Clinical Trial: A Study to Evaluate the Performance of INSTI(R) HIV Self Test When Performed by Unobserved Intended Users in the US

U.S., July 15 -- ClinicalTrials.gov registry received information related to the study (NCT07061912) titled 'A Study to Evaluate the Performance of INSTI(R) HIV Self Test When Performed by Unobserved Intended Users in the US' on July 08.

Brief Summary: The objective of this study is to evaluate the performance of INSTI(R) 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(R) 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(R) HIV Self-Test in a lay user population.

Study Start D...