- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07401251
Программа вмешательства при воздействии свинца (LEIP)
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
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Karen Jansen
- Номер телефона: 206-685-6392
- Электронная почта: kjansen@uw.edu
Места учебы
-
-
-
Nairobi, Кения
- Dandora and Baba Ndogo Health Centres
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Child age 12-72 months
- Parent or primary caregiver that is a biological relative is available to give informed consent for LEIP study
- Parent/caregiver is 18 years of age or older or is an emancipated minor
- Parent available for 9 months follow-up
Exclusion Criteria:
-Parent unwilling to be contacted for the purposes of tracing and follow-up
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Immediate messages
Caregivers of children with elevated blood lead levels will be provided with immediate messages about lead risk mitigation in the clinic setting. They will receive follow-up at 3 months and 9 months and will complete recall, behavior, and recheck questionnaires and their children will have BLL rechecks. |
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, understandability, and acceptability of the lead risk reduction messages received. |
|
Экспериментальный: Home visit
Caregivers of children with elevated blood lead levels will be provided with immediate messages about lead risk mitigation in the clinic setting. They will also receive a home observation visit and have those risk reduction methods reiterated and tailored to their home situation. They will receive follow-up at 3 months and 9 months and will complete recall, behavior, and recheck questionnaires and their children will have BLL rechecks. |
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, understandability, and acceptability of the lead risk reduction messages received. 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 sample of caregivers will complete an in-depth interview to gather barriers, understandability, and acceptability of the lead risk reduction messages received. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Recall of survey risk factors
Временное ограничение: 3 and 9 months post clinic visit
|
Lead risk surveys will be completed by participants during the clinic visit and at 3 and 9 months post home visit. Qualitative analysis of the lead risk survey will summarize themes on understandability and acceptability of survey items and messages. The rapid analysis will also explore facilitators and barriers to uptake of recommended exposure reduction measures, and individual level determinants associated with uptake (e.g., empowerment, self-efficacy). |
3 and 9 months post clinic visit
|
|
Self report of risk-reduction behavior
Временное ограничение: 3 and 9 months post clinic visit
|
Assess the proportion of caregivers self-reporting uptake of at least one of their risk reduction recommendations within arms and by BLL. |
3 and 9 months post clinic visit
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Differences in outcomes between arms
Временное ограничение: 3 and 9 months post clinic visit
|
Using risk survey responses and self-reported changes in risk reduction behavior, we will compare the participants of both arms to assess for differences. |
3 and 9 months post clinic visit
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Uptake of the BLL re-check
Временное ограничение: 3 and 9 months post-initial visit
|
Return for a re-check visit is an indicator of caregiver awareness of importance of reducing lead exposure. We will summarize the proportions of caregivers returning for each BLL re-check visit for each arm. |
3 and 9 months post-initial visit
|
|
Change in BLL
Временное ограничение: 3 and 9 months post-initial clinic visit
|
Change in BLL at re-checks. We do not anticipate observing a significant reduction in child BLL, given that caregivers might not have the ability to identify and/or modify a lead risk exposure. |
3 and 9 months post-initial clinic visit
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Sarah Benki-Nugent, University of Washington
Публикации и полезные ссылки
Общие 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY00022114
- 1R01ES036010 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
All data other than patient direct or indirect identifiers will be shared.
Критерии совместного доступа к IPD
Other researchers can contact the MPIs and complete an approved Data Sharing Agreement
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .