NCT05020353Completed
OraQuick® HIV Self-Test Study in Canada
A Study to Evaluate the Accuracy, Usability and Readability of the OraQuick® HIV Self-Test Performed by Observed Intended Users in Canada
Source: ClinicalTrials.gov · Last updated 11 May 2025
Brief summary (registry, in English)
Oral fluid based HIV Self-testing (HIVST) provides another innovative and simple option to increase opportunities for HIV testing. At-home testing for HIV using oral fluid has been FDA approved and in use in the USA since 2012, and studies have also shown that interest and acceptability of HIVST with oral fluid is high in other global settings. However data for oral fluid based HIVST within key populations and those at high risk for HIV infection in Canada is limited. This study involves around 900 persons who are non-healthcare professionals and inexperienced in HIV self-testing (intended users) and are presenting at clinic sites across Canada for HIV testing. It will evaluate the accuracy (sensitivity and specificity), usability (persons performs test correctly) and readability (persons successfully interpret test results) of the OraQuick® HIV Self-Test when performed by persons representing intended users living in Canada. A final report of study results will be provided to the Test manufacturer for inclusion in the Health Canada license application process.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 951 (actual)
- First submitted
- 18 Aug 2021
- Start date
- 21 Jun 2022
- Primary completion date
- 4 Jul 2023
- Lead sponsor
- Unity Health Toronto
- Diseases
- HIV
- NCT number
- NCT05020353
What you commit to
- Study type: Interventional
- Participants enrolled: 951
- From 21 Jun 2022 to the primary completion date, 4 Jul 2023
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are currently participating in a concurrent trial of HIV self-tests
Other illness
- Are known HIV positive
- Are on antiretroviral therapy (ART) or anti-HIV medications for the treatment of HIV, either as pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP) or experimental vaccine
- Have any experience or have ever conducted a rapid diagnostic self-test for HIV or any other sexually transmitted and blood borne illnesses disease
- 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 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.
Other
- Do not meet all the inclusion criteria
- Are investigator site employees or immediate family members of sponsor or investigator site employee
Who the study is looking for
- Are 18 years of age and older
- Are able to speak / read / write English or French
- Have presented for voluntary testing for HIV infection in the clinic or community based setting
- Are willing to participate in the study site's standard of care HIV counselling and testing program and receive the study site's standard of care test results
- Are willing to be a participant in the study
- Are able to provide informed consent i.e. understands and signs the informed consent form
- Are able to complete the required testing on the allocated testing day
- Are willing to provide the necessary oral fluid and venipuncture blood for use in the study protocol testing methods.
- Are of unknown HIV status (last HIV negative test must be a minimum of 3 months prior)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique médicale l'Actuel Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Byward Family Health Team Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Women's Health In Women's Hands Community Health Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Maple Leaf Research Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Hassle Free Clinic Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Cool Aid Community Health Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Nine Circles Community Health Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.