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Идёт набор NCT07453459

Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

Без фазы С лечением Cervical Cancer HPV Infection

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: Qualitative Interview, Virtual Visit Standard Instructions, Virtual Visit Standard Instructions + In-Person Registration Navigation.
Кому может быть актуально
Состояния в реестре: Cervical Cancer, HPV Infection. Базовые параметры: от 25 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

Feasibility of Community-based Distribution of HPV Self-Collection Kits for At Home Cervical Cancer Screening

Обзор

This study is testing and implementing an equity-focused, community-based intervention that improves women's access to cervical cancer screening and adherence to follow up after an abnormal result. The study's objective is to assess and compare the feasibility of different methods of distributing at-home HPV testing kits for cervical cancer screening among individuals who are under-screened.

Вмешательства

  • Поведенческое Qualitative Interview
    Participants will participate in a semi-structured qualitative interview conducted with a research coordinator and guided by the Capability, Opportunity, Motivation, Behavior model (COM-B).
  • Поведенческое Virtual Visit Standard Instructions
    Participants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit.
  • Поведенческое Virtual Visit Standard Instructions + In-Person Registration Navigation
    Participants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit. Participants will scan the QR code and complete the registration process onsite with a study coordinator, leaving the event with a scheduled date and time for their telehealth appointment.

Первичные конечные точки

  • Proportion of participants who returned HPV samples [Срок оценки: Up to eight weeks after enrollment]
  • Proportion of participants with completed referral visits [Срок оценки: Up to eight weeks after enrollment]
  • Time to sample return [Срок оценки: Up to eight weeks after enrollment]
  • Time to referral [Срок оценки: Up to eight weeks after enrollment]
  • Thematic findings addressing opportunity [Срок оценки: Eight weeks after enrollment]
  • Thematic findings addressing capability [Срок оценки: Eight weeks after enrollment]
  • Thematic findings addressing motivation [Срок оценки: Eight weeks after enrollment]
  • Thematic findings addressing behavior [Срок оценки: Eight weeks after enrollment]
Вторичные конечные точки (1)
  • Proportion of participants with positive results who completed follow-up [Срок оценки: Up to eight weeks after results available]

Критерии участия

Критерии включения

  • Are age 25 or older
  • Has an intact cervix
  • Self-reports that they have not been screened for cervical cancer within the last 3 years for 25-64, 5 years for 65 or older
  • Has a cellphone that can receive texts (including verification codes) and an email account
  • Has access to the internet to engage with the Teal Health mobile app and complete a Zoom interview
  • Can read, speak, write and understand English well enough to take a survey and complete an interview

Критерии исключения

  • Abnormal vaginal bleeding or discharge
  • A history of cancer of the reproductive system
  • A compromised immune system
  • Prior Diethylstilbestrol (DES) exposure
  • Currently pregnant or are within 6 weeks of giving birth
  • Treatment for a cervical precancer (e.g., loop electrosurgical excision procedure or conization) in the last 25 years.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07453459 · 202602185

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗