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Diagnostic Device

HIV Self-Test for HIV (OQHIVST Trial)

N/A
Recruiting
Led By Sean B Rourke, PhD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 - 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the OraQuick® HIV Self-Test, which lets people check for HIV at home using their saliva. It focuses on non-healthcare professionals, especially those at high risk for HIV. The test works by detecting HIV antibodies in saliva using a swab and solution. The OraQuick HIV Self-Test has been shown to be a practical and accurate method for HIV detection, especially in non-clinical settings.

Who is the study for?
This study is for Canadian residents aged 18 or older who have not been diagnosed with HIV, are not healthcare professionals experienced in HIV testing, and are not on any anti-HIV medications. Participants must be able to consent, speak English or French, provide oral fluid and blood samples, and commit to the study's process.
What is being tested?
The OraQuick® HIV Self-Test is being evaluated among about 900 individuals inexperienced in self-testing for its accuracy and user-friendliness. The test uses oral fluid to detect HIV, and participants will perform the test themselves at various clinic sites across Canada.
What are the potential side effects?
Since this trial involves a non-invasive self-test for detecting HIV using oral fluids rather than a drug intervention, there are no direct side effects associated with typical medical treatments. However, potential indirect effects may include anxiety or distress from test results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 - 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 - 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device Performance
Label Comprehension
Readability or Interpretation
+1 more
Secondary study objectives
Secondary efficacy analysis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Investigational DeviceExperimental Treatment1 Intervention
Observed self-test of oral fluid with the OraQuick HIV Self-Test
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OraQuick® HIV Self-Test
2018
N/A
~7880

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
556 Previous Clinical Trials
453,366 Total Patients Enrolled
1 Trials studying HIV Testing
600 Patients Enrolled for HIV Testing
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,184 Total Patients Enrolled
1 Trials studying HIV Testing
600 Patients Enrolled for HIV Testing
Sean B Rourke, PhDPrincipal InvestigatorMAP Centre for Urban Health Solutions, St. Micheal's Hospital
2 Previous Clinical Trials
5,600 Total Patients Enrolled
1 Trials studying HIV Testing
600 Patients Enrolled for HIV Testing

Media Library

OraQuick® HIV Self-Test (Diagnostic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05020353 — N/A
HIV Testing Research Study Groups: Investigational Device
HIV Testing Clinical Trial 2023: OraQuick® HIV Self-Test Highlights & Side Effects. Trial Name: NCT05020353 — N/A
OraQuick® HIV Self-Test (Diagnostic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020353 — N/A
~263 spots leftby Nov 2025
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