Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368453
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
A Study to Evaluate the Performance Usability and Result Interpretation of INSTI HIV Self-Test
Sponsor:
bioLytical Laboratories
Organization:
bioLytical Laboratories
Study Overview
Official Title:
A Study to Evaluate the Performance Usability and Result Interpretation of INSTI HIV Self-Test When Performed by Observed Intended Users in the US
Status:
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:
The objective of this study is to evaluate the performance usability and result interpretation of the INSTI HIV Self-Test referred to INSTI HIV ST in the intended use population across the United States US The INSTI HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood This study is designed to evaluate INSTI HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing
The study aims to
To evaluate the clinical performance ie diagnostic sensitivity and specificity of the INSTI HIV Self-Test in a lay user population
To assess the users comprehension of the INSTI HIV ST results eg interpreting positive negative and invalid results
To evaluate the usability of the INSTI HIV ST and understand users experience in performing the test
The study aims to
To evaluate the clinical performance ie diagnostic sensitivity and specificity of the INSTI HIV Self-Test in a lay user population
To assess the users comprehension of the INSTI HIV ST results eg interpreting positive negative and invalid results
To evaluate the usability of the INSTI HIV ST and understand users experience in performing the test
Detailed Description:
The objective of this study is to evaluate the performance usability and result interpretation of the INSTI HIV Self-Test referred to INSTI HIV ST in the intended user population across the United States US This study is designed to evaluate INSTI HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV self-testing
The study aims to
To evaluate the clinical performance ie diagnostic sensitivity and specificity of the INSTI HIV ST in a lay user population
To assess the users comprehension of the INSTI HIV ST results eg interpreting positive negative and invalid results
To evaluate the usability of the INSTI HIV ST and understand users experience in performing the test
Subjects will be consecutively enrolled from the general population ie all comers group of previously undiagnosed HIV individuals until a minimum of 27 HIV positive and 1000-1700 HIV negatives are obtained Subjects will be lay users recruited at multiple sites across the US This study is to determine if lay users unassisted can perform the INSTI HIV ST correctly and without significant risk of incorrect results The study will help to determine if the INSTI HIV ST instructions are easy to understand for the US public The overall study processes include a performance evaluation where subjects will perform the INSTI HIV ST a mock results interpretation study to assess the users comprehension of the INSTI HIV ST results and usability evaluation to understand users experience with the INSTI HIV ST Only a subset of the enrolled subjects 500 subjects will participate in the mock results interpretation study and usability evaluation
For the performance evaluation subjects will perform the INSTI HIV ST without any intervention from an observer Following the subjects self-testing an operator will collect an additional fingerstick sample to perform a comparator test The positive and negative percent agreement ie PPA and NPA between the INSTI HIV ST result and comparator will be calculated In the event of discrepant results between the INSTI HIV ST and comparator test an additional venous blood sample will be collected from the subject for discrepancy testing
A subset of the enrolled subjects will then participate in the mock results interpretation study and usability evaluation For the mock study the subjects will be presented with 5 mock INSTI HIV ST devices with different results and the subjects interpretation of each device will be recorded The percentage of subjects who interpreted the mock results correctly for each result type will be calculated
For the INSTI HIV ST usability evaluation the subjects will be presented with a questionnaire The overall results of the questionnaire will be used to determine the percentage of subjects who found the INSTI HIV ST easy to use
The study aims to
To evaluate the clinical performance ie diagnostic sensitivity and specificity of the INSTI HIV ST in a lay user population
To assess the users comprehension of the INSTI HIV ST results eg interpreting positive negative and invalid results
To evaluate the usability of the INSTI HIV ST and understand users experience in performing the test
Subjects will be consecutively enrolled from the general population ie all comers group of previously undiagnosed HIV individuals until a minimum of 27 HIV positive and 1000-1700 HIV negatives are obtained Subjects will be lay users recruited at multiple sites across the US This study is to determine if lay users unassisted can perform the INSTI HIV ST correctly and without significant risk of incorrect results The study will help to determine if the INSTI HIV ST instructions are easy to understand for the US public The overall study processes include a performance evaluation where subjects will perform the INSTI HIV ST a mock results interpretation study to assess the users comprehension of the INSTI HIV ST results and usability evaluation to understand users experience with the INSTI HIV ST Only a subset of the enrolled subjects 500 subjects will participate in the mock results interpretation study and usability evaluation
For the performance evaluation subjects will perform the INSTI HIV ST without any intervention from an observer Following the subjects self-testing an operator will collect an additional fingerstick sample to perform a comparator test The positive and negative percent agreement ie PPA and NPA between the INSTI HIV ST result and comparator will be calculated In the event of discrepant results between the INSTI HIV ST and comparator test an additional venous blood sample will be collected from the subject for discrepancy testing
A subset of the enrolled subjects will then participate in the mock results interpretation study and usability evaluation For the mock study the subjects will be presented with 5 mock INSTI HIV ST devices with different results and the subjects interpretation of each device will be recorded The percentage of subjects who interpreted the mock results correctly for each result type will be calculated
For the INSTI HIV ST usability evaluation the subjects will be presented with a questionnaire The overall results of the questionnaire will be used to determine the percentage of subjects who found the INSTI HIV ST easy to use
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?:
False
Is an FDA AA801 Violation?:
None