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Набор скоро начнётся NCT07401251

Lead Exposure Intervention Program

Без фазы С лечением Lead Exposure High Blood Lead Levels

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: Home visit with tailored messages, In-clinic lead risk reduction intervention.
Кому может быть актуально
Состояния в реестре: Lead Exposure, High Blood Lead Levels. Базовые параметры: 12 мес. — 72 мес. · Все.
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

The goal of this clinical trial is to learn if BLL (blood lead level) screening and "healthy home" lead prevention program created in the US is adaptable to a Sub-Saharan African context. It will also work to address child lead exposure in Nairobi, Kenya. The main questions it aims to answer is: * Can materials and protocols developed for a US audience be effective in a Sub-Saharan African one? * Is there a difference in learning and action between groups that receive different degrees of intervention? Researchers will compare the outcomes of a group that received lead risk reduction information only in the clinical setting to a group that also received a home visit and tailored risk reduction messages. Participants will: * Have their child's blood lead levels measured at several timepoints * Take part in a questionnaire about lead risk * Receive lead risk reduction messaging either only in the clinic setting or also in their homes * Have their knowledge and risk reduction behaviors measured

Вмешательства

  • Поведенческое Home visit with tailored messages
    The home visit will be conducted within 2 weeks of initial screening. During the home visit, the lead exposure risk survey will be re-administered, for comparison to in-clinic self-report survey responses. In addition, an observational checklist of potential lead exposure risk factors will be conducted to identify and discuss residential features and items in the home environment that may be influencing their BLL. Tailored messages on lead exposure risk reduction will be provided. A random samp
  • Поведенческое In-clinic lead risk reduction intervention
    For children with BLL \< 5 ug/dL, the result will be provided to the caregiver, together with standard post-test messaging on reducing lead exposure. A job-aid, such as a poster, showing common sources of lead exposure in children, and important sources of iron rich foods will be used to guide messaging. For BLLs ≥ 5, tailored messaging on potential sources identified on the risk factor survey will be provided. A random sample of caregivers will complete an in-depth interview to gather barriers

Первичные конечные точки

  • Recall of survey risk factors [Срок оценки: 3 and 9 months post clinic visit]
  • Self report of risk-reduction behavior [Срок оценки: 3 and 9 months post clinic visit]
Вторичные конечные точки (1)
  • Differences in outcomes between arms [Срок оценки: 3 and 9 months post clinic visit]

Критерии участия

Критерии включения

  • Caregivers with children ages 12-72 months attending routine care/vaccination visit at Nairobi clinical site.

Exclusion Criteria: Children outside of age range, caregivers younger than 18; plan to leave study catchment within 9 months.

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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

Kenya · 1 центр
  • Pumwani Hospital and Baba Ndogo Health Centre — Nairobi

Публикации

  • Onoh I, Mugo C, Riederer A, Maleche-Obimbo E, Were FH, Loftus C, Mukumbang F, Lumumba E, Richardson B, Edemba PW, Mutai BC, Karr C, Benki-Nugent S. Adapting, piloting, and evaluating a pediatric lead screening and risk-reduction intervention in Nairobi: A hybrid implementation-effectiveness trial protocol. PLoS One. 2026 Jun 4;21(6):e0349153. doi: 10.1371/journal.pone.0349153. eCollection 2026. PMID 42241430
  • Onoh I, Mugo C, Riederer A, Maleche-Obimbo E, Were FH, Loftus C, Mukumbang F, Lumumba E, Richardson B, Edemba PW, Mutai BC, Karr C, Benki-Nugent S. Adapting, piloting, and evaluating a pediatric lead screening and risk-reduction intervention in Nairobi: A hybrid implementation-effectiveness trial protocol. medRxiv [Preprint]. 2026 Apr 30:2026.04.28.26351918. doi: 10.64898/2026.04.28.26351918. PMID 42094172

Идентификаторы

NCT: NCT07401251 · STUDY00022114 · 1R01ES036010

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗