HIV Infections Clinical Trial
Official title:
Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
Verified date | February 2024 |
Source | Unity Health Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 600 |
Est. completion date | June 30, 2024 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Clinique médicale l'Actuel | Montréal | Quebec |
Canada | Maple Leaf Research | Toronto | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Women's Health in Women's Hands Community Health Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive and Negative Percent Agreement | At the end of the study, positive and negative percent agreement (with two-sided 95% confidence interval for both) between OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test and laboratory reference test for each matrix (fingerstick and oral fluid) will be calculated separately.
For mock device interpretation, agreement of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test results with each sample type reactivity will be calculated overall and for each healthcare provider test operator. |
1 year, year 1 | |
Secondary | Usability and Label comprehension | At the end of all testing, to assess usability, healthcare providers will interpret various mock device test results and respond to 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. | 1 year, year 1 |
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