NCT06463314

Multiplo Near Patient Non-HCP Study

A Prospective Cross-Sectional Study to Evaluate Performance and Usability of Multiplo® TP/HIV Test at Point-Of-Care Sites in the Hands of Untrained Non-Health Care Professional Operators

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) 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 Inc. (Halifax, NS, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood samples that is seeking approval from Health Canada for use by trained healthcare professionals. The goal of this study is to provide evidence that untrained, non-registered health care providers (ie. peer testers) can perform the test without any increased risk of obtaining erroneous results. This test requires no instrumentation and can be used by non-registered health care professionals including peer testers ("Operators") in multiple near patient settings such as community health centres and point of care testing locations.

Detailed description

This is a blinded, controlled study to evaluate the ability of the Operators, including peer testers, to perform and interpret the HIV and Syphilis results of the Multiplo TP/HIV Test. The non-registered health care professionals including peer testers are defined as non-health care professional (ie. Peers) paid site personnel that have no training or hands-on experience with the Multiplo Test. This protocol involves collection of fingerstick whole blood from a minimum of 800 Participants to test with the Multiplo Test. Testing will be conducted by the study Operators in near-patient clinical settings. Results from the Multiplo Test will be compared to results from blood based serological assays, including licensed 4th generation HIV EIA and syphilis EIA/RPR assays. Study Operator qualifications and assessment of the ease of device use will be evaluated. Operators will also read and interpret various contrived devices in order to assess their ability to correctly interpret a variety of potential test results. All enrolled Participants will voluntarily provide medical history and the specimens according to Section 4, Study Procedures at Visit 1 (Day 1), for the testing with the Multiplo Test. All Participants will have a laboratory test done for performance comparison, but only those with unknown HIV and/or syphilis status will be instructed to return to the clinic for a follow-up visit (Visit 2), two (2) weeks later to obtain their laboratory test results. Participants may also have a separate Point-of-Care (POC) test for HIV and/or syphilis conducted on site as part of the clinic's standard of care testing, outside of the protocol. Activities in the plan of the study include: * Selection of study Operators with informed consent for participation in the study * Completion of Untrained Operator Eligibility and Assessment Questionnaire - prior to study start * Screening of participants and obtaining informed consent * Review of inclusion/exclusion criteria and completion of Participant Enrollment Questionnaire * Specimen Collection and Testing: * Collection of venous blood for Clinical Laboratory testing for HIV and Syphilis * Collection of fingerstick whole blood for testing with the Multiplo Test * Laboratory testing for HIV and Syphilis * Clinical follow up for Participants with positive HIV and/or Syphilis test results from Clinical Laboratory testing * Participants who test negative will have opportunities for preventative services including PrEP * Completion of Untrained Operator Usability and Interpretation Questionnaire - after study completion * Untrained non-professional Operator Mock Device Interpretation Assessment Following recruitment of participants and obtaining informed consent, Participants may be enrolled in the trial.

Conditions

• HIV Infections
• Syphilis Infection

Interventions

Type	Name	Description
DEVICE	Multiplo TP/HIV Antibody Test	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.

Timeline

• Start date: 2025-05-05
• Primary completion: 2025-09-05
• Completion: 2025-09-30
• First posted: 2024-06-17
• Last updated: 2025-06-26

Locations

4 sites across 1 country: Canada