The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
1 other identifier
observational
40,000
1 country
12
Brief Summary
The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is: What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis? Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit. No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2023
CompletedStudy Start
First participant enrolled
January 25, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
ExpectedJuly 3, 2024
July 1, 2024
1.9 years
January 17, 2023
July 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
HCV treatment
12 weeks from enrolment
Secondary Outcomes (9)
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Recruitment phase
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Recruitment phase
To evaluate the HCV antibody prevalence among people tested.
Recruitment phase
To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
52 weeks
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
- +4 more secondary outcomes
Study Arms (1)
People at risk of HCV acquisition
Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing
Interventions
Participants will be offered finger-stick point-of-care testing for HCV
Eligibility Criteria
Participants will be included 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 that approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.
You may qualify if:
- Provide informed consent
- ≥ 18 years of age.
You may not qualify if:
- Is unable or unwilling to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
- Flinders Universitycollaborator
Study Sites (12)
ACT Justice Health
Canberra, Australian Capital Territory, Australia
Justice Health and Forensic Mental Health Network
Sydney, New South Wales, Australia
Queensland Injectors Health Network Ltd
Bowen Hills, Queensland, 4006, Australia
West Moreton Hospital and Health Service
Brisbane, Queensland, Australia
Lotus Glen Correctional Centre
Cairns, Queensland, Australia
Townsville Correctional Centre
Townsville, Queensland, 4810, Australia
Woodford Correctional Centre
Woodford, Queensland, Australia
South Australian Prison Health Service
Adelaide, South Australia, Australia
Hepatitis South Australia
Hackney, South Australia, 5069, Australia
Tasmanian Prison Service
Hobart, Tasmania, Australia
St Vincent's Hospital (Melbourne)
Melbourne, Victoria, Australia
WA Department of Justice
Perth, Western Australia, 6000, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2023
First Posted
February 6, 2023
Study Start
January 25, 2023
Primary Completion
January 1, 2025
Study Completion (Estimated)
January 1, 2027
Last Updated
July 3, 2024
Record last verified: 2024-07