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The Australian HCV Point-of-Care Testing Program

Study acronym: HCVPOCT
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study description revised
    • Site details revised at 8 of 69 sites
    • Eligibility criteria expanded, about 4 words
  2. Start date: Feb 22, 2022 to Feb 23, 2022v9
  3. Enrollment target: 40000 to 60000v8 Show 4 more changesShow less
    • Primary completion date: Dec 2024 to Jun 30, 2029
    • Study sites: 56 to 69
    • Study completion date: Dec 2026 to Jun 30, 2029
    • Study title shortened, about 1 word
  4. Study sites: 58 to 56
    • Primary completion date: Dec 31, 2024 to Dec 2024
    • Study completion date: Dec 31, 2025 to Dec 2026
    • Collaborators expanded, about 2 words
    v7
  5. Primary endpoint revised
    • Study sites: 54 to 58
    • Secondary endpoints revised (8)
    • Study description shortened, about 40 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 50 to 54v5
  2. Study sites: 22 to 50
    • Secondary endpoints: 7 to 8
    v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Start date changed from estimate of Nov 1, 2022 to Feb 22, 2022
    • Site details revised at 22 of 22 sites
  4. Study sites: 21 to 22v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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). Participants will attend a single visit to have their HCV RNA status tested and complete a self-administered survey. 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 NCT05042544
Lead Sponsor Kirby Institute
Collaborators: Flinders University
Conditions
(from sponsor)		 Hepatitis C
Related terms Hepatitis C
Enrollment 60,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov