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Not Yet RecruitingNCT06953024

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Nova Scotia Health Authority · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTINSTI HIV/syphilis Point of Care Self-Test AdministrationThe INSTI Human Immunodeficiency Virus (HIV)/syphilis POCT is a rapid, single-use, flow-through immunoassay that is Health Canada-approved as a screening test for detecting antibodies to HIV1/2 and syphilis using a fingerstick blood sample.

Timeline

Start date
2025-06-01
Primary completion
2026-10-01
Completion
2026-12-01
First posted
2025-05-01
Last updated
2025-05-01

Source: ClinicalTrials.gov record NCT06953024. Inclusion in this directory is not an endorsement.

Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test (NCT06953024) · Clinical Trials Directory