Xpert® HIV-1 Qual XC for HIV Detection

Not yet recruiting at 1 trial location
SB
MC
Overseen ByMegan Cedrone
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Unity Health Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this cross-sectional study is to learn if the GeneXpert system is a practical system for HIV and STBBI testing in community-based organizations and health clinics. The study involves a clinical trial to learn if the HIV-1 Qual XC test works to identify HIV in near-patient settings. The main questions it aims to answer are to create a near-patient testing model for testing and treating patients in a single visit, and to learn if the HIV-1 Qual XC test works to accurately detect HIV in patients. Patients who come to study sites to ask for HIV or STBBI testing will be given the option to participate in the study. Those who agree with provide samples for the tests of their choice and answer survey questions before and after their tests are completed. Those who participate in the clinical trial will have a blood sample sent to provincial labs to compare the results to the HIV -1 Qual XC test. Follow-up visits will be done at 1,3 and 6 months to see if patients completed treatment and/or remained connected to care.

Are You a Good Fit for This Trial?

This trial is for people who visit certain clinics or community organizations to get tested for HIV or other sexually transmitted infections. Anyone coming in for testing can choose to join, as long as they agree to provide a blood sample and answer some survey questions.

Inclusion Criteria

I am 16 years or older and getting tested for STBBIs at a participating location.
Able to provide informed consent

Exclusion Criteria

I am unable to complete all parts of the study as judged by the study doctor.
Participants who have previously enrolled in the study
I am unable to give my signed consent for the study.

What Are the Treatments Tested in This Trial?

Interventions

  • Xpert® HIV-1 Qual XC

Trial Overview

The study is testing if the Xpert HIV-1 Qual XC test can quickly and accurately detect HIV at the clinic, compared with standard lab tests. Participants may also be checked for other STIs, and follow-up will see if they stay connected to care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants seeking HIV and STBBI testingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials
572
Recruited
470,000+