Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users - Trial NCT06369116
Access comprehensive clinical trial information for NCT06369116 through Pure Global AI's free database. This phase not specified trial is sponsored by bioLytical Laboratories and is currently Recruiting. The study focuses on Hepatitis C. Target enrollment is 1400 participants.
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Study Focus
Sponsor & Location
bioLytical Laboratories
Timeline & Enrollment
N/A
Oct 12, 2023
Apr 22, 2024
Primary Outcome
Clinical sensitivity and specificity of INSTI HCV Self Test
Summary
This is a controlled study intended to evaluate the usability, label comprehension and
 performance of the INSTI® HCV Self Test in the hands of untrained lay users using fingerstick
 blood, with instructions for use specifically designed for a lay person who has not used any
 hepatitis C rapid self test prior to the study and to assess lay users ability to
 comprehend key concepts and information provided on the outside of the pouch and in the
 accompanying Instructions for Use. Comprehension will be assessed without product
 familiarization (demonstration/training) by a healthcare professional.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06369116
Device Trial