Proactive Community Case Management (Pro-CCM) in Rural Madagascar (Pro-CCM)
24 de janeiro de 2022 atualizado por: Rila Ratovoson, Institut Pasteur de Madagascar
Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar
The trial took place in a rural area hyper endemic for malaria, the hypothesis of which was that active detection and treatment of malaria in the population (all ages combined) in the event of a positive test could reduce the prevalence of malaria in the region. zoned. It was a two-armed, randomized, cluster-based community intervention trial:
- one arm with home treatment of malaria for the duration of the study for patients with a positive result in the rapid diagnostic test for malaria.
- a control arm with the usual malaria management procedures (ie consultation with community workers or the nearest health centers in the event of fever or suspected signs of malaria).
Before the start of monitoring, an initial survey (Baseline) was carried out in the "fokontany" (villages / cluster) included in the 2 arms, in order to determine the prevalence of malaria. Then, in the intervention arm, screening for malaria by RDT every 2 weeks in subjects with a suspected malaria case (fever or notion of fever in the 2 days preceding the visit) and treatment with Artesunate-amodiaquine (ACT) for patients with a positive RDT. At the end of the follow-up period, a final survey (Endline), based on the same questionnaires as during the Baseline, was carried out in the 2 villages of the 2 arms.
As a secondary objective, a study on anemia in women aged between 15 and 49 years was also carried out during the baseline and endline periods in order to compare the prevalence between the 2 periods
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This study aims to compare the prevalence of malaria in the rural community of Mananjary after the Malaria Home Care Program (PECADOM Plus).
The study will take place in fokontany rural communes of the district of Mananjary.
This district was chosen for the following reasons:
- High prevalence of malaria in this area (31% in subjects with fever and attending medical consultation in the CSB included in the sentinel IPM fever site)
- presence of Peace Corps Volunteers (PCV) in this district. Mananjary District is situated in southeastern Madagascar, located in the central part of the Vatovavy Fitovinany Region, in the province of Fianarantsoa. It is located at 21°13'52" South and 48°20'31" East. The district is composed of one urban commune and 28 rural communes. After obtaining the agreement of the ethics committee for the realization of the study, the coordinator or the assistant coordinator of the project will make courtesy visits to all administrative and health officials in the Vatovavy Fitovinany and Mananjary District (Regional Directorate, District Chief ...).A random draw of fokontany meeting the inclusion criteria will be carried out later, to identify the distribution of fokontany in the intervention arm and control arm in the project. In addition to the 22 fokontany required, a draw of 8 reserve fokontany will be made (4 for each arm).
A courtesy visit will be conducted in the fokontany raffled. The coordinator will check the number of inhabitants in these fokontany with the information gathered at the time of the preparation of the protocol (projection of the population according to the data of INSTAT, information from the Medical Inspector of Mananjary). If the fokontany will not be eligible, the reserve fokontany will replace them in the study.
Tipo de estudo
Intervencional
Inscrição (Real)
1000
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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: Fianarantsoa, Vatovavy Fitovinany
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Mananjary, : Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Andranomavo
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Fianarantsoa, Vatovavy Fitovinany
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Ambakoana
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Ambalamanasa
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Ambalaromba
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Ambinany Namorona
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Amboditandroho
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Ambohimiarina II
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Ambohinihaonana
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Ambolotara
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Andranomiteka
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Anilavinany
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Ankazotokana
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Anosimparihy
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Kianjavato
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Mahavoky Sud
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Manotro
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Maroamboka
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Sahafotahina
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Sandravakoka
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Tanambao Sud
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Tanambaobe
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Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagáscar, 317
- Fokontany Tsarahafatra
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
2 meses e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
Inclusion criteria in community:
- Fokontany in rural communes of Mananjary district (fokontany level of safety, accessibility by the study teams, and phone network availability was assessed).
- Agreement of the chief of Fokontany for the participation of his fokontany in the study
- Fokontany with at least 1,000 inhabitants
Individual inclusion criteria:
- Resident in the relevant areas during the study period and consenting to participate
Exclusion Criteria:
Exclusion criteria in community:
- Fokontany with a total population of less than 1000 inhabitants
- Fokontany in an urban commune
- Fokontany in an area whose access is risky and perilous
- Individual exclusion criteria:
None (Non-resident present at the time of passage were tested in the study if they have suggestive signs of malaria but they were considered as visitors)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention fokontany
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CHWs in the intervention arm conducted door-to-door fever screening for all inhabitants of all consenting households in their catchment area every fortnight.
All individuals with temperature ≥ 37.5°C or history of self-reported fever in the previous two weeks were tested with an RDT; positive individuals who were not pregnant and did not have signs of severe disease were treated with artesunate-amodiaquine according to treatment guidelines.
Individuals identified as requiring a referral during Pro-CCM visits were assisted with transfer to the healthcare center, with transportation handled by the project staff.
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Sem intervenção: Control fokontany
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
Prazo: an average of 1 year
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Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of malaria RDT positivity in the 2 arms
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an average of 1 year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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percent of households visited every two weeks
Prazo: The event was assessed up to 30 weeks (15 biweekly visits).
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percent of households visited every two weeks out of the number of the households registered in initial census
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The event was assessed up to 30 weeks (15 biweekly visits).
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percent of households gave consent
Prazo: The event was assessed up to 30 weeks (15 biweekly visits).
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percent of households that were visited every two weeks and gave consent for the screening during each visit
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The event was assessed up to 30 weeks (15 biweekly visits).
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Fever incidence
Prazo: The event was assessed up to 30 weeks (15 biweekly visits).
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percent of fever cases out of all individuals screened during each visit
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The event was assessed up to 30 weeks (15 biweekly visits).
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Malaria incidence
Prazo: The event was assessed up to 30 weeks (15 biweekly visits).
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percent of persons with positive RDT and fever cases out of all individuals screened during each visit
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The event was assessed up to 30 weeks (15 biweekly visits).
|
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fever cases with RDT performed
Prazo: The event was assessed up to 30 weeks (15 biweekly visits).
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percent of fever cases with RDT performed
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The event was assessed up to 30 weeks (15 biweekly visits).
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RDT-positive persons treated with an ACT
Prazo: The event was assessed up to 30 weeks (15 biweekly visits).
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percent of RDT-positive persons treated with an ACT during each visit
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The event was assessed up to 30 weeks (15 biweekly visits).
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The change in the prevalence of anemia in women aged between 15 and 49 years old in the intervention versus control fokontany
Prazo: an average of 1 year
|
Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of anemia in the 2 arms
|
an average of 1 year
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rila Ratovoson, MD, Institut Pasteur de Madagascar
- Diretor de estudo: Milijaona Randrianarivelojosia, PhD, Institut Pasteur de Madagascar
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
12 de dezembro de 2016
Conclusão Primária (Real)
12 de dezembro de 2016
Conclusão do estudo (Real)
29 de dezembro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
10 de janeiro de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de janeiro de 2022
Primeira postagem (Real)
4 de fevereiro de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de fevereiro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de janeiro de 2022
Última verificação
1 de janeiro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2017-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
All IPD that underlie results in a publication
Prazo de Compartilhamento de IPD
Some summary data are available from December 2021; and some data at the time of publication (2022)
Critérios de acesso de compartilhamento IPD
IPD and any additional supporting information will be shared in supplementary files in publication and via Harvard Dataverse
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .