Clinical trial NCT05248555: The National Australian HCV Point-of-Care Testing Program - Minimal Dataset
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
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: 2022-02-21
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). 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age.
* Received point-of-care HCV testing.

Exclusion Criteria:

* Nil

Primary outcomes:
measure: The proportion of HCV infected participants who initiate HCV treatment at 12 weeks
timeFrame: 12 Weeks from enrolment
Secondary outcomes:
measure: The proportion of participants who accept point-of-care testing
timeFrame: 2 years from recruitment commencement
measure: The prevalence of HCV infection amongst study participants tested
timeFrame: 2 years from recruitment commencement
measure: To evaluate the time to HCV treatment uptake among HCV RNA positive participants
timeFrame: 52 weeks
measure: To evaluate proportion of HCV RNA positive participants who initiate HCV treatment
timeFrame: 52 weeks
measure: To evaluate the proportion of participants who complete HCV (DAA) treatment
timeFrame: 52 weeks
measure: To evaluate the proportion of participants who achieve an SVR
timeFrame: 12 weeks
measure: To evaluate the proportion of participants who are HCV RNA negative at 12 months
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Justice Health and Forensic Mental Health Network
state: New South Wales
city: Cairns
country: Australia
facility: Lotus Glen Correctional Centre
state: Queensland
city: Coorparoo
country: Australia
facility: Hepatitis Queensland
state: Queensland
city: Ipswich
country: Australia
facility: West Moreton Hospital and Health Service
state: Queensland
city: Townsville
country: Australia
facility: Townsville Correctional Centre
state: Queensland
city: Woodford
country: Australia
facility: Woodford Correctional Centre
state: Queensland
city: Marden
country: Australia
facility: South Australian Prison Health Service
state: South Australia
city: Mount Gambier
country: Australia
facility: Mount Gambier Priosn
state: South Australia
city: Fitzroy
country: Australia
facility: St Vincent's Correctional Health Services
state: Victoria
city: Melbourne
country: Australia
facility: Medically Supervised Injecting Room
state: Victoria
city: Ravenhall
country: Australia
facility: Geo Healthcare - The Geo Group Australia Pty Ltd
state: Victoria
Study officials:
References: