Multiplo Test for HIV and Syphilis
Trial Summary
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing for HIV and syphilis, so it's likely you can continue your medications, but you should confirm with the trial organizers.
What data supports the effectiveness of the Multiplo TP/HIV Antibody Test treatment?
Is the Multiplo Test for HIV and Syphilis safe for humans?
How is the Multiplo TP/HIV Antibody Test different from other treatments for HIV and syphilis?
The Multiplo TP/HIV Antibody Test is unique because it is a rapid point-of-care test that can simultaneously detect antibodies for both HIV and syphilis using a single specimen, allowing for quick, same-day testing and treatment, which is not typically possible with separate tests for each infection.12368
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for individuals at least 16 years old who can read English or French, consent to the study, and provide a detailed medical history. Participants must be willing to give blood samples and undergo HIV and syphilis testing with the Multiplo TP/HIV Antibody Test. Those previously diagnosed with syphilis or with an unknown HIV/syphilis status (with last negative test over 3 months ago) may join.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Testing
Participants undergo fingerstick blood testing with the Multiplo Test and venous blood testing at a central laboratory
Follow-up
Participants with unknown HIV and/or syphilis status return for follow-up to obtain laboratory test results
Operator Assessment
Untrained non-professional operators complete usability and interpretation assessments
Treatment Details
Interventions
- Multiplo TP/HIV Antibody Test
Find a Clinic Near You
Who Is Running the Clinical Trial?
Unity Health Toronto
Lead Sponsor