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Идёт набор NCT06515301

Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia

Без фазы С лечением Suspicious Cervical Cancer Lesions Follow up Adherence

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: Intervention 1: Structured nurse-led telephone call reminders. Intervention 2: Home-visit reminders by health extension workers. Intervention 3: Application-based automated SMS text reminders..
Кому может быть актуально
Состояния в реестре: Suspicious Cervical Cancer Lesions Follow up Adherence. 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
Ethiopia
Следующий шаг
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Официальное название

Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia: A Pragmatic Randomized Controlled Trial

Обзор

The goal of this pragmatic randomized control trial is to evaluate the effectiveness of three interventions in improving follow-up adherence among women treated for suspicious cervical lesions in primary healthcare settings in Ethiopia. The interventions include structured nurse-led telephone call reminders, home-visit reminders led by health extension workers, and application-based automated SMS text reminders. The main questions it aims to answer are: * Does structured nurse-led telephone call reminders improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care? * Does home-reminder visits led by a Health Extension Worker (HEW) improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care? * Does app-based automated SMS reminders improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care? Structured Nurse-Led Telephone Call Reminders * Participants will receive proactive phone call reminders for scheduled follow-up visits. * The intervention includes three rounds: initially at 4 months post-recruitment, then every 4 months for HIV-negative women over a year, and every 2 months for 6 months for women living with HIV. Home-Reminder Visits Led by HEW Health Extension Workers (HEWs) will conduct door-to-door visits to remind participants of their scheduled follow-up appointments. • Door-to-door Visits will occur initially at 4 months (for HIV-negative women) and 2 months (for HIV-positive women) post-recruitment, then every 2 months for 6 months for HIV-positive and every 4 months for 12 months for HIV-negative participants. App-Based Automated SMS Reminders * Participants will receive SMS-based reminders for their follow-up visits. * The intervention consists of three rounds: initial texts at 4 months and 2 months post-recruitment for HIV-negative and HIV-positive women, respectively, followed by reminders every 2 months for 6 months for HIV-positive women and every 4 months for 12 months for HIV-negative women.

Вмешательства

  • Поведенческое Intervention 1: Structured nurse-led telephone call reminders. Intervention 2: Home-visit reminders by health extension workers. Intervention 3: Application-based automated SMS text reminders.
    Information already available

Первичные конечные точки

  • Proportion of adherence to follow up recommendations in the intervention and standard group after suspicious cervical cancer lesion treatment. [Срок оценки: re-screening (VIA) after one year (11-13 months)]

Критерии участия

Критерии включения

  • Women aged 30-49 (HIV-negative).
  • Women over 25 (HIV-positive).
  • Treated for suspicious cervical lesions after a positive VIA screening.

Критерии исключения

  • History of hysterectomy.
  • Diagnosis of other histological invasive cervical cancer.
  • Suspicious cervical cancer cases.
  • Pregnancy.
  • Prior screening history.
  • Vaginal bleeding.
  • Lack of consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Ethiopia · 1 центр
  • Worabe Health Center — Silte

Публикации

  • Destaw A, Getachew S, Getachew E, Shita A, Midaksa M, Rossner SS, Kroeber ES, Addissie A, Kantelhardt EJ, Gizaw M. Follow-up rescreening uptake and persistent positive rates among women after positive cervical cancer screening results in Ethiopia: a longitudinal cross-sectional study. BMJ Open. 2025 Jul 28;15(7):e099955. doi: 10.1136/bmjopen-2025-099955. PMID 40730399
  • Destaw A, Getachew S, Getachew E, Shita A, Midaksa M, Rossner S, Kroeber ES, Addissie A, Kantelhardt EJ, Gizaw M. Study protocol for key interventions to improve the follow-up adherence postcervical precancerous lesion treatment in Ethiopia: a pragmatic randomised controlled trial. BMJ Open. 2025 Jan 7;15(1):e091693. doi: 10.1136/bmjopen-2024-091693. PMID 39773801

Идентификаторы

NCT: NCT06515301 · 008/24/SPH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗