Health TrialsbyHealthPanel

Multiplo Tp/HIV Self-Test

ConditionsHIV InfectionSyphilis Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Multiplo TP/HIV Antibody Test

    Device

    The Multiplo TP/HIV Antibody Test (MedMira Laboratories Inc., Halifax, NS), \["Multiplo TP/HIV Test"\] is a single use, rapid, vertical-flow in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus (HIV) Type 1/Type 2 and Treponema pallidum (Syphilis) in human fingerstick blood. The Multiplo® TP/HIV Test is intended as an aid in the diagnosis of HIV1/2 and Syphilis infections in patients with signs and symptoms of HIV and syphilis. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as an in vitro diagnostic device capable of providing results in less than five minutes. The Multiplo TP/HIV Test has not yet sought approval for self-testing. All required pre and post-test counselling guidelines must be followed in each setting in which the Multiplo TP/HIV Test is used. Results are read visually.

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: Participants with unknown HIV and syphilis statusExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

The primary outcome for the study will be the 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. The percentages for positive and negative agreement will be calculated with the two-sided 95% confidence intervals for both as follows: * Positive Agreement= ((n) HIV or syphilis Multiplo reactive results )/((n) HIV or syphilis positive status)×100 * Negative Agreement= ((n)HIV or syphilis Multiplo non reactive results )/((n) HIV or syphilis negative status)×100 Percent positive and negative agreement will be calculated for each analyte (HIV or syphilis) separately.

Time frame
6 months
2

Descriptive analysis of sociodemographic characteristics of people experiencing homelessness who are accessing HIV and Syphilis testing

The embedded study aims to understand the sociodemographic and health profile of PEH accessing WHIWH. Descriptive analysis of sociodemographic variables, risk behaviours, HIV/syphilis testing variables will be completed.

Time frame
6 months

Secondary outcomes

1

Percent of correctly interpreted mock devices by self-test participants.

Participants will answer a series of questions after they complete the Multiplo® TP/HIV Self-Test assessment and Interpretation of Results - Mock Devices. Participants will be given a panel of contrived devices and asked to interpret the results of the contrived devices. Participant answers will be compared to known results from the assigned panels.

Time frame
6 months
2

Rates of Positive HIV and Syphilis and rates of first time testers among people experiencing homelessness

Number of PEH who have tested positive for HIV and/or syphilis in the laboratory test. Number of PEH tested for HIV and/or syphilis for the first time through the project. Number of PEH who have been tested for HIV and/or syphilis before the intervention and which type of service.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

University of Toronto

Collaborator

Source ClinicalTrials.gov
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