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NCT06716450Recruiting

Multiplo Tp/HIV Self-Test

A Study to Evaluate the Accuracy, Usability and Readability of the Multiplo® TP/HIV Antibody Self-Test Performed by Observed Intended Users in Canada and the Impact of Peer-led HIV and Syphilis Care Among People Experiencing Homelessness in Toronto

Source: ClinicalTrials.gov · Last updated 27 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
900 (estimated)
First submitted
18 Nov 2024
Start date
12 Jun 2025
Primary completion date
1 Apr 2026
Lead sponsor
Unity Health Toronto
Diseases
HIV
NCT number
NCT06716450

What you commit to

  • Study type: Interventional
  • Planned participants: 900
  • From 12 Jun 2025 to the primary completion date, 1 Apr 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have participated in any prior, or concurrent trial of HIV and syphilis self-tests.

Other illness

  • 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 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).

Other

  • Do not meet the inclusion criteria.
  • Are investigator site employees or immediate family members of sponsor or investigator sites.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Women's Health in Women's Hands
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Hassle Free Clinic
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Cool Aid Community Health Centre
Coordinator of this site? Confirm its status
VictoriaCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.