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NCT06953024Terminated

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Study type
Interventional
Enrollment
35 (actual)
First submitted
17 Apr 2025
Start date
6 Oct 2025
Primary completion date
18 Dec 2025
Lead sponsor
Nova Scotia Health Authority
Diseases
HIV
NCT number
NCT06953024

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Unable to speak and understand English

Criteria the registry did not label

  • 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

Age in the registry: 15 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
QEII STI Clinic
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.