An interventional study of INSTI® HIV Self-Test in Human Immunodeficiency Virus I Infection and Human Immunodeficiency Virus II Infection, sponsored by bioLytical Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by bioLytical Laboratories · Not applicable, Interventional, and Screening
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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 (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).
To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.
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 (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV ST in a lay user population.
To assess the user's comprehension of the INSTI® HIV ST results (e.g., 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 (i.e., "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 user's 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 (i.e., 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 subject's 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.
bioLytical Laboratories is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INSTI® HIV ST devices are provided to the enrolled participants to conduct the self test using the provided instruction for use while being observed by an operator. The operator records the INSTI® HIV ST results interpreted by the subjects. The operator then performs the comparator test to compare the results with the INSTI® HIV ST.
Device: INSTI® HIV Self-Test
A subset of the enrolled subjects (500 subjects) will 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 subject's 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.
Each participant will be provided with the INSTI® HIV Self-Test and asked to conduct self testing. The operator will observe the participant and record the subject's interpretation of the results. Subjects will perform the test without intervention from the operator. The operator will then perform the comparator test and collect a fingerstick blood sample. In the event of a discrepant result between the INSTI® HIV ST and comparator test, an additional venous blood sample will be collected from the subject and sent for discrepancy testing.
Clinical sensitivity and specificity of the INSTI® HIV Self-Test
The positive percent agreement (PPA) and negative percent agreement (NPA) between the INSTI® HIV ST and comparator test will be determined. The two-sided confidence interval for the PPA and NPA will be determined. The percentage of assays with INSTI® HIV ST invalid results will be determined.
Time frame: 12 Months
The INSTI® HIV Self-Test usability and result interpretation
The percentage of subjects who interpreted the INSTI® HIV ST mock results correctly for each result type will be determined. The usability questionnaire will be used to determine the following: The percentage of subjects who found the INSTI® HIV ST easy to use. The percentage of subjects who found the INSTI® HIV ST product information easy to use. The percentage of subjects willing to use the INSTI® HIV ST again The percentage of subjects willing to recommend the INSTI® HIV ST
Time frame: 12 Months
Ran from May 2024 to primary completion in Jan 2025, 8 months.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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