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- Ensayo clínico NCT02517879
Community Point Distribution of Insecticide Treated Bed Nets
4 de agosto de 2015 actualizado por: IDinsight
Measuring Attendance of Community Point Distribution of Insecticide-treated Bed Nets and the Impact of Community Health Worker Hang-up in Rural Zambia: A Randomized Controlled Trial and Cost Analysis
All households in three zones in Zambia's Eastern Province were invited to attend a community point distribution of insecticide treated bed nets (ITNs).
Households were then randomized to different intervals for a community health worker (CHW) hang-up visit.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Households were asked to attend a community point distribution of ITNs in one of three zones in Zambia's Eastern Province.
Households that had been registered to receive ITNs were then randomized to one of five groups that received a CHW visit at different intervals.
Group 1 was visited 1-3 days after distribution, group 2 was visited 5-7 days after, group 3 was visited 10-12 days after, group 4 was visited 15-17 days after, and group 5 did not receive a hang-up visit.
Groups 1-4 were categorized as having received a hang-up visit and group 5 was categorized as not having received a hang-up visit.
All households in all five groups were visited at 7-11 weeks after the distribution and again at 5-6 months after the distribution to assess short- and medium-term ITN retention and usage.
Tipo de estudio
Intervencionista
Inscripción (Actual)
560
Fase
- No aplica
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Household was pre-registered by the National Malaria Control Centre to receive ITNs ahead of the start of study activities.
- Household was located in one of the three study areas of Mukonka, Lukwipa, and Chipeketi in Rufunsa District, Zambia
Exclusion Criteria:
- Household was not pre-registered to receive ITNs
- Household was not located in one of the three study areas
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Group 1 - 1-3 days
Community health worker hang-up visit 1-3 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
Experimental: Group 2 - 5-7 days
Community health worker hang-up visit 5-7 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
Experimental: Group 3 - 10-12 days
Community health worker hang-up visit 10-12 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
Experimental: Group 4 - 15-17 days
Community health worker hang-up visit 15-17 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
Comparador de placebos: Group 5 - No hang-up visit
Did not receive any hang-up visit after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Community point distribution attendance
Periodo de tiempo: At time 0
|
The percentage of pre-registered households that collected ITNs at the community point distributions on November 14, 19, and 21, 2013.
|
At time 0
|
Self-installation of ITNs
Periodo de tiempo: Each group is randomized to receive a community health worker visit after a different duration, an average of 7 days after the point distribution
|
The percentage of ITNs distributed to a household that the CHW found hanging at his/her visit.
|
Each group is randomized to receive a community health worker visit after a different duration, an average of 7 days after the point distribution
|
Household ITN retention
Periodo de tiempo: An average of 9 weeks after community point distribution
|
The percentage of ITNs distributed to a household that were found still in the household at the 7-11 week follow-up.
|
An average of 9 weeks after community point distribution
|
Household ITN retention
Periodo de tiempo: An average of 5.5 months after community point distribution
|
The percentage of ITNs distributed to a household that were found still in the household at the 5-6 month follow-up.
|
An average of 5.5 months after community point distribution
|
Household percentage of ITNs hung
Periodo de tiempo: An average of 9 weeks after community point distribution
|
The percentage of ITNs distributed to a household that were found hanging during the 7-11 week follow-up.
|
An average of 9 weeks after community point distribution
|
Household percentage of ITNs hung
Periodo de tiempo: An average of 5.5 months after community point distribution
|
The percentage of ITNs distributed to a household that were found hanging during the 5-6 month follow-up.
|
An average of 5.5 months after community point distribution
|
Household percentage of sleeping spaces covered
Periodo de tiempo: An average of 9 weeks after community point distribution
|
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 7-11 week follow-up.
|
An average of 9 weeks after community point distribution
|
Household percentage of sleeping spaces covered
Periodo de tiempo: An average of 5.5 months after community point distribution
|
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 5-6 month follow-up.
|
An average of 5.5 months after community point distribution
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
1 de noviembre de 2013
Finalización primaria (Actual)
1 de mayo de 2014
Finalización del estudio (Actual)
1 de mayo de 2014
Fechas de registro del estudio
Enviado por primera vez
27 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2015
Publicado por primera vez (Estimar)
7 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de agosto de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
4 de agosto de 2015
Última verificación
1 de agosto de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 003 (NuSkin International)
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
producto fabricado y exportado desde los 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. .
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