Intervention Study to Improve Maternal Handwashing
22 de septiembre de 2022 actualizado por: State University of New York at Buffalo
Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period
The purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.
Descripción general del estudio
Estado
Retirado
Intervención / Tratamiento
Descripción detallada
Infectious diseases, such as umbilical cord infection, pneumonia, and sepsis, are responsible for about a quarter of neonatal deaths.
Contaminated hands likely play a role in transmitting pathogens to a neonate, therefore handwashing with soap has the potential to interrupt transmission and improve neonatal health.
The primary objective of this study is to develop and evaluate a scalable, cost-effective handwashing promotion program to improve handwashing behavior among mothers and caregivers of neonates.
The investigators will first conduct a qualitative study to assess the feasibility and acceptability of a set of interventions.
The investigators propose to evaluate the impact of the intervention components, designed as three progressively intense interventions, using a randomized controlled trial with elements of a stepped wedge design.
The study will be conducted in Meru County, Kenya, enrolling a total of 800 pregnant women who seek non-emergency antenatal care at a government health facility during a 1 year period.
Clinic based health care workers and community health volunteers will disseminate the intervention using an interactive storytelling approach.
The focus of the interactions between the health care workers and volunteers and the participant will be on addressing barriers to handwashing through interactive question and answer sessions, rather than a didactic, educational session.
The investigators will assess the impact of interventions on observed maternal and caregiver handwashing behavior and estimate the cost effectiveness for each intervention.
Tipo de estudio
Intervencionista
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
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-
Meru County
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Igembe North And Igembe South Subcounties, Meru County, Kenia
- Government funded antenatal care clinics
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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
Femenino
Descripción
Inclusion Criteria:
- Pregnant women
- Seeking routine (non-emergency) care at a participating antenatal care clinic during the study period
- Between 30 and 36 weeks pregnant (calculated based on last known menstrual period) when they seek antenatal care
- Live within 30 minutes or 1-2 km one-way travel from the clinic
- Plan to remain in the study area for at least one month post-partum
- Willing to allow the field worker to visit her home following the antenatal care visit on the day of enrollment to conduct baseline assessments at the household
- Sought antenatal care from a qualified medical provider for the first time at or after 28 weeks gestation
Exclusion Criteria:
- Excluded if another member of their household or compound/homestead enrolled in this study
- Excluded if enrolled in the formative research for this study
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control
Women will receive standard antenatal care but will not receive any additional handwashing promotion, soap, or handwashing device during their enrollment.
At the end of data collection, handwashing with soap will be recommended to participants in the control arm and their families.
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Experimental: Clinic
Handwashing promotion from healthcare workers at antenatal care clinic.
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Pregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic.
To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session.
The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home.
A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home.
A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period.
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Experimental: Clinic + home
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits.
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Women will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer.
All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate.
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Experimental: Clinic + home + handwashing device
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device.
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Women will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e.
tap and basin to use as a handwashing station) during the first home visit by the community health volunteer.
The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
Periodo de tiempo: 1 week post-natal
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Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
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1 week post-natal
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Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
Periodo de tiempo: 2 weeks post-natal
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Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
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2 weeks post-natal
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
Periodo de tiempo: 1 week post-natal
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Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
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1 week post-natal
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Number of participants with soap and water present at a handwashing station
Periodo de tiempo: 1 week post-natal
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Observed presence of soap and/or water at a handwashing station
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1 week post-natal
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Cost-effectiveness
Periodo de tiempo: 1 month post-partum
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Approximate cost of the intervention per participant
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1 month post-partum
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Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
Periodo de tiempo: 2 weeks post-natal
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Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
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2 weeks post-natal
|
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Number of participants with soap and water present at a handwashing station
Periodo de tiempo: 2 weeks post-natal
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Observed presence of soap and/or water at a handwashing station
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2 weeks post-natal
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Pavani K. Ram, M.D., State University of New York at Buffalo
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 (Anticipado)
1 de febrero de 2016
Finalización primaria (Anticipado)
1 de diciembre de 2016
Finalización del estudio (Anticipado)
1 de agosto de 2018
Fechas de registro del estudio
Enviado por primera vez
13 de enero de 2016
Primero enviado que cumplió con los criterios de control de calidad
3 de mayo de 2016
Publicado por primera vez (Estimar)
6 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de septiembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
22 de septiembre de 2022
Última verificación
1 de octubre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 748140-1
- ESRC P176/2015 (Otro identificador: Amref)
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. .
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