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OraQuick® HIV Self-Test Study in Canada

NCT05020353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 951

Last updated 2025-05-11

Study results available
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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

Interventions

DEVICE

OraQuick® HIV Self-Test

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Sean B Rourke, PhD · MAP Centre for Urban Health Solutions, St. Micheal's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2023-07-04
Completion
2024-05-15
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05020353 on ClinicalTrials.gov