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

NCT ID: NCT06357819

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 405 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2023-12-17

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].

Detailed Description

The intent of this study was to collect data regarding the result interpretation of contrived results of INSTI HCV ST. The contrived test devices refers to mock test devices pre-made by bioLytical Laboratories Inc. Each contrived/mock test device was assigned to an ID number to be randomly provided to the participants.

Primary Objectives were to document and record the following:

•Successful interpretation of contrived test results using mock test devices (strong positive, weak positive, negative and a range of invalid results).

Depending on the device being evaluated participants received a contrived INSTI® HCV Antibody Self Test membrane unit.

Participants were asked to interpret "mock" results [read contrived device results using the reference chart in the Instructions for Use (IFU)].

Participants were recruited from the Ezintsha Research Site which was a low-prevalence area and the Yeoville Harm Reduction Site which was a high-prevalence area in the city of Johannesburg in the Republic of South Africa. For the purposes of this assessment, the participant population was the general population. The participants did not have any experience in conducting any rapid diagnostic self-test using standard test kits, nor were they familiar with the prospective HCVST devices prior to entering into this mock result interpretation assessment.

Conditions

Hepatitis C

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.)

INSTI HCV Self Test

Intervention Type: 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.

Interventions

INSTI HCV Self Test

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

bioLytical Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

bioLytical Laboratories Inc.

Richmond, British Columbia, Canada

Countries

Canada

Other Identifiers

HSTAR010

Identifier Type: OTHER

Identifier Source: secondary_id

EZIMOM012

Identifier Type: OTHER

Identifier Source: secondary_id

CLS-017A

Identifier Type: -

Identifier Source: org_study_id