Multiplo Tp/HIV Self-Test
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Do not meet the inclusion criteria.
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.
Trial design
Treatments tested in this trial
- Multiplo TP/HIV Antibody Test
Treatment groups
900 Participants
are divided into 1 treatment groupSponsors and collaborators
Unity Health Toronto
Lead sponsor
University of Toronto
Collaborator
Source ClinicalTrials.gov