingsland
Melanie Kingsland
- Recruiting
Ethnic Communities Council of Queensland
West End, Queensland, 4101
Zhihong Gu
Zhihong Gu
- Recruiting
ISLHD Drug and Alcohol Service
Wollongong, New South Wales
Siyu Qian
David Reid
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
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.
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 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.
- 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 | 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. Receives: 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 HCV RNA testing.
HCV treatment
Measured: 12 Weeks from enrolment
Secondary outcomes (8)
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 time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing
Time to treatment
Measured: 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.
Initiation of treatment
Measured: 52 weeks
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.
Completion of treatment
Measured: 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.
SVR
Measured: 12 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following a detectable HCV RNA test.
HCV negative
Measured: 52 weeks
To evaluate the cost-effectiveness of different testing strategies
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 posted13 Sep 2021
- Study start23 Feb 2022
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 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
- 60,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Flinders University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042544
- Sponsor's protocol ID
- VHCRP2101
- Acronym
- HCVPOCT
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2021
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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
- ClinicalTrials.gov ID
- NCT05042544
- Acronym / sponsor ID
- HCVPOCT / VHCRP2101
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C Virus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Flinders University
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 13 Sep 2021 (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). 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People at risk of HCV acquisition | – | Diagnostic Test: Point-of-Care TestingThis 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. |
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 (5 listed)
- Provided informed consent.
- ≥ 18 years of age.
- 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).
- 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).
Key exclusion criteria (1 listed)
- Is unable or unwilling to provide informed consent or abide by the requirements of the study.
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
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
8 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 time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing
Time frame: 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
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.
Time frame: 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
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
To evaluate the cost-effectiveness of different testing strategies
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.
69 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 69 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 5 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 69 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 C 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 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.