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The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
Sponsor: Kirby Institute
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. 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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40000
Start Date
2023-01-25
Completion Date
2027-01
Last Updated
2024-07-03
Healthy Volunteers
Yes
Conditions
Interventions
Diagnostic Test: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
Locations (12)
ACT Justice Health
Canberra, Australian Capital Territory, Australia
Justice Health and Forensic Mental Health Network
Sydney, New South Wales, Australia
Queensland Injectors Health Network Ltd
Bowen Hills, Queensland, Australia
West Moreton Hospital and Health Service
Brisbane, Queensland, Australia
Lotus Glen Correctional Centre
Cairns, Queensland, Australia
Townsville Correctional Centre
Townsville, Queensland, Australia
Woodford Correctional Centre
Woodford, Queensland, Australia
South Australian Prison Health Service
Adelaide, South Australia, Australia
Hepatitis South Australia
Hackney, South Australia, Australia
Tasmanian Prison Service
Hobart, Tasmania, Australia
St Vincent's Hospital (Melbourne)
Melbourne, Victoria, Australia
WA Department of Justice
Perth, Western Australia, Australia