Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingers… (NCT04810559) | Clinical Trial Compass
CompletedNot Applicable
Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
Canada600 participantsStarted 2021-07-29
Plain-language summary
Point-of-care (POC) tests for HIV are easy to use, rapid and provide accurate results while the patient is still in-front of a healthcare provider (HCP). Currently only blood-based POC tests for HIV are licensed for use in Canada. The OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test is a POC test developed by OraSure Technologies, Inc. to detect HIV antibodies in oral fluid and fingerstick blood samples. As this device is very similar to the OraQuick HIV Self-Test, Health Canada requires evidence that HCPs can successfully perform the POC version of the OraQuick test in addition to performance of the self test version by intended users.
This study involves a minimum of 9 HCPs and 600 Patients at clinic sites in Toronto and Ottawa (Ontario), Montreal (Quebec) and Edmonton (Alberta). It will assess the OraQuick ADVANCE® Test's simplicity and accuracy in the hands of HCPs who have never used this Test.
To assess performance, using only the test kit instructions for use, HCPs will collect and test oral fluid and fingerstick blood samples from patients with the OraQuick ADVANCE® Test and will then read and interpret those results. Results of the OraQuick ADVANCE® Test will be compared with results of a venous blood sample collected from each patient and tested with a usual, licensed, laboratory test method.
To assess usability, HCPs will interpret various mock device test results and respond to a questionnaire to determine if the test instructions for use are clear and simple, that they are aware of test requirements and limitations and provide opinions on the ease of use of the test.
A final report of study results will be provided to the Test manufacturer for inclusion in the Health Canada license application process.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Healthcare provider Inclusion Criteria:
* Are at least 18 years of age
* Are able to provide informed consent
* Are paid employees of the study site(s)
* Are able to perform the study procedures outlined in the protocol
Healthcare provider Exclusion Criteria:
• Have used or watched someone use the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test
Patient Inclusion Criteria:
* Are at least 18 years of age
* Are able to provide informed consent
* Agree to provide accurate medical history
* Are able to provide up to 20mL blood by venipuncture, an oral fluid and a fingerstick blood sample
* Agree to undergo testing with the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test
* Patients with the known HIV positive status (diagnosis must be within five years of the study visit)
* Patients with unknown HIV status (last HIV negative test must be greater than 6 months prior to study visit)
Patient Exclusion Criteria:
* Are site employees
* Are in the judgment of the investigator unable to complete the study or are unlikely to comply with the study protocol; or
* Have been previously enrolled in this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.