OraQuick® HIV Self-Test for HIV Testing

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hassle Free Clinic, Toronto, Canada
HIV Testing+1 More
OraQuick® HIV Self-Test - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether oral fluid based HIV self-testing is accurate, usable and readable for persons who are non-healthcare professionals and inexperienced in HIV self-testing.

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Eligible Conditions

  • HIV Testing
  • HIV Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether OraQuick® HIV Self-Test will improve 4 primary outcomes and 1 secondary outcome in patients with HIV Testing. Measurement will happen over the course of 6 - 12 months.

6 - 12 months
Device Performance
Label Comprehension
Readability or Interpretation
Secondary efficacy analysis
Usability

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Investigational Device
1 of 1
Experimental Treatment

This trial requires 900 total participants across 1 different treatment group

This trial involves a single treatment. OraQuick® HIV Self-Test is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Investigational Device
Device
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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 - 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 - 12 months for reporting.

Closest Location

Hassle Free Clinic - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are eligible for this study if you are between the ages of 18 and 60 years old. show original
Are able to speak / read / write English or French
You have presented for voluntary testing for HIV infection in the clinic or community based setting. show original
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. show original
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
You are willing to provide the necessary oral fluid and venipuncture blood for use in the study protocol testing methods. show original
You are of unknown HIV status. show original

Patient Q&A Section

What are common treatments for hiv infections?

"In most cases, treatments for HIV infections are highly effective. However, in extreme cases, such as those infected by the rare strains of HIV that infect the central nervous system, intravenous therapy may be necessary to control the virus." - Anonymous Online Contributor

Unverified Answer

What causes hiv infections?

"HIV is transmitted through three main and variable ways: unprotected sexual activity; blood or bodily fluid exchanges from an infected person to another person, and by childbirth. Other factors that add to the risk of hiv infection include unprotected sex, sharing needles for illicit drugs use, tattooing with contaminated water, and unprotected anal or oral sex.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of hiv infections?

"The most common symptoms associated with hiv infections include fatigue, abnormal weight loss and body aches. These symptoms may indicate a HIV-related illness such as AIDS. These symptoms may also result from viral and/or fungal infections. Although these common signs of HIV infection are similar to those seen in other acute, bacterial infections, the combination may make diagnosis more difficult. The combination of symptoms is characteristic of HIV-related illnesses. The presence of additional symptoms should lead to immediate attention to symptoms associated with HIV." - Anonymous Online Contributor

Unverified Answer

How many people get hiv infections a year in the United States?

"This article discusses the HIV/AIDS epidemic. The total number of people getting hiv infections each year, whether people are getting AIDS, or not, is estimated to be about 860,000 individuals." - Anonymous Online Contributor

Unverified Answer

What is hiv infections?

"The HIV infection is a sexually transmitted disease which mainly occurs through unprotected sexual intercourse. It is associated with high morbidity and mortality and is usually diagnosed in the late stages of disease progression.\n" - Anonymous Online Contributor

Unverified Answer

Can hiv infections be cured?

"While good counseling and treatment can significantly reduce symptoms of HIV infection and thus prolong the duration of an undetectable viral load, the fact that more than 1/3 of adults with an undetectable viral load are still seropositive for HIV makes it difficult to establish whether symptomatic infection can be definitively cured. Furthermore, the fact that most infections do not spontaneously decline further points to a dilemma in the ethics of trying to eradicate HIV infections. At present, symptomatic antiretroviral treatment is an effective and relatively durable means of controlling HIV disease, but at the cost of compromising immune system function and prolonging the time required to achieve virologic suppression." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of oraquick® hiv self-test?

"A significant number of patients receiving oraquick® HIV self-test experience common side effects. However, most are mild (below grade 3) and most tolerable (granted more than three ratings). More significant side effects, including one severe (grade 4) and two painful (grade 5), occur in about two to 10% of patients, respectively. Patients should receive comprehensive patient education about common side effects, and should tell their doctor of all abnormal side effects. For those who take oraqual, [withdrawal effects include dysphoria/depression (GRADE 4), loss of desire to have sex with other men], and nausea (GRADE 4) may present 1–7 years after stopping oraqual use." - Anonymous Online Contributor

Unverified Answer

Has oraquick® hiv self-test proven to be more effective than a placebo?

"Results demonstrated a significant effect of Oraquick® hiv self-test compared to placebo in reducing self-perceived anxiety associated with HIV testing. More importantly, Oraquick® hiv self-test was also superior to waitlist control for the detection of HIV infection in the study population." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving oraquick® hiv self-test?

"ORAKIV is FDA-approved for the hIV self-testing product by Orasure Labs which is marketed by CVM Life Sciences Group, LLC. The ORAKIV product is also available in France through Orasure and in the U.K. through Novartis.\n" - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hiv infections?

"The average age when hiv infection is acquired is 19 years, with a standard deviation of 3 years.. A large part of people in the United States currently do not have the virus [70%(95% confidence interval, 65–75) do not have the virus] which means that most of those that acquire the virus will need to be vaccinated. If you're the person in this country not having the infection, you are unlikely to transmit it to your child. For those children, and their unborn child, [there is a] much more realistic expectation of your child being HIV-positive." - Anonymous Online Contributor

Unverified Answer

How does oraquick® hiv self-test work?

"OraQuick was well received and showed accuracy comparable with hiv-1 rapid tests but with an advantage of not necessitating fingerling/obtaining fingerstick samples for hiv screening." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hiv infections?

"HIV may be transmitted through heterosexual or homosexual intercourse. The CDC advises that for the majority of men who will have intercourse in the future, the primary mode of transmission will be via a non-partner. The CDC recommends that men practice safe sex." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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