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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
120
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)
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