Mail-in HPV Screening Program in NJ
3 de agosto de 2026 actualizado por: Ana Isabel Tergas, MD, MPH, Rutgers, The State University of New Jersey
A Mail-based HPV Sampling Program to Increase Cervical Cancer Screening in New Jersey
The purpose of this study is to help people who have missed their regular cervical cancer screening.
The investigators are evaluating whether mailing an HPV self-sampling kit to participant home makes it easier and more convenient for people to get screened for cervical cancer.
This study will also help to understand if people find this process acceptable and whether it is an effective way to improve screening rates.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
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
-
-
New Jersey
-
Newark, New Jersey, Estados Unidos, 07103
- Rutgers New Jersey Medical School
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-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Women, transgender men, and nonbinary individuals aged 30 to 75 who have a cervix.
- No history of hysterectomy or cervical cancer.
- No documented cervical cancer screening within guideline-recommended intervals: specifically, no Pap test in the past 3.5 years, no Pap/HPV co-test in the past 5.5 years, and no standalone HPV test results in the past 5.5 years. (A 6-month grace period is included to allow time for response to usual care outreach.)
- At least two visits to University Hospital ambulatory care over the past five years, ensuring opportunity for follow-up and continuity of care.
Exclusion Criteria:
- History of cervical dysplasia within the past 3.5 years, reflecting those likely under active surveillance or treatment protocols.
- Currently pregnant, due to differing screening recommendations and clinical considerations.
- Prior or current diagnosis of cervical cancer or ongoing treatment for cervical neoplasia.
- Physical, cognitive, or functional limitations that would preclude use of the mailed self-sampling kit without assistance. Examples include severe arthritis or significant impairment affecting self-collection capability.
- Lack of a telephone number or reliable mailing address on file.
- Inability to communicate in English or Spanish, given study materials and staffing capabilities. Use of additional language services is not available.
- Current enrollment in other cervical cancer screening or intervention studies that may interfere with participation or outcomes.
- Inability to provide informed consent or comprehend study procedures based on cognitive capacity, as assessed by the Research Coordinator during initial contact.
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: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Standard Pap Smear
Participants will have the option to choose a standard pap smear for cervical cancer screening
|
Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample
|
|
Experimental: HPV Self-Sampling Test
Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening
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Self-collected cervicovaginal sample
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Completion of CC screening within 6 months of initial outreach.
Periodo de tiempo: Outcome will be measured at 6 months post-initial outreach call.
|
Defined as either (a) return of a valid HPV self-sample kit to the processing laboratory, or (b) attendance for a clinic-based Pap test documented in the medical record.
|
Outcome will be measured at 6 months post-initial outreach call.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Screening Pathway Choices and Performance
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Proportion of participants selecting self-sampling vs clinic-based Pap test (percentage of women choosing each modality after initial outreach)
|
From enrollment to the end of participation at 9 months
|
|
Screening Pathway Choices and Performance
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Timeliness of screening completion (measured as days from outreach to Pap attendance or kit return).
|
From enrollment to the end of participation at 9 months
|
|
Screening Pathway Choices and Performance
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Screening test result distribution (categorized as negative, positive, or inadequate, stratified by modality).
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From enrollment to the end of participation at 9 months
|
|
Screening Pathway Choices and Performance
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
HPV genotype distribution among positive samples (individual and group reporting per lab protocol)
|
From enrollment to the end of participation at 9 months
|
|
Clinical Follow-Up and Downstream Outcomes
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Clinical follow-up completion after abnormal results (attendance at colposcopy or initiation of treatment).
|
From enrollment to the end of participation at 9 months
|
|
Clinical Follow-Up and Downstream Outcomes
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Detection of histologically confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) or invasive cervical cancer.
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From enrollment to the end of participation at 9 months
|
|
Clinical Follow-Up and Downstream Outcomes
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Treatment initiation and completion rates among those diagnosed with CIN2+ or cancer.
|
From enrollment to the end of participation at 9 months
|
|
Exploratory and Patient-Reported Outcomes
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Associations between demographic/clinical factors and screening completion (e.g., race/ethnicity, insurance status, education, prior screening history).
|
From enrollment to the end of participation at 9 months
|
|
Exploratory and Patient-Reported Outcomes
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Patient-reported experiences including satisfaction, ease of kit use, clarity of instructions, stress/anxiety during self-sampling, trust in results, and willingness to undergo self-sampling in future screening.
|
From enrollment to the end of participation at 9 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reach and Adoption
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Proportion of eligible participants successfully contacted and offered the intervention.
|
From enrollment to the end of participation at 9 months
|
|
Reach and Adoption
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Participant acceptance vs refusal rates, stratified by screening modality.
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From enrollment to the end of participation at 9 months
|
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Reach and Adoption
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Equity assessment: Differences in screening uptake across demographic and socioeconomic subgroups.
|
From enrollment to the end of participation at 9 months
|
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Feasibility and Fidelity
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Return rate of mailed self-sampling kits (valid, invalid, and late returns).
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From enrollment to the end of participation at 9 months
|
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Feasibility and Fidelity
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Proportion requiring replacement kits.
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From enrollment to the end of participation at 9 months
|
|
Feasibility and Fidelity
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Staff adherence to outreach protocol (number, spacing, and mode of call attempts and reminders per protocol).
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From enrollment to the end of participation at 9 months
|
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Acceptability and Sustainability
Periodo de tiempo: From enrollment to the end of participation at 9 months
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Barriers and facilitators to participation identified via telephone structured surveys.
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From enrollment to the end of participation at 9 months
|
|
Acceptability and Sustainability
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Acceptability of self-sampling as routine care (participant endorsement of future use of mail-based HPV kits).
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From enrollment to the end of participation at 9 months
|
|
Acceptability and Sustainability
Periodo de tiempo: From enrollment to the end of participation at 9 months
|
Institutional ability to sustain or scale implementation strategies (assessed through staff feedback and system-level considerations).
|
From enrollment to the end of participation at 9 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ana Tergas, MD, MPH, Rutgers, The State University of New Jersey
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)
20 de julio de 2026
Finalización primaria (Estimado)
1 de febrero de 2027
Finalización del estudio (Estimado)
16 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
8 de febrero de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2026
Publicado por primera vez (Actual)
8 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Pro2025001687
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.
Sí
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