Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test
- Conditions
- HivSyphilis
- Registration Number
- NCT06953024
- Lead Sponsor
- Nova Scotia Health Authority
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 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 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.
- Secondary Outcome Measures
Name Time Method
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