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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Device: Diagnostic Test: Point-of-Care Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide informed consent ≥ 18 years of age. Exclusion Criteria: Is unable or unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| People at risk of HCV acquisition<br>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<br>* Participants will be offered finger-stick point-of-care testing for HCV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | HCV treatment | 12 weeks from enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the proportion of people who accept point-of-care testing among those offered testing. | Accepting testing | Recruitment phase | 
| To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. | Prevalence | Recruitment phase | 
| To evaluate the HCV antibody prevalence among people tested. | Prevalence | 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 to treatment | 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. | Initiation of treatment | 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; | Completion of treatment | 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 | SVR | 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. | HCV negative | 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. | Cost-effectiveness | 52 weeks |