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The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 4 months later Jan 2025 → Jun 2029
See other at-risk trials from Kirby Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Study sites: 12 to 13
    • Eligibility criteria expanded, about 3 words
  2. Notable Primary completion pushed from Jan 2025 to Jun 2029
    • Study completion pushed from Jan 2027 to Jun 2029
    • Start date: Jan 25, 2023 to Feb 23, 2023
    • Site details revised at 1 of 12 sites
    v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Study sites: 7 to 12
    • Primary completion date: Dec 31, 2024 to Jan 2025
    • Study completion date: Dec 31, 2025 to Jan 2027
    • Start date changed from estimate of Aug 14, 2023 to Jan 25, 2023
    • Collaborators expanded, about 2 words
  5. Notable Start date: Mar 1, 2023 to Aug 14, 2023
    • Study sites: 0 to 7
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05713136
Lead Sponsor Kirby Institute
Collaborators: Flinders University
Conditions
(from sponsor)
Hepatitis C
Related terms Hepatitis C
Enrollment 40,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov