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National Rapid TLC: Testing and Linkage to Care

27 juli 2026 bijgewerkt door: Unity Health Toronto

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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]

Studietype

Ingrijpend

Inschrijving (Geschat)

2500

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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 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.
Andere namen:
  • Xpert® HIV-1 VL XC
  • Xpert® CT/NG
  • Xpert® HCV VL Fingerstick
  • Xpert® HPV

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Descriptive analysis of patient and site acceptability of GeneXpert testing
Tijdsspanne: 2 years

Patients will complete a survey after GeneXpert testing assessing their experience (e.g., comfort levels, recommend to others, ease of testing process).

A descriptive analysis of the patient experience survey will be completed and stratified by negative and positive results by test type.

Site staff will complete a survey after GeneXpert testing assessing their experience using the test (e.g., ease of use, ease of interpretation of results). A descriptive analysis of healthcare provider experience survey will be conducted.
2 years
Proportion of True Positives and True Negatives in GeneXpert HIV-1 Qual XC testing to Standard Laboratory Testing (Sensitivity and Specificity Analysis)
Tijdsspanne: 2 years

The primary analyses will be positive and negative percent agreement (PPA, NPA) of the Xpert HIV-1 Qual XC results compared to the cobas®HIV-1/HIV-2 QUALITATIVE/cobas®5800 system. The 95% confidence interval will also be determined by the Wilson Score Method.

PPA = [TP / (TP + FN)] x 100, where

TP (true positive) is positive Xpert HIV-1 Qual XC Test in agreement with cobas® HIV-1/HIV-2 QUALITATIVE reactive and FN (false negative) is negative Xpert HIV-1 Qual XC Test discordant with cobas® HIV-1/HIV-2 QUALITATIVE reactive.

NPA = [TN / (TN + FP)] x100, where TN (true negative) is negative Xpert HIV-1 Qual XC Test in agreement with non-reactive cobas® HIV-1/HIV-2 QUALITATIVE and FP (false positive) is positive Xpert HIV-1 Qual XC Test discordant with cobas® HIV-1/HIV-2 QUALITATIVE non-reactive.
2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Diagnosis following Point-of-Care Testing vs. Standard Testing
Tijdsspanne: 2 years
Chi-square analysis will be used to assess the time to diagnosis relative to standard testing. A two-sided p value of < 0.05 will be considered statistically significant.
2 years
Matrix Equivalency: Proportion of True Positives and True Negatives across sample types
Tijdsspanne: 2 years

EDTA whole blood DBS, capillary EDTA whole blood DBS, and direct fingerstick blood DBS will be determined with a 95% confidence interval calculations (Wilson score interval).

A paired-samples T-test will be performed on the HIV-1 positive paired specimens to compare the mean HIV-1 Ct values between capillary and venous WB.

Acceptance criteria:

Following CLSI guideline EP35 Edition 1 Assessment of Equivalence or suitability of specimen types for medical laboratory measurement procedures, venous EDTA whole blood DBS, capillary EDTA whole blood DBS, and direct fingerstick blood DBS shall have a Positive Percentage Agreement (PPA) and Negative Percentage Agreement (NPA) > 95%.

There should be no significant difference (p >0.05) in mean HIV-1 Ct value between HIV-1 positive matching DBS specimens using paired T tests.
2 years
Time to treatment or time linkage to HIV care following Point-of-Care Testing vs. Standard Testing
Tijdsspanne: 2 years
Time to treatment or linkage to HIV care will be examined with chi-square analysis applied to assess categorical variables where appropriate. A two-sided p value of < 0.05 will be considered statistically significant.
2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Unity Health Toronto

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 maart 2028

Studieregistratiedata

Eerst ingediend

13 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 juli 2026

Eerst geplaatst (Werkelijk)

28 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

27 juli 2026

Laatst geverifieerd

1 februari 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • REACH-RapidTLC-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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