The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
Study Details
Study Description
Brief Summary
This is an observational cohort study. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to have HCV point-of-care testing. Participants who have not previously received HCV treatment will have a point-of-care HCV antibody test, followed by reflex point-of-care HCV RNA test if positive. Those who have a history of HCV treatment will proceed straight to point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will receive treatment via standard of care. The purpose of this study is to look at the effect of finger-stick point-of-care hepatitis C testing, to see if it increases the number of tests, diagnoses, and treatments for people with a risk factor of having hepatitis C in Australia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| People at risk of HCV acquisition 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 |
Device: Diagnostic Test: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
|
Outcome Measures
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. [12 weeks from enrolment]
HCV treatment
Secondary Outcome Measures
- To evaluate the proportion of people who accept point-of-care testing among those offered testing. [Recruitment phase]
Accepting testing
- To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. [Recruitment phase]
Prevalence
- 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 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 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
- 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 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 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provide informed consent
-
≥ 18 years of age.
Exclusion Criteria:
- Is unable or unwilling to provide informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kirby Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VHCRP2203