BridgeMD
New treatment option for HIV Infection
Official title Multiplo Tp/HIV Self-Test
ClinicalTrials.gov ID: NCT06716450
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Are willing to be a participant in the study.
You likely can't join if
- 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.
See the full eligibility 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).
- 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 study team makes the final eligibility decision.
Where it's taking place
- Victoria, British Columbia, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Victoria, British Columbia, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.