Proactive Community Case Management (Pro-CCM) in Rural Madagascar (Pro-CCM)
24 de enero de 2022 actualizado 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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
1000
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
: Fianarantsoa, Vatovavy Fitovinany
-
Mananjary, : Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Andranomavo
-
-
Fianarantsoa, Vatovavy Fitovinany
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Ambakoana
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Ambalamanasa
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Ambalaromba
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Ambinany Namorona
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Amboditandroho
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Ambohimiarina II
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Ambohinihaonana
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Ambolotara
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Andranomiteka
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Anilavinany
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Ankazotokana
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Anosimparihy
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Kianjavato
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Mahavoky Sud
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Manotro
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Maroamboka
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Sahafotahina
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Sandravakoka
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Tanambao Sud
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Tanambaobe
-
Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
- Fokontany Tsarahafatra
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
2 meses y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention fokontany
|
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.
|
|
Sin intervención: Control fokontany
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
Periodo de tiempo: an average of 1 year
|
Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of malaria RDT positivity in the 2 arms
|
an average of 1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
percent of households visited every two weeks
Periodo de tiempo: The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of households visited every two weeks out of the number of the households registered in initial census
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
percent of households gave consent
Periodo de tiempo: The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of households that were visited every two weeks and gave consent for the screening during each visit
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
Fever incidence
Periodo de tiempo: The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of fever cases out of all individuals screened during each visit
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
Malaria incidence
Periodo de tiempo: The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of persons with positive RDT and fever cases out of all individuals screened during each visit
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
fever cases with RDT performed
Periodo de tiempo: The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of fever cases with RDT performed
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
RDT-positive persons treated with an ACT
Periodo de tiempo: The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of RDT-positive persons treated with an ACT during each visit
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
The change in the prevalence of anemia in women aged between 15 and 49 years old in the intervention versus control fokontany
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rila Ratovoson, MD, Institut Pasteur de Madagascar
- Director de estudio: Milijaona Randrianarivelojosia, PhD, Institut Pasteur de Madagascar
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de diciembre de 2016
Finalización primaria (Actual)
12 de diciembre de 2016
Finalización del estudio (Actual)
29 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
10 de enero de 2022
Primero enviado que cumplió con los criterios de control de calidad
24 de enero de 2022
Publicado por primera vez (Actual)
4 de febrero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
24 de enero de 2022
Última verificación
1 de enero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2017-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All IPD that underlie results in a publication
Marco de tiempo para compartir IPD
Some summary data are available from December 2021; and some data at the time of publication (2022)
Criterios de acceso compartido de IPD
IPD and any additional supporting information will be shared in supplementary files in publication and via Harvard Dataverse
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .