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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- Descriptive analysis of patient and site acceptability of GeneXpert testing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals accessing STBBI testing at specific locations who are ≥ 16 years of age
- •Able to provide informed consent.
排除标准
- •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.
结局指标
主要结局
Descriptive analysis of patient and site acceptability of GeneXpert testing
时间窗: 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)
时间窗: 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.
次要结局
- 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)