Hiv, Syphilis
Conditions
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.
Interventions
DIAGNOSTIC_TESTINSTI 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.
Sponsors
Nova Scotia Health Authority
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed