Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810559
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2021-03-15
Brief Title:
Near Patient Study of the OraQuick ADVANCE HIV-12 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Near Patient Study of the OraQuick ADVANCE HIV-12 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Point-of-care POC tests for HIV are easy to use rapid and provide accurate results while the patient is still in-front of a healthcare provider HCP Currently only blood-based POC tests for HIV are licensed for use in Canada The OraQuick ADVANCE HIV-12 Rapid Antibody Test is a POC test developed by OraSure Technologies Inc to detect HIV antibodies in oral fluid and fingerstick blood samples As this device is very similar to the OraQuick HIV Self-Test Health Canada requires evidence that HCPs can successfully perform the POC version of the OraQuick test in addition to performance of the self test version by intended users
This study involves a minimum of 9 HCPs and 600 Patients at clinic sites in Toronto and Ottawa Ontario Montreal Quebec and Edmonton Alberta It will assess the OraQuick ADVANCE Tests simplicity and accuracy in the hands of HCPs who have never used this Test
To assess performance using only the test kit instructions for use HCPs will collect and test oral fluid and fingerstick blood samples from patients with the OraQuick ADVANCE Test and will then read and interpret those results Results of the OraQuick ADVANCE Test will be compared with results of a venous blood sample collected from each patient and tested with a usual licensed laboratory test method
To assess usability HCPs will interpret various mock device test results and respond to a questionnaire to determine if the test instructions for use are clear and simple that they are aware of test requirements and limitations and provide opinions on the ease of use of the test
A final report of study results will be provided to the Test manufacturer for inclusion in the Health Canada license application process
This study involves a minimum of 9 HCPs and 600 Patients at clinic sites in Toronto and Ottawa Ontario Montreal Quebec and Edmonton Alberta It will assess the OraQuick ADVANCE Tests simplicity and accuracy in the hands of HCPs who have never used this Test
To assess performance using only the test kit instructions for use HCPs will collect and test oral fluid and fingerstick blood samples from patients with the OraQuick ADVANCE Test and will then read and interpret those results Results of the OraQuick ADVANCE Test will be compared with results of a venous blood sample collected from each patient and tested with a usual licensed laboratory test method
To assess usability HCPs will interpret various mock device test results and respond to a questionnaire to determine if the test instructions for use are clear and simple that they are aware of test requirements and limitations and provide opinions on the ease of use of the test
A final report of study results will be provided to the Test manufacturer for inclusion in the Health Canada license application process
Detailed Description:
Background and Rationale
At the end of 2018 the Public Health Agency of Canada PHAC noted 2242 new HIV infections incidence rate of 6 per 100000 people representing a slight increase from 2016 estimates For the same period PHAC estimated there were 62050 Canadians living with HIV prevalence rate 167 per 100000 and about 18700 Canadians were missed throughout the HIV care continuum including 8300 who are living with HIV but were undiagnosed This represents about 13 of Canadians living with HIV but are unaware of their status and not in care
As testing is the entry point to HIV care it is likely that those who are undiagnosed are not engaging in HIV testing services PHACs Pan-Canadian Framework for Action sets out an overarching and comprehensive approach to address sexually transmitted and blood-borne infections including HIV and is composed of 26 opportunities for action including enhancing testing Testing opportunities which include elimination of barriers to access testing and normalization of testing through primary healthcare providers HCPs strategies that use community-based services and HIV self-testing could help Canada reach the undiagnosed However testing by HCPs within clinical settings remains the foundation to Canadian HIV care programs
Point-of-care POC tests for HIV may have substantial utility for increased identification of HIV-infected individuals through their relative ease of use and portability as well as their ability to deliver rapid actionable results while the HCP still has access to the patient OraSure Technologies Inc has developed a POC test the OraQuick ADVANCE HIV-12 Rapid Antibody Test which requires no additional instrumentation and can be used by HCPs in multiple near patient settings The OraQuick ADVANCE Test is a single-use visually read qualitative in vitro lateral flow immunoassay to detect antibodies to HIV-1 and HIV-2 in oral fluid and fingerstick blood The Test package includes a specific step-by-step instructions the device testing buffer solution and a device stand It is available in the United States FDA approved but is not currently approved for use in Canada
Currently only blood-based POC tests for HIV are licensed for use in Canada Having a licensed oral-fluid test in addition to blood-based tests available for use in Canada provides another option to increase the uptake of HIV testing and further increase the potential of reaching undiagnosed individuals living with HIV in Canada Studies have shown that interest and acceptability of testing with oral fluid is high
The objective of this near patient study is to demonstrate the simplicity and accuracy of the OraQuick ADVANCE HIV-12 Rapid Antibody Test when used by untrained HCPs in a clinical setting A secondary objective includes the ability of HCPs to correctly interpret a variety of contrived mock test device results
Hypothesis The OraQuickADVANCE HIV-12 Rapid Antibody Test as performed by untrained HCPs will meet or exceed the accuracy usability and label comprehension requirements from Health Canada for license as a Class IV in vitro diagnostic device for Canadian market entry
Study Design
This study was designed around the requirements set out in the Health Canada Guidance Document Guidance for Manufacturers of Human Immunodeficiency Virus HIV Rapid Diagnostic Tests RDTs for Use at Point of Care or Self Testing 2017 It is a blinded controlled study to evaluate the ability of HCPs to perform and interpret the results of the OraQuick ADVANCE HIV-12 Rapid Antibody Test
This protocol involves collection of oral fluid and fingerstick whole blood from approximately 600 patients to test with the OraQuick ADVANCE Test device Testing will be conducted by HCPs blinded to patients history and HIV diagnosis in clinical settings All patient participants will also have a venous blood sample collected prior to fingerstick and oral fluid collection for testing of plasma at a central laboratory with a 4th generation HIV AgAb EIA licensed for use in Canada and positives will be confirmed using a standard HIV testing algorithm in place at the respective central laboratories Results from the OraQuick ADVANCE Test will be compared to results from the blood based 4th generation EIA The sensitivity and specificity of the test result will be calculated relative to the confirmatory test process where applicable HCP qualification and assessment of the ease of device use will be evaluated HCPs will also read and interpret 20 contrived mock device results in order to assess their ability to correctly interpret 5 potential test results ie strong positive weak positive negative invalid with no control and no test line and invalid with no control and a positive test line
Investigators will provide descriptive statistics for subject and HCP parameters Test results will be compared to a Health Canada licensed 4th generation EIA test and investigators will calculate positive and negative percent agreement with two-sided 95 confidence interval for both for each matrix fingerstick and oral fluid separately For mock device interpretation agreement of the OraQuick ADVANCE HIV-12 Rapid Antibody Test results with each sample type reactivity will be calculated overall and for each HCP operator Safety will be assessed by the incidence of reported adverse events
Sample population
The study population requirements published by Health Canada for near patient studies of untrained HCP testers stipulates that the prospective study include A minimum of 3 POC sites different geographic locations a minimum of 9 HCPs 200 known HIV positive individuals and 400 individuals whose HIV status is unknown including 200 individuals at high risk of HIV infection eg intravenous drug users men who have sex with men etc Self-reported practices or behaviour will be used to define those at high risk
Hypothesis The OraQuickADVANCE HIV-12 Rapid Antibody Test as performed by untrained HCPs will meet or exceed the accuracy usability and label comprehension requirements from Health Canada for license as a Class IV in vitro diagnostic device for Canadian market entry
Study Design
This study was designed around the requirements set out in the Health Canada Guidance Document Guidance for Manufacturers of Human Immunodeficiency Virus HIV Rapid Diagnostic Tests RDTs for Use at Point of Care or Self Testing 2017 It is a blinded controlled study to evaluate the ability of HCPs to perform and interpret the results of the OraQuick ADVANCE HIV-12 Rapid Antibody Test
This protocol involves collection of oral fluid and fingerstick whole blood from approximately 600 patients to test with the OraQuick ADVANCE Test device Testing will be conducted by HCPs blinded to patients history and HIV diagnosis in clinical settings All patient participants will also have a venous blood sample collected prior to fingerstick and oral fluid collection for testing of plasma at a central laboratory with a 4th generation HIV AgAb EIA licensed for use in Canada and positives will be confirmed using a standard HIV testing algorithm in place at the respective central laboratories Results from the OraQuick ADVANCE Test will be compared to results from the blood based 4th generation EIA The sensitivity and specificity of the test result will be calculated relative to the confirmatory test process where applicable HCP qualification and assessment of the ease of device use will be evaluated HCPs will also read and interpret 20 contrived mock device results in order to assess their ability to correctly interpret 5 potential test results ie strong positive weak positive negative invalid with no control and no test line and invalid with no control and a positive test line
Investigators will provide descriptive statistics for subject and HCP parameters Test results will be compared to a Health Canada licensed 4th generation EIA test and investigators will calculate positive and negative percent agreement with two-sided 95 confidence interval for both for each matrix fingerstick and oral fluid separately For mock device interpretation agreement of the OraQuick ADVANCE HIV-12 Rapid Antibody Test results with each sample type reactivity will be calculated overall and for each HCP operator Safety will be assessed by the incidence of reported adverse events
Sample population
The study population requirements published by Health Canada for near patient studies of untrained HCP testers stipulates that the prospective study include A minimum of 3 POC sites different geographic locations a minimum of 9 HCPs 200 known HIV positive individuals and 400 individuals whose HIV status is unknown including 200 individuals at high risk of HIV infection eg intravenous drug users men who have sex with men etc Self-reported practices or behaviour will be used to define those at high risk
Study Intervention Details
HCPs will be recruited by site coordinators first If HCPs are interested in participating they will complete the informed consent process and then complete an initial HCP questionnaire which will collect information such as demographics occupation and POC device experience about 15 minutes
After this patients will be recruited to the study when they come in for voluntary HIV testing eg POC testing and routine HIV follow-up care at study sites If patients consent to participating all those enrolled will voluntarily complete a questionnaire collecting demographics and HIV medical history information and then provide their venous whole blood sample for clinical laboratory testing and fingerstick and oral fluid specimens for the testing with the OraQuick ADVANCE Test - Visit 1 day 1 about 40 - 60 minutes as per protocol and study procedures An unblinded HCP will administer the patient questionnaire and collect the venous whole blood sample All patients will have a clinical laboratory test done for performance comparison using their venous sample but only those with unknown HIV status will be instructed to return to the clinic for a follow-up visit two 2 weeks later to obtain their laboratory test results Visit 2 about 10 - 15 minutes Patients may also have a point-of-care POC test conducted on site as part of the clinics standard of care testing outside of the protocol and after all study procedures for Visit 1 are completed
Two HCPs who are blinded to the patient history including HIV diagnosis will collect and test patient specimens either the oral fluid or the fingerstick whole blood using the OraQuick ADVANCE Test by following the instructions provided in the Step-by-Step Instruction Guide and Package Insert for the Test HCPs will then read interpret following the instruction guide and document these test results for each patient Sampling testing and recording is estimated between 20 - 40 minutes per patient participant At the end of testing at a site HCPs will complete a second questionnaire which will include reading and interpreting 20 mock contrived device results comprehension questions and collect information about ease of use and experience with the Test about 1 hour
At the end of 2018 the Public Health Agency of Canada PHAC noted 2242 new HIV infections incidence rate of 6 per 100000 people representing a slight increase from 2016 estimates For the same period PHAC estimated there were 62050 Canadians living with HIV prevalence rate 167 per 100000 and about 18700 Canadians were missed throughout the HIV care continuum including 8300 who are living with HIV but were undiagnosed This represents about 13 of Canadians living with HIV but are unaware of their status and not in care
As testing is the entry point to HIV care it is likely that those who are undiagnosed are not engaging in HIV testing services PHACs Pan-Canadian Framework for Action sets out an overarching and comprehensive approach to address sexually transmitted and blood-borne infections including HIV and is composed of 26 opportunities for action including enhancing testing Testing opportunities which include elimination of barriers to access testing and normalization of testing through primary healthcare providers HCPs strategies that use community-based services and HIV self-testing could help Canada reach the undiagnosed However testing by HCPs within clinical settings remains the foundation to Canadian HIV care programs
Point-of-care POC tests for HIV may have substantial utility for increased identification of HIV-infected individuals through their relative ease of use and portability as well as their ability to deliver rapid actionable results while the HCP still has access to the patient OraSure Technologies Inc has developed a POC test the OraQuick ADVANCE HIV-12 Rapid Antibody Test which requires no additional instrumentation and can be used by HCPs in multiple near patient settings The OraQuick ADVANCE Test is a single-use visually read qualitative in vitro lateral flow immunoassay to detect antibodies to HIV-1 and HIV-2 in oral fluid and fingerstick blood The Test package includes a specific step-by-step instructions the device testing buffer solution and a device stand It is available in the United States FDA approved but is not currently approved for use in Canada
Currently only blood-based POC tests for HIV are licensed for use in Canada Having a licensed oral-fluid test in addition to blood-based tests available for use in Canada provides another option to increase the uptake of HIV testing and further increase the potential of reaching undiagnosed individuals living with HIV in Canada Studies have shown that interest and acceptability of testing with oral fluid is high
The objective of this near patient study is to demonstrate the simplicity and accuracy of the OraQuick ADVANCE HIV-12 Rapid Antibody Test when used by untrained HCPs in a clinical setting A secondary objective includes the ability of HCPs to correctly interpret a variety of contrived mock test device results
Hypothesis The OraQuickADVANCE HIV-12 Rapid Antibody Test as performed by untrained HCPs will meet or exceed the accuracy usability and label comprehension requirements from Health Canada for license as a Class IV in vitro diagnostic device for Canadian market entry
Study Design
This study was designed around the requirements set out in the Health Canada Guidance Document Guidance for Manufacturers of Human Immunodeficiency Virus HIV Rapid Diagnostic Tests RDTs for Use at Point of Care or Self Testing 2017 It is a blinded controlled study to evaluate the ability of HCPs to perform and interpret the results of the OraQuick ADVANCE HIV-12 Rapid Antibody Test
This protocol involves collection of oral fluid and fingerstick whole blood from approximately 600 patients to test with the OraQuick ADVANCE Test device Testing will be conducted by HCPs blinded to patients history and HIV diagnosis in clinical settings All patient participants will also have a venous blood sample collected prior to fingerstick and oral fluid collection for testing of plasma at a central laboratory with a 4th generation HIV AgAb EIA licensed for use in Canada and positives will be confirmed using a standard HIV testing algorithm in place at the respective central laboratories Results from the OraQuick ADVANCE Test will be compared to results from the blood based 4th generation EIA The sensitivity and specificity of the test result will be calculated relative to the confirmatory test process where applicable HCP qualification and assessment of the ease of device use will be evaluated HCPs will also read and interpret 20 contrived mock device results in order to assess their ability to correctly interpret 5 potential test results ie strong positive weak positive negative invalid with no control and no test line and invalid with no control and a positive test line
Investigators will provide descriptive statistics for subject and HCP parameters Test results will be compared to a Health Canada licensed 4th generation EIA test and investigators will calculate positive and negative percent agreement with two-sided 95 confidence interval for both for each matrix fingerstick and oral fluid separately For mock device interpretation agreement of the OraQuick ADVANCE HIV-12 Rapid Antibody Test results with each sample type reactivity will be calculated overall and for each HCP operator Safety will be assessed by the incidence of reported adverse events
Sample population
The study population requirements published by Health Canada for near patient studies of untrained HCP testers stipulates that the prospective study include A minimum of 3 POC sites different geographic locations a minimum of 9 HCPs 200 known HIV positive individuals and 400 individuals whose HIV status is unknown including 200 individuals at high risk of HIV infection eg intravenous drug users men who have sex with men etc Self-reported practices or behaviour will be used to define those at high risk
Hypothesis The OraQuickADVANCE HIV-12 Rapid Antibody Test as performed by untrained HCPs will meet or exceed the accuracy usability and label comprehension requirements from Health Canada for license as a Class IV in vitro diagnostic device for Canadian market entry
Study Design
This study was designed around the requirements set out in the Health Canada Guidance Document Guidance for Manufacturers of Human Immunodeficiency Virus HIV Rapid Diagnostic Tests RDTs for Use at Point of Care or Self Testing 2017 It is a blinded controlled study to evaluate the ability of HCPs to perform and interpret the results of the OraQuick ADVANCE HIV-12 Rapid Antibody Test
This protocol involves collection of oral fluid and fingerstick whole blood from approximately 600 patients to test with the OraQuick ADVANCE Test device Testing will be conducted by HCPs blinded to patients history and HIV diagnosis in clinical settings All patient participants will also have a venous blood sample collected prior to fingerstick and oral fluid collection for testing of plasma at a central laboratory with a 4th generation HIV AgAb EIA licensed for use in Canada and positives will be confirmed using a standard HIV testing algorithm in place at the respective central laboratories Results from the OraQuick ADVANCE Test will be compared to results from the blood based 4th generation EIA The sensitivity and specificity of the test result will be calculated relative to the confirmatory test process where applicable HCP qualification and assessment of the ease of device use will be evaluated HCPs will also read and interpret 20 contrived mock device results in order to assess their ability to correctly interpret 5 potential test results ie strong positive weak positive negative invalid with no control and no test line and invalid with no control and a positive test line
Investigators will provide descriptive statistics for subject and HCP parameters Test results will be compared to a Health Canada licensed 4th generation EIA test and investigators will calculate positive and negative percent agreement with two-sided 95 confidence interval for both for each matrix fingerstick and oral fluid separately For mock device interpretation agreement of the OraQuick ADVANCE HIV-12 Rapid Antibody Test results with each sample type reactivity will be calculated overall and for each HCP operator Safety will be assessed by the incidence of reported adverse events
Sample population
The study population requirements published by Health Canada for near patient studies of untrained HCP testers stipulates that the prospective study include A minimum of 3 POC sites different geographic locations a minimum of 9 HCPs 200 known HIV positive individuals and 400 individuals whose HIV status is unknown including 200 individuals at high risk of HIV infection eg intravenous drug users men who have sex with men etc Self-reported practices or behaviour will be used to define those at high risk
Study Intervention Details
HCPs will be recruited by site coordinators first If HCPs are interested in participating they will complete the informed consent process and then complete an initial HCP questionnaire which will collect information such as demographics occupation and POC device experience about 15 minutes
After this patients will be recruited to the study when they come in for voluntary HIV testing eg POC testing and routine HIV follow-up care at study sites If patients consent to participating all those enrolled will voluntarily complete a questionnaire collecting demographics and HIV medical history information and then provide their venous whole blood sample for clinical laboratory testing and fingerstick and oral fluid specimens for the testing with the OraQuick ADVANCE Test - Visit 1 day 1 about 40 - 60 minutes as per protocol and study procedures An unblinded HCP will administer the patient questionnaire and collect the venous whole blood sample All patients will have a clinical laboratory test done for performance comparison using their venous sample but only those with unknown HIV status will be instructed to return to the clinic for a follow-up visit two 2 weeks later to obtain their laboratory test results Visit 2 about 10 - 15 minutes Patients may also have a point-of-care POC test conducted on site as part of the clinics standard of care testing outside of the protocol and after all study procedures for Visit 1 are completed
Two HCPs who are blinded to the patient history including HIV diagnosis will collect and test patient specimens either the oral fluid or the fingerstick whole blood using the OraQuick ADVANCE Test by following the instructions provided in the Step-by-Step Instruction Guide and Package Insert for the Test HCPs will then read interpret following the instruction guide and document these test results for each patient Sampling testing and recording is estimated between 20 - 40 minutes per patient participant At the end of testing at a site HCPs will complete a second questionnaire which will include reading and interpreting 20 mock contrived device results comprehension questions and collect information about ease of use and experience with the Test about 1 hour
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None