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Investigational Device for Human Immunodeficiency Virus Infection

N/A
Waitlist Available
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 1 year, year 1
Awards & highlights

Study Summary

This trial is testing a new rapid HIV test to see if it is easy to use and accurate. Healthcare providers will collect samples from patients and test them using the new device. Results will be compared to a laboratory test. Healthcare providers will also answer questions about the test to see if it is easy to use.

Who is the study for?
This trial is for healthcare providers (HCPs) who are at least 18 years old, can give informed consent, and are employees at the study sites in Canada. They will be testing a rapid HIV test on patients.Check my eligibility
What is being tested?
The OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test is being evaluated for its ease of use and accuracy by HCPs. It tests for HIV using oral fluid and fingerstick blood samples, with results compared to standard lab tests.See study design
What are the potential side effects?
There may not be direct side effects from participating as this trial involves non-invasive testing methods; however, discomfort or stress from the fingerstick blood collection could occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, year 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, year 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive and Negative Percent Agreement
Secondary outcome measures
Usability and Label comprehension

Side effects data

From 2021 Phase 2 trial • 22 Patients • NCT03019640
100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Nausea
100%
Fever
100%
Platelet count decreased
100%
Anemia
100%
Neutrophil count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Hypotension
59%
Anorexia
55%
Hypophosphatemia
55%
Constipation
55%
Edema limbs
55%
Rash maculo-papular
50%
Headache
45%
Hypoalbuminemia
45%
Hypocalcemia
45%
Alanine aminotransferase increased
41%
Hypokalemia
41%
Dizziness
36%
Hyponatremia
36%
Anxiety
32%
Investigations
32%
Insomnia
32%
Vomiting
32%
Chills
32%
Cough
32%
Febrile neutropenia
32%
Hypertension
27%
Pain
27%
Alkaline phosphatase increased
27%
Aspartate aminotransferase increased
23%
Hypomagnesemia
23%
Infections and infestations
23%
Dysphagia
23%
Arthralgia
23%
Esophagitis
23%
Hiccups
18%
Dehydration
18%
Hypoxia
18%
Abdominal pain
18%
Allergic rhinitis
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hemorrhoids
14%
Infusion related reaction
14%
INR increased
14%
Immune system disorders
14%
Bloating
14%
Paresthesia
14%
Pleural effusion
14%
Dyspepsia
14%
Hypermagnesemia
14%
Rectal pain
9%
Upper respiratory infection
9%
Sore throat
9%
Blood bilirubin increased
9%
Bone pain
9%
Cholesterol high
9%
Creatinine increased
9%
Nasal congestion
9%
Papulopustular rash
9%
Arthritis
9%
Back pain
9%
Dry skin
9%
Dysgeusia
9%
Flushing
9%
General disorders and administration site conditions
9%
Hypernatremia
9%
Hyperuricemia
9%
Non-cardiac chest pain
9%
Renal and urinary disorders
9%
Skin ulceration
5%
Hypoglycemia
5%
Lymph node pain
5%
Tremor
5%
Hypothyroidism
5%
Lung infection
5%
Thromboembolic event
5%
Urinary tract pain
5%
Vascular disorders
5%
Weight gain
5%
Lymphocyte count increased
5%
Myalgia
5%
Urinary tract infection
5%
Urinary frequency
5%
Lung
5%
Eye disorders
5%
Gastroesophageal reflux disease
5%
Mucosal infection
5%
Metabolism and nutrition disorders
5%
Musculoskeletal and connective tissue disorder
5%
Peripheral motor neuropathy
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Rash acneiform
5%
Respiratory failure
5%
Acute kidney injury
5%
Ear pain
5%
Edema face
5%
Encephalopathy
5%
Endocrine disorders
5%
Atelectasis
5%
Atrial fibrillation
5%
Bladder infection
5%
Epistaxis
5%
Flatulence
5%
Gastrointestinal pain
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypercalcemia
5%
Neck pain
5%
Nervous system disorders
5%
Pain in extremity
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Skin hyperpigmentation
5%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Investigational DeviceExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,165 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,452,817 Total Patients Enrolled
Sean B Rourke, PhDPrincipal InvestigatorMAP Centre for Urban Health Solutions, St. Micheal's Hospital
2 Previous Clinical Trials
5,900 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any more participants being taken on for this experiment?

"This trial is actively recruiting volunteers, with the initial posting of the study occurring on July 29th 2021 and last modified November 8th 2022."

Answered by AI

How many individuals have so far signed up for this research endeavor?

"This clinical trial necessitates 600 participants who meet the requisite qualifications. Potential enrollees can choose to join from two locations in Ontario: University of Ottawa Health Services & Hôpital Montfort Research Institute and Maple Leaf Research in Toronto."

Answered by AI

Is the trial being conducted widely in North America?

"Currently, this trial has 7 active recruitment sites including University of Ottawa Health Services & Hôpital Montfort Research Institute in Ottawa, Maple Leaf Research in Toronto, and St. Michael's Hospital in Montréal. There are also 4 other locations where enrolment is taking place."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
St. Michael's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. St. Michael's Hospital: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
2021. "Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04810559.
~164 spots leftby Apr 2025
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