National Rapid TLC: Testing and Linkage to Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xpert® HIV-1 Qual XC.
- Who it may be relevant to
- Registry conditions: HIV, Chlamydia, Gonorrhea, HCV. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Rapid Testing and Linkage to Care for Underserved and Undiagnosed Populations at Risk of HIV and STBBIs or Living With HIV and STBBIs Across Canada Using the GeneXpert System
Overview
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.
Detailed description
A nationwide test, treat, and connect intervention will be implemented to reach 2,500 individuals attending clinics for routine sexually transmitted and blood-borne infection (STBBI) testing. The intervention will provide opportunities for immediate treatment and culturally appropriate care for hepatitis C virus (HCV), chlamydia, gonorrhea, and HIV.
The Xpert HIV-1 Qual XC test performance evaluation will be conducted in community-based point-of-care (POC) settings across Canada to reach up to 1,000 individuals presenting for HIV testing, including those with suspected HIV infection, those at high risk of HIV acquisition, and individuals known to be living with HIV. The evaluation will provide opportunities for newly diagnosed individuals to receive immediate treatment and culturally appropriate HIV care.
Critical to the success of this initiative is the engagement and support of people with lived experience, peer navigators, and leaders from community-based organizations in all aspects of the work through shared leadership, collaboration, and joint decision-making. This approach will help address barriers to testing, diagnosis, and care experienced by underserved and undiagnosed populations in inner-city, remote, rural, and isolated communities.
All participating sites will use Health Canada-approved rapid antibody point-of-care tests to screen for HIV, combined HIV/syphilis, and/or HCV.
All investigational and licensed molecular point-of-care testing (POCT) devices utilize the GeneXpert (GX) Instrument System to automate and integrate sample preparation, nucleic acid extraction, amplification, and target sequence detection in simple and complex specimens using real-time reverse transcription polymerase chain reaction (RT-PCR). The system consists of an instrument, a personal computer, and preloaded software for performing tests and reviewing results. Testing requires the use of single-use disposable GeneXpert cartridges containing the RT-PCR reagents and supporting all RT-PCR processes. The self-contained cartridge design minimizes the risk of cross-contamination between samples.
The Xpert HIV-1 Qual XC assay includes reagents for the detection of HIV-1 total nucleic acids, as well as an internal control to verify adequate target processing and monitor for the presence of inhibitors during the reverse transcription and PCR reactions. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling within the cartridge, probe integrity, and dye stability.
Investigational and Licensed POCT Devices
* Xpert® HIV-1 Qual XC \[investigational\] * Xpert® HIV-1 VL XC \[licensed\] * Xpert® CT/NG \[licensed\] * Xpert® HCV VL Fingerstick \[licensed\] * Xpert® HPV \[licensed\]
Interventions
- Device Xpert® HIV-1 Qual XC
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 mi
Primary outcome measures
- Descriptive analysis of patient and site acceptability of GeneXpert testing [Time frame: 2 years]
- Proportion of True Positives and True Negatives in GeneXpert HIV-1 Qual XC testing to Standard Laboratory Testing (Sensitivity and Specificity Analysis) [Time frame: 2 years]
Secondary outcome measures (3)
- Time to Diagnosis following Point-of-Care Testing vs. Standard Testing [Time frame: 2 years]
- Matrix Equivalency: Proportion of True Positives and True Negatives across sample types [Time frame: 2 years]
- Time to treatment or time linkage to HIV care following Point-of-Care Testing vs. Standard Testing [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Individuals accessing STBBI testing at specific locations who are ≥ 16 years of age
- Able to provide informed consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 2 centers
- Anishnawbe Health Toronto — Toronto
- Women's Health In Women's Hands Community Health Centre — Toronto
Identifiers
NCT: NCT07730801 · REACH-RapidTLC-001