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

Kirby Institute

Status: Enrolling

Conditions: Hepatitis C

Treatments: Device: Diagnostic Test: Point-of-Care Testing

Study type: Observational

Funder types: Other

Identifiers

NCT05713136

VHCRP2203

Details and patient eligibility

About

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.

Enrollment: 40,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provide informed consent
• ≥ 18 years of age.

Exclusion criteria

• Is unable or unwilling to provide informed consent

Trial design

40,000 participants in 1 patient group

People at risk of HCV acquisition

Description:

Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing

Treatment:

Device: Diagnostic Test: Point-of-Care Testing