Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INSTI HIV/syphilis Point of Care Self-Test Administration.
- Who it may be relevant to
- Registry conditions: Hiv, Syphilis. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test INSTI HIV/syphilis Point of Care Self-Test Administration
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.
Primary outcome measures
- 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)]
Eligibility criteria
Branch #1: Participants known to have an HIV infection - Inclusion criteria:
- Previously documented positive HIV serology
Branch #2: Participants known to have a history of syphilis infection - Inclusion criteria:
- Documented positive syphilis serology
Branch #3: Participants with no known HIV or syphilis infections - Inclusion criteria:
- No documented positive HIV or syphilis serology
Exclusion criteria
Unable to speak and understand English
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06953024 · 73074