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Automuestreo de VPH de St. Joseph: Ofreciendo una opción de automuestreo en la clínica

15 de septiembre de 2026 actualizado por: Christina Scartozzi, Milton S. Hershey Medical Center

Aumento de las pruebas de detección de cáncer entre las pacientes de sexo femenino en la Clínica de residencia de PSH St. Joseph: Ofreciendo una opción de automuestreo en la clínica

This study aims to evaluate the effectiveness of offering self-sampled human papillomavirus (HPV) tests in increasing participation in cervical cancer screening, compared to the standard of care clinician-sampled test. The primary study endpoints are (1) patients' acceptability of self-sampled HPV tests vs. clinician-sampled test, and (2) patients' completion of self-sampled HPV test. The secondary study endpoint to be measured is the increase in cervical cancer screenings of any type in the PSH St. Joseph's residency clinic patient population.

Descripción general del estudio

Estado

Activo, no reclutando

Intervención / Tratamiento

Descripción detallada

Patients will be recruited during their appointment at the PSH St. Joseph's residency clinic. If a patient is due for cervical cancer screening, they will be presented with the study letter that allows them to choose between (1) receiving the self-sampled HPV test after their appointment, (2) scheduling an in-person cervical cancer screening at a later date, or (3) indicating they are not interested in either option at this time (see study letter). If the patient requests the self-sampled HPV test (option 1), they will be given a package that contains the HPV self-sampling test and directions for use, the Summary Explanation of Research, the package cover letter, the Penn State Health Clinical Laboratory Pathology Services Special Account Requisition form, and a pre-paid return envelope. The patient will fill in the Pathology Services Special Account Requisition form with their name, date of birth, sex, and date and time of sample collection. The completed test and Pathology Services Special Account Requisition form will be placed in the pre-paid return envelope and sent to the Penn State Health Clinical Laboratory. A note will be added to the patient's medical record stating that a self-sampled HPV test was provided, including the date it was given.

Patients who choose option 2, to schedule an in-person cervical cancer screening at a later date, will be given the time to do so when checking out from their current clinic appointment. Appointment information will be shared with the study team to ensure that their appointment is kept or rescheduled, if needed.

No additional follow-up is needed for patients who choose option 3. A note will be added to the patient's medical record stating that they declined HPV screening, including the date the screening was declined.

Results of the self-sampled HPV tests will be securely sent from the Penn State Health Clinical Laboratory to the project manager for tracking. Then, the results will be sent to a member of the study team at the PSH St. Joseph residency clinic, who will upload the results into the patient's medical records. If the test result indicates that the patient is positive for low-risk HPV, the patient will be contacted by their primary care physician to schedule a Pap test. If the test result indicates that the patient is positive for high-risk HPV, patient will be contacted by their primary care physician to schedule a colposcopy. Scheduling a Pap test or colposcopy is standard of care for a low-risk or high-risk HPV result, respectively. If the test result indicates that the patient is negative for HPV, the results will be entered into the patient medical record and the patient notified via telephone, but the patient will not receive any follow-up procedures after the self-sampled test.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Pennsylvania
      • Reading, Pennsylvania, Estados Unidos, 19605
        • Penn State Health St. Joseph's

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

30 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Eligible but out-of-date for cervical cancer screening
  • Able to speak, read, and communicate well in English or Spanish
  • Not at greater than average risk for cervical cancer

Exclusion Criteria:

  • Pregnant

  • Incarcerated

  • Greater than average risk for cervical cancer, for example:

    • Already diagnosed with high-grade precancerous cervical cancer or cervical lesions
    • Has a compromised immune system
  • Unable to speak, read, and communicate well in English or Spanish

  • Unable or unwilling to give implied consent or otherwise complete study requirements

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Requested self-sampled HPV test

This group will receive the self-sampled HPV test. Included with the test are the test instructions, a lab requisition form, and a pre-paid mailer so that it can be sent back to the lab for testing. Results of the test will be shared with the participant.

A self-sampling brush to collect cervical cells for screening purposes.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of patients who request the self-sampled HPV test
Periodo de tiempo: 12 months after enrollment begins

This outcome is measuring the number of patients who select to receive a self-sampled HPV test out of all patients presented with the research opportunity. The results will be presented as the acceptance rate of the self-sampled HPV test. The measurement tool for this outcome is a patient-completed questionnaire where the patient can request 1) a self-sampled HPV test, 2) a clinician-sampled test, or 3) to not receive their cervical cancer screening at this time.

12 months after enrollment begins
Number of patients who request the clinician-sampled test
Periodo de tiempo: 12 months after enrollment begins

This outcome is measuring the number of patients who select to receive a clinician-sampled cervical cancer screening out of all patients presented with the research opportunity. The results will be presented as the acceptance rate of the clinician-sampled test. The measurement tool for this outcome is a patient-completed questionnaire where the patient can request 1) a self-sampled HPV test, 2) a clinician-sampled test, or 3) to not receive their cervical cancer screening at this time.

12 months after enrollment begins
Number of patients who complete the self-sampled HPV test
Periodo de tiempo: 1 month after patient is given self-sampled HPV test

This outcome is measuring the number of patients who complete and return the self-sampled HPV test out of all the patients who receive a self-sampled HPV test. A patient will have up to one month to complete and return the self-sampled HPV test. The final outcome results will be calculated one month after the last patient receives a self-sampled HPV test.

1 month after patient is given self-sampled HPV test

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the number of patients considered up-to-date with cervical cancer screening of any type at the Penn State Health St. Joseph's residency clinic
Periodo de tiempo: 3 months after study enrollment ends

This outcome is measuring the change in the number of patients considered up-to-date with cervical cancer screening of any type at the Penn State Health St. Joseph's residency clinic. This data will be collected 3 months after study enrollment ends, and will be compared to the number of patients considered up-to-date with cervical cancer screening in this patient population before study enrollment began to determine if overall screening rates have increased, decreased, or stayed the same.

3 months after study enrollment ends

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Christina Scartozzi, DO, Penn State College of Medicine

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de septiembre de 2023

Finalización primaria (Actual)

23 de julio de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

27 de septiembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

11 de octubre de 2021

Publicado por primera vez (Actual)

25 de octubre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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