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临床试验/NCT02764528
NCT02764528撤回不适用

Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period

State University of New York at Buffalo2 个研究点 分布在 1 个国家开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Excluded if another member of their household or compound/homestead enrolled in this study
  • Excluded if enrolled in the formative research for this study

结局指标

主要结局

Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate

时间窗: 2 weeks post-natal

Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate

次要结局

  • Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)(2 weeks post-natal)
  • Number of participants with soap and water present at a handwashing station(2 weeks post-natal)
  • Cost-effectiveness(1 month post-partum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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