NCT05713136

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40,000 (estimated)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DEVICE	Diagnostic Test: Point-of-Care Testing	Participants will be offered finger-stick point-of-care testing for HCV

Timeline

• Start date: 2023-01-25
• Primary completion: 2025-01-01
• Completion: 2027-01-01
• First posted: 2023-02-06
• Last updated: 2024-07-03

Locations

12 sites across 1 country: Australia