Can a simple finger-prick test help find hidden HIV and syphilis cases?
NCT ID NCT06716450
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checks if a new self-test for HIV and syphilis is accurate and easy for people to use at home. About 900 adults in Canada will try the test and compare results to lab tests. The study also looks at how peer support can help homeless people in Toronto get tested and treated for these infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 900 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cool Aid Community Health Centre
RECRUITINGVictoria, British Columbia, V8W 1M8, Canada
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Hassle Free Clinic
RECRUITINGToronto, Ontario, M5B 1G3, Canada
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Women's Health in Women's Hands
RECRUITINGToronto, Ontario, M5B 1J3, Canada
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Other studies related to the condition(s) this trial covers.
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- How do HIV drugs behave when kidneys fail? study measures blood levels
- Can HIV-Positive mothers breastfeed without passing the virus to their babies?