The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset

ConditionHepatitis C
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKirby Institute

About this trial

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.

Eligibility criteria

Qualifiers

Provide informed consent

≥ 18 years of age.

Disqualifiers

Is unable or unwilling to provide informed consent

Trial design

Treatments tested in this trial

  • Diagnostic Test: Point-of-Care Testing

Treatment groups

40,000 Participants
are divided into 1 treatment group

Locations

12
ACT Justice Health CanberraAustralian Capital Territory, Australia
Justice Health and Forensic Mental Health Network SydneyNew South Wales, Australia
Queensland Injectors Health Network Ltd4006, Bowen HillsQueensland, Australia
West Moreton Hospital and Health Service BrisbaneQueensland, Australia

Sponsors and collaborators

Kirby Institute

Lead sponsor

Flinders University

Collaborator