The National Australian HCV Point-of-Care Testing Program

Study Overview
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Brief Summary
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The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). Participants will attend a single visit to have their HCV RNA status tested and complete a self-administered survey. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.

Detailed Description
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The advent of simple direct-acting antiviral hepatitis C (HCV) therapies with cure rates >95% is one of the greatest medical advances in decades, having led to a reversal in liver-related mortality. In Australia, treatment uptake has declined between 2016 (32,000 treated) and 2019/20 (2019: 11,500; 2020: 8,500).1 Progress towards HCV elimination has been impeded by COVID-19, affecting the delivery of national and state-based HCV strategies. Improving HCV treatment uptake to reduce disease burden is a key aim of global, national and state-based HCV strategies.2-4 Scale-up of HCV testing and treatment will be required to achieve elimination by 2030. Current diagnostic pathways require multiple visits to a practitioner reducing the proportion who receive a diagnosis. In Australia, 81% of people have had HCV antibody testing (indicates exposure), but only 47% have been HCV RNA tested (indicates active infection and the need for HCV treatment).5 Mathematical modelling suggests that HCV RNA testing needs to increase by at least 50% annually to achieve elimination in Australia by 2030.6 The Kirby Institute is an international leader in research evaluating the Xpert HCV assay (Grebely Lancet Gastro Hep 2017), having built a large network of Xpert platforms for HCV testing in needle and syringe programs, prisons, drug treatment clinics, tertiary hospitals, and Aboriginal Community Controlled Health Service. In Kirby-led research, point-of-care HCV testing interventions in needle and syringe programs and prisons have resulted in high HCV treatment uptake (70-90%). The Kirby Institute and Flinders University also have a strong track record of implementing point-of-care testing for STIs and COVID-19, providing an ideal foundation to scale-up Xpert HCV testing in Australia. The Kirby Institute and Flinders University will establish the Australian National HCV Point-of-care Testing Program for the scale-up of point-of-care HCV RNA testing in services with high prevalence of HCV infection, including community health centres, drug treatment clinics, needle and syringe programs, and prisons. This program will include the development of standard operating procedures, logistics/deployment, initial set-up, an operator training program, and quality assurance and competency assessment program. An observational cohort study that will be established to evaluate HCV treatment uptake following scale-up of point-of-care HCV testing among people with a risk factor for acquisition of HCV infection or people attending a service caring for people with risk factors for the acquisition of HCV infection. This study will also include the linkage of survey data to a range of administrative datasets which will be used to evaluate the impact of HCV testing and treatment scale-up on a range of long-term health outcomes. 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 receive point-of-care HCV testing and complete a self-administered survey. In settings with high anticipated HCV antibody prevalence (>15%; e.g. drug treatment, prisons, needle and syringe programs), people who have previously been told they have HCV infection, or for people who have previously received HCV treatment, testing will be performed using point-of-care HCV RNA testing (results in one hour). In settings with a low anticipated HCV antibody prevalence (<15%; e.g. mental health, homelessness), testing will be performed using point-of-care HCV antibody testing (results in 20 minutes) and if positive, point-of-care HCV RNA testing will be performed. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care for any other clinical assessments and treatment initiation.

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

Conditions
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Hepatitis C

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provided informed consent. ≥ 18 years of age. Have a risk factor for the acquisition of HCV infection (including current or past injecting drug use, previous incarceration, HIV infection, receiving blood products prior to 1990, having a tattoo or piercing in an unregulated environment, a needle-stick injury, or a mother with HCV). OR: Are attending a service caring for people with risk factors for the acquisition of HCV infection (e.g. drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, and homelessness services). Exclusion Criteria: a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.

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. In settings with high anticipated HCV antibody prevalence (>15%; e.g. drug treatment, prisons, needle and syringe programs), people who have previously been told they have HCV infection, or people who have previously received HCV treatment, testing will be performed using point-of-care HCV RNA testing. In settings with a low anticipated HCV antibody prevalence (<15%; e.g. mental health, homelessness), testing will be performed using point-of-care HCV antibody testing and if positive, point-of-care HCV RNA testing will be performed. | 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 |
| --- | --- | --- |
| 1. To evaluate the proportion of people who accept point-of-care testing among those offered testing. | Accepting testing | Recruitment phase | 
| 2. To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. | Prevalence | Recruitment phase | 
| 3. To evaluate the time to HCV treatment uptake among people who receive treatment. | Time to treatment | 52 weeks | 
| 4. 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 | 
| 5. To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment. | Completion of treatment | 52 weeks | 
| 6. To evaluate the proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit of quantitation at post treatment week 12). | SVR | 12 weeks | 
| 7. 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 | 
| 8. To evaluate the cost-effectiveness of different testing strategies | Cost-effectiveness | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus