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

Hepatitis C Clinical Trial

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 - Minimal Dataset

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248555
• Other study ID #: VHCRP2104
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: Kirby Institute
• Contact: David Silk, BSc
• Phone: +61293850900
• Email: dsilk[@]kirby.unsw.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.

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 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.

Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. All participants who undergo point-of-care HCV testing at the study site will be included in the data collection. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40000
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age.

• Received point-of-care HCV testing.

Exclusion Criteria:

• Nil

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Diagnostic Test:
• Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV

Locations

Country	Name	City	State
Australia	Lotus Glen Correctional Centre	Cairns	Queensland
Australia	Hepatitis Queensland	Coorparoo	Queensland
Australia	St Vincent's Correctional Health Services	Fitzroy	Victoria
Australia	West Moreton Hospital and Health Service	Ipswich	Queensland
Australia	South Australian Prison Health Service	Marden	South Australia
Australia	Medically Supervised Injecting Room	Melbourne	Victoria
Australia	Mount Gambier Priosn	Mount Gambier	South Australia
Australia	Geo Healthcare - The Geo Group Australia Pty Ltd	Ravenhall	Victoria
Australia	Justice Health and Forensic Mental Health Network	Sydney	New South Wales
Australia	Townsville Correctional Centre	Townsville	Queensland
Australia	Woodford Correctional Centre	Woodford	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Kirby Institute	Flinders University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of HCV infected participants who initiate HCV treatment at 12 weeks	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
Secondary	The proportion of participants who accept point-of-care testing	To evaluate the proportion of people who accept point-of-care testing among those offered testing.	2 years from recruitment commencement
Secondary	The prevalence of HCV infection amongst study participants tested	To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.	2 years from recruitment commencement
Secondary	To evaluate the time to HCV treatment uptake among HCV RNA positive participants	To evaluate the length of time participants take to initiate HCV treatment after diagnosis	52 weeks
Secondary	To evaluate proportion of HCV RNA positive participants who initiate HCV 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
Secondary	To evaluate the proportion of participants who complete HCV (DAA) treatment	To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.	52 weeks
Secondary	To evaluate the proportion of participants who achieve an SVR	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).	12 weeks
Secondary	To evaluate the proportion of participants who are HCV RNA negative at 12 months	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