NCT06716450Toboroz
Multiplo Tp/HIV Self-Test
A Study to Evaluate the Accuracy, Usability and Readability of the Multiplo® TP/HIV Antibody Self-Test Performed by Observed Intended Users in Canada and the Impact of Peer-led HIV and Syphilis Care Among People Experiencing Homelessness in Toronto
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 27.
Rövid összefoglaló (regiszter, angolul)
To help reach the undiagnosed living with HIV and/or syphilis in Canada, self-tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Laboratories Inc. (Halifax, Nova Scotia, Canada) has developed a point-of-care (POC) test to detect HIV and Syphilis antibodies in fingerstick blood samples that is under final review by Health Canada for use by trained Healthcare professionals. A self-test version of this test, with simplified instructions for use has been developed for investigational studies. The goal of the following study sponsored by REACH Nexus is to provide evidence that untrained lay persons / intended users can perform the Multiplo Tp/HIV Self-Test without any increased risk of obtaining erroneous results.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 900 (tervezett)
- Első benyújtás
- 2024. nov. 18.
- Kezdés
- 2025. jún. 12.
- Elsődleges befejezés
- 2026. ápr. 1.
- Fő szponzor
- Unity Health Toronto
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT06716450
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 900
- 2025. jún. 12. és az elsődleges befejezés (2026. ápr. 1.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Have participated in any prior, or concurrent trial of HIV and syphilis self-tests.
Más betegség
- Are known HIV and/or syphilis positive.
- Have ever tested positive for syphilis or HIV at any time.
- Have any experience in conducting rapid point-of-care tests on patients for HIV, syphilis or any other infectious disease.
- Are familiar with the Multiplo® TP/HIV Self-Test.
- Are a practicing medical healthcare professional (doctor, nurse or HIV counsellor that performs HIV testing with Rapid Tests).
- Any condition which, in the opinion of the Observer, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome (e.g. being unable to see/read by forgetting to bring reading glasses, being intoxicated, acute sickness, visibly distressed).
Egyéb
- Do not meet the inclusion criteria.
- Are investigator site employees or immediate family members of sponsor or investigator sites.
Kiket keres a vizsgálat
- Are ≥18 years of age.
- Can speak/read/write English or French.
- Have presented for voluntary testing for HIV and/or syphilis infection in the clinic or community-based setting.
- Are willing to participate in the study site's standard of care HIV and syphilis counselling and testing program and receive the study site's standard of care test results.
- Are willing to be a participant in the study.
- Can provide informed consent i.e. understand and sign or instruct the Observer to sign the informed consent form.
- Can complete the required testing on the allocated testing day.
- Are willing to provide the necessary fingerstick and venipuncture blood for use in the study protocol testing methods.
- Are of unknown HIV and syphilis status (last HIV and syphilis negative test must be a minimum of 3 months prior).
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Women's Health in Women's Hands | Toronto | Kanada | Toboroz |
| Hassle Free Clinic | Toronto | Kanada | Toboroz |
| Cool Aid Community Health Centre | Victoria | Kanada | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.