Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test

ConditionsHiv Syphilis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age15+

SponsorNova Scotia Health Authority

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

INSTI HIV/syphilis Point of Care Self-Test Administration
Diagnostic 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.

Treatment groups

120 Participants

are divided into 1 treatment group

Group A: INSTI HIV/syphilis Point of Care Self-TestOther 1 intervention

Trial outcomes

Primary outcomes

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)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Scotia Health Authority

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: