HIVNCT07730801
National Rapid TLC: Testing and Linkage to Care
A study testing Xpert® HIV-1 Qual XC in people with HIV and Chlamydia, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- What is being tested?
- Xpert® HIV-1 Qual XC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Aug 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals accessing STBBI testing at specific locations who are ≥ 16 years of age
- Able to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Anishnawbe Health Toronto
Toronto, Ontario
Women's Health In Women's Hands Community Health Centre
Toronto, Ontario
Wangari Tharao, (416) 593-7655, wangari@whiwh.com
About this study
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
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.
Read the 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]
- Being tested
- Xpert® HIV-1 Qual XC
- Keywords
- device trial, Canada, GeneXpert
- Medical subject headings
- Chlamydia Infections, Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert® HIV-1 Qual XCDevice
Also called Xpert® HIV-1 VL XC, Xpert® CT/NG, Xpert® HCV VL Fingerstick, Xpert® HPV
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 group | Role | What they receive |
|---|---|---|
| Participants seeking HIV and STBBI testing | Experimental | 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. Receives: Device: Xpert® HIV-1 Qual XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of patient and site acceptability of GeneXpert testing
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.
Measured: 2 years
Proportion of True Positives and True Negatives in GeneXpert HIV-1 Qual XC testing to Standard Laboratory Testing (Sensitivity and Specificity Analysis)
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.
Measured: 2 years
Secondary outcomes (3)
Time to Diagnosis following Point-of-Care Testing vs. Standard Testing
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.
Measured: 2 years
Matrix Equivalency: Proportion of True Positives and True Negatives across sample types
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.
Measured: 2 years
Time to treatment or time linkage to HIV care following Point-of-Care Testing vs. Standard Testing
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients self-presenting for HIV or STBBI testing will be offered a choice-based model for testing within the study.
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730801
- Sponsor's protocol ID
- REACH-RapidTLC-001
- Status last verified
- Feb 2026
- First submitted
- 13 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07730801
- Acronym / sponsor ID
- REACH-RapidTLC-001
- Keywords
- device trial, Canada, GeneXpert
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients self-presenting for HIV or STBBI testing will be offered a choice-based model for testing within the study.
| Arm | Type | Receives |
|---|---|---|
| Participants seeking HIV and STBBI testing | Experimental | Device: Xpert® HIV-1 Qual XCParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals accessing STBBI testing at specific locations who are ≥ 16 years of age
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert® HIV-1 Qual XCAlso: Xpert® HIV-1 VL XC, Xpert® CT/NG, Xpert® HCV VL Fingerstick, Xpert® HPVXpert® 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. | Device | Participants seeking HIV and STBBI testing |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpert® HIV-1 Qual XC in people with HIV and Chlamydia, run by Unity Health Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean B Rourke (416-878-2779, Sean.Rourke@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of patient and site acceptability of GeneXpert testing (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.