Estudio de investigación para evaluar la pantalla de sífilis DPP® y confirmar la prueba de punto de atención de anticuerpos (POCT) para diagnosticar la sífilis infecciosa
Un estudio de investigación transversal para evaluar la sensibilidad, la especificidad y la utilidad de la pantalla DPP® de la sífilis y confirmar la prueba de punto de atención de anticuerpos (POCT) para diagnosticar la sífilis infecciosa en los participantes que asisten al Centro de Salud Comunitaria de los Nueve Círculos en Winnipeg, Manitobaba, ManitobaBa.
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
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, R3G 0X2
- Nine Circles Community Health Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: CROSS_SECTIONAL
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Point of Care Test Performance
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Secondary POCT Performance Measures
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Principal Investigator, University of Manitoba
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Infecciones
- Enfermedades contagiosas
- Enfermedades de transmisión sexual
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias gramnegativas
- Infecciones por espiroquetas
- Enfermedades De Transmisión Sexual Bacterianas
- Infecciones treponémicas
- Sífilis
Otros números de identificación del estudio
- HS26266
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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).
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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