Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369116
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-08
Brief Title:
Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users
Sponsor:
bioLytical Laboratories
Organization:
bioLytical Laboratories
Study Overview
Official Title:
A Controlled Observed Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
This is a controlled study intended to evaluate the usability label comprehension and performance of the INSTI HCV Self Test in the hands of untrained lay users using fingerstick blood with instructions for use specifically designed for a lay person who has not used any hepatitis C rapid self test prior to the study and to assess lay users ability to comprehend key concepts and information provided on the outside of the pouch and in the accompanying Instructions for Use Comprehension will be assessed without product familiarization demonstrationtraining by a healthcare professional
Detailed Description:
The HSTAR012 is a controlled study intended to evaluate the usability label comprehension and performance of the INSTI HCV Self Test in the hands of untrained lay users using fingerstick blood with instructions for use specifically designed for a lay person who has not used any hepatitis C rapid self test prior to the study and to assess lay users ability to comprehend key concepts and information provided on the outside of the pouch and in the accompanying Instructions for Use Comprehension will be assessed without product familiarization demonstrationtraining by a healthcare professional
Specific critical and non-critical steps are identified from the self-test products Instructions for Use The untrained lay user is evaluated for process success or difficulty by a silent non-interacting observer in the same room Overall processes include self-test Usability observation to determine if a participant performs all critical steps correctly Interpretation of results confirmation by staff to determine if participant interprets their test correctly and labelling Comprehension questionnaire to determine that the participant is aware of test limitations and what to do following the test result The successful completion of steps will be evaluated as a percentage of the overall process with all critical and non-critical errors identified and reported All self-test results will be confirmed by testing with the same test by collecting additional fingerstick samples by a trained HCP aka Trained Observer The level of agreement between the results of the investigated test ie INSTI HCV Self Test obtained by a lay user and those obtained by a healthcare worker will be calculated
Additionally EDTA venous blood samples will be collected from each participant and sent to a laboratory to perform an enzyme immunoassay EIA using a state-of-the-art quality-assured assay prequalified by WHO CE-IVD or FDA approved The sensitivity and specificity of the INSTI HCV Self Test will be also calculated and the results from both tests conducted by the lay user and trained HCP compared to the results of the laboratory assay
In the event of discrepant results between INSTI HCV Self Test and the laboratory-based EIA assay EDTA venous whole blood will be collected to perform HCV RNA assay to confirm active infection study participants with positive results in HCV RNA test will be contacted and linked to care following local algorithms
Study Aim
1 To evaluate the ability of untrained lay users to obtain an accurate test result using the INSTI HCV Self Test
2 To evaluate the untrained lay users interaction with the device in terms of effectiveness and efficiency ie successfulunsuccessful completion and difficulty of the critical steps as per the Instructions for Use
3 To evaluate the performance diagnostic sensitivity and specificity of INSTI HCV self-test by the lay user in comparison with laboratory confirmatory test
4 To evaluate the performance diagnostic sensitivity and specificity of INSTI HCV self-test by the healthcare professional in comparison with laboratory confirmatory test
5 To evaluate the concordance of the results between the trained observer and the untrained lay user
6 To assess the ability of untrained lay users to correctly comprehend key messaging from device packaging and labelling including the Instructions for Use
7 To understand the experience and satisfaction of study participants with the overall self-testing process
8 To assess whether or not the participants locate and read the information included in the IFU know what the products are used for and when its appropriateinappropriate to use the product
Specific critical and non-critical steps are identified from the self-test products Instructions for Use The untrained lay user is evaluated for process success or difficulty by a silent non-interacting observer in the same room Overall processes include self-test Usability observation to determine if a participant performs all critical steps correctly Interpretation of results confirmation by staff to determine if participant interprets their test correctly and labelling Comprehension questionnaire to determine that the participant is aware of test limitations and what to do following the test result The successful completion of steps will be evaluated as a percentage of the overall process with all critical and non-critical errors identified and reported All self-test results will be confirmed by testing with the same test by collecting additional fingerstick samples by a trained HCP aka Trained Observer The level of agreement between the results of the investigated test ie INSTI HCV Self Test obtained by a lay user and those obtained by a healthcare worker will be calculated
Additionally EDTA venous blood samples will be collected from each participant and sent to a laboratory to perform an enzyme immunoassay EIA using a state-of-the-art quality-assured assay prequalified by WHO CE-IVD or FDA approved The sensitivity and specificity of the INSTI HCV Self Test will be also calculated and the results from both tests conducted by the lay user and trained HCP compared to the results of the laboratory assay
In the event of discrepant results between INSTI HCV Self Test and the laboratory-based EIA assay EDTA venous whole blood will be collected to perform HCV RNA assay to confirm active infection study participants with positive results in HCV RNA test will be contacted and linked to care following local algorithms
Study Aim
1 To evaluate the ability of untrained lay users to obtain an accurate test result using the INSTI HCV Self Test
2 To evaluate the untrained lay users interaction with the device in terms of effectiveness and efficiency ie successfulunsuccessful completion and difficulty of the critical steps as per the Instructions for Use
3 To evaluate the performance diagnostic sensitivity and specificity of INSTI HCV self-test by the lay user in comparison with laboratory confirmatory test
4 To evaluate the performance diagnostic sensitivity and specificity of INSTI HCV self-test by the healthcare professional in comparison with laboratory confirmatory test
5 To evaluate the concordance of the results between the trained observer and the untrained lay user
6 To assess the ability of untrained lay users to correctly comprehend key messaging from device packaging and labelling including the Instructions for Use
7 To understand the experience and satisfaction of study participants with the overall self-testing process
8 To assess whether or not the participants locate and read the information included in the IFU know what the products are used for and when its appropriateinappropriate to use the product
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSTAR012 | OTHER | None | None |
| WRHI071 | OTHER | Ezintsha | None |