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
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.
• 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).