The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic Test: Point-of-Care Testing.
- Who it may be relevant to
- Registry conditions: Hepatitis C. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Device Diagnostic Test: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
Primary outcome measures
- 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. [Time frame: 12 weeks from enrolment]
Secondary outcome measures (9)
- To evaluate the proportion of people who accept point-of-care testing among those offered testing. [Time frame: Recruitment phase]
- To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. [Time frame: Recruitment phase]
- To evaluate the HCV antibody prevalence among people tested. [Time frame: Recruitment phase]
- 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; [Time frame: 52 weeks]
- 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. [Time frame: 52 weeks]
- 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; [Time frame: 52 weeks]
- 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 [Time frame: 52 weeks]
- 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. [Time frame: 52 weeks]
- 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. [Time frame: 52 weeks]
Eligibility criteria
Inclusion criteria
- Provide informed consent
- ≥ 18 years of age.
Exclusion criteria
- Is unable or unwilling to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Australia · 12 centers
- ACT Justice Health — Canberra
- Justice Health and Forensic Mental Health Network — Sydney
- Queensland Injectors Health Network Ltd — Bowen Hills
- West Moreton Hospital and Health Service — Brisbane
- Lotus Glen Correctional Centre — Cairns
- Townsville Correctional Centre — Townsville
- Woodford Correctional Centre — Woodford
- South Australian Prison Health Service — Adelaide
- … and 4 more centers
Identifiers
NCT: NCT05713136 · VHCRP2203