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Trial record 1 of 1 for:    OraQuick ADVANCE | Canada
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Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04810559
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : June 29, 2022
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Unity Health Toronto

Brief 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.


Condition or disease Intervention/treatment Phase
HIV Testing HIV Infections Device: OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cross-sectional, prospective, field trial (near patient study)
Masking: None (Open Label)
Masking Description: Subject enrollment is by unblinded staff and testing is by blinded healthcare providers
Primary Purpose: Diagnostic
Official Title: Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
Actual Study Start Date : July 29, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Investigational Device Device: OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test
OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in oral fluid and fingerstick blood conducted by untrained healthcare providers compared to laboratory 4th generation Ag/Ab EIA results performed on venous blood.




Primary Outcome Measures :
  1. Positive and Negative Percent Agreement [ Time Frame: 1 year, year 1 ]

    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.



Secondary Outcome Measures :
  1. Usability and Label comprehension [ Time Frame: 1 year, year 1 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810559


Contacts
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Contact: Sean B Rourke, PhD (416) 878-2779 sean.rourke@utoronto.ca
Contact: Darshanand Maraj, MBBS (416) 864-6060 ext 46493 darshanand.maraj@unityhealth.to

Locations
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Canada, Alberta
The LGBTQ+ Wellness Centre (Medi Drugs Millcreek) Not yet recruiting
Edmonton, Alberta, Canada
Contact: Dylan Moulton, PharmD         
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Darrell Tan, MD         
Women's Health in Women's Hands Community Health Centre Recruiting
Toronto, Ontario, Canada
Contact: Megan Saunders, MD         
Canada, Quebec
Clinique médicale l'Actuel Recruiting
Montréal, Quebec, Canada
Contact: Réjean Thomas, MD         
Sponsors and Collaborators
Unity Health Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Sean B Rourke, PhD MAP Centre for Urban Health Solutions, St. Micheal's Hospital
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT04810559    
Other Study ID Numbers: 20-253
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Unity Health Toronto:
HIV
Testing
Point-of-care
OraQuick
Canada
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs