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

NCT ID: NCT06953024

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hiv Syphilis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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INSTI HIV/syphilis Point of Care Self-Test

Group Type OTHER

INSTI HIV/syphilis Point of Care Self-Test Administration

Intervention Type DIAGNOSTIC_TEST

The 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.

Interventions

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INSTI HIV/syphilis Point of Care Self-Test Administration

The 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

• Previously documented positive HIV serology


• Documented positive syphilis serology


• No documented positive HIV or syphilis serology

Exclusion Criteria

Unable to speak and understand English
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Tasha Ramsey

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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73074

Identifier Type: -

Identifier Source: org_study_id

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