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Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test

StatusTerminated
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Not Yet Recruiting → Terminated Sponsor's reason: The study was terminated prematurely because the futility threshold was met. Show 6 more changesShow less
    • Start date changed from estimate of Jun 2025 to Oct 6, 2025
    • Primary endpoints: details revised at 2 of 2 entries
    • Final enrollment: 35 participants (planned 120)
    • Primary completion date changed from estimate of Oct 2026 to Dec 18, 2025
    • Study completion date changed from estimate of Dec 2026 to Jan 5, 2026
    • Interventions: INSTI HIV/syphilis Point of Care Self-Test Administration (Diagnostic Test) to INSTI HIV/syphilis Point of Care Self-Test Administration (Diagnostic Test)
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study aims to validate the percent agreement of the INSTI Multiplex Human Immunodeficiency (HIV) 1/2 syphilis antibody (Ab) test (INSTI POCT) when used as a self-test by patients compared to conventional serologic testing.
Trial Details
NCT Number NCT06953024
Lead Sponsor Nova Scotia Health Authority
Conditions
(from sponsor)		 Hiv, Syphilis
Related terms Acquired Immunodeficiency Syndrome, Syphilis
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov