RecruitingNot ApplicableNCT06716450

Multiplo Tp/HIV Self-Test

A Study to Evaluate the Accuracy, Usability and Readability of the Multiplo® TP/HIV Antibody Self-Test Performed by Observed Intended Users in Canada and the Impact of Peer-led HIV and Syphilis Care Among People Experiencing Homelessness in Toronto

Sponsor

Unity Health Toronto

Enrollment

900 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

HIV Infection Syphilis Infection

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the accuracy and ease of use of the Multiplo TP/HIV Self-Test — a home-use test that checks for both HIV and syphilis from a single fingerprick blood sample. Participants test themselves and their results are compared with standard clinic testing. **You may be eligible if...** - You are 18 or older - You speak, read, or write English or French - You are seeking voluntary HIV and syphilis testing at a clinic or community site - Your HIV and syphilis status is unknown (last negative test was at least 3 months ago) - You are willing to provide a fingerprick and a standard blood draw **You may NOT be eligible if...** - You already know you are HIV or syphilis positive - You have ever tested positive for HIV or syphilis - You are a healthcare professional who performs HIV or syphilis rapid tests - You have experience conducting rapid point-of-care tests - You are already familiar with this specific self-test brand - You have participated in a similar trial before Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMultiplo TP/HIV Antibody Test

The Multiplo TP/HIV Antibody Test (MedMira Laboratories Inc., Halifax, NS), \["Multiplo TP/HIV Test"\] is a single use, rapid, vertical-flow in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus (HIV) Type 1/Type 2 and Treponema pallidum (Syphilis) in human fingerstick blood. The Multiplo® TP/HIV Test is intended as an aid in the diagnosis of HIV1/2 and Syphilis infections in patients with signs and symptoms of HIV and syphilis. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as an in vitro diagnostic device capable of providing results in less than five minutes. The Multiplo TP/HIV Test has not yet sought approval for self-testing. All required pre and post-test counselling guidelines must be followed in each setting in which the Multiplo TP/HIV Test is used. Results are read visually.