OraQuick® HIV Self-Test Study in Canada

NCT05020353 | Completed Results FDA Device

• 1 other identifier: REACH - HIV - OraQuick - 2.0
• Study Type: interventional
• Target: 951
• Locations: 1 country
• Sites: 7

Brief Summary

Oral fluid based HIV Self-testing (HIVST) provides another innovative and simple option to increase opportunities for HIV testing. At-home testing for HIV using oral fluid has been FDA approved and in use in the USA since 2012, and studies have also shown that interest and acceptability of HIVST with oral fluid is high in other global settings. However data for oral fluid based HIVST within key populations and those at high risk for HIV infection in Canada is limited. This study involves around 900 persons who are non-healthcare professionals and inexperienced in HIV self-testing (intended users) and are presenting at clinic sites across Canada for HIV testing. It will evaluate the accuracy (sensitivity and specificity), usability (persons performs test correctly) and readability (persons successfully interpret test results) of the OraQuick® HIV Self-Test when performed by persons representing intended users living in Canada. 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; Self-testing; HIVST

Outcome Measures

Primary Outcomes (4)

• Device Performance: Positive and Negative Percent Agreement

  Sensitivity and specificity of study participants' self-interpreted self-test results with the OraQuick® HIV Self-Test versus the HIV status as determined by the 4th generation EIA and confirmatory testing for HIV as necessary.

  Outcome measured following POC tests on Visit 1, Day 1 for each participant.

• Observer Usability Assessment

  Observation to determine if participants perform all critical steps correctly

  Outcome measured following POC tests on Visit 1, Day 1 for each participant.

• Participant and Observer Interpretations

  Confirmation by Observer to determine if participant interprets test results correctly and successful interpretation of various contrived (mock) test device results.

  Outcome measured following POC tests on Visit 1, Day 1 for each participant.

• Label Comprehension

  To determine that the participant is aware of key messages in labelling including test limitations and what to do following the test result.

  Outcome measured following POC tests on Visit 1, Day 1 for each participant.

Secondary Outcomes (1)

• Readability or Interpretation (Mock Devices)

  Outcome measured following mock device interpretation on Visit 1, Day 1 for each participant.

Study Arms (1)

Investigational Device

EXPERIMENTAL

Observed self-test of oral fluid with the OraQuick HIV Self-Test

Device: OraQuick® HIV Self-Test

Interventions

OraQuick® HIV Self-Test DEVICE

OraQuick® HIV Self-Test in oral fluid conducted by observed intended users (non-healthcare professional and inexperienced in HIV self-testing) compared to laboratory 4th generation Ag/Ab enzyme immunoassay (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 18 years of age and older
• Are able to speak / read / write English or French
• Have presented for voluntary testing for HIV infection in the clinic or community based setting
• Are willing to participate in the study site's standard of care HIV counselling and testing program and receive the study site's standard of care test results
• Are willing to be a participant in the study
• Are able to provide informed consent i.e. understands and signs the informed consent form
• Are able to complete the required testing on the allocated testing day
• Are willing to provide the necessary oral fluid and venipuncture blood for use in the study protocol testing methods.
• Are of unknown HIV status (last HIV negative test must be a minimum of 3 months prior)

You may not qualify if:

• Are known HIV positive
• Are on antiretroviral therapy (ART) or anti-HIV medications for the treatment of HIV, either as pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP) or experimental vaccine
• Have any experience or have ever conducted a rapid diagnostic self-test for HIV or any other sexually transmitted and blood borne illnesses disease
• Are currently participating in a concurrent trial of HIV self-tests
• Are investigator site employees or immediate family members of sponsor or investigator site employee
• Are a practicing medical healthcare professional (doctor, nurse or HIV counsellor that performs HIV testing with Rapid Tests)
• Any condition which, in the opinion of the Observer, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment and questionnaire etc. or bias the outcome, e.g. being unable to see / read by forgetting to bring reading glasses, being intoxicated, acute sickness, visibly distressed.

Sponsors & Collaborators

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

Study Sites (7)

Cool Aid Community Health Centre

Vancouver, British Columbia, Canada

Location

Nine Circles Community Health Centre

Winnipeg, Manitoba, Canada

Location

ByWard Family Health Team

Ottawa, Ontario, Canada

Location

Hassle Free Clinic

Toronto, Ontario, Canada

Location

Maple Leaf Research

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

Limitations and Caveats

This is a prospective study for which the prevalence of infection is low.

Results Point of Contact

• Title: Sean B. Rourke
• Organization: Li Ka Shing Knowledge Institute, St. Michael's Hospital

sean.rourke@utoronto.ca

(416) 878-2779

Study Officials

• Sean B Rourke, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional, prospective, field trial (untrained self-tester)

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: June 21, 2022
• Primary Completion: July 4, 2023
• Study Completion: May 15, 2024
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)