The National Australian HCV Point-of-Care Testing Program

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042544
• Other study ID #: VHCRP2101
• Status: Recruiting
• Start date: February 22, 2022
• Est. completion date: December 2026

Study information

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

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). 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.

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.

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:

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.

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	Central Adelaide Local Health Network	Adelaide	South Australia
Australia	Drug and Alcohol Services South Australia	Adelaide	South Australia
Australia	North Adelaide Local Health Network	Adelaide	South Australia
Australia	South Adelaide Local Health Network	Adelaide	South Australia
Australia	ADSCA - Alice Springs Hospital	Alice Springs	Northern Territory
Australia	Western NSW LHD	Bathurst	New South Wales
Australia	Alcohol and Harm Reduction Biala	Brisbane	Queensland
Australia	Micah Projects	Brisbane	Queensland
Australia	Far West LHD	Broken Hill	New South Wales
Australia	Maari Ma Health Aboriginal Corporation	Broken Hill	New South Wales
Australia	Peer Based Harm Reduction Bunbury	Bunbury	Western Australia
Australia	Cairns Sexual Health Service	Cairns	Queensland
Australia	Hepatitis ACT	Canberra	Australian Capital Territory
Australia	Galambila Aboriginal Health Service	Coffs Harbour	New South Wales
Australia	Hepatitis QLD	Coorparoo	Queensland
Australia	Western Health	Footscray	Victoria
Australia	South Terrace Clinic - Fremantle Hospital	Fremantle	Western Australia
Australia	Central Coast LHD	Gosford	New South Wales
Australia	Hepatitis SA	Hackney	South Australia
Australia	Clinic 60 (Sexual Health Services)	Hobart	Tasmania
Australia	Kombi Clinic	Inala	Queensland
Australia	Metro South Addiction Services - Inala ADS	Inala	Queensland
Australia	Armajun Health Service Aboriginal Corporation	Inverell	New South Wales
Australia	Ipswich AODS	Ipswich	Queensland
Australia	Ipswich Sexual Health and BBV Service, West Moreton Health	Ipswich	Queensland
Australia	Rekindling the Spirit Health Service	Lismore	New South Wales
Australia	OneBridge	Maroochydore	Queensland
Australia	Eastern Health	Melbourne	Victoria
Australia	St Vincent's Hospital (Melbourne)	Melbourne	Victoria
Australia	Youth Projects - The Living Room	Melbourne	Victoria
Australia	Latrobe Community Health Service Liited	Morwell	Victoria
Australia	Pangula Mannamurna Aboriginal Corporation	Mount Gambier	South Australia
Australia	Moreton Group Rural Health	New Town	Tasmania
Australia	Nepean Blue Mountains LHD	Penrith	New South Wales
Australia	Hepatitis WA	Perth	Western Australia
Australia	Next Step East Perth	Perth	Western Australia
Australia	Next Step Fremantle	Perth	Western Australia
Australia	Next Step Warwick	Perth	Western Australia
Australia	Peer Based Harm Reduction WA	Perth	Western Australia
Australia	North and Mid North Coast LHD	Port Macquarie	New South Wales
Australia	Walhallow Aboriginal Corporation	Quirindi	New South Wales
Australia	Bulgarr Ngaru Medical Aboriginal Corporation	South Grafton	New South Wales
Australia	Hepatitis NSW	Sydney	New South Wales
Australia	Kirketon Road Centre	Sydney	New South Wales
Australia	NSLHD	Sydney	New South Wales
Australia	NSW Users and AIDS Association	Sydney	New South Wales
Australia	Prince of Wales Hospital	Sydney	New South Wales
Australia	SESLHD Community and Mental Health POCT Allicance (SCAMPA)	Sydney	New South Wales
Australia	SESLHD Drug Health	Sydney	New South Wales
Australia	South West Sydney LHD	Sydney	New South Wales
Australia	Storr Liver Clinic (Westmead Hospital)	Sydney	New South Wales
Australia	Sydney Local Health District	Sydney	New South Wales
Australia	WSLHD Drug Health	Sydney	New South Wales
Australia	Murrumbidgee & Southern LHD	Wagga Wagga	New South Wales
Australia	Hunter New England LHD	Waratah	New South Wales
Australia	ISLHD Drug and Alcohol Service	Wollongong	New South Wales

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	To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following HCV RNA testing.	HCV treatment	12 Weeks from enrolment
Secondary	To evaluate the proportion of people who accept point-of-care testing among those offered testing.	Accepting testing	Recruitment phase
Secondary	To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.	Prevalence	Recruitment phase
Secondary	To evaluate the time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing	Time to treatment	52 weeks
Secondary	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.	Initiation of treatment	52 weeks
Secondary	To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.	Completion of treatment	52 weeks
Secondary	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.	SVR	12 weeks
Secondary	To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following a detectable HCV RNA test.	HCV negative	52 weeks
Secondary	To evaluate the cost-effectiveness of different testing strategies	Cost-effectiveness	52 weeks