Clinical trial NCT05042544: The National Australian HCV Point-of-Care Testing Program
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C
Keywords: Hepatitis C Virus
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: Flinders University
First posted: 2021-09-13
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following HCV RNA testing.
timeFrame: 12 Weeks from enrolment
Secondary outcomes:
measure: To evaluate the proportion of people who accept point-of-care testing among those offered testing.
timeFrame: Recruitment phase
measure: To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
timeFrame: Recruitment phase
measure: To evaluate the time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing
timeFrame: 52 weeks
measure: 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.
timeFrame: 52 weeks
measure: To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.
timeFrame: 52 weeks
measure: 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.
timeFrame: 12 weeks
measure: To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following a detectable HCV RNA test.
timeFrame: 52 weeks
measure: To evaluate the cost-effectiveness of different testing strategies
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Hepatitis ACT
state: Australian Capital Territory
city: Bathurst
country: Australia
facility: Western NSW LHD
state: New South Wales
city: Broken Hill
country: Australia
facility: Far West LHD
state: New South Wales
city: Broken Hill
country: Australia
facility: Maari Ma Health Aboriginal Corporation
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Galambila Aboriginal Health Service
state: New South Wales
city: Gosford
country: Australia
facility: Central Coast LHD
state: New South Wales
city: Inverell
country: Australia
facility: Armajun Health Service Aboriginal Corporation
state: New South Wales
city: Lismore
country: Australia
facility: Rekindling the Spirit Health Service
state: New South Wales
city: Penrith
country: Australia
facility: Nepean Blue Mountains LHD
state: New South Wales
city: Port Macquarie
country: Australia
facility: North and Mid North Coast LHD
state: New South Wales
city: Quirindi
country: Australia
facility: Walhallow Aboriginal Corporation
state: New South Wales
city: South Grafton
country: Australia
facility: Bulgarr Ngaru Medical Aboriginal Corporation
state: New South Wales
city: Sydney
country: Australia
facility: Kirketon Road Centre
state: New South Wales
city: Sydney
country: Australia
facility: NSLHD
state: New South Wales
city: Sydney
country: Australia
facility: WSLHD Drug Health
state: New South Wales
city: Sydney
country: Australia
facility: South West Sydney LHD
state: New South Wales
city: Sydney
country: Australia
facility: Hepatitis NSW
state: New South Wales
city: Sydney
country: Australia
facility: NSW Users and AIDS Association
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: SESLHD Community and Mental Health POCT Allicance (SCAMPA)
state: New South Wales
city: Sydney
country: Australia
facility: SESLHD Drug Health
state: New South Wales
city: Sydney
country: Australia
facility: Storr Liver Clinic (Westmead Hospital)
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Local Health District
state: New South Wales
city: Wagga Wagga
country: Australia
facility: Murrumbidgee & Southern LHD
state: New South Wales
city: Waratah
country: Australia
facility: Hunter New England LHD
state: New South Wales
city: Wollongong
country: Australia
facility: ISLHD Drug and Alcohol Service
state: New South Wales
city: Alice Springs
country: Australia
facility: ADSCA - Alice Springs Hospital
state: Northern Territory
city: Brisbane
country: Australia
facility: Alcohol and Harm Reduction Biala
state: Queensland
city: Brisbane
country: Australia
facility: Micah Projects
state: Queensland
city: Cairns
country: Australia
facility: Cairns Sexual Health Service
state: Queensland
city: Coorparoo
country: Australia
facility: Hepatitis QLD
state: Queensland
city: Inala
country: Australia
facility: Kombi Clinic
state: Queensland
city: Inala
country: Australia
facility: Metro South Addiction Services - Inala ADS
state: Queensland
city: Ipswich
country: Australia
facility: Ipswich AODS
state: Queensland
city: Ipswich
country: Australia
facility: Ipswich Sexual Health and BBV Service, West Moreton Health
state: Queensland
city: Maroochydore
country: Australia
facility: OneBridge
state: Queensland
city: Adelaide
country: Australia
facility: Central Adelaide Local Health Network
state: South Australia
city: Adelaide
country: Australia
facility: Drug and Alcohol Services South Australia
state: South Australia
city: Adelaide
country: Australia
facility: North Adelaide Local Health Network
state: South Australia
city: Adelaide
country: Australia
facility: South Adelaide Local Health Network
state: South Australia
city: Hackney
country: Australia
facility: Hepatitis SA
state: South Australia
city: Mount Gambier
country: Australia
facility: Pangula Mannamurna Aboriginal Corporation
state: South Australia
city: Hobart
country: Australia
facility: Clinic 60 (Sexual Health Services)
state: Tasmania
city: New Town
country: Australia
facility: Moreton Group Rural Health
state: Tasmania
city: Footscray
country: Australia
facility: Western Health
state: Victoria
city: Melbourne
country: Australia
facility: Eastern Health
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital (Melbourne)
state: Victoria
city: Melbourne
country: Australia
facility: Youth Projects - The Living Room
state: Victoria
city: Morwell
country: Australia
facility: Latrobe Community Health Service Liited
state: Victoria
city: Bunbury
country: Australia
facility: Peer Based Harm Reduction Bunbury
state: Western Australia
city: Fremantle
country: Australia
facility: South Terrace Clinic - Fremantle Hospital
state: Western Australia
city: Perth
country: Australia
facility: Peer Based Harm Reduction WA
state: Western Australia
city: Perth
country: Australia
facility: Hepatitis WA
state: Western Australia
city: Perth
country: Australia
facility: Next Step East Perth
state: Western Australia
city: Perth
country: Australia
facility: Next Step Fremantle
state: Western Australia
city: Perth
country: Australia
facility: Next Step Warwick
state: Western Australia
Study officials:
References: