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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 6 months
2
Descriptive analysis of sociodemographic characteristics of people experiencing homelessness who are accessing HIV and Syphilis testing