Intervention Study to Improve Maternal Handwashing
22 de setembro de 2022 atualizado 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.
Visão geral do estudo
Status
Retirado
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
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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Meru County
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Igembe North And Igembe South Subcounties, Meru County, Quênia
- Government funded antenatal care clinics
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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
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Pavani K. Ram, M.D., State University of New York at Buffalo
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 (Antecipado)
1 de fevereiro de 2016
Conclusão Primária (Antecipado)
1 de dezembro de 2016
Conclusão do estudo (Antecipado)
1 de agosto de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
13 de janeiro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de maio de 2016
Primeira postagem (Estimativa)
6 de maio de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de setembro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de setembro de 2022
Última verificação
1 de outubro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 748140-1
- ESRC P176/2015 (Outro identificador: Amref)
Informações sobre medicamentos e dispositivos, documentos de estudo
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