Integração de Testes de Ponto de Cuidado (POCT) Para Rastreio Neonatal e Cuidados Precoces para a Doença das Células Falciformes em Yopougon, Costa do Marfim (STEP)
Integração de Testes de Ponto de Cuidado (POCT) Para Rastreio Neonatal e Cuidados Precoces para a Anemia Falciforme em Yopougon, Costa do Marfim
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.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Acellam Charles Abongomera, MD, MPH, PhD
- Número de telefone: +41612848629
- E-mail: charles.abongomera@swisstph.ch
Estude backup de contato
- Nome: Benjamin Koudou, PhD
- Número de telefone: +2250777205263
- E-mail: guibehi.koudou@csrs.ci
Locais de estudo
-
-
-
Abidjan, Costa do Marfim
- Recrutamento
- Yopougon Millionnaire extension health center
-
Contato:
- Benjamin Koudou, PhD
- Número de telefone: +2250777205263
- E-mail: guibehi.koudou@csrs.ci
-
Contato:
- Aurelien Yapi, MD, MSc.
- Número de telefone: +2250777205263 +41612848629
- E-mail: aurelienyapi@hotmail.fr
-
Yopougon, Costa do Marfim
- Ainda não está recrutando
- Yopougon SCD Center of Excellence
-
Contato:
- Benjamin Koudou, PhD
- Número de telefone: +2250777205263
- E-mail: guibehi.koudou@csrs.ci
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
Prazo: 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:
Prazo: 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
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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:
Prazo: 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
|
|
The budget impact (per year) associated with early comprehensive SCD care for all children who test positive in Côte d'Ivoire
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- AO_2025-00105
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .