The National Australian HCV Point-of-Care Testing Program - Minimal Dataset
1 other identifier
observational
40,000
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
11 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
Study Start
First participant enrolled
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJune 13, 2024
June 1, 2024
3 years
December 12, 2021
June 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
The proportion of participants who accept point-of-care testing
2 years from recruitment commencement
The prevalence of HCV infection amongst study participants tested
2 years from recruitment commencement
To evaluate the time to HCV treatment uptake among HCV RNA positive participants
52 weeks
To evaluate proportion of HCV RNA positive participants who initiate HCV treatment
52 weeks
To evaluate the proportion of participants who complete HCV (DAA) treatment
52 weeks
- +2 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 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.
You may qualify if:
- ≥ 18 years of age.
- Received point-of-care HCV testing.
You may not qualify if:
- Nil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
- Flinders Universitycollaborator
Study Sites (11)
Justice Health and Forensic Mental Health Network
Sydney, New South Wales, Australia
Lotus Glen Correctional Centre
Cairns, Queensland, Australia
Hepatitis Queensland
Coorparoo, Queensland, 4151, Australia
West Moreton Hospital and Health Service
Ipswich, Queensland, Australia
Townsville Correctional Centre
Townsville, Queensland, Australia
Woodford Correctional Centre
Woodford, Queensland, Australia
South Australian Prison Health Service
Marden, South Australia, 5070, Australia
Mount Gambier Priosn
Mount Gambier, South Australia, 5290, Australia
St Vincent's Correctional Health Services
Fitzroy, Victoria, 3065, Australia
Medically Supervised Injecting Room
Melbourne, Victoria, 3000, Australia
Geo Healthcare - The Geo Group Australia Pty Ltd
Ravenhall, Victoria, 3023, 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
December 12, 2021
First Posted
February 21, 2022
Study Start
December 1, 2021
Primary Completion
December 1, 2024
Study Completion (Estimated)
December 1, 2026
Last Updated
June 13, 2024
Record last verified: 2024-06