Recruiting

Multiplo Tp/HIV Self-Test

Sponsor:

Unity Health Toronto

Code:

NCT06716450

Conditions

HIV Infection

Syphilis Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Multiplo TP/HIV Antibody Test

Study Details

Brief summary:

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.

Conditions

HIV Infection

Syphilis Infection

Study ID

NCT06716450

Start date

Jun 12, 2025

Status verified date

Jan, 2026

Completion date

Dec 10, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

900 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Participants with unknown HIV and syphilis status

All participants will self-test fingerstick blood testing with the test device, along with venous blood testing at a central laboratory using licensed gold standard comparator methods.

Interventions

Multiplo TP/HIV Antibody Test

The Multiplo TP/HIV Antibody Test (MedMira Laboratories Inc., Halifax, NS), \["Multiplo TP/HIV Test"\] is a single use, rapid, vertical-flow in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus (HIV) Type 1/Type 2 and Treponema pallidum (Syphilis) in human fingerstick blood. The Multiplo® TP/HIV Test is intended as an aid in the diagnosis of HIV1/2 and Syphilis infections in patients with signs and symptoms of HIV and syphilis. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as an in vitro diagnostic device capable of providing results in less than five minutes. The Multiplo TP/HIV Test has not yet sought approval for self-testing. All required pre and post-test counselling guidelines must be followed in each setting in which the Multiplo TP/HIV Test is used. Results are read visually.

Primary outcome measure

  • Percent positive and negative agreement of the Multiplo® TP/HIV Self-Test to the Participant's HIV and/or syphilis status confirmed by the lab results. [ Time Frame: 6 months ]
  • Descriptive analysis of sociodemographic characteristics of people experiencing homelessness who are accessing HIV and Syphilis testing [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Megan Cedrone, BSc, MSc

647-786-8711Megan.Cedrone@unityhealth.to

Locations

Cool Aid Community Health Centre

Recruiting

Victoria, British Columbia, Canada, V8W 1M8

Contacts

Marion Selfridge

250-385-1466mselfridge@coolaid.org

Katie Besko

mselfridge@coolaid.org

Principal Investigator:

Chris Fraser, MD

Hassle Free Clinic

Recruiting

Toronto, Ontario, Canada, M5B 1G3

Contacts

Francois MacDonald Research Coordinator

416-922-0566francois@hasslefreeclinic.org

Women's Health in Women's Hands

Recruiting

Toronto, Ontario, Canada, M5B 1J3

Contacts

Wangari Tharao

416-263-4870wangari@whiwh.com

Nonty Nkala

nonty@whiwh.com

Principal Investigator:

Megan Saunders, MD, CCFP

More Information

Sponsor

Unity Health Toronto

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

  • self-test
  • device trial
  • screen test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-01-27.