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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463314
• Other study ID #: REACH Multiplex CLS-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Unity Health Toronto
• Contact: Sean Rourke, PhD
• Phone: 416-878-2779
• Email: sean.rourke[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 341
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• • Are at least 16 years of age

• Are able to read/understand English or French

• Are able to provide informed consent

• Agree to provide accurate medical history

• Are able to provide up to 20mL blood by venipuncture, and a small amount of blood by fingerstick

• Agree to undergo testing for HIV and syphilis with the INSTI Multiplex Test

• For the Participants previously diagnosed with syphilis, diagnosis can have occurred at any time prior to enrolment

• For the Participants with unknown HIV and/or syphilis status - last HIV negative test must be greater than 3 months prior to date of consent

Exclusion Criteria:

• • Are site employees

• Are in the judgment of the investigator to be unable to complete the study or are unlikely to comply with the study protocol

• Are known to be living with HIV, ie previously diagnosed with HIV regardless of treatment status

• Have been previously enrolled in this study

Related Conditions & MeSH terms

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

Intervention

Device:
• INSTI Multiplex HIV/Syphilis Antibody Test
The INSTI® Multiplex HIV-1/HIV-2 Syphilis Antibody Test (bioLytical Laboratories Inc., Richmond, BC), ["INSTI Multiplex Test"] is a single use, rapid, flow-through in vitro qualitative immunoassay for the detection of antibodies to HIV Type 1 and 2 and Treponema pallidum (Syphilis) in human fingerstick blood and serum. The test is intended to screen for 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 one minute. This test is licensed by Health Canada.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	demonstrate the simplicity and accuracy of the INSTI Multiplex Test	The objective of this study is to demonstrate the simplicity and accuracy of the INSTI Multiplex Test when used by non-registered health care professionals including peer testers ("Operators) in a clinical near-patient setting. Non-Health Care Professional (Non-HCP) will will administer the test to the 341 participants of both known and unknown status by following the IFU and recording the details in the database. The results of the INSTI Multiplex Test performed by these Operators (the result that is interpreted from the test device) will be compared with the result obtained by the licensed blood-based laboratory serological assays for HIV and syphilis. A positive and negative percent agreement will be calculated.	6 months
Secondary	A secondary objective includes the ability of the study Operators to correctly interpret a variety of mock test results.	Non-health care professionals will be asked to read results from a variety of mock test results. These mock tests will be blind coded, provided to the non-HCP in random order followed by review and documentation of the panels of contrived test results to be interpreted by study Operators. The results indicated by the non-HCP will be compared against the code to determine the ability of the non-HCP to correctly interpret a variety of results including, strong positive, weak positive, invalid, weak negative and strong negative. Each Operator will read a total of fifteen (15) mock devices. A minimum of 9 non-HCP operators will be part of this study.	1 month