Multiplo HIV and syphilis self-test for adults

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

This project will see if adults seeking HIV or syphilis testing can correctly use the Multiplo HIV/syphilis self-test to get accurate results.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Unity Health Toronto (other)
• Locations: 3 sites (Victoria, British Columbia and 2 other locations)
• Trial ID: NCT06716450 on ClinicalTrials.gov

What this trial studies

This cross-sectional, observational study asks untrained adult participants to read the instructions and perform the Multiplo TP/HIV self-test while a trained observer documents use and independently reads results. Participants also provide venous blood for central laboratory testing with a 4th-generation HIV EIA and standard syphilis serology to establish clinical truth for sensitivity and specificity calculations. A subset of 400 participants will interpret ten mock devices with a range of positive, negative, and invalid results and complete questionnaires on usability and label comprehension. No prior training is provided and self-test results will be compared to laboratory-confirmed HIV and syphilis results.

Who should consider this trial

Good fit: Adults (18+) in Canada seeking voluntary HIV and/or syphilis testing who can read English or French and do not already know they are HIV or syphilis positive.

Not a fit: People who are known to be HIV or syphilis positive, are under 18, cannot read the instructions, or cannot provide blood samples are unlikely to benefit from this study.

Why it matters

Potential benefit: If accurate, the self-test could help more people identify HIV and syphilis infections earlier by making screening easier and more accessible outside traditional clinics.

How similar studies have performed: Standalone HIV rapid self-tests have shown good performance in prior studies, but combined HIV/syphilis self-testing devices are less well established and this device is relatively novel.

Eligibility criteria

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 this trial is running

Victoria, British Columbia and 2 other locations

• Cool Aid Community Health Centre — Victoria, British Columbia, Canada (RECRUITING)
• Hassle Free Clinic — Toronto, Ontario, Canada (RECRUITING)
• Women's Health in Women's Hands — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Megan Cedrone, BSc, MSc

Conditions: HIV Infection, Syphilis Infection, self-test, device trial, screen test