Status:

COMPLETED

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

Lead Sponsor:

Unity Health Toronto

Collaborating Sponsors:

Canadian Institutes of Health Research (CIHR)

Conditions:

HIV Testing

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

NA

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 a...

Detailed Description

Background and Rationale: At the end of 2018, the Public Health Agency of Canada (PHAC) noted 2,242 new HIV infections (incidence rate of 6 per 100,000 people) representing a slight increase from 201...

Eligibility Criteria

Inclusion

  • Healthcare provider
  • 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

  • • 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

Key Trial Info

Start Date :

July 29 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2024

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT04810559

Start Date

July 29 2021

End Date

June 30 2024

Last Update

July 30 2024

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Maple Leaf Research

Toronto, Ontario, Canada, M5G 1K2

2

St. Michael's Hospital

Toronto, Ontario, Canada

3

Women's Health in Women's Hands Community Health Centre

Toronto, Ontario, Canada

4

Clinique médicale l'Actuel

Montreal, Quebec, Canada

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