Multiplo Tp/HIV Self-Test
Recruiting · NCT06716450 · Interventional (participants receive a specific treatment) · Lead sponsor: Unity Health Toronto
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
- 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 trial of HIV and syphilis self-tests.
- 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).
Where it is running
3 locations listed.
- Cool Aid Community Health Centre - Victoria, British Columbia, Canada
- Hassle Free Clinic - Toronto, Ontario, Canada
- Women's Health in Women's Hands - Toronto, Ontario, Canada