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Набор по приглашению NCT07575217

Mail-in HPV Screening Program in NJ

Без фазы С лечением Cervical Cancer Screening

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: BD Onclarity HPV test, Standard Pap Smear.
Кому может быть актуально
Состояния в реестре: Cervical Cancer Screening. Базовые параметры: 30 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Mail-based HPV Sampling Program to Increase Cervical Cancer Screening in New Jersey

Обзор

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.

Вмешательства

  • Диагностический тест BD Onclarity HPV test
    Self-collected cervicovaginal sample
  • Диагностический тест Standard Pap Smear
    Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample

Первичные конечные точки

  • Completion of CC screening within 6 months of initial outreach. [Срок оценки: Outcome will be measured at 6 months post-initial outreach call.]
Вторичные конечные точки (9)
  • Screening Pathway Choices and Performance [Срок оценки: From enrollment to the end of participation at 9 months]
  • Screening Pathway Choices and Performance [Срок оценки: From enrollment to the end of participation at 9 months]
  • Screening Pathway Choices and Performance [Срок оценки: From enrollment to the end of participation at 9 months]
  • Screening Pathway Choices and Performance [Срок оценки: From enrollment to the end of participation at 9 months]
  • Clinical Follow-Up and Downstream Outcomes [Срок оценки: From enrollment to the end of participation at 9 months]
  • Clinical Follow-Up and Downstream Outcomes [Срок оценки: From enrollment to the end of participation at 9 months]
  • Clinical Follow-Up and Downstream Outcomes [Срок оценки: From enrollment to the end of participation at 9 months]
  • Exploratory and Patient-Reported Outcomes [Срок оценки: From enrollment to the end of participation at 9 months]
  • Exploratory and Patient-Reported Outcomes [Срок оценки: From enrollment to the end of participation at 9 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • Rutgers New Jersey Medical School — Newark

Идентификаторы

NCT: NCT07575217 · Pro2025001687

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗