Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463314
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-31
Brief Title:
Multiplex Near Patient Non-HCP Study
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
A Prospective Cross-Sectional Study to Evaluate Performance and Usability of INSTI Multiplex HIVSyphilis Antibody Test at Point-Of-Care Sites in the Hands of Untrained Non-Health Care Professional Operators
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To help reach the undiagnosed living with HIV andor 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
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 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 EIARPR 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 andor 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 andor syphilis conducted on site as part of the clinics 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 inclusionexclusion 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 andor 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
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 andor 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 andor syphilis conducted on site as part of the clinics 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 inclusionexclusion 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None