Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya
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: DADA LINK.
- Кому может быть актуально
- Состояния в реестре: Cervical Cancer, Cervical Cancer Screening, HPV DNA. Базовые параметры: 25 лет — 49 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
- Kenya
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study aims to test the use of a multi-component care strategy (DADA LINK) designed to improve cervical cancer screening and linkage to treatment. The duration of the trial is 12 months, with a 6-month follow-up period to evaluate intervention costs and measure maintenance of the care strategies. Study staff at each clinic will abstract data on cervical cancer screening and triage/treatment. Clinics randomized to the intervention arm will have care coordinators who motivate clinic staff to adhere to cervical cancer care guidelines, conduct patient exit surveys to assess intervention fidelity, and support care coordination through use of the mHealth platform (WEMA).
Подробное описание
The highest global incidence of cervical cancer is in sub-Saharan Africa, and it is the leading cause of cancer mortality among women in Kenya. Barriers to cervical cancer screening and treatment have been identified at the patient-, provider-, and facility-level, demonstrating the need for a multi-strategy approach to enhance cervical cancer control. In this research study, formative qualitative research and clinic mapping processes were conducted with primary care clinics in Nairobi County to select contextually appropriate strategies targeting the primary barriers to cervical cancer screening and linkage to treatment in Nairobi, Kenya. This study seeks to evaluate the implementation and effectiveness of a care package designed to enhance the early detection and treatment of precancerous cervical lesions among women aged 25-49 years in Kenya.
Trained study staff will abstract patient data from existing clinic records to monitor and assess rates of cervical cancer screening and linkage to treatment.
Study staff at the intervention clinics (i.e., care coordinators) will motivate and support clinic staff to adhere to cervical cancer care guidelines. Care coordinators will use a mHealth platform (i.e., WEMA) tailored for use in primary care clinics in Kenya to track patient exit interview responses regarding uptake of HPV self-sampling kits and to support clinic staff by tracking cervical cancer screening, follow-up, and linkage to treatment, when appropriate. WEMA will serve as an information management system in the intervention clinics, providing a data dashboard to track patient follow-up and enable text communication with patients.
Вмешательства
- Поведенческое DADA LINK
Intervention facilities will receive the DADA-LINK intervention, comprised of: 1. HPV self-sampling: We will provide clinics with HPV self-sampling kits to administer to eligible patients. 2. Care Navigation: One study-supported non-physician care navigator will be assigned to each clinic to support the clinic staff. These trained individuals will be responsible for managing data collection through the mHealth platform to aid the coordination of services and for motivating the clinic staff to a
Первичные конечные точки
- Primary implementation outcome: Cervical cancer screening uptake [Срок оценки: 1 day (on the day of clinic visit)]
- Primary effectiveness outcome: Receipt of triage and/or treatment [Срок оценки: within 12 months]
Вторичные конечные точки (4)
- Secondary effectiveness outcomes: Form of triage and/or treatment received [Срок оценки: within 12 months]
- Secondary effectiveness outcomes: Form of triage and/or treatment received [Срок оценки: within 12 months]
- Secondary effectiveness outcomes: Form of triage and/or treatment received [Срок оценки: within 12 months]
- Communication of HPV test result to patients via mHealth messages [Срок оценки: Within 10 days of results being made available]
Критерии участия
Критерии включения
\- Women ages 25-49 years
Критерии исключения
- Pregnant women
- Women ≤6 weeks postpartum
- Women already confirmed to have cervical cancer
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
- Профилактика
Центры проведения
Kenya · 1 центр
- Kenyatta National Hospital — Nairobi
Идентификаторы
NCT: NCT07050745 · P864/11/2023 · U54CA284036