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

Nova Scotia Health Authority (NSHA)

Status: Begins enrollment this month

Conditions: Syphilis; Hiv

Treatments: Diagnostic Test: INSTI HIV/syphilis Point of Care Self-Test Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06953024

73074

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

INSTI HIV/syphilis Point of Care Self-Test

Other group

Treatment:

Diagnostic Test: INSTI HIV/syphilis Point of Care Self-Test Administration