NCT07730801

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable hiv

Timeline
19mo left

Started Aug 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

July 28, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

April 13, 2026

Last Update Submit

July 27, 2026

Conditions

HIVChlamydiaGonorrheaHCVHPV

Keywords

device trialCanadaGeneXpert

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 years

Secondary Outcomes (3)

  • Time to Diagnosis following Point-of-Care Testing vs. Standard Testing

    2 years

  • Matrix Equivalency: Proportion of True Positives and True Negatives across sample types

    2 years

  • Time to treatment or time linkage to HIV care following Point-of-Care Testing vs. Standard Testing

    2 years

Study Arms (1)

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.

Device: Xpert® HIV-1 Qual XC

Interventions

Xpert® HIV-1 Qual XCDEVICE

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
Participants seeking HIV and STBBI testing

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals accessing STBBI testing at specific locations who are ≥ 16 years of age
  • Able to provide informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anishnawbe Health Toronto

Toronto, Ontario, Canada

Location

Women's Health In Women's Hands Community Health Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Chlamydia InfectionsGonorrhea

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesNeisseriaceae Infections

Central Study Contacts

Sean B Rourke

CONTACT

416-878-2779Sean.Rourke@unityhealth.to

Megan Cedrone

CONTACT

(647)-786-8711Megan.Cedrone@unityhealth.to

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients self-presenting for HIV or STBBI testing will be offered a choice-based model for testing within the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

July 28, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

July 28, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)