National Australian Study on Finger-stick Point-of-Care Testing for Hepatitis C to Improve Diagnosis and Treatment

What this Trial Is About

This observational study aims to examine whether offering a rapid finger-stick screening test for Hepatitis C virus HCV exposure before conducting a diagnostic test can improve testing, diagnosis, and treatment rates among adults at risk of HCV infection. Participants will be recruited from settings where people with risk factors for HCV acquisition receive services. The main focus is to determine what proportion of those diagnosed with HCV start treatment within 12 weeks after diagnosis. Participants will have one in-person visit where they provide informed consent and undergo a finger-prick rapid test for HCV antibodies. Those without a previous HCV infection history will receive this screening test, and participants with a positive result or prior infection history will then have a diagnostic HCV RNA test during the same visit. No treatment is provided within the study individuals diagnosed with HCV will be referred to standard care clinics for further assessment and treatment initiation. Participant involvement includes the single study visit for testing and consent, followed by a review of medical records 12 weeks later to evaluate treatment initiation. Additional secondary outcomes, such as acceptance rates of point-of-care testing, prevalence of infection, treatment completion, and sustained virological response, will be monitored up to 52 weeks. The study also assesses the cost-effectiveness of different testing approaches and includes long-term data collection through record review, with total participation spanning at least one year after enrollment.

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