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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
Otro: 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.
Otro: Community health worker hang-up visit
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
Otro: 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.
Otro: Community health worker hang-up visit
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
Otro: 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.
Otro: Community health worker hang-up visit
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
Otro: 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.
Otro: Community health worker hang-up visit
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
Otro: 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

IDinsight

Colaboradores

National Malaria Control Centre, Zambia
Ministry of Health, Zambia
Clinton Health Access Initiative Inc.

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 (033)

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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