Study to Evaluate Accuracy, Usability, and Readability of the Multiplo TP/HIV Antibody Self-Test and Peer-led HIV and Syphilis Care in People Experiencing Homelessness in Toronto

What this Trial Is About

Researchers are evaluating the Multiplo TP/HIV Self-Test to identify HIV and syphilis infections among people in Canada, especially aiming to reach those undiagnosed. This study investigates whether untrained individuals can accurately perform this self-test, which is designed to provide quick results from a fingerstick blood sample. The test is under review for use by trained healthcare professionals, while this study explores its use as a self-test by lay persons. Participants will use the Multiplo TP/HIV Self-Test on their own without prior training, following only written instructions. A trained observer will watch and record their testing process and independently interpret the self-test results. About 400 participants will also interpret ten mock test devices showing various results to assess their ability to read test outcomes. All participants will provide venous blood samples for laboratory testing with standard HIV and syphilis tests to compare accuracy. During the study, participants will complete questionnaires about the test's usability and clarity of instructions. They will return for a follow-up visit about two weeks later to receive their laboratory test results. The study measures how well the self-test agrees with laboratory results and evaluates participants' understanding and interpretation of test results. Safety and suitability will be monitored, and counselling may be provided if reactive results are found. Total study participation involves initial testing and a follow-up visit approximately two weeks later.

Multiplo Tp/HIV Self-Test