Self-test for HIV and syphilis antibodies in people experiencing homelessness
Tests a self-test device for HIV and syphilis in adults experiencing homelessness.
Plain-language title generated from the registry record
Registry title: Multiplo Tp/HIV Self-Test
Key facts
- Where
- Toronto and Victoria, CanadaSee the 3 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who come for voluntary HIV and/or syphilis testing and do not know their HIV or syphilis status. They will try a self-test.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- People of unknown HIV and syphilis status; the last negative test must be at least 3 months ago
Main reasons for not taking part
- Known HIV and/or syphilis positive, or ever tested positive
- Experience doing rapid point-of-care tests for HIV, syphilis or other infections
- Familiar with the Multiplo TP/HIV Self-Test
- Working as a doctor, nurse or HIV counsellor who does rapid HIV testing
- Took part in any earlier or current HIV or syphilis self-test trial
Read by machine on 9 November 2026.
Where in Canada
- Hassle Free ClinicToronto, CanadaTaking people
- Women's Health in Women's HandsToronto, CanadaTaking people
- Cool Aid Community Health CentreVictoria, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Unity Health Toronto
- Trial code
- NCT06716450
- Record updated
- 27 January 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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).
Exclusion: Have participated in any prior, or concurrent trial of HIV and syphilis self-tests; 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 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); Do not meet the inclusion criteria; Are investigator site employees or immediate family members of sponsor or investigator sites.