N/A
N=951
OraQuick® HIV Self-Test Study in Canada
HIV Testing · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT05020353 ↗Enrolled (actual)
951
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Device Performance: Positive and Negative Percent Agreement — 1; 0; 880; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OraQuick® HIV Self-Test (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Unity Health Toronto
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Performance: Positive and Negative Percent Agreement |
1; 0; 880; 0; 1; 1 | — |
| PRIMARY Observer Usability Assessment |
859; 47; 701; 205; 864; 42 | — |
| PRIMARY Participant and Observer Interpretations |
884; 22 | — |
| PRIMARY Label Comprehension |
881; 22; 878; 24; 878; 24 | — |
| SECONDARY Readability or Interpretation (Mock Devices) |
418; 329; 453; 273; 448 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- Do not meet all the inclusion criteria
- 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 currently participating in a concurrent trial of HIV self-tests
- Are investigator site employees or immediate family members of sponsor or investigator site employee
- 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.
Data sourced from ClinicalTrials.gov (NCT05020353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.