OraQuick® HIV Self-Test Study in Canada

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation 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.