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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06357819
• Other study ID #: CLS-017A
• Secondary ID: HSTAR010EZIMOM01
• Status: Completed
• Start date: October 12, 2023
• Est. completion date: December 17, 2023

Study information

• Verified date: April 2024
• Source: bioLytical Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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].

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 17, 2023
• Est. primary completion date: December 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Exclusion Criteria:

• Does not meet the inclusion criteria

• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	bioLytical Laboratories Inc.	Richmond	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
bioLytical Laboratories

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Interpretation of contrived devices		3 Months