Multiplo Near Patient Non-HCP Study
Megadott ok: The device manufacturer is no longer seeking licensure for this use-case in Canada.
Key facts
- Where
- Toronto, Victoria és Winnipeg, KanadaSee the 4 sites
Where in Kanada
- Hassle Free ClinicToronto, KanadaNo longer taking part
- Women's Health in Women's HandsToronto, KanadaNo longer taking part
- Cool Aid Community Health CentreVictoria, KanadaNo longer taking part
- Nine Circles Community Health CentreWinnipeg, KanadaNo longer taking part
Trial details
- Who runs it
- Unity Health Toronto
- Trial code
- NCT06463314
- Record updated
- 2025. június 26.
- Original description
To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) 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 Inc. (Halifax, NS, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood samples that is seeking approval from Health Canada for use by trained healthcare professionals. The goal of this study is to provide evidence that untrained, non-registered health care providers (ie. peer testers) can perform the test without any increased risk of obtaining erroneous results. This test requires no instrumentation and can be used by non-registered health care professionals including peer testers ("Operators") in multiple near patient settings such as community health centres and point of care testing locations.Read full original descriptionShow less
A Prospective Cross-Sectional Study to Evaluate Performance and Usability of Multiplo® TP/HIV Test at Point-Of-Care Sites in the Hands of Untrained Non-Health Care Professional Operators
To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) 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 Inc. (Halifax, NS, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood samples that is seeking approval from Health Canada for use by trained healthcare professionals. The goal of this study is to provide evidence that untrained, non-registered health care providers (ie. peer testers) can perform the test without any increased risk of obtaining erroneous results. This test requires no instrumentation and can be used by non-registered health care professionals including peer testers ("Operators") in multiple near patient settings such as community health centres and point of care testing locations.
Inclusion: Participants considered eligible for inclusion are those who:; Are at least 18 years of age; Are able to read/understand English or French; Are able to provide informed consent; Agree to provide accurate medical history; Are able to provide up to 20mL blood by venipuncture, and a small amount of blood by fingerstick; Agree to undergo testing for HIV and syphilis with the Multiplo® TP/HIV Test; For the Participants previously diagnosed with HIV and/or syphilis, diagnosis can have occurred at any time prior to enrolment; For the Participants with negative or unknown HIV and/or syphilis status - last HIV negative test must be greater than 3 months prior to date of consent.
Exclusion: Have been previously enrolled in this study; Participants considered ineligible for participation in the trial are those who meet any of the following exclusion criteria:; Are site employees; Are in the judgment of the investigator to be unable to complete the study or are unlikely to comply with the study protocol.