Studio studiativo per valutare il test del punto di cura dell'anticorpo (POCT) per diagnosticare la sifilide infettiva per diagnosticare la sifilide infettiva per diagnosticare la sifilide infettiva
A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Nine Circles Community Health Centre in Winnipeg, Manitoba
The goal of this observational study is to evaluate the sensitivity, specificity, and utility of the DPP® Syphilis Screen & Confirm antibody point-of-care test (POCT) to diagnose infectious syphilis in participants attending the Nine Circles Community Health Centre in Winnipeg, Manitoba.
The main questions are: Does the POCT provide accurate results compared to conventional syphilis serology methods? and Can the use of POCT improve the timeline for diagnosis and treatment of syphilis?
Researchers will compare the POCT results with conventional laboratory testing to assess if the rapid test can reliably diagnose syphilis during the initial clinic visit.
Participants will: Provide a blood sample via fingerstick for POCT testing and complete a feedback survey to evaluate the POCT experience.
Key details: This study will involve approximately 600 participants aged 18 and older over the course of 12 months which includes both new and repeat visits
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Manitoba
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Winnipeg, Manitoba, Canada, R3G 0X2
- Nine Circles Community Health Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
The study population for this research comprises individuals seeking care at the Nine Circles Community Health Centre in Winnipeg, Manitoba, Canada. Participants are adults (aged 18 years or older) attending the clinic for routine sexual health care, which includes syphilis testing as part of their standard care. The clinic caters to a diverse urban population which is comprised of newcomers to Canada, indigenous, and LGBTQ2S+ community and receives a significant number of syphilis serology specimens annually, reflecting a broad spectrum of individuals who may present with varying sexual health needs. This setting provides a unique opportunity to evaluate the performance of the DPP® Syphilis Screen & Confirm antibody point-of-care test in a real-world clinical environment
Descrizione
Inclusion Criteria:
- Individuals attending the Clinic for routine sexual health care and requiring syphilis testing as part of this care
- Be able to provide informed consent and are a minimum 18 years of age are eligible for this study
- Those who had other STIs in the past, or being suspected of having other STIs, are not excluded as long as testing for syphilis is part of the care provided to them
Exclusion Criteria:
- Those who, at the discretion of the HCP/Research Nurse, appear intoxicated and/or with extreme distress, or confused, will be excluded
- Those below the age of 18 years
- if it has been less than 90 days since their last POCT study visit and they are asymptomatic.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: CROSS_SECTIONAL
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Point of Care Test Performance
Lasso di tempo: From start of enrollment to the end of the enrollment period (12 months)
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Sensitivity of POCT: Percentage of participants with laboratory-confirmed active syphilis who are identified as positive by the POCT, Specificity of POCT: Percentage of participants without laboratory-confirmed active syphilis who are identified as negative by the POCT |
From start of enrollment to the end of the enrollment period (12 months)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Secondary POCT Performance Measures
Lasso di tempo: From start of enrollment to the end of the enrollment period (12 months)
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False Positive Rate: Percentage of participants without active syphilis who test positive by POCT for active syphilis. False Negative Rate: Percentage of participants with active syphilis who test negative by POCT for active syphilis. |
From start of enrollment to the end of the enrollment period (12 months)
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Comparison of Results by POCT Methodology
Lasso di tempo: From start of enrollment to the end of the enrollment period (12 months)
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Comparison of visual vs micro-reader assisted results |
From start of enrollment to the end of the enrollment period (12 months)
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Principal Investigator, University of Manitoba
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HS26266
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Data and information will not be shared outside agencies for safety and privacy of the participants. Performance of POCT will be evaluated by the research team and the findings may be used for publication; however, any published or disseminated results will omit information that could potentially identify participants (name, date of birth, address and provincial health identifier number).
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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