National Rapid TLC: Testing and Linkage to Care

Sponsor
Unity Health Toronto
Study ID
NCT07730801
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Xpert® HIV-1 Qual XC — DEVICE
    Xpert® HIV-1 Qual XC: Xpert HIV-1 Qual XC (extended coverage) is an in vitro nucleic acid amplification test for the qualitative detection of HIV-1 total nucleic acids, on the automated GeneXpert® system. Xpert HIV-1 Qual XC is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other point-of-care and laboratory markers in infant, adolescent, and adult populations. It is a molecular point-of-care test that delivers actionable results in around 90 minutes. The HIV-1 Qual XC assay uses reverse transcription polymerase chain reaction (RT-PCR) technology to achieve high sensitivity for the qualitative detection of HIV-1 total nucleic acids in WB or DBS specimen types.

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Aug 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
2,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Participants seeking HIV and STBBI testing
    Participants will screen with Health Canada approved rapid antibody tests for HIV, syphillis and/or HCV. Screen results may impact which GeneXpert test that participants can receive.

Primary Outcome Measure

Descriptive analysis of patient and site acceptability of GeneXpert testing [ Time Frame: 2 years ]

Central Contacts

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