Внедрение тестирования у постели больного (POCT) для скрининга новорождённых и раннего оказания помощи при серповидноклеточной анемии в Япугоне, Кот-д'Ивуар (STEP)
Внедрение тестирования у постели больного (POCT) для скрининга новорождённых и раннего лечения серповидноклеточной анемии в Япуго́не, Кот-д'Ивуар
The goal of this clinical trial is to learn if a multifaceted intervention composed of Gazelle-Multispectral sickle cell disease (SCD) point of care testing (POCT) and early initiation of comprehensive SCD care in children with SCD disease aged 0 - 6 months can improve their clinical outcomes.
The main questions it aims to answer are:
- Does the intervention lower the number of SCD-related illnesses?
- Does the intervention lower the illness incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to a SCD related illness?
- Does the intervention lower all-cause death rate (at the end of 1, 2, 3 and 3.5 years of follow-up)?
Researchers will compare the multifaceted intervention results with those of historical data (based on erratic SCD testing and treatment) from the region.
Participants will undergo a SCD screening test using the Gazelle Multispectral platform and if positive they will undergo confirmatory testing with HemoTypeSC™. Participants with SCD will receive early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea, parental education about the need for regular and, if necessary, urgent medical care.
Обзор исследования
Статус
Условия
Подробное описание
Sickle cell disease (SCD) is an inherited life-threatening hematological disorder. Globally, every year, an estimated 300,000 children are born with sickle cell anemia (SCD - SS, homozygous form), the most severe form of SCD. About 75% of these births occur in Sub-Saharan Africa (SSA), of whom 50-90% die before their 5th birthday. In high income countries, it has been shown that newborn SCD screening and early comprehensive clinical interventions such as penicillin prophylaxis, safe blood transfusion, hydroxyurea and acute medical care, substantially reduces SCD morbidity and mortality. In low and middle-income countries (LMICs), the implementation of newborn SCD screening and early clinical interventions are largely poor.
The most commonly used newborn SCD screening techniques are isoelectric focusing (IEF), capillary electrophoresis (CE) and cation-exchange high performance liquid chromatography (HPLC). These techniques have a high cost, require skilled staff and a reliable electricity supply, and are therefore not suitable for remote settings in LMICs. In order to overcome these challenges, several point of care tests (POCTs) have been recently developed. The Gazelle Multispectral platform is the first SCD POCT that can be used to identify and quantify hemoglobin variants in newborns and people of any age.
In Côte d'Ivoire, as in many other African countries, the implementation of newborn SCD screening and early clinical interventions are lagging behind, and subsequently SCD morbidity and mortality are high. In this project, the investigators will implement a novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral POCT for newborn SCD screening; and 2) initiation of early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea, parental education about the need for regular and, if necessary, urgent medical care. The investigators will assess the effectiveness and cost of the multifaceted intervention. The effectiveness will be assessed based on the 2.5 - 3.5 years follow-up clinical records of SCD morbidity and mortality (clinical outcomes). The effectiveness data will be compared descriptively with historical data from the region, and used to inform SCD policy in Côte d'Ivoire. Historical data will be obtained from published literature in Cote d'Ivoire or nearby Countries such as Ghana. After three and a half years, the investigators aim to hand over the project to the Ministry of Health of Côte d'Ivoire for integration into its routine health care activities and potential nation-wide scale up.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 4
Контакты и местонахождение
Контакты исследования
- Имя: Acellam Charles Abongomera, MD, MPH, PhD
- Номер телефона: +41612848629
- Электронная почта: charles.abongomera@swisstph.ch
Учебное резервное копирование контактов
- Имя: Benjamin Koudou, PhD
- Номер телефона: +2250777205263
- Электронная почта: guibehi.koudou@csrs.ci
Места учебы
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Abidjan, Берег Слоновой Кости
- Рекрутинг
- Yopougon Millionnaire extension health center
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Контакт:
- Benjamin Koudou, PhD
- Номер телефона: +2250777205263
- Электронная почта: guibehi.koudou@csrs.ci
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Контакт:
- Aurelien Yapi, MD, MSc.
- Номер телефона: +2250777205263 +41612848629
- Электронная почта: aurelienyapi@hotmail.fr
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Yopougon, Берег Слоновой Кости
- Еще не набирают
- Yopougon SCD Center of Excellence
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Контакт:
- Benjamin Koudou, PhD
- Номер телефона: +2250777205263
- Электронная почта: guibehi.koudou@csrs.ci
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Children aged 0 - 6 months old identified at selected health facilities within the study area
- Babies whose age plus the gestation period reaches 37 weeks or more
- Children who did not receive a blood transfusion within the past 90 days
- Children whose parents or guardians have consented to participate in the study by signing a consent form
Exclusion Criteria:
- Children already diagnosed with SCD
- Children that are participating in another clinical research project
- Children that are critically ill and require emergency treatment
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Gazelle-Multispectral for newborn sickle cell disease screening; and early clinical interventions
A novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral point of care testing (POCT) for newborn sickle cell disease (SCD) screening; and 2) initiation of early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea and parental education about SCD medical care. |
A novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral point of care testing (POCT) for newborn sickle cell disease (SCD) screening; and 2) initiation of early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea and parental education about SCD medical care. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
Временное ограничение: Baseline, 1 year, 2 years, 3 years, and 3.5 years
|
1a. Number of SCD related morbidity and events i.e. i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations 1b. Morbidity incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to one of the following SCD related morbidity and events: i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations 1c. All-cause mortality rate (at the end of 1, 2, 3 and 3.5 years of follow-up) Note: The clinical outcomes are a summation of all the different parameters indicated. ''Morbidity'' includes vaso-occlusive crises (VOC); acute chest syndrome, stroke and other underlying causes of illness. ''Events'' include blood transfusions. ''All cause hospitalizations'' are a result of ''morbidities''. |
Baseline, 1 year, 2 years, 3 years, and 3.5 years
|
|
The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
Временное ограничение: Baseline, 1 year, 2 years, 3 years, and 3.5 years
|
1a. Number of SCD related morbidity and events i.e. i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations 1b. Morbidity incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to one of the following SCD related morbidity and events: i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations 1c. All-cause mortality rate (at the end of 1, 2, 3 and 3.5 years of follow-up) |
Baseline, 1 year, 2 years, 3 years, and 3.5 years
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The implementation costs and the cost-effectiveness of a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
Временное ограничение: Baseline, 1 year, 2 years, 3 years, and 3.5 years
|
1a. Total financial and economic costs associated with program roll out 1b. Costs per child screened with POCT 1c. Costs per SCD screen positive child 1d. Annual costs associated with early comprehensive SCD care 1e. Number of morbidity and mortality averted 1f. Cost per morbidity and mortality averted by the multifaceted intervention Note: Outcomes 1a. to 1d. indicate and represent ''implementation costs''. Outcome 1e. indicates and represents ''effectiveness''. Outcomes 1f. refers to ''cost effectiveness''. |
Baseline, 1 year, 2 years, 3 years, and 3.5 years
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The budget impact (per year) associated with early comprehensive SCD care for all children who test positive in Côte d'Ivoire
Временное ограничение: Baseline, 1 year, 2 years, 3 years, and 3.5 years
|
1. Annual costs associated with early comprehensive SCD care for all children who test positive |
Baseline, 1 year, 2 years, 3 years, and 3.5 years
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
- AO_2025-00105
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
De-identified individual participant data (IPD) are available on request to bona fide researchers via the Swiss Center for Scientific Research in Côte d'Ivoire (CSRS), Swiss Tropical and Public Health Institute (Swiss TPH) and Novartis Pharma AG. Data can be granted on a case-by-case basis jointly by the project leaders at the CSRS, Swiss TPH and Novartis. This process is designed to protect participants' confidentiality, which might be compromised if data were publicly available. Requests to access data should be made to Prof. Dr. Benjamin Koudou (CSRS) via guibehi.koudou@csrs.ci or Dr. Acellam Charles Abongomera (Swiss TPH) via charles.abongomera@swisstph.ch or to Novartis according to the criteria and processes described on the Clinical Study Data Request website ClinicalStudyDataRequest.com
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.
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