The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
- Conditions
- Hepatitis C
- Registration Number
- NCT05713136
- Lead Sponsor
- Kirby Institute
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40000
- Provide informed consent
- ≥ 18 years of age.
- Is unable or unwilling to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing. 12 weeks from enrolment HCV treatment
- Secondary Outcome Measures
Name Time Method To evaluate the proportion of people who accept point-of-care testing among those offered testing. Recruitment phase Accepting testing
To evaluate the HCV antibody prevalence among people tested. Recruitment phase Prevalence
To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment; 52 weeks Time to treatment
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. Recruitment phase Prevalence
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing. 52 weeks HCV negative
To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing. 52 weeks Initiation of treatment
To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment 52 weeks SVR
To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care. 52 weeks Cost-effectiveness
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment; 52 weeks Completion of treatment
Trial Locations
- Locations (12)
Hepatitis South Australia
🇦🇺Hackney, South Australia, Australia
West Moreton Hospital and Health Service
🇦🇺Brisbane, Queensland, Australia
ACT Justice Health
🇦🇺Canberra, Australian Capital Territory, Australia
Queensland Injectors Health Network Ltd
🇦🇺Bowen Hills, Queensland, Australia
Townsville Correctional Centre
🇦🇺Townsville, Queensland, Australia
Woodford Correctional Centre
🇦🇺Woodford, Queensland, Australia
South Australian Prison Health Service
🇦🇺Adelaide, South Australia, Australia
Justice Health and Forensic Mental Health Network
🇦🇺Sydney, New South Wales, Australia
WA Department of Justice
🇦🇺Perth, Western Australia, Australia
Lotus Glen Correctional Centre
🇦🇺Cairns, Queensland, Australia
Tasmanian Prison Service
🇦🇺Hobart, Tasmania, Australia
St Vincent's Hospital (Melbourne)
🇦🇺Melbourne, Victoria, Australia