RecruitingNCT05713136

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

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


Sponsor

Kirby Institute

Enrollment

40,000 participants

Start Date

Jan 25, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Provide informed consent
  • ≥ 18 years of age.

Exclusion Criteria1

  • Is unable or unwilling to provide informed consent

Interventions

DEVICEDiagnostic 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

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NCT05713136


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