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Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users

NCT06369116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1415

Last updated 2025-02-21

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DEVICE

INSTI HCV Self Test

Each participant will be presented with a packaged self-test and asked to conduct self testing. The Trained Observer will only watch the participant process at a short distance and take notes on the process; at no point will the observer respond to questions or assist with the testing process - only to encourage the participant to try to figure out the process as best they can use the instruction sheet. The participant will then be permitted to perform the self-test and read their self test result. The observer is also going to observe the test result interpreted by the lay user and also themselves. After this step is complete, the Trained Observer will then perform fingerstick sample collection from lay user and run the sample on INSTI® HCV Self Test. The Trained Observer will then draw a venous whole blood sample from the participant for laboratory testing and final diagnosis will be given to the participant once laboratory results have been received.

Sponsors & Collaborators

  • bioLytical Laboratories

    lead INDUSTRY

Principal Investigators

  • Mohammed Majam · Ezintsha, a division of Wits Health Consortium (Pty) Ltd

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2024-04-25
Completion
2024-05-03

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06369116 on ClinicalTrials.gov