Hepatitis CNCT06369116
Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users
A study testing INSTI HCV Self Test in people with Hepatitis C, run by bioLytical Laboratories at 1 site in South Africa.
Trial 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… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,415 participants
- Where
- 1 siteSouth Africa
- Study dates
- 12 Oct 2023to 3 May 2024
- Phase
- Interventional
- 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
Who may be able to join
- ≥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.
Who cannot join
- Do not meet all of the inclusion criteria.
- 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.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Ezintsha, a division of Wits Health Consortium (Pty) Ltd
Parktown, 2193
About this study
Official title: A Controlled, Observed Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users
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.
Read the detailed description
The HSTAR012 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.
Specific critical and non-critical steps are identified from the self-test product's Instructions for Use. The untrained lay user is evaluated for process success or difficulty by a silent, non-interacting observer in the same room. Overall processes include self-test Usability (observation to determine if a participant performs all critical steps correctly), Interpretation of results (confirmation by staff to determine if participant interprets their test correctly), and labelling Comprehension (questionnaire to determine that the participant is aware of test limitations and what to do following the test result). The successful completion of steps will be evaluated as a percentage of the overall process, with all critical and non-critical errors identified and reported. All self-test results will be confirmed by testing with the same test by collecting additional fingerstick samples by a trained HCP (aka. Trained Observer). The level of agreement between the results of the investigated test (i.e., INSTI® HCV Self Test) obtained by a lay user and those obtained by a healthcare worker will be calculated.
Additionally, EDTA venous blood samples will be collected from each participant and sent to a laboratory to perform an enzyme immunoassay (EIA) using a state-of-the-art quality-assured assay (prequalified by WHO, CE-IVD or FDA approved). The sensitivity and specificity of the INSTI® HCV Self Test will be also calculated and the results from both tests conducted by the lay user and trained HCP compared to the results of the laboratory assay.
In the event of discrepant results between INSTI® HCV Self Test and the laboratory-based EIA assay, EDTA venous whole blood will be collected to perform HCV RNA assay to confirm active infection, study participants with positive results in HCV RNA test will be contacted and linked to care following local algorithms.
Study Aim
- To evaluate the ability of untrained lay users to obtain an accurate test result using the INSTI® HCV Self Test.
- To evaluate the untrained lay users' interaction with the device in terms of effectiveness and efficiency, i.e., successful/unsuccessful completion and difficulty of the critical steps as per the Instructions for Use.
- To evaluate the performance (diagnostic sensitivity and specificity) of INSTI® HCV self-test by the lay user in comparison with laboratory confirmatory test.
- To evaluate the performance (diagnostic sensitivity and specificity) of INSTI® HCV self-test by the healthcare professional in comparison with laboratory confirmatory test.
- To evaluate the concordance of the results between the trained observer and the untrained lay user
- To assess the ability of untrained lay users to correctly comprehend key messaging from device packaging and labelling, including the Instructions for Use.
- To understand the experience and satisfaction of study participants with the overall self-testing process.
- To assess whether or not the participants locate and read the information included in the IFU, know what the products are used for, and when it's appropriate/inappropriate to use the product.
- Conditions
- Hepatitis C
- Being tested
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (1)
To assess the usability and label comprehension of the INSTI HCV Self Test
To assess the usability and label comprehension of the self-testing device and the ability of the participant to correctly comprehend the Instruction For Use of the self-test by observation of the self-testing procedure and documenting effectiveness and efficiency, i.e., successful / unsuccessful completion and difficulty of the critical steps as per the Instructions for Use. The label comprehension scoring spans from exceptionally satisfactory (score 5) to completely unsatisfactory (score 1).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start12 Oct 2023
- Primary completion25 Apr 2024
- Study completion3 May 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Participants are recruited and enrolled to conduct INSTI HCV Self Test and then participate in the usability portion of the study.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,415 participants (actual)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammed Majam, Principal investigator, Ezintsha, a division of Wits Health Consortium (Pty) Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369116
- Sponsor's protocol ID
- CLS-017B
- Other IDs
- HSTAR012, WRHI071
- Status last verified
- Feb 2025
- First submitted
- 8 Apr 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Observed Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users
- ClinicalTrials.gov ID
- NCT06369116
- Acronym / sponsor ID
- CLS-017B
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,415 participants (actual)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 16 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.
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.
Detailed description
The HSTAR012 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.
Specific critical and non-critical steps are identified from the self-test product's Instructions for Use. The untrained lay user is evaluated for process success or difficulty by a silent, non-interacting observer in the same room. Overall processes include self-test Usability (observation to determine if a participant performs all critical steps correctly), Interpretation of results (confirmation by staff to determine if participant interprets their test correctly), and labelling Comprehension (questionnaire to determine that the participant is aware of test limitations and what to do following the test result). The successful completion of steps will be evaluated as a percentage of the overall process, with all critical and non-critical errors identified and reported. All self-test results will be confirmed by testing with the same test by collecting additional fingerstick samples by a trained HCP (aka. Trained Observer). The level of agreement between the results of the investigated test (i.e., INSTI® HCV Self Test) obtained by a lay user and those obtained by a healthcare worker will be calculated.
Additionally, EDTA venous blood samples will be collected from each participant and sent to a laboratory to perform an enzyme immunoassay (EIA) using a state-of-the-art quality-assured assay (prequalified by WHO, CE-IVD or FDA approved). The sensitivity and specificity of the INSTI® HCV Self Test will be also calculated and the results from both tests conducted by the lay user and trained HCP compared to the results of the laboratory assay.
In the event of discrepant results between INSTI® HCV Self Test and the laboratory-based EIA assay, EDTA venous whole blood will be collected to perform HCV RNA assay to confirm active infection, study participants with positive results in HCV RNA test will be contacted and linked to care following local algorithms.
Study Aim
- To evaluate the ability of untrained lay users to obtain an accurate test result using the INSTI® HCV Self Test.
- To evaluate the untrained lay users' interaction with the device in terms of effectiveness and efficiency, i.e., successful/unsuccessful completion and difficulty of the critical steps as per the Instructions for Use.
- To evaluate the performance (diagnostic sensitivity and specificity) of INSTI® HCV self-test by the lay user in comparison with laboratory confirmatory test.
- To evaluate the performance (diagnostic sensitivity and specificity) of INSTI® HCV self-test by the healthcare professional in comparison with laboratory confirmatory test.
- To evaluate the concordance of the results between the trained observer and the untrained lay user
- To assess the ability of untrained lay users to correctly comprehend key messaging from device packaging and labelling, including the Instructions for Use.
- To understand the experience and satisfaction of study participants with the overall self-testing process.
- To assess whether or not the participants locate and read the information included in the IFU, know what the products are used for, and when it's appropriate/inappropriate to use the product.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants are recruited and enrolled to conduct INSTI HCV Self Test and then participate in the usability portion of the study.
| Arm | Type | Receives |
|---|---|---|
| Performance | Experimental | Device: INSTI HCV Self TestINSTI 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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.
Key exclusion criteria (6 listed)
- Do not meet all of the inclusion criteria.
- 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)
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 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. | Device | Performance |
Primary outcome
Clinical sensitivity and specificity of INSTI HCV Self Test
Time frame: 6 Months
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.
1 secondary outcome
To assess the usability and label comprehension of the INSTI HCV Self Test
Time frame: 1 month
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 21 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Mohammed Majam principal investigator
Ezintsha, a division of Wits Health Consortium (Pty) Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSTI HCV Self Test in people with Hepatitis C, run by bioLytical Laboratories at 1 site in South Africa.
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 6 inclusion and 6 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 21 Feb 2025. 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 South Africa. 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?
Clinical sensitivity and specificity of INSTI HCV Self Test (time frame: 6 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 21 Feb 2025.