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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INSTI HIV/syphilis Point of Care Self-Test | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | This measure includes two domains assessed immediately following completion of the self-test:
Responses to Likert-style questions will be reported as percentages of participants selecting each category (agree, neutral, disagree) per question. | Immediately after self-testing (Day 0) |
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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
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |