An interventional study of INSTI HIV/syphilis Point of Care Self-Test Administration in Hiv and Syphilis, sponsored by Nova Scotia Health Authority. Terminated at 1 site in Canada. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Other
The study was terminated prematurely because the futility threshold was met.
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.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's enrollment of 35 is below the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 79 are open to participants now.
Compared within Syphilis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Branch #1: Participants known to have an infection - Inclusion criteria:
Branch #2: Participants known to have a history of syphilis infection - Inclusion criteria:
Branch #3: Participants with no known HIV or syphilis infections - Inclusion criteria:
Exclusion criteria:
Unable to speak and understand English
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Time frame: Immediately after self-testing (Day 0)
The study was terminated prematurely because the futility threshold was met.
The study was terminated prematurely because the futility threshold was met.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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