INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation

NCT06357819 | Completed

• 3 other identifiers: CLS-017AHSTAR010EZIMOM012
• Study Type: observational
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization \[demonstration\].

Conditions

Hepatitis C

Keywords

Hepatitis C Self Test; Hepatitis C Rapid Test; HCV antibody; INSTI HCV Self Test

Outcome Measures

Primary Outcomes (1)

• Successful Interpretation of contrived devices

  3 Months

Study Arms (1)

Mock Result Interpretation

Testing with non-functional devices (Mock-ups) that are modified to display contrived results to assess the ability of previously untrained users to correctly interpret one of the possible results as defined by each device manufacturer (e.g., Negative/Non-Reactive, Positive/Reactive, Invalid etc.)

Device: INSTI HCV Self Test

Interventions

INSTI HCV Self Test DEVICE

Each participant was provided with contrived INSTI membrane units by the study observer, in random order, and was asked to interpret the results using the INSTI HCV ST Instructions for Use.

Mock Result Interpretation

Eligibility Criteria

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

Study Population

Participants were recruited and enrolled from high and low HCV-prevalence areas to participate in mock result interpretation of INSTI HCV Selt Tests.

You may qualify if:

• Understands and sign the written informed Consent form
• Able to complete the required testing on the allocated testing day\[s\]
• Able to speak/read English
• ≥18 years of age
• Provide a level of education (minimum grade 7)

You may not qualify if:

• A practicing medical healthcare professional \[doctor, nurse or counsellor that performs testing with Rapid Tests\]
• Has used blood-based RDT for self-testing previously, either HIV or HCV
• 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 mock result interpretation assessment, consent form and questionnaire etc. or bias the outcome

Sponsors & Collaborators

• bioLytical Laboratories: lead

Study Sites (1)

bioLytical Laboratories Inc.

Richmond, British Columbia, V6V 2A2, Canada

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 Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: October 12, 2023
• Primary Completion: December 17, 2023
• Study Completion: December 17, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CA (1)