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.

Background and Rationale:

Self-testing for HIV is an approach with the potential to increase the access, uptake and frequency of HIV testing for those who may not otherwise test and remain undiagnosed. There is increasing evidence showing the acceptability and usability of HIV self-testing (HIVST) in various key populations. In 2016 the World Health Organization recommended HIVST as an alternative option to complement existing HIV testing opportunities. Since then, HIVST use has been scaling up rapidly; for example, Canada's first blood-based (fingerstick) HIV self-test was licensed for use in November 2020.

Oral fluid based 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.

Having a licensed oral fluid HIV self-test in addition to the licensed blood-based HIV self-test will allow individuals to choose what is best for them and increase the potential to reach the undiagnosed living with HIV.

Objective:

This study will evaluate the accuracy, 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.

Hypothesis:

The OraQuick Self-test as performed by intended users (non-healthcare professional and inexperienced in HIV self-testing) will meet or exceed the accuracy, usability and label comprehension requirements from Health Canada for license as a Class IV in vitro diagnostic device for Canadian market entry.

Study Design:

This study was designed around the requirements set out in the Health Canada Guidance Document: "Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDT's) for Use at Point of Care or Self Testing, 2017". It is an investigational device trial designed as a cross-sectional study which employs observational and interview-based methods.

Sample population:

The study population requirements published by Health Canada stipulates that the prospective study include: 900 lay persons with unknown HIV status including 400 persons at risk for HIV infection (e.g. intravenous drug users, men who have sex with men, etc.). Self-reported practices or behaviour will be used to define those at high risk.

A minimum of 900 participants (non-healthcare professional and inexperienced in HIV self-testing) will read the instructions for use and conduct the OraQuick® HIV Self-Test. They will not be provided any training prior to use of the test. A trained healthcare provider or researcher (trained Observer) will watch, and document use of the test and independently read the participants self-test result. The participants will then complete a questionnaire to share their opinion on usability and label comprehension of this test.

A minimum of 400 (of the 900) participants will also be provided five mock devices with different results and asked to interpret those results i.e. strong positive; weak positive, negative, invalid with no control and no test line, and invalid with no control and a positive test line. This will evaluate readability of this test.

All participants will also have a venous blood sample collected for testing of plasma at a central laboratory with a 4th generation (Ag/Ab combo) HIV enzyme immunoassay that will serve as the comparator method (laboratory reference testing). All self-tests will be confirmed using a Canadian standard HIV testing algorithm. The sensitivity and specificity of the self-test result will be calculated relative to the "clinical truth" of the participants' HIV status determined by the confirmatory test process, where applicable. Participants will be instructed to return to the clinic for a follow-up visit, two (2) weeks after self-testing to obtain their laboratory test results which will be their official result.

Study Intervention Details:

Participants will be recruited to the study when they come in for voluntary HIV testing (e.g. POC testing) at a minimum of 3 study sites (different geographic locations). If persons consent to participating, all those enrolled will voluntarily complete a questionnaire (collecting demographics and HIV medical history information) and then provide their venous whole blood sample (for standard of care, laboratory confirmatory testing and comparator method), complete the OraQuick® HIV Self-Test (read test instructions, sample collection, sample testing, result interpretation), complete mock result interpretation, and complete questionnaires - Visit 1 (day 1; about 60 minutes). All patients will be instructed to return to the clinic for a follow-up visit two (2) weeks later to obtain their laboratory test results (Visit 2; about 15 - 60 minutes), post -test counselling, and to be linked to appropriate care depending on the test results..

Patients may also have a point-of-care (POC) test conducted on site as part of the clinic's standard of care testing, outside of the protocol and after all study procedures for Visit 1 are completed.

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.

Self-testing participants with unknown HIV status

Adverse event data were collected over the two week time frame in which the participant completed visit 1 and visit 2.

This is a prospective study for which the prevalence of infection is low.