Who is sponsoring NCT04810559?

NCT04810559 is sponsored by Unity Health Toronto.

What drugs are being tested in NCT04810559?

Interventions in NCT04810559: OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test.

What condition does NCT04810559 study?

NCT04810559 studies HIV Testing, HIV Infections.

Is NCT04810559 still recruiting?

NCT04810559 is currently completed. Last updated 30 July 2024.

Last reviewed 2024-07-30 · How we verify

NCT04810559

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood

Completed NA Last updated 30 July 2024

What this trial tests

NA trial testing OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in HIV Testing in 600 participants. Completed in 30 June 2024.

Timeline

29 July 2021

Primary endpoint
28 February 2023

30 June 2024

Quick facts

Lead sponsor	Unity Health Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	600
Start date	29 July 2021
Primary completion	28 February 2023
Estimated completion	30 June 2024
Sites	4 locations across Canada

Drugs / interventions tested

OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test

Conditions studied

HIV Testing — all drugs for HIV Testing →
HIV Infections — all drugs for HIV Infections →

Sponsor

Unity Health Toronto — full company profile →

Who can join

18 and older, any sex, with HIV Testing or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for HIV Testing

Currently open trials in the same condition.

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NCT06785376 — P3 Trial: Estimating the Impact of a Multilevel, Multicomponent Intervention to Increase Uptake of HIV Testing and Biome · NA · recruiting
NCT05384145 — Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Su · NA · recruiting

Other Unity Health Toronto trials

Trials by the same sponsor.

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NCT07455487 — First Appendectomy Using Revolve Surgical Robotic Arm · NA · not yet recruiting
NCT07301632 — Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial · Phase 2 · recruiting
NCT07314905 — Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) · Phase 3 · not yet recruiting
NCT06571916 — Brief Skills for Safer Living (Brief-SfSL) · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04810559 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Unity Health Toronto
Last refreshed: 30 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04810559.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing