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临床试验/NCT05964478
NCT05964478已完成不适用

Hands4Health: Hand Hygiene, Water Quality and Sanitation in Schools Not Connected to a Functional Water Supply System: a Cluster-randomized Controlled Trial in Nigeria and Palestine

Swiss Tropical & Public Health Institute2 个研究点 分布在 2 个国家目标入组 2,600 人开始时间: 2023年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,600
试验地点
2
主要终点
Number of participants who wash their hands with water and soap before eating in the school

研究概览

简要总结

The aim of this study is to assess the impact of the hands4health hand hygiene multi-component intervention on students and teachers in primary schools with limited access to water in Nigeria and Palestine. To evaluate the effects of the intervention, the investigators will involve the participants in the included schools in the following data collection methods, including (i) a survey regarding their thoughts, behaviours, and practices related to handwashing at school, (ii) structured observation of their handwashing behaviour (iii) hand rinse sample collection to check for bacteria on their hands, (iv) absenteeism tracking through a daily journal to record the reasons for any absences, with a specific focus on identifying if they are related to hygiene-related diseases, and (v) discussions and interviews to gather their perspectives on the perceived impacts of the intervention on their health and well-being.

The investigators will collect data using these methods before the intervention starts, a few months after it begins, and again one year later. The schools will be randomly divided into two groups: one group will receive the intervention activities, including handwashing station/rehabilitation of water, sanitation and hygiene infrastructure, behavioural change intervention, capacity development, and management support. The other group will not receive any intervention until the end of the study. By comparing the two groups, the investigators will determine if the intervention had any impact on health determinants including, hygiene infrastructure, handwashing knowledge, behaviour, beliefs, etc.

详细描述

The overall project will follow a multi-center cluster-randomized controlled trial (cRCT) design. Prior to this study, a group of schools in the study's target areas were surveyed by the Tdh (in Nigeria) and Cesvi (in Palestine) using the Facility Evaluation Tool for WASH in Schools (FACET WINS) which is a monitoring tool for WASH delivery services in schools. From these schools a subsample was identified which fulfils certain inclusion criteria (see Eligibility). This subsample was handed over to the local Tdh and Cesvi collaborators who carefully assessed the security situation around the schools. The Tdh and Cesvi collaborators then selected 26 facilities per country, which are most probable to still be accessible for data collection within the next year. These 26 schools will then be allocated to the two arms (intervention vs. control) with covariate constrained stratified randomization using computer-generated randomization code provided by a statistician not involved in any field activities. The intervention arm will receive the full intervention package (see multi-component intervention in primary schools). The control arm will receive nothing for the duration of the intervention (12 months). Afterwards, they will receive the same intervention package with potential improvements identified in the former intervention group.

Objectives of the study:

  • Primary objective: Evaluate the effects of the H4H multi-component intervention on hand hygiene of primary school students in Nigeria and Palestine.

  • Secondary objectives:

  • Evaluate the effects of the H4H multi-component on the well-being of primary school students in Nigeria and Palestine

  • Assess the effect of the H4H multi-component package on hygiene-related risks, attitudes, norms, abilities and self-regulation (RANAS) behavioural factors of primary school students

  • Explore the associations of personal, physical and social contextual factors with hand hygiene and the well-being of primary school students in Palestine

  • Explore the perceived impacts of the H4H multi-component package on the health and well-being of primary school students

  • Explorative object: Assess the effect of the H4H multi-component package on hygiene-related health outcomes and absenteeism incidence of primary school students in Nigeria and Palestine.

In the schools, the investigators selected 50 eligible students from each school from one or two classes within the age group of 10-12 years using random sampling. If a school had a single class consisting of ≥ 50 students within the study's target age group, the investigators selected the sample from that class. However, if no class with the target age group had more than 50 students, the investigators randomly selected two classes from within the target age group and selected the sample from these classes. For different data collection modules, the investigators randomly selected subsets from the 50 previously selected students.

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
None

盲法说明

The laboratory technicians involved in the processing and analysis of the hand rinse samples will be masked and therefore do not know if the sample comes from the intervention or the control group

入排标准

年龄范围
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of participants who wash their hands with water and soap before eating in the school

时间窗: Up to 12 months

The primary outcome of the study aims to assess the occurrence, frequency, and technique of participants' handwashing practice with water and soap before eating in the school. This assessment will be conducted through structured observations taking place over a 3-hour period on a single day.

次要结局

  • The cumulative count of respiratory tract infections incidences(Up to 8 months)
  • Number of participants who wash their hands with water and soap after using the toilet in the school(Up to 12 months)
  • Change in self-reported handwashing practice(Up to 12 months)
  • Change in self-reported well-being(Up to 12 months)
  • Change in the log-transformed number of total coliforms and E.coli CFUs on the hands of participants(Up to 12 months)
  • The cumulative count of school absences attributed to hygiene-related illnesses(Up to 8 months)
  • The cumulative count of diarrhoea incidences(Up to 8 months)
  • The total number of helminth infections incidences(Up to 8 months)
  • The total number of head lice incidences(Up to 8 months)
  • The total number of trachoma incidences(Up to 8 months)
  • The total number of skin infections incidences(Up to 8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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