A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test

NACompletedINTERVENTIONAL
Enrollment

1,728

Participants

Timeline

Start Date

May 2, 2024

Primary Completion Date

January 8, 2025

Study Completion Date

January 8, 2025

Conditions
Human Immunodeficiency Virus I InfectionHuman Immunodeficiency Virus II Infection
Interventions
DEVICE

INSTI® HIV Self-Test

"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."

Trial Locations (1)

33308

Therafirst Medical Center, Fort Lauderdale

Sponsors
All Listed Sponsors
lead

bioLytical Laboratories

INDUSTRY