Multiplex Near Patient Non-HCP Study

HIV Infections Clinical Trial

Official title: A Prospective Cross-Sectional Study to Evaluate Performance and Usability of INSTI® Multiplex HIV/Syphilis Antibody Test at Point-Of-Care Sites in the Hands of Untrained Non-Health Care Professional Operators

Status Not yet recruiting

Clinical Trial 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. bioLytical Laboratories Inc. (Richmond, BC, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood sample that was licensed by Health Canada in March 2023 for use by trained health care 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.

Clinical Trial 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 INSTI Multiplex 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 INSTI Multiplex Test. This protocol involves collection of fingerstick whole blood from a minimum of 341 Participants to test with the INSTI Multiplex Test. Testing will be conducted by the study Operators in near-patient clinical settings. Results from the INSTI Multiplex 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 INSTI Multiplex 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 INSTI Multiplex 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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections
• Syphilis
• Syphilis Infection

• NCT number: NCT06463314
• Study type: Interventional
• Source: Unity Health Toronto
• Contact: Sean Rourke, PhD
• Phone: 416-878-2779
• Email: sean.rourke@utoronto.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Completion date: December 2024