NCT07061912

A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: bioLytical Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to perform the INSTI® HIV Self Test correctly and without significant risk of incorrect results. The study aims to evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.

Detailed description

The objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to perform the INSTI® HIV Self Test correctly and without significant risk of incorrect results. The study aims to evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population. The study population will be based on a general all-comers group of subjects. This includes both unknown HIV status and potentially known HIV positive status subjects. The number of valid positives from the comparator test will be monitored during the course of the study. When the comparator test reaches 10 valid positive results, the INSTI® HIV ST results for the same 10 subjects will be checked to see if they are also valid. If not, additional subjects will be recruited until there are at least 10 valid INSTI® HIV ST results within the comparator valid positive test results. Once the threshold has been reached recruiting will end. For known HIV positive subjects, site(s) will be requested to provide HIV-1/2 viral load and/or CD4 count laboratory results if available. Additionally, known HIV positive subjects on Anti-Retroviral Treatment (ART) should be on medication for less than 12 months. The study will initially recruit HIV unknown status subjects, at 50% of total enrollment (i.e., 50 out of 100 subjects) if the 10 HIV positives is deemed unattainable then HIV known subjects may be recruited to make up the 10 total HIV positives. The study is designed to evaluate INSTI® HIV ST performance when used unobserved by non-professional, untrained intended users that are inexperienced in self-testing.

Conditions

• Human Immunodeficiency Virus I Infection
• Human Immunodeficiency Virus II Infection

Interventions

Type	Name	Description
DEVICE	NSTI® HIV Self-Test	Each participant will be provided with the INSTI® HIV Self-Test(s) and asked to conduct self testing, unobserved. The participant will record their interpretation of the results. Subjects will perform the test without intervention or observation from the operator. The operator will then enter the room and also interpret the subject's self-test results then perform the comparator test. 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

Timeline

• Start date: 2025-07-24
• Primary completion: 2025-08-06
• Completion: 2025-08-06
• First posted: 2025-07-14
• Last updated: 2025-08-20

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study