HivNCT06953024
Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test
A study testing INSTI HIV/syphilis Point of Care Self-Test Administration in people with Hiv and Syphilis, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
This study aims to validate the percent agreement of the INSTI Multiplex Human Immunodeficiency (HIV) 1/2 syphilis antibody (Ab) test (INSTI POCT) when used as a self-test by patients compared to conventional serologic testing. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- What is being tested?
- INSTI HIV/syphilis Point of Care Self-Test Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2025to 5 Jan 2026
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unable to speak and understand English
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to validate the percent agreement of the INSTI Multiplex Human Immunodeficiency (HIV) 1/2 syphilis antibody (Ab) test (INSTI POCT) when used as a self-test by patients compared to conventional serologic testing.
- Being tested
- INSTI HIV/syphilis Point of Care Self-Test Administration
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSTI HIV/syphilis Point of Care Self-Test AdministrationDiagnostic test
The INSTI Human Immunodeficiency Virus (HIV)/syphilis POCT is a rapid, single-use, flow-through immunoassay that is Health Canada-approved as a screening test for detecting antibodies to HIV1/2 and syphilis using a fingerstick blood sample.
| Study group | Role | What they receive |
|---|---|---|
| INSTI HIV/syphilis Point of Care Self-Test | Other | Not described Receives: Diagnostic Test: INSTI HIV/syphilis Point of Care Self-Test Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent agreement of the INSTI HIV/syphilis POCT when used to self-test for antibodies to HIV 1/2 and syphilis when compared to conventional serologic results.
Measured: Determined at the end of the implementation period (approximately 6 months).
Participant-rated clarity of instructional materials and satisfaction with INSTI HIV/syphilis self-testing
This measure includes two domains assessed immediately following completion of the self-test:
- Instructional Clarity: Proportion of participants who agree, are neutral, or disagree with statements related to the clarity and usefulness of the video and infographic
- Self-Test Satisfaction: Proportion of participants who agree, are neutral, or disagree with statements related to their satisfaction with the self-testing experience.
Responses to Likert-style questions will be reported as percentages of participants selecting each category (agree, neutral, disagree) per question.
Measured: Immediately after self-testing (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start6 Oct 2025
- Primary completion18 Dec 2025
- Study completion5 Jan 2026
Why it stopped: The study was terminated prematurely because the futility threshold was met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasha Ramsey, Nova Scotia Health Authority
- Investigators
- Tasha D Ramsey, Principal investigator, Nova Scotia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953024
- Sponsor's protocol ID
- 73074
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2025
- Last updated
- 1 Oct 2026
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test
- ClinicalTrials.gov ID
- NCT06953024
- Acronym / sponsor ID
- 73074
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely because the futility threshold was met.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 1 May 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.
This study aims to validate the percent agreement of the INSTI Multiplex Human Immunodeficiency (HIV) 1/2 syphilis antibody (Ab) test (INSTI POCT) when used as a self-test by patients compared to conventional serologic testing.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INSTI HIV/syphilis Point of Care Self-Test | Other | Diagnostic Test: INSTI HIV/syphilis Point of Care Self-Test Administration |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Unable to speak and understand English
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 HIV/syphilis Point of Care Self-Test AdministrationThe INSTI Human Immunodeficiency Virus (HIV)/syphilis POCT is a rapid, single-use, flow-through immunoassay that is Health Canada-approved as a screening test for detecting antibodies to HIV1/2 and syphilis using a fingerstick blood sample. | Diagnostic test | INSTI HIV/syphilis Point of Care Self-Test |
Primary outcome
Percent agreement of the INSTI HIV/syphilis POCT when used to self-test for antibodies to HIV 1/2 and syphilis when compared to conventional serologic results.
Time frame: Determined at the end of the implementation period (approximately 6 months).
Participant-rated clarity of instructional materials and satisfaction with INSTI HIV/syphilis self-testing
Time frame: Immediately after self-testing (Day 0)
This measure includes two domains assessed immediately following completion of the self-test: 1. Instructional Clarity: Proportion of participants who agree, are neutral, or disagree with statements related to the clarity and usefulness of the video and infographic 2. Self-Test Satisfaction: Proportion of participants who agree, are neutral, or disagree with statements related to their satisfaction with the self-testing experience. Responses to Likert-style questions will be reported as percentages of participants selecting each category (agree, neutral, disagree) per question.
Results and safety
The study was stopped early (reason given: The study was terminated prematurely because the futility threshold was met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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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.
Tasha D Ramsey principal investigator
Nova Scotia Health
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 HIV/syphilis Point of Care Self-Test Administration in people with Hiv and Syphilis, run by Nova Scotia Health Authority 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 0 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Oct 2026. 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 was stopped early (reason given: The study was terminated prematurely because the futility threshold was met.). Results are not available in the source record.
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?
Percent agreement of the INSTI HIV/syphilis POCT when used to self-test for antibodies to HIV 1/2 and syphilis when compared to conventional serologic results. (time frame: Determined at the end of the implementation period (approximately 6 months).). The study lists 2 primary outcomes in all. 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 1 Oct 2026.