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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 11 months later Dec 2024 → Dec 2029
See other at-risk trials from Kirby Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 40000 → 80000 participants
    • Trial sites expanded: 11 → 16 locations
    • Study description revised
    • Eligibility criteria expanded, about 3 words
  2. Primary completion pushed from Dec 2024 to Dec 2029
    • Start date: Dec 1, 2021 to Jan 23, 2023
    • Study completion pushed from Dec 2026 to Dec 2029
    v4
  3. Primary completion date: Jul 31, 2023 to Dec 2024v3 Show 4 more changesShow less
    • Study sites: 4 to 11
    • Study completion date: Jul 31, 2024 to Dec 2026
    • Start date: Jan 16, 2023 to Dec 1, 2021
    • Collaborators expanded, about 2 words
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 15, 2022 to Jan 16, 2023
    • Study sites: 0 to 4
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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 Details
NCT Number NCT05248555
Lead Sponsor Kirby Institute
Collaborators: Flinders University
Conditions
(from sponsor)		 Hepatitis C
Related terms Hepatitis C
Enrollment 80,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov