The National Australian HCV Point-of-Care Testing Program

Recruiting

• Conditions: Hepatitis C

• Registration Number: NCT05042544
• Lead Sponsor: Kirby Institute

Brief Summary

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

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. Testing will be performed using point-of-care HCV antibody testing (results within 1-20 minutes, depending on the test) and if positive, HCV RNA testing will be performed. Participants who have previously had HCV infection or previously received HCV treatment will be tested using point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA detectable will be linked to standard of care for any other clinical assessments and treatment initiation.

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-13
• Study Start: 2022-02-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

1. Provided informed consent.

2. ≥ 18 years of age.

3. 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:

4. 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.

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 HCV RNA testing.	12 Weeks from enrolment	HCV treatment

Secondary Outcome Measures

Name	Time	Method
To evaluate the time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing	52 weeks	Time to treatment
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 proportion of participants who are HCV RNA negative at 12 months (52 weeks) following a detectable HCV RNA test.	52 weeks	HCV negative
To evaluate the cost-effectiveness of different testing strategies	52 weeks	Cost-effectiveness
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.	52 weeks	Completion of treatment
To evaluate the proportion of HCV RNA detectable participants who initiate HCV treatment at 12 months (52 weeks) following detectable finger-stick point-of-care HCV RNA testing.	52 weeks	Initiation of treatment
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) following a detectable HCV RNA test result.	12 weeks	SVR

Trial Locations

Locations (56)

Hepatitis ACT; 🇦🇺 Canberra, Australian Capital Territory, Australia

Western NSW LHD; 🇦🇺 Bathurst, New South Wales, Australia

Far West LHD; 🇦🇺 Broken Hill, New South Wales, Australia

Maari Ma Health Aboriginal Corporation; 🇦🇺 Broken Hill, New South Wales, Australia

Galambila Aboriginal Health Service; 🇦🇺 Coffs Harbour, New South Wales, Australia

Central Coast LHD; 🇦🇺 Gosford, New South Wales, Australia

Armajun Health Service Aboriginal Corporation; 🇦🇺 Inverell, New South Wales, Australia

Rekindling the Spirit Health Service; 🇦🇺 Lismore, New South Wales, Australia

Nepean Blue Mountains LHD; 🇦🇺 Penrith, New South Wales, Australia

North and Mid North Coast LHD; 🇦🇺 Port Macquarie, New South Wales, Australia

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