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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
OQHIVST Trial Summary
This trial is testing a new method of at-home HIV testing using oral fluid. They want to see if it is accurate and easy to use.
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.Check my eligibility
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.See study design
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.
OQHIVST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 - 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 - 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device Performance
Label Comprehension
Readability or Interpretation
+1 moreSecondary outcome measures
Secondary efficacy analysis
OQHIVST 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
544 Previous Clinical Trials
449,542 Total Patients Enrolled
1 Trials studying HIV Testing
600 Patients Enrolled for HIV Testing
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,454,685 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You 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.You understand the details of the study and agree to participate by signing the consent form.You are eligible for this study if you are between the ages of 18 and 60 years old.You can understand and communicate in English or French.You have presented for voluntary testing for HIV infection in the clinic or community based setting.You agree to take part in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide me with a count of the number of Canadian medical sites currently conducting this research?
"The current clinical trial is active at 5 different medical centres, including Clinique médicale l'Actuel in Montreal, Hassle Free Clinic in Ottawa, and ByWard Family Health Team in Vancouver. An additional five sites are also participating."
Answered by AI
How many participants are being welcomed into this experiment?
"Affirmative, the information hosted on clinicaltrials.gov discloses that this medical trial is currently looking for participants. It was initially posted on June 21st 2022 and underwent its last modification two days later. This research project needs to recruit 900 individuals at 5 different sites to meet its quotas."
Answered by AI
Are participants being sought for this research endeavor at the present time?
"According to the clinicaltrials.gov webpage, this experiment is currently recruiting volunteers. The trial was made public on June 21st 2022 and edited for a second time two days later."
Answered by AI
Who else is applying?
What state do they live in?
British Columbia
California
How old are they?
18 - 65
What site did they apply to?
Cool Aid Community Health Centre
Hassle Free Clinic
What portion of applicants met pre-screening criteria?
Met criteria
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