The National Australian HCV Point-of-Care Testing Program - Minimal Dataset
NCT ID: NCT05248555
Last Updated: 2024-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40000 participants
OBSERVATIONAL
2021-12-01
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
Interventions
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Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
Eligibility Criteria
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Inclusion Criteria
* Received point-of-care HCV testing.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Flinders University
OTHER
Kirby Institute
OTHER_GOV
Responsible Party
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Locations
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Justice Health and Forensic Mental Health Network
Sydney, New South Wales, Australia
Lotus Glen Correctional Centre
Cairns, Queensland, Australia
Hepatitis Queensland
Coorparoo, Queensland, Australia
West Moreton Hospital and Health Service
Ipswich, Queensland, Australia
Townsville Correctional Centre
Townsville, Queensland, Australia
Woodford Correctional Centre
Woodford, Queensland, Australia
South Australian Prison Health Service
Marden, South Australia, Australia
Mount Gambier Priosn
Mount Gambier, South Australia, Australia
St Vincent's Correctional Health Services
Fitzroy, Victoria, Australia
Medically Supervised Injecting Room
Melbourne, Victoria, Australia
Geo Healthcare - The Geo Group Australia Pty Ltd
Ravenhall, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Tracey Brown
Role: primary
Darren Russell
Role: primary
Rachael Bryett
Role: primary
Blake Ponting
Role: primary
John Morey
Role: primary
Rajendra Prakash
Role: primary
Tom Turnbull
Role: primary
William Galloway
Role: primary
Alex Thompson
Role: primary
Nathan Stam
Role: primary
David Grace
Role: primary
Other Identifiers
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VHCRP2104
Identifier Type: -
Identifier Source: org_study_id
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