xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05964478</url>
    </required_header>
    <id_info>
      <org_study_id>7F-l 0345.03.01A</org_study_id>
      <nct_id>NCT05964478</nct_id>
    </id_info>
    <brief_title>Hands4Health: A Multi-component Intervention on Hand Hygiene &amp; Well-being in Schools in Nigeria &amp; Palestine (H4H)</brief_title>
    <acronym>H4H</acronym>
    <official_title>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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Swiss Tropical &amp; Public Health Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Applied Sciences and Arts Northwestern Switzerland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Terre des Hommes</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>CESVI</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Swiss Tropical &amp; Public Health Institute</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to assess the impact of the hands4health hand hygiene&#xD;
        multi-component intervention on students and teachers in primary schools with limited access&#xD;
        to water in Nigeria and Palestine. To evaluate the effects of the intervention, the&#xD;
        investigators will involve the participants in the included schools in the following data&#xD;
        collection methods, including (i) a survey regarding their thoughts, behaviours, and&#xD;
        practices related to handwashing at school, (ii) structured observation of their handwashing&#xD;
        behaviour (iii) hand rinse sample collection to check for bacteria on their hands, (iv)&#xD;
        absenteeism tracking through a daily journal to record the reasons for any absences, with a&#xD;
        specific focus on identifying if they are related to hygiene-related diseases, and (v)&#xD;
        discussions and interviews to gather their perspectives on the perceived impacts of the&#xD;
        intervention on their health and well-being.&#xD;
  &#xD;
        The investigators will collect data using these methods before the intervention starts, a few&#xD;
        months after it begins, and again one year later. The schools will be randomly divided into&#xD;
        two groups: one group will receive the intervention activities, including handwashing&#xD;
        station/rehabilitation of water, sanitation and hygiene infrastructure, behavioural change&#xD;
        intervention, capacity development, and management support. The other group will not receive&#xD;
        any intervention until the end of the study. By comparing the two groups, the investigators&#xD;
        will determine if the intervention had any impact on health determinants including, hygiene&#xD;
        infrastructure, handwashing knowledge, behaviour, beliefs, etc.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The overall project will follow a multi-center cluster-randomized controlled trial (cRCT)&#xD;
        design. Prior to this study, a group of schools in the study's target areas were surveyed by&#xD;
        the Tdh (in Nigeria) and Cesvi (in Palestine) using the Facility Evaluation Tool for WASH in&#xD;
        Schools (FACET WINS) which is a monitoring tool for WASH delivery services in schools. From&#xD;
        these schools a subsample was identified which fulfils certain inclusion criteria (see&#xD;
        Eligibility). This subsample was handed over to the local Tdh and Cesvi collaborators who&#xD;
        carefully assessed the security situation around the schools. The Tdh and Cesvi collaborators&#xD;
        then selected 26 facilities per country, which are most probable to still be accessible for&#xD;
        data collection within the next year. These 26 schools will then be allocated to the two arms&#xD;
        (intervention vs. control) with covariate constrained stratified randomization using&#xD;
        computer-generated randomization code provided by a statistician not involved in any field&#xD;
        activities. The intervention arm will receive the full intervention package (see&#xD;
        multi-component intervention in primary schools). The control arm will receive nothing for&#xD;
        the duration of the intervention (12 months). Afterwards, they will receive the same&#xD;
        intervention package with potential improvements identified in the former intervention group.&#xD;
  &#xD;
        Objectives of the study:&#xD;
  &#xD;
          -  Primary objective: Evaluate the effects of the H4H multi-component intervention on hand&#xD;
             hygiene of primary school students in Nigeria and Palestine.&#xD;
  &#xD;
          -  Secondary objectives:&#xD;
  &#xD;
               -  Evaluate the effects of the H4H multi-component on the well-being of primary school&#xD;
                  students in Nigeria and Palestine&#xD;
  &#xD;
               -  Assess the effect of the H4H multi-component package on hygiene-related risks,&#xD;
                  attitudes, norms, abilities and self-regulation (RANAS) behavioural factors of&#xD;
                  primary school students&#xD;
  &#xD;
               -  Explore the associations of personal, physical and social contextual factors with&#xD;
                  hand hygiene and the well-being of primary school students in Palestine&#xD;
  &#xD;
               -  Explore the perceived impacts of the H4H multi-component package on the health and&#xD;
                  well-being of primary school students&#xD;
  &#xD;
          -  Explorative object: Assess the effect of the H4H multi-component package on&#xD;
             hygiene-related health outcomes and absenteeism incidence of primary school students in&#xD;
             Nigeria and Palestine.&#xD;
  &#xD;
        In the schools, the investigators selected 50 eligible students from each school from one or&#xD;
        two classes within the age group of 10-12 years using random sampling. If a school had a&#xD;
        single class consisting of ≥ 50 students within the study's target age group, the&#xD;
        investigators selected the sample from that class. However, if no class with the target age&#xD;
        group had more than 50 students, the investigators randomly selected two classes from within&#xD;
        the target age group and selected the sample from these classes. For different data&#xD;
        collection modules, the investigators randomly selected subsets from the 50 previously&#xD;
        selected students.&#xD;
  &#xD;
        The modules of the study incudes qualitative and quantitative data approaches in order to&#xD;
        enable a triangulation of the overall project results. The following modules will be used in&#xD;
        the cRCT and the overall project: (i) Module 1: Combined RANAS and well-being survey, (ii)&#xD;
        Module 2: Structured handwashing observations, (iii) Module 3: Microbiological analysis of&#xD;
        hand rinse samples, (iv) Module 4: Diary approach for health outcomes and absenteeism, (v)&#xD;
        Module 5: personal, physical and social contextual factors survey (vi) Module 6: Focus Group&#xD;
        Discussions (FGDs) and (vii) Module 7: Key informant interviews (KIIs)..&#xD;
  &#xD;
        Local collaborators from Tdh and Cesvi and the regional Ministries of Education (MoE) were&#xD;
        involved from the study's kick-off meeting onwards and are regularly being consulted in&#xD;
        bi-weekly meetings and additional ToC workshops led by Skat Foundation. The data collection&#xD;
        methods for each module will be described in further detail:&#xD;
  &#xD;
        (i) Module 1: Combined RANAS and well-being survey: The survey will be developed through&#xD;
        RANAS approach that targets the underlying psychological factors that are postulated as&#xD;
        important precursors for effective behaviour change by the model. These factors include&#xD;
        handwashing-related perceived risks, attitudes, norms, abilities and self-regulation. The&#xD;
        well-being of the participants will be assessed in the survey using the KINDL tool which is&#xD;
        designed to measure health-related quality of life in children and adolescents by looking&#xD;
        into different domains of well-being (e.g. physical, mental and school). The survey will also&#xD;
        contain questions assessing the perceived sufficiency and safety of the water supply,&#xD;
        satisfaction with the available infrastructure for handwashing, and obstacles to water&#xD;
        access. The survey will be administered to a randomly selected subset of 25 students per&#xD;
        primary school three times in total; as a baseline survey before the implementation of the&#xD;
        intervention package, about three months after the intervention and about a year after the&#xD;
        baseline survey with the software Open Data Kit (ODK) Central (version 2022.3.1) on Android&#xD;
        tablets. Informed consent forms will be obtained from the participants' guardians before the&#xD;
        day of data collection. In addition, oral assent will also be obtained from the participants&#xD;
        at the beginning of the interview for filling out the survey.&#xD;
  &#xD;
        (ii) Module 2: Structured handwashing observations: The observations will be administered&#xD;
        three times at the same time points as the survey in Module 1. To be able to assess&#xD;
        individual behaviours and link them to data collected using other tools, all of the students&#xD;
        in the classes selected for the study will be assigned coloured badges with their unique IDs.&#xD;
        Students will be informed that they are randomly assigned the colours. However, the data&#xD;
        collector will agree with the school teachers on a specific colour to be assigned to the 50&#xD;
        students selected for the study from these classes. The observation will start at 9:00 am (60&#xD;
        minutes before the breakfast break) and end at 12:00 pm (90 minutes after the break). The&#xD;
        data collector will pilot the observation process before the intervention and in coordination&#xD;
        with the school staff.&#xD;
  &#xD;
        The occurrence of handwashing with soap will be observed for each of the two critical&#xD;
        handwashing events (after using the toilet and before eating) for each included student. To&#xD;
        observe handwashing before eating (study's primary outcome), the investigators will engage&#xD;
        participants in a painting activity, followed by a popcorn snack, which should prompt&#xD;
        handwashing. During snack time, observers stationed at handwashing points will document who&#xD;
        washes their hands. Observations will also include other handwashing opportunities, such as&#xD;
        after toilet use. Outcomes will indicate whether or not handwashing with soap occurred at&#xD;
        these key events, with some considerations for unforeseen field complications. If feasible,&#xD;
        the investigators will observe the handwashing steps of students who do wash their hands.&#xD;
        Consent for observation will be obtained at a school level, from the principal of the school,&#xD;
        as well as from the parents.&#xD;
  &#xD;
        (iii) Module 3: Microbiological analysis of hand rinse samples: This module focuses on the&#xD;
        microbiological analysis of hand rinse samples from a random subset of 12 students three&#xD;
        times at the same time points as the survey in Module 1 and observation in Module 2. The&#xD;
        modified glove juice method is the process used for that and it involves shaking and&#xD;
        massaging participant's hands in 350 mL of clean water contained in a 710 mL Whirl-Pak bag&#xD;
        (NASCO Corp., Fort Atkinson, WI), followed by drying. The bags with samples are kept on ice&#xD;
        and processed within four hours. Using membrane filtration, the investigators will detect E.&#xD;
        Coli and total coliforms colony-forming units (CFUs). This will involve filtering the bag&#xD;
        contents through a 47-mm-diameter 0.45 µm cellulose filter, applying the filter to growth&#xD;
        media, and incubating it at 35°C ± 0.5°C for a duration of 24 hours. the investigators plan&#xD;
        to filter 100 mL per bag; however, the exact amount of mL will be established during piloting&#xD;
        as the volume used is dependent on the degree of bacterial contamination on the hands. The&#xD;
        investigators will utilize compact dry plates to detect E.coli and total coliforms, and the&#xD;
        detection limits will be calculated based on the filtrate volume and Whirl-Pak volume. The&#xD;
        lower detection limit of CFUs will be calculated by dividing 1 CFU/plate by the filtrate&#xD;
        volume and then multiplying it with the total Whirl-Pak volume of 350 mL. The upper detection&#xD;
        limit will be calculated by dividing 500 CFUs/plate by the filtrate volume and then&#xD;
        multiplying it with the Whirl-Pak volume. For analysis, CFUs per hand will be normalized and&#xD;
        log10 transformed.&#xD;
  &#xD;
        (iv) Module 4: Diary approach for health outcomes and absenteeism incidence: The approach&#xD;
        uses a diary method to track hygiene-related health outcomes and absenteeism&#xD;
        post-intervention. The key measure is hygiene-related absenteeism, tied to conditions like&#xD;
        diarrhea, respiratory and skin infections, helminth infections, head lice, and trachoma. A&#xD;
        teacher in each school will record daily absences and reasons in an electronic/paper diary.&#xD;
        To account for the cluster design, the investigators will separately calculate&#xD;
        hygiene-related absenteeism rates for each medical condition in each school by dividing the&#xD;
        number of absences by student-weeks, yielding rates per 100 student-weeks.&#xD;
  &#xD;
        (v) Module 5: personal, physical and social contextual factors survey. The cultural and&#xD;
        contextual factors that may influence students' handwashing and well-being will be covered in&#xD;
        this survey. Given the unique stressors of military occupation in Palestine, it's crucial to&#xD;
        understand these conditions' impact on life beyond school. The investigators will analyse&#xD;
        determinants of hygiene behaviour before starting the intervention, providing insight into&#xD;
        how to maximize effectiveness for broader hygiene interventions in Palestine. The study uses&#xD;
        a cross-sectional baseline design, with an initial assessment conducted before school&#xD;
        randomization. Parents of the 50 included students will complete a survey assessing household&#xD;
        hygiene services, their hygiene knowledge and habits, and their child's hygiene behaviour.&#xD;
  &#xD;
        (vi) Module 6: Focus Group Discussions (FGDs): The FGDs generate extensive data quicker than&#xD;
        individual interviews. The investigators will conduct 10 gender-separated FGDs in the&#xD;
        selected schools during autumn 2023. This separation also encourages open, free-speaking&#xD;
        environments without fear of teasing or embarrassment. Each group will consist of 5-8&#xD;
        students, ensuring a fair representation from each class participating in the study. To avoid&#xD;
        dominance issues, the investigators will ensure all students within a group are of the same&#xD;
        age. Furthermore, there will be 5 FGDs specifically designed for 5-8 teachers from schools&#xD;
        involved in the intervention. The team conducting the FGDs, ideally including the SwissTPH&#xD;
        PhD student, will consist of a moderator and a note-taker. FGDs will be tape-recorded,&#xD;
        transcribed, and translated into English for analysis, with observations noted in a field&#xD;
        research journal. Analysis will be conducted using MaxQDA (VERBI Software, Marburg, Germany)&#xD;
        or NVivo software (QSR International, Melbourne, Australia).&#xD;
  &#xD;
        (vii) Module 7: Key informant interviews (KIIs): The key informant interviews will be with&#xD;
        education ministry stakeholders, school committee members, and community leaders, to gain&#xD;
        detailed insights into specific issues and proposed solutions. This data will be collected in&#xD;
        autumn 2023, providing depth that FGDs might miss due to group dynamics. Interviewers,&#xD;
        trained similarly to those for FGDs, will audio record interviews, with transcripts&#xD;
        translated into English for analysis using either MaxQDA (VERBI Software, Marburg, Germany)&#xD;
        or NVivo software. In some cases, interviews may be conducted remotely in English.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 29, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The study is a multi-center Cluster Randomised Controlled Trial being conducted across two countries. Within each country, there will be two arms: an intervention arm and a control arm.&#xD;
  The intervention arm will receive a comprehensive multi-component intervention package. On the other hand, the control arm will not receive the intervention package during the data collection phase, serving as a comparison group.&#xD;
  However, It will receive the same intervention package (with potential improvements) once the data collection period concludes, specifically at the endline assessment after one year from the baseline</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>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</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants who wash their hands with water and soap before eating in the school</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants who wash their hands with water and soap after using the toilet in the school</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>The participants' handwashing practice with water and soap after using the toilet in the school will be assessed through structured observations conducted over a single day within a 3-hour period. The observations will focus on capturing the occurrence, frequency, and technique of handwashing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-reported handwashing practice</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Within the RANAS survey, participants' handwashing practice is assessed using two key event-based inquiries: before eating and after using the toilet. Participants are invited to express their frequency of handwashing on a five-point Likert scale, spanning from &quot;almost never&quot; to &quot;almost always&quot;, with &quot;almost always&quot; signifying the most desirable outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-reported well-being</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>The well-being of the participants will be evaluated using the KINDL tool which is a questionnaire specifically designed to measure the health-related quality of life in children and adolescents. This questionnaire assesses 6 domains of well-being, including physical health, general feeling, self-feeling, family, friends and school. Participants will respond to the questionnaire using a 5-point Likert scale, which ranges from &quot;almost never&quot; to &quot;almost always&quot;. The optimal response, either &quot;almost always&quot; or &quot;almost never,&quot; is question-dependent. The domain-specific and overall well-being can be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the log-transformed number of total coliforms and E.coli CFUs on the hands of participants</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Bacterial contamination on the participants' hands will be assessed by quantifying the colony-forming units (CFUs) of E. coli and total coliforms in a sample obtained from their hand rinse. The CFUs will be normalized and transformed using a logarithmic base 10 (log10) to facilitate analysis and comparison</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The cumulative count of school absences attributed to hygiene-related illnesses</measure>
      <time_frame>Up to 8 months</time_frame>
      <description>The daily absenteeism of participants in each cluster, along with the reasons for their absence, will be recorded by a designated teacher. The focus will be on identifying absenteeism incidences due to hygiene-related illnesses such as diarrhoea, respiratory tract infections, helminth infections, head lice, trachoma, and skin infections. The feasibility of these health outcomes will be reassessed with local experts prior to the intervention. To account for the cluster design effect, rates of hygiene-related absenteeism will be calculated separately for each school. This will involve dividing the total number of hygiene-related absences by the number of student-weeks, multiplying the result by 100, and presenting it using descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The cumulative count of diarrhoea incidences</measure>
      <time_frame>Up to 8 months</time_frame>
      <description>The cumulative occurrences of diarrhoea, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The cumulative count of respiratory tract infections incidences</measure>
      <time_frame>Up to 8 months</time_frame>
      <description>The cumulative occurrences of respiratory tract infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The total number of helminth infections incidences</measure>
      <time_frame>Up to 8 months</time_frame>
      <description>The cumulative occurrences of helminth infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The total number of head lice incidences</measure>
      <time_frame>Up to 8 months</time_frame>
      <description>The cumulative occurrences of head lice infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The total number of trachoma incidences</measure>
      <time_frame>Up to 8 months</time_frame>
      <description>The cumulative occurrences of trachoma infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The total number of skin infections incidences</measure>
      <time_frame>Up to 8 months</time_frame>
      <description>The cumulative occurrences of skin infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Covariate 1: Age</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Age assessed in years serves as a covariate when estimating the total effect of RANAS factors on handwashing. It will be assessed as part of the combined RANAS and well-being questionnaire, offering answer options within the 10-12 years range.</description>
    </other_outcome>
    <other_outcome>
      <measure>Covariate 2: Education</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Education level serves as a covariate when estimating the total effect of RANAS factors on handwashing. It will be assessed as part of the combined RANAS and well-being questionnaire, providing answer options that span from the third to the seventh grade.</description>
    </other_outcome>
    <other_outcome>
      <measure>Covariate 3: Sex</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Sex serves as a covariate when estimating the total effect of RANAS factors on handwashing. It will be assessed as part of the combined RANAS and well-being questionnaire with two response options: male and female</description>
    </other_outcome>
    <other_outcome>
      <measure>Covariate 4: Socio-economic status</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Socio-economic status serves as a covariate when estimating the total effect of RANAS factors on handwashing. Since directly inquiring about family income from children aged 10-12 years is both difficult and culturally inappropriate, the number of siblings is used as an indicator of the family's socio-economic status. This also provides a proxy for the level of parental attention and hygiene supervision each child might receive, given the number of children the parents have to look after. The information will be collected through the combined RANAS and well-being questionnaire, leaving the response open to the actual number of siblings.</description>
    </other_outcome>
    <other_outcome>
      <measure>Covariate 5: School water infrastructure</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>The school infrastructure serves as a covariate when estimating the total effect of RANAS factors on handwashing. This will be assessed through assessing the perceived sufficiency and safety of the school's water supply, satisfaction with the school's available infrastructure for handwashing and obstacles to water access in school. This measure will be part of the combined RANAS and well-being questionnaire offering a five-point Likert scale answers ranging between &quot;Almost never&quot; to &quot;Almost always&quot;, with &quot;almost always&quot; signifying the most desirable outcome.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2600</enrollment>
    <condition>Hand Hygiene</condition>
    <condition>Handwashing Behaviour</condition>
    <condition>Well-Being</condition>
    <arm_group>
      <arm_group_label>Intervention arm of schools in Nigeria and Palestine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participating schools in this arm will receive the multi-component hand hygiene intervention package for a duration of one year</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm of schools in Nigeria and Palestine</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Multi-component hand hygiene intervention in primary schools not connected to functional water supply system in Nigeria and Palestine</intervention_name>
      <description>Each participating school receives: (i) Two Gravit'eau handwashing stations (http://www.graviteau.ch): these systems recycle on-site greywater and operate through gravity and a manual foot pump, and can be produced locally. (ii) Behavior change activities: Developed by a group of expert psychologists (http://www.ranasmosler.com/ranas), utilizing the risks, attitudes, norms, abilities, and self-regulation (RANAS) approach. (iii) WASH infrastructure rehabilitation and soap dispenser installation. (iv) Controlled chlorine monitoring: Equipment provided for monitoring chlorine concentration in water storage, with staff training. (v) Preventive maintenance: Trained circuit rider inspects infrastructure regularly under WASH committee supervision</description>
      <arm_group_label>Intervention arm of schools in Nigeria and Palestine</arm_group_label>
      <other_name>Gravit'eau handwashing system</other_name>
      <other_name>RANAS4schools</other_name>
      <other_name>Chlorination support</other_name>
      <other_name>Preventive maintenance</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Study participants will be primary school students of schools selected to be included in&#xD;
          this study. Schools were selected based on accessibility for the study teams, not having a&#xD;
          water source directly connected to the building of the school, and having ≤ 7000 students.&#xD;
          50 students between the ages of 10-12 years old from one or two classes (depending on the&#xD;
          number of students in classes) of the 5th-7th grades will be included in the study from&#xD;
          each included school. However, due to the large size of the schools and the high number of&#xD;
          classes in Nigeria, the 50 students will be selected from two classes of the 5th-7th grades&#xD;
          close to where the handwashing stations (Gravit'eau) will be positioned. The 50 selected&#xD;
          students will be targeted with the handwashing observation (Module 2) and followed for&#xD;
          their hygiene-related health outcomes and absenteeism during the course of the study&#xD;
          (Module 4), while 25 of them will be targeted with RANAS and well-being survey (Module 1)&#xD;
          and 12 of them will be targeted with collecting their hand-rinse samples (Module 3).&#xD;
          Students in the selected classes in each school will be delivered a survey to be&#xD;
          self-reported by one of their parents about contextual factors that could affect the&#xD;
          hygiene practice of students (Module 5 in Palestine only).&#xD;
  &#xD;
          Inclusion criteria Modules 1-4: students must fulfil all the inclusion criteria:&#xD;
  &#xD;
            -  Primary school students aged 10-12 years attending included schools&#xD;
  &#xD;
            -  Students must be in the same school for the course of the study (1 year).&#xD;
  &#xD;
          Inclusion criteria Module 5: students must fulfil all the inclusion criteria:&#xD;
  &#xD;
          - Students of the classes included in the study in each included school in Palestine&#xD;
  &#xD;
          Inclusion criteria Module 6:&#xD;
  &#xD;
            -  Students of the intervention schools&#xD;
  &#xD;
            -  Students need to represent each included class in the intervention.&#xD;
  &#xD;
          The teachers invited to participate in the FGDs should be&#xD;
  &#xD;
            -  Aged ≥ 18 years old&#xD;
  &#xD;
            -  Permanent employees in the school&#xD;
  &#xD;
            -  Teaching one of the classes included in the intervention&#xD;
  &#xD;
          Inclusion criteria Module 7:&#xD;
  &#xD;
            -  The participant needs to be:&#xD;
  &#xD;
                 1. a stakeholder within the community, state, or region of the intervention whose&#xD;
                    position is related in any way to WASH in schools&#xD;
  &#xD;
                 2. working in one of the intervention schools. They can be hygiene technicians,&#xD;
                    teachers, school's principal, or in a leading position in the school.&#xD;
  &#xD;
                 3. Aged ≥ 18 years old&#xD;
  &#xD;
                    5.3 Exclusion criteria Exclusion criteria Modules 1-4: included students must not&#xD;
                    fulfil any of the following exclusion criteria:&#xD;
  &#xD;
            -  Refusal to participate by not providing signed consent and assent forms&#xD;
  &#xD;
            -  Having any medical condition that prevents them from washing their hands&#xD;
  &#xD;
            -  Having unexplained intermittent attendance in school (school teachers will be&#xD;
               consulted and the school's absenteeism records will be checked for that)&#xD;
  &#xD;
            -  Not being at the same school for the course of the study (1 year)&#xD;
  &#xD;
          Exclusion criteria Module 5: Refusal to participate by the student or his/her parents.&#xD;
  &#xD;
          Exclusion criteria Module 6: Refusals to participate.&#xD;
  &#xD;
          Exclusion criteria Module 7: Refusals to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mirko S. Winler, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>wiss Tropical and Public Health Institute and University of Basel</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yaman Q. Abuzahra</last_name>
      <phone>+41767816111</phone>
      <email>yaman.abuzahra@swisstph.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mirko S. Winler, Prof.</last_name>
      <phone>+41612848339</phone>
      <email>mirko.winkler@swisstph.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>26 Primary Schools</name>
        <address>
          <city>Maiduguri</city>
          <state>Borno State</state>
          <country>Nigeria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zainab Abdulkarim</last_name>
        <phone>+234 (0) 803 828 0076</phone>
        <email>zainab.abdulkarim@tdh.ch</email>
      </contact>
      <investigator>
        <last_name>Yaman Abuzahra</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>26 Primary Schools</name>
        <address>
          <city>Hebron</city>
          <country>Palestinian Territory, occupied</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Issa Younan</last_name>
        <phone>+970592859990</phone>
        <email>technical_supervisor@cesvioverseas.org</email>
      </contact>
      <investigator>
        <last_name>Yaman Abuzahra</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Nigeria</country>
      <country>Palestinian Territory, occupied</country>
    </location_countries>
    <link>
      <url>http://hands4health.dev/</url>
      <description>Hands4health project website</description>
    </link>
    <link>
      <url>http://www.graviteau.ch/</url>
      <description>Gravit'eau handwashing system website</description>
    </link>
    <link>
      <url>http://www.ranasmosler.com/ranas</url>
      <description>RANAS Ltd. website</description>
    </link>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Behaviour Change</keyword>
    <keyword>WASH Infrastructure</keyword>
    <keyword>Handwashing Station</keyword>
    <keyword>Handwashing</keyword>
    <keyword>Students</keyword>
    <keyword>Primary Schools</keyword>
    <keyword>Humanitarian</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The consortium members can share coded or anonymized individual participant data (IPD) internally under the following conditions:&#xD;
  The ownership of research results belongs to the consortium member(s) whose personnel generated them.&#xD;
  Each consortium member has the right to utilize the research results of other consortium members for research purposes.&#xD;
  Research results generated jointly are equally owned by the involved consortium members and can be utilized by all members.&#xD;
  The use of data by third parties requires written approval from all consortium members.&#xD;
  After the project is officially concluded and the data has been published, all consortium members are free to conduct secondary data analysis, provided it adheres to ethical agreements and proper acknowledgment is given to the original data.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Our partners in Nigeria (Tdh) and Palestine (Cesvi) have direct access to the individual participant data (IPD) as they collect and perform quality control on the data in the field. Other consortium members can request access to the IPD once the data collection is complete and it has been cleaned.</ipd_time_frame>
      <ipd_access_criteria>Within the consortium:&#xD;
  Data gathered using ODK or KoboToolbox is stored on the ODK central server. The data collecting organizations (Tdh, CESVI), RANAS, and Swiss TPH have direct access to this server. Consortium members who require access to the data can contact someone with server access to request the coded data.&#xD;
  Outside the consortium:&#xD;
  Written approval from all consortium members is necessary for third parties to use the data.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>June 2, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT05964478/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05964478
  org study id: 7F-l 0345.03.01A
  nct id: NCT05964478
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  
        The modules of the study incudes qualitative and quantitative data approaches in order to
        enable a triangulation of the overall project results. The following modules will be used in
        the cRCT and the overall project: (i) Module 1: Combined RANAS and well-being survey, (ii)
        Module 2: Structured handwashing observations, (iii) Module 3: Microbiological analysis of
        hand rinse samples, (iv) Module 4: Diary approach for health outcomes and absenteeism, (v)
        Module 5: personal, physical and social contextual factors survey (vi) Module 6: Focus Group
        Discussions (FGDs) and (vii) Module 7: Key informant interviews (KIIs)..
  
        Local collaborators from Tdh and Cesvi and the regional Ministries of Education (MoE) were
        involved from the study's kick-off meeting onwards and are regularly being consulted in
        bi-weekly meetings and additional ToC workshops led by Skat Foundation. The data collection
        methods for each module will be described in further detail:
  
        (i) Module 1: Combined RANAS and well-being survey: The survey will be developed through
        RANAS approach that targets the underlying psychological factors that are postulated as
        important precursors for effective behaviour change by the model. These factors include
        handwashing-related perceived risks, attitudes, norms, abilities and self-regulation. The
        well-being of the participants will be assessed in the survey using the KINDL tool which is
        designed to measure health-related quality of life in children and adolescents by looking
        into different domains of well-being (e.g. physical, mental and school). The survey will also
        contain questions assessing the perceived sufficiency and safety of the water supply,
        satisfaction with the available infrastructure for handwashing, and obstacles to water
        access. The survey will be administered to a randomly selected subset of 25 students per
        primary school three times in total; as a baseline survey before the implementation of the
        intervention package, about three months after the intervention and about a year after the
        baseline survey with the software Open Data Kit (ODK) Central (version 2022.3.1) on Android
        tablets. Informed consent forms will be obtained from the participants' guardians before the
        day of data collection. In addition, oral assent will also be obtained from the participants
        at the beginning of the interview for filling out the survey.
  
        (ii) Module 2: Structured handwashing observations: The observations will be administered
        three times at the same time points as the survey in Module 1. To be able to assess
        individual behaviours and link them to data collected using other tools, all of the students
        in the classes selected for the study will be assigned coloured badges with their unique IDs.
        Students will be informed that they are randomly assigned the colours. However, the data
        collector will agree with the school teachers on a specific colour to be assigned to the 50
        students selected for the study from these classes. The observation will start at 9:00 am (60
        minutes before the breakfast break) and end at 12:00 pm (90 minutes after the break). The
        data collector will pilot the observation process before the intervention and in coordination
        with the school staff.
  
        The occurrence of handwashing with soap will be observed for each of the two critical
        handwashing events (after using the toilet and before eating) for each included student. To
        observe handwashing before eating (study's primary outcome), the investigators will engage
        participants in a painting activity, followed by a popcorn snack, which should prompt
        handwashing. During snack time, observers stationed at handwashing points will document who
        washes their hands. Observations will also include other handwashing opportunities, such as
        after toilet use. Outcomes will indicate whether or not handwashing with soap occurred at
        these key events, with some considerations for unforeseen field complications. If feasible,
        the investigators will observe the handwashing steps of students who do wash their hands.
        Consent for observation will be obtained at a school level, from the principal of the school,
        as well as from the parents.
  
        (iii) Module 3: Microbiological analysis of hand rinse samples: This module focuses on the
        microbiological analysis of hand rinse samples from a random subset of 12 students three
        times at the same time points as the survey in Module 1 and observation in Module 2. The
        modified glove juice method is the process used for that and it involves shaking and
        massaging participant's hands in 350 mL of clean water contained in a 710 mL Whirl-Pak bag
        (NASCO Corp., Fort Atkinson, WI), followed by drying. The bags with samples are kept on ice
        and processed within four hours. Using membrane filtration, the investigators will detect E.
        Coli and total coliforms colony-forming units (CFUs). This will involve filtering the bag
        contents through a 47-mm-diameter 0.45 µm cellulose filter, applying the filter to growth
        media, and incubating it at 35°C ± 0.5°C for a duration of 24 hours. the investigators plan
        to filter 100 mL per bag; however, the exact amount of mL will be established during piloting
        as the volume used is dependent on the degree of bacterial contamination on the hands. The
        investigators will utilize compact dry plates to detect E.coli and total coliforms, and the
        detection limits will be calculated based on the filtrate volume and Whirl-Pak volume. The
        lower detection limit of CFUs will be calculated by dividing 1 CFU/plate by the filtrate
        volume and then multiplying it with the total Whirl-Pak volume of 350 mL. The upper detection
        limit will be calculated by dividing 500 CFUs/plate by the filtrate volume and then
        multiplying it with the Whirl-Pak volume. For analysis, CFUs per hand will be normalized and
        log10 transformed.
  
        (iv) Module 4: Diary approach for health outcomes and absenteeism incidence: The approach
        uses a diary method to track hygiene-related health outcomes and absenteeism
        post-intervention. The key measure is hygiene-related absenteeism, tied to conditions like
        diarrhea, respiratory and skin infections, helminth infections, head lice, and trachoma. A
        teacher in each school will record daily absences and reasons in an electronic/paper diary.
        To account for the cluster design, the investigators will separately calculate
        hygiene-related absenteeism rates for each medical condition in each school by dividing the
        number of absences by student-weeks, yielding rates per 100 student-weeks.
  
        (v) Module 5: personal, physical and social contextual factors survey. The cultural and
        contextual factors that may influence students' handwashing and well-being will be covered in
        this survey. Given the unique stressors of military occupation in Palestine, it's crucial to
        understand these conditions' impact on life beyond school. The investigators will analyse
        determinants of hygiene behaviour before starting the intervention, providing insight into
        how to maximize effectiveness for broader hygiene interventions in Palestine. The study uses
        a cross-sectional baseline design, with an initial assessment conducted before school
        randomization. Parents of the 50 included students will complete a survey assessing household
        hygiene services, their hygiene knowledge and habits, and their child's hygiene behaviour.
  
        (vi) Module 6: Focus Group Discussions (FGDs): The FGDs generate extensive data quicker than
        individual interviews. The investigators will conduct 10 gender-separated FGDs in the
        selected schools during autumn 2023. This separation also encourages open, free-speaking
        environments without fear of teasing or embarrassment. Each group will consist of 5-8
        students, ensuring a fair representation from each class participating in the study. To avoid
        dominance issues, the investigators will ensure all students within a group are of the same
        age. Furthermore, there will be 5 FGDs specifically designed for 5-8 teachers from schools
        involved in the intervention. The team conducting the FGDs, ideally including the SwissTPH
        PhD student, will consist of a moderator and a note-taker. FGDs will be tape-recorded,
        transcribed, and translated into English for analysis, with observations noted in a field
        research journal. Analysis will be conducted using MaxQDA (VERBI Software, Marburg, Germany)
        or NVivo software (QSR International, Melbourne, Australia).
  
        (vii) Module 7: Key informant interviews (KIIs): The key informant interviews will be with
        education ministry stakeholders, school committee members, and community leaders, to gain
        detailed insights into specific issues and proposed solutions. This data will be collected in
        autumn 2023, providing depth that FGDs might miss due to group dynamics. Interviewers,
        trained similarly to those for FGDs, will audio record interviews, with transcripts
        translated into English for analysis using either MaxQDA (VERBI Software, Marburg, Germany)
        or NVivo software. In some cases, interviews may be conducted remotely in English.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study is a multi-center Cluster Randomised Controlled Trial being conducted across two countries. Within each country, there will be two arms: an intervention arm and a control arm.
  The intervention arm will receive a comprehensive multi-component intervention package. On the other hand, the control arm will not receive the intervention package during the data collection phase, serving as a comparison group.
  However, It will receive the same intervention package (with potential improvements) once the data collection period concludes, specifically at the endline assessment after one year from the baseline
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: 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
  measure: Number of participants who wash their hands with water and soap before eating in the school
  time frame: Up to 12 months
  description: 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.
  measure: Number of participants who wash their hands with water and soap after using the toilet in the school
  time frame: Up to 12 months
  description: The participants' handwashing practice with water and soap after using the toilet in the school will be assessed through structured observations conducted over a single day within a 3-hour period. The observations will focus on capturing the occurrence, frequency, and technique of handwashing.
  measure: Change in self-reported handwashing practice
  time frame: Up to 12 months
  description: Within the RANAS survey, participants' handwashing practice is assessed using two key event-based inquiries: before eating and after using the toilet. Participants are invited to express their frequency of handwashing on a five-point Likert scale, spanning from "almost never" to "almost always", with "almost always" signifying the most desirable outcome.
  measure: Change in self-reported well-being
  time frame: Up to 12 months
  description: The well-being of the participants will be evaluated using the KINDL tool which is a questionnaire specifically designed to measure the health-related quality of life in children and adolescents. This questionnaire assesses 6 domains of well-being, including physical health, general feeling, self-feeling, family, friends and school. Participants will respond to the questionnaire using a 5-point Likert scale, which ranges from "almost never" to "almost always". The optimal response, either "almost always" or "almost never," is question-dependent. The domain-specific and overall well-being can be assessed.
  measure: Change in the log-transformed number of total coliforms and E.coli CFUs on the hands of participants
  time frame: Up to 12 months
  description: Bacterial contamination on the participants' hands will be assessed by quantifying the colony-forming units (CFUs) of E. coli and total coliforms in a sample obtained from their hand rinse. The CFUs will be normalized and transformed using a logarithmic base 10 (log10) to facilitate analysis and comparison
  measure: The cumulative count of school absences attributed to hygiene-related illnesses
  time frame: Up to 8 months
  description: The daily absenteeism of participants in each cluster, along with the reasons for their absence, will be recorded by a designated teacher. The focus will be on identifying absenteeism incidences due to hygiene-related illnesses such as diarrhoea, respiratory tract infections, helminth infections, head lice, trachoma, and skin infections. The feasibility of these health outcomes will be reassessed with local experts prior to the intervention. To account for the cluster design effect, rates of hygiene-related absenteeism will be calculated separately for each school. This will involve dividing the total number of hygiene-related absences by the number of student-weeks, multiplying the result by 100, and presenting it using descriptive statistics.
  measure: The cumulative count of diarrhoea incidences
  time frame: Up to 8 months
  description: The cumulative occurrences of diarrhoea, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.
  measure: The cumulative count of respiratory tract infections incidences
  time frame: Up to 8 months
  description: The cumulative occurrences of respiratory tract infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.
  measure: The total number of helminth infections incidences
  time frame: Up to 8 months
  description: The cumulative occurrences of helminth infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.
  measure: The total number of head lice incidences
  time frame: Up to 8 months
  description: The cumulative occurrences of head lice infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.
  measure: The total number of trachoma incidences
  time frame: Up to 8 months
  description: The cumulative occurrences of trachoma infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.
  measure: The total number of skin infections incidences
  time frame: Up to 8 months
  description: The cumulative occurrences of skin infections, reported during students' absentee tracking by the appointed teacher, will be calculated. To adjust for the cluster design effect, individual school diarrhoea rates will be determined by dividing total instances of diarrhoea by student-weeks, then multiplying the outcome by 100. These rates will be presented using descriptive statistics.
  measure: Covariate 1: Age
  time frame: Up to 12 months
  description: Age assessed in years serves as a covariate when estimating the total effect of RANAS factors on handwashing. It will be assessed as part of the combined RANAS and well-being questionnaire, offering answer options within the 10-12 years range.
  measure: Covariate 2: Education
  time frame: Up to 12 months
  description: Education level serves as a covariate when estimating the total effect of RANAS factors on handwashing. It will be assessed as part of the combined RANAS and well-being questionnaire, providing answer options that span from the third to the seventh grade.
  measure: Covariate 3: Sex
  time frame: Up to 12 months
  description: Sex serves as a covariate when estimating the total effect of RANAS factors on handwashing. It will be assessed as part of the combined RANAS and well-being questionnaire with two response options: male and female
  measure: Covariate 4: Socio-economic status
  time frame: Up to 12 months
  description: Socio-economic status serves as a covariate when estimating the total effect of RANAS factors on handwashing. Since directly inquiring about family income from children aged 10-12 years is both difficult and culturally inappropriate, the number of siblings is used as an indicator of the family's socio-economic status. This also provides a proxy for the level of parental attention and hygiene supervision each child might receive, given the number of children the parents have to look after. The information will be collected through the combined RANAS and well-being questionnaire, leaving the response open to the actual number of siblings.
  measure: Covariate 5: School water infrastructure
  time frame: Up to 12 months
  description: The school infrastructure serves as a covariate when estimating the total effect of RANAS factors on handwashing. This will be assessed through assessing the perceived sufficiency and safety of the school's water supply, satisfaction with the school's available infrastructure for handwashing and obstacles to water access in school. This measure will be part of the combined RANAS and well-being questionnaire offering a five-point Likert scale answers ranging between "Almost never" to "Almost always", with "almost always" signifying the most desirable outcome.
  arm group label: Intervention arm of schools in Nigeria and Palestine
  arm group type: Experimental
  description: The participating schools in this arm will receive the multi-component hand hygiene intervention package for a duration of one year
  arm group label: Control arm of schools in Nigeria and Palestine
  arm group type: No Intervention
  description: 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
  intervention type: Other
  intervention name: Multi-component hand hygiene intervention in primary schools not connected to functional water supply system in Nigeria and Palestine
  description: Each participating school receives: (i) Two Gravit'eau handwashing stations (http://www.graviteau.ch): these systems recycle on-site greywater and operate through gravity and a manual foot pump, and can be produced locally. (ii) Behavior change activities: Developed by a group of expert psychologists (http://www.ranasmosler.com/ranas), utilizing the risks, attitudes, norms, abilities, and self-regulation (RANAS) approach. (iii) WASH infrastructure rehabilitation and soap dispenser installation. (iv) Controlled chlorine monitoring: Equipment provided for monitoring chlorine concentration in water storage, with staff training. (v) Preventive maintenance: Trained circuit rider inspects infrastructure regularly under WASH committee supervision
  arm group label: Intervention arm of schools in Nigeria and Palestine
  other name: Gravit'eau handwashing system
  other name: RANAS4schools
  other name: Chlorination support
  other name: Preventive maintenance
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mirko S. Winler, Prof.
  role: Principal Investigator
  affiliation: wiss Tropical and Public Health Institute and University of Basel
  last name: Yaman Q. Abuzahra
  phone: +41767816111
  email: yaman.abuzahra@swisstph.ch
  last name: Mirko S. Winler, Prof.
  phone: +41612848339
  email: mirko.winkler@swisstph.ch
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Nigeria
  country: Palestinian Territory, occupied
  url: http://hands4health.dev/
  description: Hands4health project website
  url: http://www.graviteau.ch/
  description: Gravit'eau handwashing system website
  url: http://www.ranasmosler.com/ranas
  description: RANAS Ltd. website
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: The consortium members can share coded or anonymized individual participant data (IPD) internally under the following conditions:
  The ownership of research results belongs to the consortium member(s) whose personnel generated them.
  Each consortium member has the right to utilize the research results of other consortium members for research purposes.
  Research results generated jointly are equally owned by the involved consortium members and can be utilized by all members.
  The use of data by third parties requires written approval from all consortium members.
  After the project is officially concluded and the data has been published, all consortium members are free to conduct secondary data analysis, provided it adheres to ethical agreements and proper acknowledgment is given to the original data.
  ipd info type: Study Protocol
  ipd time frame: Our partners in Nigeria (Tdh) and Palestine (Cesvi) have direct access to the individual participant data (IPD) as they collect and perform quality control on the data in the field. Other consortium members can request access to the IPD once the data collection is complete and it has been cleaned.
  ipd access criteria: Within the consortium:
  Data gathered using ODK or KoboToolbox is stored on the ODK central server. The data collecting organizations (Tdh, CESVI), RANAS, and Swiss TPH have direct access to this server. Consortium members who require access to the data can contact someone with server access to request the coded data.
  Outside the consortium:
  Written approval from all consortium members is necessary for third parties to use the data.
  provided document: 