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

NCT06369116 | Completed

• 3 other identifiers: CLS-017BHSTAR012WRHI071
• Study Type: interventional
• Target: 1,415
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clinical sensitivity and specificity of INSTI HCV Self Test

  To evaluate the concordance between the results obtained by untrained lay users self-test to those results obtained by the HCP using another self-test device and lab-based confirmatory test and to ascertain the clinical sensitivity and specificity of the HCV Self-Test when compared to an approved state-of-the-art laboratory test.

  6 Months

Secondary Outcomes (1)

• To assess the usability and label comprehension of the INSTI HCV Self Test

  1 month

Study Arms (2)

Performance

EXPERIMENTAL

INSTI HCV Self Test devices are provided to the enrolled participants to conduct the self test using the provided instruction for use (IFU) as they are observed by a healthcare professional. The healthcare professional records observations while the participant is performing the self test and interpret the results. The trained healthcare professional is responsible for verifying the self-test result interpreted by the participant and further running another INSTI HCV Self-test to compare the results.

Device: INSTI HCV Self Test

Usability and Label Comprehension

NO INTERVENTION

Participants are provided a usability and label comprehension questionnaire to score their experience with the INSTI HCV Self Test by referring to the provided Instruction For Use (IFU).

Interventions

INSTI HCV Self Test DEVICE

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.

Performance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Understand and sign the written informed Consent Form in English
• Have unknown HCV serology status, i.e., never tested for HCV or tested negative but the last testing was done at least 6 months before the enrolment date.
• Able to complete the required testing on the allocated testing day\[s\]
• Agree to provide accurate medical history, required specimens of finger prick blood samples for self-test devices, and up to 3.5ml of blood by venipuncture for laboratory testing.
• Able to speak and read English.

You may not qualify if:

• Are known HCV positive.
• Have received any experimental HCV vaccine.
• Have participated in any prior, or concurrent studies of self-testing including any blood based RDTs.
• A practicing medical healthcare professional (doctor, nurse or Counsellor that performs testing with RDTs)
• Any condition which, in the opinion of the facilitator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome, i.e., being unable to see / read by forgetting to bring reading glasses, being intoxicated or acute sickness.

Sponsors & Collaborators

• bioLytical Laboratories: lead

Study Sites (1)

Ezintsha, a division of Wits Health Consortium (Pty) Ltd

Parktown, 2193, South Africa

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Mohammed Majam

  Ezintsha, a division of Wits Health Consortium (Pty) Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are recruited and enrolled to conduct INSTI HCV Self Test and then participate in the usability portion of the study.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 16, 2024
• Study Start: October 12, 2023
• Primary Completion: April 25, 2024
• Study Completion: May 3, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)