Not Yet RecruitingNot Applicable

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

120 participantsStarted 2025-06

Plain-language 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.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 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

Timeframe: Immediately after self-testing (Day 0)

Trial details

NCT IDNCT06953024

SponsorNova Scotia Health Authority

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

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