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

NACompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

July 24, 2025

Primary Completion Date

August 6, 2025

Study Completion Date

August 6, 2025

Conditions
Human Immunodeficiency Virus I InfectionHuman Immunodeficiency Virus II Infection
Interventions
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

Trial Locations (1)

V6V 2A2

bioLytical Laboratories Inc., Richmond

Sponsors
All Listed Sponsors
lead

bioLytical Laboratories

INDUSTRY