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

NCT04810559 | Completed FDA Device

• 1 other identifier: REACH - HIV- OraQuick- 1.0
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Testing; HIV Infections

Keywords

HIV; Testing; Point-of-care; OraQuick; Canada

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Usability and Label comprehension

  1 year, year 1

Study Arms (1)

Investigational Device

EXPERIMENTAL

Device: OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test

Interventions

OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test DEVICE

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.

Investigational Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have used or watched someone use the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test
• 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)
• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Maple Leaf Research

Toronto, Ontario, M5G 1K2, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

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

Toronto, Ontario, Canada

Location

Clinique médicale l'Actuel

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sean B Rourke, PhD

  MAP Centre for Urban Health Solutions, St. Micheal's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subject enrollment is by unblinded staff and testing is by blinded healthcare providers
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional, prospective, field trial (near patient study)

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 23, 2021
• Study Start: July 29, 2021
• Primary Completion: February 28, 2023
• Study Completion: June 30, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)