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Multiplo Tp/HIV Self-Test

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 27, 2026 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Sep 1, 2025 to Apr 1, 2026 · Start date changed from estimate of Feb 10, 2025 to Jun 12, 2025 · Study sites: 4 to 3 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Sep 1, 2025 to Apr 1, 2026
    • Start date changed from estimate of Feb 10, 2025 to Jun 12, 2025
    • Study sites: 4 to 3
    • Completion date: Dec 10, 2025 to Dec 10, 2026
  2. Start date: Dec 10, 2024 to Feb 10, 2025 Primary completion date: May 30, 2025 to Sep 1, 2025 · Site contacts updated at 4 of 4 sitesv2 Show 2 more changesShow less
    • Primary completion date: May 30, 2025 to Sep 1, 2025
    • Site contacts updated at 4 of 4 sites
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To help reach the undiagnosed living with HIV and/or syphilis in Canada, self-tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Laboratories Inc. (Halifax, Nova Scotia, Canada) has developed a point-of-care (POC) test to detect HIV and Syphilis antibodies in fingerstick blood samples that is under final review by Health Canada for use by trained Healthcare professionals. A self-test version of this test, with simplified instructions for use has been developed for investigational studies. The goal of the following study sponsored by REACH Nexus is to provide evidence that untrained lay persons / intended users can perform the Multiplo Tp/HIV Self-Test without any increased risk of obtaining erroneous results.
Trial Details
NCT Number NCT06716450
Lead Sponsor Unity Health Toronto
Collaborators: University of Toronto
Conditions HIV Infection, Syphilis Infection
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov