Who is eligible for clinical trial NCT06716450?

Participants must meet protocol criteria for HIV Infection. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06716450 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-01-23

Multiplo Tp/HIV Self-Test (NCT06716450)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Unity Health Toronto

🩺 Plain-English Summary (8th-Grade Level)

To help reach the undiagnosed living with HIV and/or syphilis in Canada, self-tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Laboratories Inc. (Halifax, Nova Scotia, Canada) has developed a point-of-care (POC) test to detect HIV and Syphilis antibodies in fingerstick blood samples that is under final review by Health Canada for use by trained Healthcare professionals. A self-test version of this test, with simplified instructions for use has been developed for investigational studies. The goal of the following study sponsored by REACH Nexus is to provide evidence that untrained lay persons / intended users can perform the Multiplo Tp/HIV Self-Test without any increased risk of obtaining erroneous results.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (10 items).

Location: Cool Aid Community Health Centre — Victoria, British Columbia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Are ≥18 years of age.
Can speak/read/write English or French.
Have presented for voluntary testing for HIV and/or syphilis infection in the clinic or community-based setting.
Are willing to participate in the study site's standard of care HIV and syphilis counselling and testing program and receive the study site's standard of care test results.
Are willing to be a participant in the study.
Can provide informed consent i.e. understand and sign or instruct the Observer to sign the informed consent form.
Can complete the required testing on the allocated testing day.
Are willing to provide the necessary fingerstick and venipuncture blood for use in the study protocol testing methods.
Are of unknown HIV and syphilis status (last HIV and syphilis negative test must be a minimum of 3 months prior).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Do not meet the inclusion criteria.
Are known HIV and/or syphilis positive.
Have ever tested positive for syphilis or HIV at any time.
Have any experience in conducting rapid point-of-care tests on patients for HIV, syphilis or any other infectious disease.
Are familiar with the Multiplo® TP/HIV Self-Test.
Are investigator site employees or immediate family members of sponsor or investigator sites.
Have participated in any prior, or concurrent trial of HIV and syphilis self-tests.
Are a practicing medical healthcare professional (doctor, nurse or HIV counsellor that performs HIV testing with Rapid Tests).
Any condition which, in the opinion of the Observer, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome (e.g. being unable to see/read by forgetting to bring reading glasses, being intoxicated, acute sickness, visibly distressed).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Cool Aid Community Health Centre — Victoria, British Columbia
Hassle Free Clinic — Toronto, Ontario
Women's Health in Women's Hands — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗