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

NCT06953024 | Not Yet Recruiting

• 1 other identifier: 73074
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Hiv; Syphilis

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  This measure includes two domains assessed immediately following completion of the self-test: 1. Instructional Clarity: Proportion of participants who agree, are neutral, or disagree with statements related to the clarity and usefulness of the video and infographic 2. Self-Test Satisfaction: Proportion of participants who agree, are neutral, or disagree with statements related to their satisfaction with the self-testing experience. Responses to Likert-style questions will be reported as percentages of participants selecting each category (agree, neutral, disagree) per question.

  Immediately after self-testing (Day 0)

Study Arms (1)

INSTI HIV/syphilis Point of Care Self-Test

OTHER

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

Interventions

INSTI HIV/syphilis Point of Care Self-Test Administration 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.

INSTI HIV/syphilis Point of Care Self-Test

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously documented positive HIV serology
• Documented positive syphilis serology
• No documented positive HIV or syphilis serology

You may not qualify if:

• Unable to speak and understand English

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Syphilis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 1, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04