National Rapid TLC: Testing and Linkage to Care

July 27, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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]

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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 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.
Other Names:
  • Xpert® HIV-1 VL XC
  • Xpert® CT/NG
  • Xpert® HCV VL Fingerstick
  • Xpert® HPV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Descriptive analysis of patient and site acceptability of GeneXpert testing
Time Frame: 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)
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Diagnosis following Point-of-Care Testing vs. Standard Testing
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REACH-RapidTLC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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