Hepatitis CNCT06357819
INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation
An observational study of Hepatitis C, run by bioLytical Laboratories at 1 site in Canada.
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]. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- INSTI HCV Self Test
- Type of treatment
- Medical device
- How many people
- 405 participants
- Where
- 1 siteCanada
- Study dates
- 12 Oct 2023to 17 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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].
Read the 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
- Being tested
- INSTI HCV Self Test
- Keywords
- Hepatitis C Self Test, Hepatitis C Rapid Test, HCV antibody, INSTI HCV Self Test
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSTI HCV Self TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: Device: INSTI HCV Self Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Interpretation of contrived devices
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start12 Oct 2023
- Primary completion17 Dec 2023
- Study completion17 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357819
- Sponsor's protocol ID
- CLS-017A
- Other IDs
- HSTAR010, EZIMOM012
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation
- ClinicalTrials.gov ID
- NCT06357819
- Acronym / sponsor ID
- CLS-017A
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C Self Test, Hepatitis C Rapid Test, HCV antibody, INSTI HCV Self Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 17 Dec 2023 (actual)
- Study completion
- 17 Dec 2023 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mock Result Interpretation | – | Device: INSTI HCV Self TestTesting 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INSTI HCV Self TestEach 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. | Device | Mock Result Interpretation |
Primary outcome
Successful Interpretation of contrived devices
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by bioLytical Laboratories at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Interpretation of contrived devices (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.