Human Immunodeficiency Virus I InfectionNCT07061912
A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US
A study testing NSTI® HIV Self-Test in people with Human Immunodeficiency Virus I Infection and Human Immunodeficiency Virus II Infection, run by bioLytical Laboratories at 1 site in Canada.
Trial summary
The objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to perform the INSTI® HIV Self Test correctly and without significant risk of incorrect… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection
- What is being tested?
- NSTI® HIV Self-Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jul 2025to 6 Aug 2025
- 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 or older
- Operator/study staff must complete the subject's Enrolment Questionnaire
- Subject to sign and date the Informed Consent Form
- Able to complete the required testing on the allocated testing day(s)
- Able to speak/ read/write English or Spanish
- Willingness to provide the fingerstick blood sample and if necessary, the volume of whole blood collected through venous blood draw (approximately 7 ml)
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- Willingness to participate in the study site's standard of care HIV counselling and testing program and receive the study site's standard of care test results
- Unknown HIV Status or known HIV positive status with less than 12 months of ART
- For known HIV positive status subjects, willingness to share ART start date
Who cannot join
- Has participated in any prior, or concurrent trial of HIV self-tests
- Is a practicing medical healthcare professional (doctor, nurse or HIV Counsellor that performs HIV testing with Rapid Tests)
- Has used a Rapid Diagnostic Test for HIV blood-based self-testing previously
- Has received any experimental HIV vaccine
- Has a bleeding disorder
- Known HIV positive subjects and currently on an Anti-Retroviral Treatment (ART) for 12 months or longer and/or not willing to share ART start date
- Any condition which, in the opinion of the Operator, 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, or visibly distressed.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to perform the INSTI® HIV Self Test correctly and without significant risk of incorrect results. The study aims to evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
Read the detailed description
The objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to perform the INSTI® HIV Self Test correctly and without significant risk of incorrect results. The study aims to evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
The study population will be based on a general all-comers group of subjects. This includes both unknown HIV status and potentially known HIV positive status subjects.
The number of valid positives from the comparator test will be monitored during the course of the study. When the comparator test reaches 10 valid positive results, the INSTI® HIV ST results for the same 10 subjects will be checked to see if they are also valid. If not, additional subjects will be recruited until there are at least 10 valid INSTI® HIV ST results within the comparator valid positive test results. Once the threshold has been reached recruiting will end. For known HIV positive subjects, site(s) will be requested to provide HIV-1/2 viral load and/or CD4 count laboratory results if available. Additionally, known HIV positive subjects on Anti-Retroviral Treatment (ART) should be on medication for less than 12 months.
The study will initially recruit HIV unknown status subjects, at 50% of total enrollment (i.e., 50 out of 100 subjects) if the 10 HIV positives is deemed unattainable then HIV known subjects may be recruited to make up the 10 total HIV positives.
The study is designed to evaluate INSTI® HIV ST performance when used unobserved by non-professional, untrained intended users that are inexperienced in self-testing.
- Being tested
- NSTI® HIV Self-Test
- Keywords
- HIV Self Test, INSTI HIV Self Test, At-Home HIV Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSTI® HIV Self-TestDevice
Each participant will be provided with the INSTI® HIV Self-Test(s) and asked to conduct self testing, unobserved. The participant will record their interpretation of the results. Subjects will perform the test without intervention or observation from the operator. The operator will then enter the room and also interpret the subject's self-test results then perform the comparator test. In the event of a discrepant result between the INSTI® HIV ST and comparator test, an additional venous blood sample will be collected from the subject and sent for discrepancy testing
| Study group | Role | What they receive |
|---|---|---|
| Performance | Experimental | INSTI® HIV ST devices are provided to the enrolled participants to conduct the self test using the provided instruction for use, unobserved. The participant records the INSTI® HIV ST results. The operator then enters the room and also interprets the participants self-test, the operator then performs the comparator test to compare the results with the INSTI® HIV ST. Receives: Device: NSTI® HIV Self-Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sensitivity and specificity of the INSTI® HIV Self-Test
- Percent agreement for fingerstick blood between INSTI® HIV ST results obtained and interpreted by the subject and Comparator Test result obtained by the operator. Percent agreement will be calculated for all sites combined.
- Point estimate for positive percent agreement will be calculated for all subjects.
- Negative percent agreement values and 95% CIs will be calculated for all subjects.
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 posted14 Jul 2025
- Study start24 Jul 2025
- Primary completion6 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus I InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 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
- NCT07061912
- Sponsor's protocol ID
- CLS-003A
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US
- ClinicalTrials.gov ID
- NCT07061912
- Acronym / sponsor ID
- CLS-003A
- Keywords
- HIV Self Test, INSTI HIV Self Test, At-Home HIV Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 14 Jul 2025 (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 objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to perform the INSTI® HIV Self Test correctly and without significant risk of incorrect results. The study aims to evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
Detailed description
The objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to perform the INSTI® HIV Self Test correctly and without significant risk of incorrect results. The study aims to evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
The study population will be based on a general all-comers group of subjects. This includes both unknown HIV status and potentially known HIV positive status subjects.
The number of valid positives from the comparator test will be monitored during the course of the study. When the comparator test reaches 10 valid positive results, the INSTI® HIV ST results for the same 10 subjects will be checked to see if they are also valid. If not, additional subjects will be recruited until there are at least 10 valid INSTI® HIV ST results within the comparator valid positive test results. Once the threshold has been reached recruiting will end. For known HIV positive subjects, site(s) will be requested to provide HIV-1/2 viral load and/or CD4 count laboratory results if available. Additionally, known HIV positive subjects on Anti-Retroviral Treatment (ART) should be on medication for less than 12 months.
The study will initially recruit HIV unknown status subjects, at 50% of total enrollment (i.e., 50 out of 100 subjects) if the 10 HIV positives is deemed unattainable then HIV known subjects may be recruited to make up the 10 total HIV positives.
The study is designed to evaluate INSTI® HIV ST performance when used unobserved by non-professional, untrained intended users that are inexperienced in self-testing.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Performance | Experimental | Device: NSTI® HIV Self-TestINSTI® HIV ST devices are provided to the enrolled participants to conduct the self test using the provided instruction for use, unobserved. The participant records the INSTI® HIV ST results. The operator then enters the room and also interprets the participants self-test, the operator then performs the comparator test to compare the results with the INSTI® HIV ST. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- Operator/study staff must complete the subject's Enrolment Questionnaire
- Subject to sign and date the Informed Consent Form
- Able to complete the required testing on the allocated testing day(s)
- Able to speak/ read/write English or Spanish
Key exclusion criteria (7 listed)
- Has participated in any prior, or concurrent trial of HIV self-tests
- Is a practicing medical healthcare professional (doctor, nurse or HIV Counsellor that performs HIV testing with Rapid Tests)
- Has used a Rapid Diagnostic Test for HIV blood-based self-testing previously
- Has received any experimental HIV vaccine
- Has a bleeding disorder
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 |
|---|---|---|
| NSTI® HIV Self-TestEach participant will be provided with the INSTI® HIV Self-Test(s) and asked to conduct self testing, unobserved. The participant will record their interpretation of the results. Subjects will perform the test without intervention or observation from the operator. The operator will then enter the room and also interpret the subject's self-test results then perform the comparator test. In the event of a discrepant result between the INSTI® HIV ST and comparator test, an additional venous blood sample will be collected from the subject and sent for discrepancy testing | Device | Performance |
Primary outcome
Clinical sensitivity and specificity of the INSTI® HIV Self-Test
Time frame: 1 month
* Percent agreement for fingerstick blood between INSTI® HIV ST results obtained and interpreted by the subject and Comparator Test result obtained by the operator. Percent agreement will be calculated for all sites combined. * Point estimate for positive percent agreement will be calculated for all subjects. * Negative percent agreement values and 95% CIs will be calculated for all subjects.
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 20 Aug 2025.
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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?
A study testing NSTI® HIV Self-Test in people with Human Immunodeficiency Virus I Infection and Human Immunodeficiency Virus II Infection, 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 9 inclusion and 7 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 20 Aug 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 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?
Clinical sensitivity and specificity of the INSTI® HIV Self-Test (time frame: 1 month). 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 20 Aug 2025.