Not Yet RecruitingNot Applicable

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

120 participantsStarted 2025-06

Plain-language 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 conventional serologic testing.

Who can participate

Age range15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percent agreement of the INSTI HIV/syphilis POCT when used to self-test for antibodies to HIV 1/2 and syphilis when compared to conventional serologic results.

Timeframe: Determined at the end of the implementation period (approximately 6 months).

Participant-rated clarity of instructional materials and satisfaction with INSTI HIV/syphilis self-testing

Timeframe: Immediately after self-testing (Day 0)

Trial details

NCT IDNCT06953024

SponsorNova Scotia Health Authority

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Hiv trials