122
Participants
Start Date
July 24, 2025
Primary Completion Date
August 6, 2025
Study Completion Date
August 6, 2025
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
bioLytical Laboratories Inc., Richmond
Lead Sponsor
bioLytical Laboratories
INDUSTRY