National Rapid TLC: Testing and Linkage to Care

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Individuals accessing STBBI testing at specific locations who are ≥ 16 years of age
• Able to provide informed consent.

🚫 You may not be able to join if…

• Unable to provide signed informed consent (e.g., intoxicated)
• In the opinion of the site PI /study operator, the participant is unable to complete the study elements.
• Participants who have previously enrolled in the study.

Where this trial is running

• Anishnawbe Health Toronto, Toronto, Ontario, Canada
• Women's Health In Women's Hands Community Health Centre, Toronto, Ontario, Canada

Who to contact

Sean B Rourke · 416-878-2779 · Sean.Rourke@unityhealth.to

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07730801.