Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Nova Scotia Health Authority

Conditions:

Hiv

Syphilis

Eligibility:

All Genders

15+ years

Phase:

NA

Brief Summary

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 conv...

Eligibility Criteria

Inclusion

  • Branch #1: Participants known to have an HIV infection - Inclusion criteria:
  • • Previously documented positive HIV serology
  • Branch #2: Participants known to have a history of syphilis infection - Inclusion criteria:
  • • Documented positive syphilis serology
  • Branch #3: Participants with no known HIV or syphilis infections - Inclusion criteria:
  • • No documented positive HIV or syphilis serology
  • Exclusion criteria:
  • Unable to speak and understand English

Exclusion

    Key Trial Info

    Start Date :

    June 1 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2026

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT06953024

    Start Date

    June 1 2025

    End Date

    December 1 2026

    Last Update

    May 1 2025

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