Actively Recruiting
Multiplo Tp/HIV Self-Test
Led by Unity Health Toronto · Updated on 2026-01-27
900
Participants Needed
3
Research Sites
78 weeks
Total Duration
On this page
Sponsors
U
Unity Health Toronto
Lead Sponsor
U
University of Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multiplo Tp/HIV Self-Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are 18 years of age or older
- Can speak, read, and write English or French
- Have presented for voluntary testing for HIV and/or syphilis infection in a clinic or community setting
- Are willing to participate in the site's standard of care HIV and syphilis counselling and testing program and receive test results
- Are willing to be participants in the study
- Can provide informed consent
- Can complete required testing on the assigned testing day
- Are willing to provide fingerstick and venipuncture blood samples for study testing
- Are of unknown HIV and syphilis status (last negative test at least 3 months prior)
You will not qualify if you...
- Do not meet inclusion criteria
- Are known HIV and/or syphilis positive
- Have ever tested positive for HIV or syphilis
- Have experience conducting rapid point-of-care tests for HIV, syphilis, or other infectious diseases
- 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 trials of HIV and syphilis self-tests
- Are practicing medical healthcare professionals performing HIV rapid tests
- Have any condition that would make participation unsafe, unsuitable, or interfere with study completion (e.g., inability to see/read, intoxication, acute illness, distress)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Cool Aid Community Health Centre
Victoria, British Columbia, Canada, V8W 1M8
Actively Recruiting
2
Hassle Free Clinic
Toronto, Ontario, Canada, M5B 1G3
Actively Recruiting
3
Women's Health in Women's Hands
Toronto, Ontario, Canada, M5B 1J3
Actively Recruiting
Research Team
M
Megan Cedrone, BSc, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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