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
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:
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Primary objective: Evaluate the effects of the H4H multi-component intervention on hand hygiene of primary school students in Nigeria and Palestine.
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Secondary objectives:
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Evaluate the effects of the H4H multi-component on the well-being of primary school students in Nigeria and Palestine
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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
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Explore the associations of personal, physical and social contextual factors with hand hygiene and the well-being of primary school students in Palestine
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Explore the perceived impacts of the H4H multi-component package on the health and well-being of primary school students
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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
- 是
入选标准
- •Study participants will be primary school students of schools selected to be included in this study. Schools were selected based on accessibility for the study teams, not having a water source directly connected to the building of the school, and having ≤ 7000 students. 50 students between the ages of 10-12 years old from one or two classes (depending on the number of students in classes) of the 5th-7th grades will be included in the study from each included school. However, due to the large size of the schools and the high number of classes in Nigeria, the 50 students will be selected from two classes of the 5th-7th grades close to where the handwashing stations (Gravit'eau) will be positioned. The 50 selected students will be targeted with the handwashing observation (Module 2) and followed for their hygiene-related health outcomes and absenteeism during the course of the study (Module 4), while 25 of them will be targeted with RANAS and well-being survey (Module 1) and 12 of them will be targeted with collecting their hand-rinse samples (Module 3). Students in the selected classes in each school will be delivered a survey to be self-reported by one of their parents about contextual factors that could affect the hygiene practice of students (Module 5 in Palestine only).
- •Inclusion criteria Modules 1-4: students must fulfil all the inclusion criteria:
- •Primary school students aged 10-12 years attending included schools
- •Students must be in the same school for the course of the study (1 year).
- •Inclusion criteria Module 5: students must fulfil all the inclusion criteria:
- •Students of the classes included in the study in each included school in Palestine
- •Inclusion criteria Module 6:
- •Students of the intervention schools
- •Students need to represent each included class in the intervention.
- •The teachers invited to participate in the FGDs should be
- •Aged ≥ 18 years old
- •Permanent employees in the school
- •Teaching one of the classes included in the intervention
- •Inclusion criteria Module 7:
- •The participant needs to be:
- •a stakeholder within the community, state, or region of the intervention whose position is related in any way to WASH in schools
- •working in one of the intervention schools. They can be hygiene technicians, teachers, school's principal, or in a leading position in the school.
- •Aged ≥ 18 years old
排除标准
- •Exclusion criteria Modules 1-4: included students must not fulfil any of the following exclusion criteria:
- •Refusal to participate by not providing signed consent and assent forms
- •Having any medical condition that prevents them from washing their hands
- •Having unexplained intermittent attendance in school (school teachers will be consulted and the school's absenteeism records will be checked for that)
- •Not being at the same school for the course of the study (1 year)
- •Exclusion criteria Module 5: Refusal to participate by the student or his/her parents.
- •Exclusion criteria Module 6: Refusals to participate.
- •Exclusion criteria Module 7: Refusals to participate
研究组 & 干预措施
Intervention arm of schools in Nigeria and Palestine
The participating schools in this arm will receive the multi-component hand hygiene intervention package for a duration of one year
干预措施: Multi-component hand hygiene intervention in primary schools not connected to functional water supply system in Nigeria and Palestine (Other)
Control arm of schools in Nigeria and Palestine
The participating schools in this arm will not receive the multi-component hand hygiene intervention package until the conclusion of the study, which occurs one year after the completion of data collection at the endline assessment
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
- 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 diarrhoea incidences(Up to 8 months)
- The cumulative count of school absences attributed to hygiene-related illnesses(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)
- The cumulative count of respiratory tract infections 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)