Multiplo Tp/HIV Self-Test

Launched by UNITY HEALTH TORONTO · Nov 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new self-test for HIV and syphilis, which are infections that can be serious if not diagnosed and treated early. The goal is to see if people who are not trained in healthcare can use this self-test correctly and safely, helping to find individuals who might be living with these infections without knowing it. The test uses a small drop of blood from a finger prick and provides quick results, making it easier for patients to get tested in a comfortable setting.

To be eligible for the study, participants need to be at least 18 years old, able to read and understand English or French, and willing to undergo standard counseling and testing for HIV and syphilis. They should also not have tested positive for these infections before and must not have any experience with performing such tests. If you decide to participate, you’ll provide a small blood sample for the test and receive support and information throughout the process. This trial is important because it aims to help more people get diagnosed and treated for these infections, leading to better health outcomes for everyone.

Gender

ALL

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).