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

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.

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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.

Time frame: 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

Time frame: Immediately after self-testing (Day 0)
This measure includes two domains assessed immediately following completion of the self-test:
- Instructional Clarity: Proportion of participants who agree, are neutral, or disagree with statements related to the clarity and usefulness of the video and infographic
- 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.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 1, 2025
Registry last updated: May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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