An interventional study of Xpert® HIV-1 Qual XC in HIV, Chlamydia and Gonorrhea, sponsored by Unity Health Toronto. Not yet recruiting at 2 sites in Canada. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Diagnostic
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.
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
134 studies on the registry are indexed under Chlamydia Infections; 23 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 600 across 94 interventional studies indexed under Chlamydia Infections.
Browse Chlamydia Infections studies →Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Xpert® HIV-1 VL XC, Xpert® CT/NG, Xpert® HCV VL Fingerstick, Xpert® HPV
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.
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)
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.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Plan to share: No
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Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 26 interventional studies with no phase under Chlamydia Infections, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 16 months is below that.
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