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
Phase: NA
Conditions: Hand Hygiene, Handwashing Behaviour, Well-Being
Sponsor: Swiss Tropical & Public Health Institute

H4H 
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Study Protocol 
(Epi & non-clinical studies) 
 
“hands4health: Hand hygiene, water quality and sanitation in schools  
not connected to functional water supply system: a cluster-randomized controlled 
trial in Nigeria and Palestine” 
 
 
Type of Research 
Project 
Research projects (HRO) - Research projects – involving 
measures or sampling of biological material or collection of 
health-related data from persons. 
 
 
Study acronym/ID 
H4H 
Protocol Version Nr 
1.0 
Date 
02.06.2023 
Project Leader / 
Responsible 
Prof. Dr. Mirko Winkler 
Swiss Tropical and Public Health Institute 
Kreuzstrasse 2 
4132 Allschwil 
Phone: +41612848339 
mirko.winkler@unibas.ch 
Funding Agency 
Swiss Agency for Development and Cooperation (SDC) 
Freiburgstrasse 130 
3003 Bern 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 GENERAL INFORMATION 
 
I. 
List of Project Leaders and other key persons involved in the study 
 
 
Title 
Names 
Institution 
Position 
Function in 
study 
Prof. Dr. 
Mirko Winkler 
Swiss TPH 
Group Leader 
PI of the 
present study 
Dr. 
Maryna Peter 
FHNW 
Group Leader 
Lead of the H4H 
project and lead 
at FHNW 
 
Bruno Pascual 
Terre des 
hommes 
Lausanne 
WASH Advisor  
WASH 
coordinator at 
Terre des 
hommes 
Lausanne 
 
Zainab 
Abdulkarim 
Terre des 
hommes Nigeria 
 WASH 
responsible  
Lead of Terre 
des hommes 
Nigeria 
 
Roberto Turcato Cesvi 
Technical 
Coordinator 
Lead of Cesvi 
Palestine 
 
Issa Younan 
Cesvi 
Local 
Coordinator 
Local WASH 
coordinator  
Dr. 
Andrea Tamas 
Ranas Ltd. 
Senior 
Behaviour 
Change Expert 
Behaviour 
Change work 
package 
Dr. 
Jan Hattendorf 
Swiss TPH 
Scientific Project 
Leader 
Statistician 
 
Yaman 
Abuzahra 
Swiss TPH 
PhD Candidate 
Investigator 
 
Rena salzmann 
Skat Foundation Programme and 
communication 
officer 
Knowledge 
broker 
 
The project leaders are qualified individuals by education and training and are responsible for 
the whole project. All further key persons are also qualified by education and training to 
perform their assigned tasks and responsibilities. 
 
 
 
 

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II. 
Signatures 
 
Study Title 
hands4health: Hand hygiene, water quality and sanitation in schools not 
connected to functional water supply system: a cluster-randomized 
controlled trial in Nigeria and Palestine 
 
The following project leaders have approved the protocol version [1.0 (dated 02.06.2023)], and 
confirm hereby to conduct the project according to the current version of the Declaration of 
Helsinki /, and Essentials of Good Epidemiological Practice issued by Public Health 
Switzerland (EGEP) / ISO EN 14155  / CIOMS International Ethical Guidelines for 
epidemiological studies 2009 as well as all national legal requirements and guidelines as 
applicable. 
 
 
Project Leader 
• I have read this protocol (version 1.0, dated 02.06.2023) and agree that it contains all 
necessary details for carrying out this study. I will conduct the study as outlined herein 
and will complete the study within the time designated. 
• I will ensure that all individuals and parties contributing to this study are qualified and I will 
implement procedures to ensure integrity of study tasks and data. 
• I will provide copies of the protocol and all pertinent information to all individuals 
responsible to me who assist in the conduct of this study. I will discuss this material with 
them to ensure they are fully informed and trained regarding their activities within the 
study conduct. 
• I will use only approved informed consent forms and will fulfil all responsibilities for 
submitting pertinent information to the Independent Ethics Committees responsible for 
this study. 
• It is understood that this protocol will not be disclosed to others without prior written 
authorisation from the Project Leader or Sponsor, except where required by applicable 
local laws 
 
Project Leader (lead centre/site) 
 
Signature 
 
 
 
 
Name  
Mirko Winkler 
Date of Signature 
(DD.MM.YYYY) 
Title 
Prof Dr. 
Institution 
Swiss Tropical and Public Health Institute 
Address 
Kreuzstrasse 2 
4123 Allschwil 
Phone 
+41612848339 
 
 
 
05-Jun-2023 | 14:04:15 CEST

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Local Project Leader at local center/site Nigeria 
Signature 
 
 
 
 
Name  
Zainab Abdulkarim 
Date of Signature 
(DD.MM.YYYY) 
Title 
WaSH Officer 
Institution 
Terre des hommes Nigeria 
Address 
No. 46 Talba Road, By Horama Specialist Hospital Junction, off Alamin 
Dagash Road - Maiduguri 
Phone 
+234 (0) 803 828 0076 
 
Local Project Leader at local center/site Palestine 
Signature 
 
 
 
 
Name  
Issa Younan 
Date of Signature 
(DD.MM.YYYY) 
Title 
Project coordinator 
Institution 
Cesvi Palestine 
Address 
Ata Al-Zir Street 15, Beit Hanina, Jerusalem 
Palestine 
Phone 
+970592859990 
 
 
Statistician 
Signature 
 
 
 
 
Name  
Jan Hattendorf 
Date of Signature 
(DD.MM.YYYY) 
Title 
Dr. 
Institution 
Swiss TPH 
Address 
Kreuzstrasse 2 
4123 Allschwil 
Phone 
+41612848193 
 
 
 
 
 
05-Jun-2023 | 14:12:30 CEST
08-Jun-2023 | 17:30:46 CEST
05-Jun-2023 | 16:46:51 CEST

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Table of contents 
 
1 
General Information 
2 
I. 
List of Project Leaders and other key persons involved in the study 
2 
II. 
Signatures 
3 
III. 
Abbreviations / Glossary of terms 
7 
IV. 
Synopsis 
9 
2 
Background information 
14 
2.1 
Global public health relevance of water and hygiene ................................................................................................. 14 
2.1.1 
Access to water and hygiene for disease prevention 
14 
2.1.2 
Access to water and hygiene for the well-being 
14 
2.1.3 
Access to water and hygiene in humanitarian settings 
15 
2.2 
Hand hygiene in schools ........................................................................................................................................... 15 
2.3 
The hands4health project .......................................................................................................................................... 16 
2.3.1 
Gravit’eau handwashing station 
16 
2.3.2 
Rehabilitation of WASH infrastructures 
17 
2.3.3 
Behavioural change intervention 
17 
2.3.4 
Capacity development and training for monitoring residual chlorine in water storage 
18 
2.3.5 
The management of WASH infrastructure at schools 
19 
3 
Objectives and purpose 
19 
3.1 
Study rationale and objectives .................................................................................................................................. 19 
3.1.1 
Study rationale 
19 
3.1.2 
Primary objective 
20 
3.1.3 
Secondary objectives 
20 
Additionally to the primary objective, the H4H project aims to address the following secondary objectives and research 
questions: 
20 
3.1.4 
Explorative objectives 
21 
3.2 
Scientific justification of study population .................................................................................................................. 21 
4 
Study design 
22 
4.1 
Primary endpoint ....................................................................................................................................................... 28 
4.2 
Secondary endpoints ................................................................................................................................................ 28 
4.3 
Measures to minimize bias ........................................................................................................................................ 29 
4.4 
Study duration and duration of participant’s participation ........................................................................................... 31 
4.4.1 
Schedule of events 
32 
4.5 
Amendments ............................................................................................................................................................ 33 
4.6 
Withdrawal and discontinuation ................................................................................................................................. 33 
4.7 
End of project............................................................................................................................................................ 33 
5 
Selection of study participants 
33 
5.1 
Recruitment .............................................................................................................................................................. 33 
5.2 
Inclusion criteria ........................................................................................................................................................ 34 
5.3 
Exclusion criteria ....................................................................................................................................................... 34 
5.4 
Criteria for discontinuation of study ........................................................................................................................... 35 
5.4.1 
Discontinuation of individual participants 
35 
6 
Statistics 
36 
6.1 
Hypothesis ................................................................................................................................................................ 36 
6.1.1 
Primary hypothesis 
36 
6.1.2 
Secondary hypotheses 
36 
6.2 
Determination of sample size .................................................................................................................................... 36 
6.3 
Description of statistical methods .............................................................................................................................. 37 
6.3.1 
Datasets to be analysed, analysis populations 
37 
6.3.1.1 
Primary Analysis 
37 
6.3.1.2 
Secondary Analyses 
38 
6.4 
Handling of missing data ........................................................................................................................................... 38 
7 
Description of data management 
39 
7.1 
Specification of source documents ............................................................................................................................ 39 
7.2 
Data recording and source data ................................................................................................................................ 41 
7.3 
Confidentiality and coding ......................................................................................................................................... 41 
7.4 
Retention and destruction of study data and biological material ................................................................................ 41 
7.5 
Data security, access, archiving and back up ............................................................................................................ 42 
8 
Quality control and quality assurance 
42 
8.1 
Supervision / Continuous Checks ............................................................................................................................. 42 
8.2 
Confidentiality, data protection .................................................................................................................................. 42 
8.3 
Translations - Reference language ........................................................................................................................... 42 
8.4 
Storage of biological material and related health data ............................................................................................... 43 
9 
Ethical considerations 
43 
9.1 
Independent Ethics Committee (IEC) ........................................................................................................................ 43 
9.2 
Risk-benefit ratio ....................................................................................................................................................... 43 
9.3 
Participant information and consent .......................................................................................................................... 43 
9.4 
Participant confidentiality .......................................................................................................................................... 44 
9.5 
Participants requiring particular protection ................................................................................................................ 44 
9.6 
Participant compensation .......................................................................................................................................... 44 
9.7 
Damage coverage / Insurance .................................................................................................................................. 44 
9.8 
Other aspects ........................................................................................................................................................... 44 

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10 
Funding 
45 
11 
Dissemination of results and publication policy 
45 
11.1 Dissemination to scientific community; incl. lead in publications ................................................................................ 45 
11.2 Information of community and policy makers ............................................................................................................ 45 
12 
References 
46 
 
 

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III. 
Abbreviations / Glossary of terms 
 
CFU 
Colony-Forming Unit 
COVID-19 
Coronavirus Disease 2019 
cRCT 
Cluster-Randomized Controlled Trial 
CRF 
Case Report Form 
Eawag 
Swiss Federal Institute of Aquatic Science and Technology 
EPFL 
Ecole Polythechnique Fédérale de Lausanne 
FACET WINS 
Facility Evaluation Tool for WASH in Schools 
FGD 
Focus Group Discussion 
FHNW 
Fachhochschule Nordwestschweiz 
H4H 
Hands4Health 
HRO 
Ordinance of Human Research with the Exception of Clinical Trial (Switzerland) 
ICF 
Informed Consent Form 
IDP 
Internally Displaced People 
IEC 
Independent Ethics Committee 
ICP 
Infection Prevention and Control 
JMP 
Joint Monitoring Programme 
KII 
Key Informant Interview 
LDCs 
Least Developed Countries 
LMIC 
Low and Middle-Income Country 
MCI 
Multi-component intervention 
NGO 
Non-Governmental Organization 
ODK 
Open Data Kit 
RANAS 
Risk, Attitude, Norm, Ability and Self-regulation 
SDC 
Swiss Agency for Development and Cooperation 
SDG 
Sustainable Development Goal 
Swiss TPH 
Swiss Tropical and Public Health Institute 
Tdh 
Terre des hommes 
ToA 
Theory Of Action 
ToC 
Theory Of Change 
UNICEF 
United Nations Children’s Fund 

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WASH 
Water, Sanitation and Hygiene 
WHO 
World Health Organization 
 
 
 

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IV. 
Synopsis 
 
Project Leader 
Prof. Dr Mirko Winkler 
Study Title 
hands4health: Hand hygiene, water quality and sanitation in schools not 
connected to functional water supply system: a cluster-randomized 
controlled trial in Nigeria and Palestine 
Short Title/Study ID 
Hand hygiene intervention in schools- H4H 
Protocol Version and 
Date 
Version 1.0, 02.06.2023 
 
 
Study Category with 
Rationale 
Non-clinical study, risk category A: no drugs are being tested, and only 
hand-rinse samples are being taken 
 
 
 
Background and 
Rationale 
Despite the effectiveness of hand hygiene in reducing the transmission of 
infectious diseases – as demonstrated by the COVID-19 pandemic – 2.3 
billion people – primarily located in low- and middle-income countries 
(LMICs) – are exposed to increased risk of infectious diseases as a result 
of lack of access to water and hygiene services. Improving hand hygiene is 
most challenging in humanitarian contexts, where challenges in water 
availability and quality in combination with overcrowded conditions often 
limit access to sanitation and hygiene services. Schools are one of the most 
critical places where adequate water, sanitation and hygiene (WASH) 
should be provided in such settings. 
Against this background, the Hand4Health (H4H) project will implement a 
multicomponent intervention (MCI) designed to improve hand hygiene and 
access to water for students in schools not connected to functional water 
systems in Nigeria and Palestine by providing them with a sustainable 
handwashing system and a package of systematic handwashing-behaviour 
change activities. 
Objective(s) 
Primary objective: 
Evaluate the effects of the H4H multi-component intervention (MCI) 
package on hand hygiene of primary school students in Nigeria and 
Palestine. 
 
Secondary objectives: 
1) Evaluate the effects of the H4H MCI package on the well-being of 
primary school students in Nigeria and Palestine 
2) Assess the impact of the H4H MCI package on hygiene-related 
risks, attitudes, norms, abilities and self-regulation (RANAS) 
behavioural factors of primary school students in Nigeria and 
Palestine 
3) Assess the effect of the H4H MCI package on absenteeism 
incidence and hygiene-related health outcomes of primary school 
students in Nigeria and Palestine 
4) Explore the associations of personal, physical and social 
contextual factors with hand hygiene and the well-being of primary 
school students in Palestine 
5) Explore the perceived impacts of the H4H MCI package on the 
health and well-being of primary school students in Nigeria and 
Palestine 

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Primary Endpoint 
Secondary Endpoints 
The primary endpoint of this study will be good handwashing practice 
defined as students who wash their hands with water and soap before 
eating assessed by structured handwashing observations.  
 
The secondary endpoints are:  
 
A) Good handwashing practice defined as students who wash their 
hands with water and soap after using the toilet assessed by 
structured handwashing observation 
B) Self-reported handwashing practice answered for two critical 
events; before eating and after using the toilet, on a Likert scale 
ranging from almost never to almost always.  
C) The well-being of students assessed by KINDL tool 
D) Number of total coliforms and E.coli colony-forming units (CFUs) 
per hand before handwashing. 
E) Hygiene-related health outcomes and absenteeism incidence. The 
health outcomes will be reassessed with local experts in the 
country to assure feasibility before the start of the intervention. 
 
Study Design 
Overall project: Multi-center cluster-randomized controlled trial (cRCT) 
design.  
 
Module 1-3 will be repeated three times within the cRCT at baseline, three 
months post-intervention and at endline. Module 4 data collection will take 
place in both study arms longitudinally starting after the intervention has 
been implemented. Module 5 will be a self-reported survey administered for 
the parents of the students included in the study at baseline in Palestine. 
Module 6 and 7 are qualitative focus group discussions (FGDs) and 
interviews and will take place after the second round of data collection in 
Modules 1-3. 
Inclusion/Exclusion 
Criteria 
Study participants are primary school students aged 10-12 years attending 
eligible schools that were selected to be included in this study.  
 
Inclusion criteria Modules 1-4: 
Schools were selected based on accessibility for the study teams, not 
having a water source directly connected to the building of the school, 
having primary grades (5th-7th), having ≤ 7000 students and being impacted 
by conflict.  
 
50 students will be randomly selected from one or two classes in the 
included schools and they must fulfil all the inclusion criteria: 
- 
Age between 10-12 years or attending grades 5th-7th  
- 
Students, male and female, who are in classes close to where the 
handwashing stations (Gravit’eau) will be positioned in the school 
(in Nigeria) 
- 
Students must be in the same school for the course of the study 
(1 year). 
 
Exclusion criteria Modules 1-4: students must not fulfil any of the 
following exclusion criteria: 
- 
Refusal to participate by not providing signed consent forms or oral 
assent 
- 
having any medical condition that prevents them from washing their 
hands 
- 
having unexplained intermittent attendance in school (school 
teachers will be consulted and school’s absenteeism records will 
be checked for that) 
- 
will not be at the same school for the course of the study (1 year) 

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- 
not meeting the inclusion criteria 
Inclusion criteria Module 5:  
- 
Students of the classes included in the study in each included 
school in Palestine 
Exclusion criteria Module 5: Refusal to participate by the student or 
his/her parents  
 
Inclusion criteria Module 6:  
For students: 
- 
Students of the intervention schools 
- 
Students from the 50-student sample selected in each included 
school 
For teachers: 
- 
Aged ≥ 18 years old 
- 
Permanent employees in the school  
- 
Teaching one of the classes included in the intervention 
 
Exclusion criteria Module 6: Not providing signed consent form and/or 
oral assent 
 
Inclusion criteria Module 7:  
- 
The 
participant 
needs 
to 
be: 
a) a stakeholder within the community, state, region or country of 
the intervention whose position is related in any way to WASH in 
schools 
b) working in one of the intervention schools. They can be teachers, 
hygiene technicians or in a leading position of the school. 
c) Minimum age of 18 years 
 
Exclusion criteria Module 7: Refusals to participate 
Measurements and 
Procedures 
Different methods across modules will be used to achieve the objectives of 
this project. These modules will include 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: A combined RANAS and wellbeing survey, (ii) Module 2: 
Structured handwashing observations, (iii) Module 3: Microbiological 
analysis of hand rinse samples, (iv) Module 4: Diary approach for pre-
defined health outcomes and absenteeism incidence, (v) Module 5: 
personal, physical, and social contextual factor survey, (vi) Module 6:FGDs 
and (vii) Module 7: Key informant interviews (KIIs). 
Endpoints of Modules 1-3 will be assessed at baseline, at follow-up and 
endline of the cRCT. Module 4 will be used to collect data longitudinally 
over the course of 12 months. Module 5 will be assessed at baseline and 
only in Palestine, Module 6 and 7 will be used in the middle of the 
intervention phase in the intervention groups. 
Number of 
Participants with 
Rationale (if no 
Power Analysis 
conducted) 
The sample size calculation yielded that 13 schools are needed per arm 
with 50 students per school. With political instability and other factors which 
might lead to a loss of follow-up, we have 7 schools as backup schools. 
This will lead to 26 schools in total with a total number of 1300 students. 
The number of students participating in different modules will differ due to 
the capacity limitation of assessing the 50 students included in each school. 
For module 1, only 25 students of the 50 students included in the study in 
each school. For module 2, the 50 students included in the study in each 
school will be targeted for assessment using this module. For Module 3, 12 
students out of the 25 randomly selected students to be targeted with 
RANAS and well-being survey will be targeted for assessment using this 
module. 

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Module 4 follows the sample size calculation of the cRCT design, hence 50 
students from each of the 26 schools will be monitored. For Module 5, all 
students in the included classes in each school in Palestine will be delivered 
a survey to be self-reported by their parents. 
For Module 6, 10 FGDs (including students) and 5 FGDs (including 
teachers) will be administered and for Module 7, 10-20 interviews. 
Study Duration 
14 months 
Study Schedule 
For Nigeria: May 2023 of First-Participant-In 
July 2024 of Last-Participant-Out 
For Palestine: March 2023 of First-Participant-In 
May 2024 of Last-Participant-Out  
 
Investigator(s) 
Prof. Dr. Mirko Winkler  
Swiss Tropical and Public Health Institute 
Kreuzstrasse 2 
4132 Allschwil 
Phone: +41612848339 
mirko.winkler@unibas.ch 
 
PhD candidate (research assistant) under supervision of Prof Dr. Mirko 
Winkler: 
Yaman Abuzahra 
Swiss Tropical and Public Health Institute 
Kreuzstrasse 2 
4132 Allschwil, Switzerland 
yaman.abuzahra@swisstph.ch 
 
Zainab Abdulkarim 
Terre des hommes Nigeria 
No. 46 Talba Road, By Horama Specialist Hospital Junction  
off Allamin Daggash Road 
Maiduguri, Borno State, Nigeria 
Phone: 08065541603,08029218162 
Zainab.abdulkarim@tdh.ch 
 
Issa Younan 
Project coordinator 
Cesvi Palestine 
Ata Al-Zir Street 15, Beit Hanina, Jerusalem, Palestine 
+970592859990 
technical_supervisor@cesvioverseas.org 
 
Rena Salzmann 
Junior Programme Officer 
Skat Foundation 
Benevolpark, St.Leonhard-Strasse 45 
9000 St.Gallen, Switzerland 
+41 71 227 07 99 
rena.salzmann@skat-foundation.ch 
Study Centre(s) 
Nigeria and Palestine 
Statistical Analysis 
incl. Power Analysis 
The number of clusters (schools) and students per school were calculated 
using the software R with a power simulation of 80% developed by Dr Jan 
Hattendorf. The Intraclass Correlation Coefficient (ICC) was assumed at 
0.2. The simulation assumed a prevalence of handwashing occurrence 
before eating during the time of observation (3 hours) taking place over one 
day of 20% in control vs 45% in intervention schools after 1 year from the 

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baseline. Based on this assumption, 13 schools are needed per arm with 
50 students per school. 
 
The baseline data will be reported descriptively. The imbalance at baseline 
between trial arms will be assessed in terms of clinical importance rather 
than in terms of statistical significance. The intervention effect will be 
estimated with logistic mixed effect regression to adjust for potential 
correlation within schools. For the primary analysis, the model will include 
only the outcome (handwashing occurrence before eating during the time 
of observation (3 hours) taking place over one day and assessed at the 
endline) and the intervention as a predictor and school as a random effect. 
Further analyses will include known confounders and variables imbalanced 
at baseline. All analyses will use the available case population. No 
imputation of missing data will be done because loss to follow-up is usually 
small to moderate in school-based studies.  
Ethical consideration 
This project will be carried out in accordance with the research plan outlined 
in this protocol and with principles enunciated in the current version of the 
Declaration of Helsinki / Essentials of Good Epidemiological Practice 
issued by Public Health Switzerland (EGEP) / ISO EN 14155  / CIOMS 
International Ethical Guidelines for epidemiological studies 2009 as well as 
all national legal requirements and guidelines as applicable.  
This protocol will be reviewed by the Ethikkommission Nordwest- und 
Zentralschweiz (EKNZ, Ethics Committee of Northern and Central 
Switzerland) and also be reviewed and approved by the National Health 
Research Ethics Committee. This trial will be registered at the U.S. National 
Library of Medicine under ttps://www.clinicaltrials.gov. 
 
 
 
 
 
 

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2 BACKGROUND INFORMATION  
 
2.1 
Global public health relevance of water and hygiene 
Water insecurity has been a primary underlying determinant of global health disparities 
(Stevenson et al. 2012). In recognition of the importance of achieving universal access to safe 
water and hygiene services, one of the 17 Sustainable Development Goals (SDGs) 
established by the United Nations in 2015 is dedicated to “ensure availability and sustainable 
management of water and sanitation for all” (SDG 6) (UN 2015). Improving access to water 
and hygiene contributes to enhancing several essential aspects of life and achieving other 
SDGs (UN 2006), such as contributing to ending poverty (SDG 1) and hunger (SDG 2), 
promoting health and well-being for all at all ages (SDG 3) and empowering women (SDG 5) 
(UN 2015). 
 
Despite considerable progress in increasing access to safe water and sanitation, billions of 
people –primarily located in low- and middle-income countries (LMICs) (Guardiola et al. 2014; 
Kangmennaang and Elliott 2021) – still lack access to essential water and hygiene services 
required for a healthy life and well-being (WHO and UNICEF 2019). More specifically, a third 
of the world’s population does not have access to safe drinking water and 40% lack access to 
basic handwashing facilities with water and soap (WHO and UNICEF 2019). Consequently, 
billions of people are exposed to increased risk of water and hygiene-related diseases, with 
an estimated 2 million people, predominantly children, dying each year from diarrheal diseases 
alone (WHO and UNICEF 2019). A problem that is aggravated among children under five in 
LMICs by the exposure to drought that is likely to increase due to climate change (Wang et al. 
2022). 
2.1.1 Access to water and hygiene for disease prevention 
Studies have shown that proper handwashing with soap reduces the transmission of diarrheal 
diseases by 30% to 48% (Bloomfield et al. 2007; Ejemot et al. 2008; Freeman et al. 2014; 
Prüss-Ustün et al. 2019) and respiratory diseases by 21% (Aiello et al. 2008; Warren‐Gash et 
al. 2013). Furthermore, proper hand hygiene plays an important role in controlling the spread 
of epidemics such as cholera (Taylor et al. 2015; Ngwa et al. 2020), ebola (Wolfe et al. 2017), 
hepatitis E (Teshale et al. 2010), SARS (Fung and Cairncross 2006), and shigellosis (Khan 
1982). Also, during the current COVID-19 pandemic, handwashing with soap has received 
unprecedented attention for being the most effective measure to reduce the transmission of 
the infection. For example, Beale et al. (2021) showed that improved hand hygiene reduced 
the likelihood of contracting a COVID-19 infection by 36% (Beale et al. 2021). Indeed, if there 
is anything that the COVID-19 pandemic has reinforced, it is that increasing access to 
sustainable sanitation and handwashing facilities is more important than ever. 
2.1.2 Access to water and hygiene for the well-being 
In addition to contributing to the transmission of infectious diseases – as demonstrated by the 
COVID-19 pandemic (WHO 2020)–, there is substantial evidence of the adverse effects that 
a lack of access to water and hygiene can have on people’s psychological and physical status, 
social relationships and interactions with the environment (Guardiola et al. 2014). Yet we do 
not fully understand how water stressors impact people’s overall satisfaction with their lives 
(Rosinger and Young 2020; Kangmennaang and Elliott 2021). 

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2.1.3 Access to water and hygiene in humanitarian settings 
In humanitarian settings1, providing access to improved water2 and hygiene is often 
particularly challenging (Ersel 2015). For example, because of the ongoing crisis in Palestine 
due to the long-standing Israeli occupation that started in 1967 (OCHA 2021), more than 1.6 
million Palestinians in West Bank and Gaza have limited access to their basic WASH needs 
including access to water, sanitation and hygiene services (OCHA 2021). In Area C, which 
represents 60% of the West Bank and is under Israeli administrative and military control (UN 
HRC 2021), Palestinians have no access to their natural water resources due to the activity of 
Israeli settlements illegally established in this area (UN HRC 2021). Indeed, Israeli settlers 
diverted water resources and seized water wells under the cover of the military (UN HRC 
2013; B'Tselem 2017). Consequently, the decreased amount of available water to Palestinians 
leads to a decrease in access to sanitation and hygiene. In such conditions, the need for 
sustainable interventions to support WASH services significantly increases, and the well-being 
benefit of according interventions is expectedly very high. However, the complex and 
multidimensional nature of the crisis in Palestine makes tackling WASH vulnerability even 
more challenging. 
Another setting where access to WASH services frequently falls short of minimum 
requirements is refugee camps where limited water resources along with high population 
density result in restricted availability of drinking and use water for refugees (UNHCR 2022). 
For example, in the Mafa displacement camp in Borno state, Nigeria, WASH access for 
Internally Displaced People (IDP) is very limited, with waiting times for being provided with 
water supplies often ranging between three to six hours (UN 2020). This situation became 
even more challenging when parts of the camp were destroyed twice by fire in 2018 and 2022 
(the Guardian and the Tdh). In addition, the escalating tensions between the jihadist group 
Boko Haram and the Nigerian army triggered an increase in the number of IDPs, making 
drinking and cooking a higher priority than providing access to sanitation and handwashing. 
 
On one hand, challenges in accessing water and WASH services at large are causing a wide 
range of adverse health conditions in humanitarian contexts. On the other hand, the promotion 
of access to water and hand hygiene has proven to significantly reduce the transmission of 
infectious diseases (Pittet 2017), including COVID-19 (UN 2020). Hence, for promoting health 
and well-being in a humanitarian context there is a strong need to promote and evaluate 
interventions that aim to improve access to water and hand hygiene. 
 
2.2 
Hand hygiene in schools 
The latest data reported by the WHO and UNICEF Joint Monitoring Programme for Water 
Supply, Sanitation and Hygiene (JMP) revealed that 42% of schools (affecting 802 million 
schoolchildren) lack access to handwashing facilities, basic hygiene and water supply systems 
(UNICEF and WHO 2022). To achieve universal coverage of basic hygiene in schools by 
2030, a 5-fold increase in the current progress rates is needed (UNICEF and WHO 2022). 
33% of the schools lacking access to handwashing facilities are found in the Least Developed 
Countries (LDCs)3 and over 50% of them are found in fragile contexts4. Also, according to the 
WHO, the staff in the schools in LDCs and fragile contexts often lack the knowledge and 
                                                 
1 Humanitarian setting is where an event or series of events, usually over a large area, poses a serious threat to the health, 
safety, security, or well-being of a community or other large population which requires large amounts of external assistance, 
resources, and a multi-sectoral response involving a wide range of international humanitarian organizations to ensure people’s 
survival, care, and protection (UNICEF 2022) 
2 Improved water is protected water from outside contamination, specifically from faecal contamination (WHO 2022) 
3 Least developed countries (LDCs) are “low-income countries confronting severe structural impediments to sustainable 
development. They are highly vulnerable to economic and environmental shocks and have low levels of human assets” (un.org). 
4 Fragile contexts are “contexts where there is an accumulation and combination of risks as a result of context-specific underlying 
causes combined with insufficient coping capacity of the state, system and/or communities to manage, absorb or mitigate those 
risks.” (unicef.org) 

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capacity of managing WASH services adequately (UNICEF and WHO 2022). Therefore, it is 
crucial to concentrate efforts on providing adequate WASH services in such contexts by 
targeting school staff and students with sustainable interventions that improve their level of 
water access and hand hygiene behaviour, also given that children in these schools likely also 
have no or very limited hand hygiene resources at home and in their family environment. The 
Hands4Health (H4H) project primarily addresses such contexts where WASH services are 
inadequate, and large investments for improvement of infrastructure are unlikely in the near 
future. This is the case in many conflict areas, refugee and internally displaced population 
camps, informal settlements and remote rural areas with poor or failed institutional structures. 
Within this project schools located in such contexts in Nigeria and Palestine are targeted to 
implement the H4H Multi-Component Intervention (MCI). 
2.3 
The hands4health project 
This 
project 
is 
funded 
by 
the 
Swiss 
Development 
Cooperation 
(SDC) 
(https://hands4health.dev/) and aims to increase hygiene in schools without any direct access 
to water in the context of humanitarian crises. The project has a strong focus on the 
Sustainable Development Goal (SDG) 6, clean water and sanitation. In addition, the SDG 1 
(no poverty), SDG 3 (good health and wellbeing), SDG 4 (quality education), SDG 5 (gender 
equality), SDG 10 (reduced inequalities), and SDG 11 (sustainable cities and communities) 
are targeted (Pradhan et al. 2017). The project is led by 10 partners from academia, non-
governmental organizations (NGOs), and the private sector. To increase the level of hygiene, 
an intervention package consisting of (i) a handwashing station called Gravit’eau (only in 
Nigeria), (ii) rehabilitation of WASH infrastructure (only in Palestine) (iii) a behaviour change 
intervention from Ranas Ltd., a spin-off company of the Swiss Federal Institute of Aquatic 
Science and Technology (Eawag), (iv) training for monitoring residual chlorine in water storage 
by Fachhochschule Nordwestschweiz (FHNW) (only for Palestine), (v) capacity development 
on O&M and overall management by Fachhochschule Nordwestschweiz (FHNW), and (vi) the 
management of WASH infrastructure at facilities, including water storage, water distribution, 
handwashing and sanitation by FHNW. The Gravit’eau is designed by Gravit`eau Association, 
and evaluated by FHNW previously together with Gravit`eau and will be tested by the FHNW 
with filters supplied from the company Martin Systems. The Ecole Polythechnique Fédérale 
de Lausanne (EPFL) will test different greywater disinfection methods. The behavioural 
change intervention will be designed and lead by Ranas Ltd. The NGOs Terre des hommes 
(Tdh) and Cesvi will support the intervention and all data collection with local teams and 
expertise in Nigeria and Palestine, respectively. The Swiss Tropical and Public Health Institute 
(Swiss TPH) will lead the efficacy assessment of the project. The Palestinian Polytechnic 
University (PPU) and the University of Maiduguri (UNIMAID) have leading roles in the 
technology evaluation and user-centered design for local context; impact evaluation; water 
quality analysis, data collection and analysis; and quality control. Skat Foundation will 
coordinate the development of a systematic approach to facilitate handwashing in institutional 
settings, as well as develop an overall Theory of Change (ToC) for the intervention and a 
stakeholder engagement strategy. The ToC process, which will be continued throughout the 
project duration, and the systematic approach are directly related – both processes provide 
feedback to each other. One of the main results will be a Theory of Action (ToA), which will 
help the field and project teams to plan and implement their activities in a strategic and 
targeted way. The ToC aims to help local teams and the researchers to understand how the 
local WASH system works in schools in Nigeria and Palestine, and to identify the interplay of 
actors and factors that shape the overall system dynamic. 
2.3.1 
Gravit’eau handwashing station 
Gravit’eau is a handwashing station which recycles water with gravity (Gravit’eau 2022). The 
station does not need to be connected to an electricity source as it is activated by a foot pump. 
The design of the station is adaptable to the context of use and can hold up to 90 litres of 
water. The used water is collected and treated using gravity in a grease trap and by gravity-

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driven membrane filtration. The membrane module contains an ultrafiltration membrane that 
removes pathogenic microorganisms. In schools, chlorine can be added as a second barrier. 
The then pathogen-free water is stored in a storage tank until its next use 
(http://www.graviteau.ch). To keep an acceptable water quality also in terms of colour, the 
water needs to be replaced about once a month and the filter needs to be replaced every five 
to eight years (Gravit’eau 2022).  
 
In contrast to pre-existing handwashing stations using a bucket with a tap, Gravit’eau can save 
time and water resources by reducing the frequency of refilling the water tank from once a day 
to once a month. Consequently, more water can be saved for other purposes such as drinking 
or sanitation and the time efforts of the staff of the facility are reduced as well. Moreover, the 
station is built by local contractors using local materials, which enhances durability, facilitates 
maintenance and offers an opportunity to adapt the design to the needs of the facility and the 
context (like the size of the doors in the facility, inside or outside, etc.). So far, the station has 
been tested in a laboratory at FHNW, at a German Music Festival, in mobile health clinics in 
Palestine, in child-friendly spaces and schools in Nigeria, and in health clinics in Mali. 
However, these tests did not involve long-term data collection. In order to scale up the use of 
Gravit’eau, the station needs to be tested in the field for at least nine months to take into 
account daily use, seasonal water shortages, local adaptation, and climate conditions. 
 
2.3.2 
Rehabilitation of WASH infrastructures 
 
At an early stage of the H4H project, it became clear that the implementation of the Gravit’eau 
devices in Palestinian schools is not culturally acceptable. The Palestinian Ministry of 
Education refused to use recycled water due to social and administrative obstacles. 
Alternatively, different rehabilitation works will take place in the schools according to each 
school need. These activities include, construction of drinking stations, rehabilitation of toilets 
and handwashing stations, installing water-saving taps and installing soap dispensers at 
drinking and handwashing stations.  
2.3.3 
Behavioural change intervention 
The risks, attitudes, norms, abilities, and self-regulation (RANAS) model was developed based 
on theories from environmental and health psychology in order to systematically change 
behaviour (Figure 1). To change behaviour effectively, the underlying behavioural factors need 
to be addressed and changed (Mosler and Contzen 2016). According to the developers of the 
RANAS approach, “[RANAS] is an easily applied method for measuring behavioural factors, 
assessing their relevance for the target behaviour, designing tailored strategies that change 
the target behaviour, and measuring the effectiveness of these” (Mosler and Contzen, 2016: 
5) (Mosler and Contzen 2016). The RANAS approach consists of four phases: (i) identification 
of potential behavioural factors through an explorative phase with qualitative data collection 
tools; (ii) measurement of these factors with a questionnaire and determination of the relevant 
factors steering the behaviour (i.e. hand washing with soap) through statistical analyses; (iii) 
selection of behaviour change techniques from a standardized catalogue of Behaviour 
Change Techniques and development of campaign activities; and (iv) implementation and 
evaluation of these behaviour change activities. The RANAS approach is always tailored to 
the local context and takes into account a wide range of potential behavioural barriers and 
motivators based on the RANAS model, namely risk factors, attitude factors, norm factors, 
ability factors and self-regulation factors as well as social, physical and personal context. 
Ranas trains local “Ranas experts” and supports them in developing a behaviour change 
activity catalogue adapted to the local schools’ context, which will be thoroughly piloted before 
implementation. The RANAS approach has been applied successfully in a variety of settings 

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to change hygiene behaviour (Contzen et al. 2015, Gamma et al. 2017, Friedrich et el. 2018, 
Chidziwisano et al. 2019). 
 
 
Figure 1: RANAS model for behaviour change (Mosler and Contzen 2016) 
2.3.4 
Capacity development and training for monitoring residual chlorine in water storage 
The Ministry of Health (MoH) in Palestine chlorinates the water in the main reservoirs before 
being distributed to houses and community institutions, including the schools. However, 
water could be contaminated while being transferred to or stored in schools. The schools 
usually send water samples to test for any physical and biological contamination once per 
semester. No further testing of the water takes place in schools due to the shortage of the 
staff of the Ministry of Health who can perform the testing. Additionally, the schools are 
missing the tools needed for monitoring processes. There is a need for regular water testing 
to monitor the concentration of residual chlorine. The staff needs to be able to ensure water 
is chlorinated regularly and properly and requires: 
• 
hardware to monitor chlorine to be available 
• 
knowledge of how to measure concentrations  
FHNW supports the Cesvi team to choose the equipment to monitor chlorine concentration. 
During the training of trainers workshop they will train the teams and representatives of the 
Ministry of Education on these aspects and discuss with them the possibility of training the 
staff of the schools and supporting the overall maintenance of infrastructure to introduce 
controlled monitoring of residual chlorine. The Cesvi team will train the staff of the schools 
afterwards and review the management systems to ensure the chlorine testing is functional 
and there is quality control and monitoring in place 

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2.3.5 
The management of WASH infrastructure at schools 
The support in the management of the WASH system in each school will be carried out 
according to improvement plans resulting from the discussion with School WASH Committee. 
In this context, regular check of infrastructure, support from, a trained person, and equipped 
with proper tools under the supervision of the School WASH committee could be delivered. 
The regular checks aim to provide preventive maintenance to WASH infrastructures and/or 
support the capacity development of the institutions’ staff in daily management. The goal is to 
treat small issues before they grow in magnitude. 
 
According to the local context and needs, appropriate activities might be the following: 
● 
Providing routine maintenance of WASH infrastructure and equipment 
● 
Providing regular follow-up to the staff in the proper operation of WASH infrastructure, 
basic maintenance, water treatment methods, and responding to additional training 
requests from staff as needed 
● 
Build the capacity of school principals on budget planning for the maintenance of 
WASH equipment 
● 
Providing timely repairs (e.g. plumbing fixtures and water supplies, latrines, 
handwashing stations) 
• 
Providing regular maintenance to Gravit’eau stations 
● 
Inspecting and servicing latrines, tanks, sinks, handwashing stations 
● 
Conducting water quality tests to ensure drinking water standards are met  
● 
Reporting on WASH functionality to the relevant stakeholders 
● 
Conducting assessment and identification of further needs 
 
3 OBJECTIVES AND PURPOSE 
 
3.1 
Study rationale and objectives 
 
3.1.1 
Study rationale 
 
Due to the critical role hand hygiene plays in disease transmission, promoting hand hygiene 
became a mainstay in national infection prevention and control (ICP) strategies (WHO 2015). 
However, systematic reviews of hygiene promotion interventions showed mixed results on the 
effectiveness of these interventions for improving hand hygiene and identified, at the same 
time, a range of challenges, including the need to identify different factors responsible for hand 
hygiene (Naikoba and Hayward 2001; Wilson et al. 2011; Luangasanatip et al. 2014; De Buck 
et al. 2017; Mbakaya et al. 2017; Slekiene and Mosler 2017; Watson et al. 2017; Martin et al. 
2018). Furthermore, there is a lack of information to draw conclusions about the factors 
affecting hand hygiene in humanitarian settings (White et al. 2020). 
 
Behavioural determinants of hand hygiene can also be affected by different contextual factors 
(Mosler 2012), especially during a humanitarian crisis (Contzen and Mosler 2013). It remains 
plausible that major disruptions of someone’s social life, psychological or physical status, such 
as thos experienced during crises or emergencies could lead to changes in the handwashing 
behaviour determinants (Mosler 2012; De Buck et al. 2017). Therefore, it remains crucial for 
the effectiveness and also the local adaptation of hand hygiene promotion interventions to 
include a “soft” component that addresses a range of behavioural determinants of 
handwashing along with different contextual factors that can influence the behaviour. 
 
Furthermore, there is a lack of understanding of the many pathways and mechanisms through 
which insufficient access to water and hygiene services impacts the overall well-being and 
associated dimensions (Kangmennaang and Elliott 2021). Overall, only a few tools exist to 
conceptualise and quantitatively measure the association between water access and overall 

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health and well-being (Kangmennaang and Elliott 2021). This represents a limitation in 
comprehensively measuring and evaluating the broad health and well-being effects of WASH 
interventions (Kangmennaang and Elliott 2021). 
 
Knowledge about the effectiveness of hand hygiene campaigns in the context of humanitarian 
emergencies is extremely scarce due to the lack of baseline data and monitoring and 
evaluation activities (Vujcic  et al. 2014, Als et al. 2020). In conflict settings, hand hygiene is 
mostly being investigated in community settings, but not in schools where infections can easily 
spread (Als et al. 2020, Domini  et al. 2020). In addition, data mainly relies on self-reporting 
and can therefore rarely be triangulated. Moreover, information about barriers and motivators 
of handwashing campaigns in emergency settings is scarce (Vujcic  et al. 2014). Finally, data 
on handwashing interventions in complex emergencies is rarely shared publicly and therefore 
is not being used to inform other handwashing campaigns (Vujcic  et al. 2014). 
The Gravit’eau handwashing station is a promising invention to increase access to water in 
settings suffering water scarcity and humanitarian crises. However, its impacts on health 
determinants and outcomes of its users have to date never been assessed in a real-world 
setting over long time periods (Gravit’eau 2022). For scaling up the use of Gravit’eau, scientific 
evidence about its impact and potential barriers to implementation are much needed. 
 
3.1.2 
Primary objective 
Evaluate the effects of the H4H MCI on hand hygiene of primary school students in Nigeria 
and Palestine. In this objective, the following research question will be addressed. 
RQ 1.1 Can a quantifiable change in hand hygiene be detected due to the intervention? 
 
3.1.3 
Secondary objectives 
Additionally to the primary objective, the H4H project aims to address the following secondary objectives 
and research questions:  
 
1) Evaluate the effects of the H4H MCI on the well-being of primary school students 
in Nigeria and Palestine 
RQ 1.1 Can a quantifiable change in well-being be detected due to the intervention? 
2) Assess the effect of the H4H MCI package on hygiene-related risks, attitudes, 
norms, abilities and self-regulation (RANAS) behavioural factors of primary 
school students 
 
RQ 2.1: Can the H4H intervention package be associated with a change in hygiene-
related RANAS behavioural factors of primary school students? 
RQ 2.2: Which factors promote the uptake of the intervention? 
 
3) Explore the associations of personal, physical and social contextual factors with 
hand hygiene and well-being of primary school students in Palestine 
 
RQ 4.1 Which factors related to personal, social or physical contexts are 
independently or jointly associated with hand hygiene and well-being? 
 
4) Explore the perceived impacts of the H4H MCI package on the health and well-
being of primary school students 
 
RQ 4.1 What are the students’ and teachers’ perceived impacts of the H4H MCI on 
their hand hygiene, health and other issues? 

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RQ 4.2 What are the students’ and teachers’ perceived obstacles and challenges for 
scaling up the H4H MCI in the schools? 
RQ 4.3 What are the proposed solutions for addressing these challenges? 
 
3.1.4 
Explorative objectives 
 
1) Assess the effect of the H4H MCI package on hygiene-related health outcomes 
and absenteeism incidence of primary school students in Nigeria and Palestine 
 
RQ 1.1 What are the trends in students’ absenteeism resulting from hygiene-related 
infections over time in the two arms of the trial? 
RQ 1.2 What are the trends in hand hygiene-related health outcomes over time in the 
two arms of the trial? 
3.2 
Scientific justification of study population 
The schools’ teachers and students are at increased risk for disease transmission, particularly 
during disease outbreaks (Wolf et al. 2018). Improved water access and hand hygiene are 
essential to maintaining a hygienic environment for controlling infectious disease transmission 
in schools (Robinson 2001). In addition, schools are well positioned in principle to implement 
equitable and sustainable health-related behaviour changes that track from childhood to 
adulthood (Moore et al. 2015). 
In Nigeria, it was reported that 70% of the schools lack hygiene services and 43% of them 
lack sanitation services (UNICEF & WHO 2022). A recent study also showed that there is a 
significant WASH inequality between private and public schools in Nigeria (Wada et al. 2022). 
None of the public schools included in the study (5 schools) provided any sanitation or hygiene 
services whereas the other 5 private schools provided both services. The authors of the study 
indicated that there is a need for sustainable WASH interventions engaging local community 
stakeholders to facilitate the narrowing of existing inequalities (Wada et al. 2022).  
The overcrowding conditions in the schools where the average number of students per 
elementary class ranged from 51 to101, along with the humanitarian crisis urge the need for 
targeting these schools with sustainable interventions promoting WASH services and hand 
hygiene. The targeted schools in H4H project lie around Maiduguri, the capital and the largest 
city of Borno State in north-eastern Nigeria. The humanitarian needs are increasing in all 
locations in Borno state due to escalating crisis between the Boko Haram group and the 
Nigerian army, however, many places like the Mafa refugee camp are hardly or not accessible 
due to deteriorated security. The focus has been shifted to the schools around Maiduguri, 
which are likely to remain accessible.  
In a different fragile setting, a long-lasting military occupation in Palestine created an unstable 
and coercive humanitarian environment that left a lot of schools, specifically in Area C, 
deprived of basic water and hygiene services. According to the JMP report, basic hygiene 
services are available in only 21% of the schools in Palestine (UNICEF and WHO 2022). There 
are 3 types of schools in Palestine; public, private and UNRWA5-administered. The schools 
lie in Area C are either public or under the administration of UNRWA. The latter type lies in 
refugee camps that are completely under the supervision of UNRWA. The project targets 
public schools in remote and rural areas in Area C that are most in need for WASH services 
improvement. The average number of students per elementary class in these schools is about 
30. Usually, in such schools any improvement to WASH sector is challenging due to 
restrictions on infrastructure rehabilitation imposed by the Israeli military occupation. 
The H4H project primarily addresses such contexts where WASH services are inadequate, 
and large investments for the improvement of infrastructure are unlikely in the near future. 
This is the case in many conflict areas, refugee and internally displaced population camps, 
                                                 
5 UNRWA is The United Nations Relief and Works Agency for Palestine Refugees in the Near East 

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informal settlements and remote rural areas with poor or failed institutional structures. Within 
this project schools located in such contexts are targeted to implement the H4H MCI. 
Tdh and Cesvi have established offices in Nigeria and Palestine supporting health and WASH 
interventions in schools. Tdh and Cesvi collaborate closely with local authorities and the most 
relevant stakeholders who expressed their support for this project. 
4 STUDY DESIGN 
The overall project will follow a multi-center cluster-randomized controlled trial (cRCT) design 
(Figure 2). 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 (for the 
inclusion criteria see chapter 5.2 Inclusion criteria).  
 
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 (handwashing station, 
behavioural change intervention, capacity development, and management support). 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.  
 
In the selected schools, 50 eligible students from each school will be selected from one or two 
classes within the age group (10-12 years) using random sampling. If the school has at least 
one class that has ≥ 50 students within the target age group, the sample will be selected from 
that class, otherwise, the sample can be selected from two classes. For module 1, only 25 
students of the 50 students included in the study in each school will be involved. For module 
2, the 50 students included in the study in each school will be targeted for assessment using 
this module. For Module 3, 12 students out of the 25 students targeted with assessment using 
module 1 will be targeted for assessment using this module. 
Module 4 follows the sample size calculation of the cRCT design, hence 50 students from 
each of the 24 schools will be monitored. For module 5 which is only restricted to students 
from Palestine, the same sampling plan of the cRCT will be used, and the sample size will be 
the one foreseen to fulfil the main study objectives. For Module 6, 10 FGDs (including 
students) and 5 FGDs (including teachers) will be administered and for Module 7, 10-20 
interviews. 
 
 

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The methods to achieve the different objectives of this project are summarized in Table 1. 
These modules will include 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). 
 
 
Figure 2: Consort flow diagram of the schools selection for the H4H cRCT in Nigeria 

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Table 1: Overview of different project modules and analysis by objective 
Module 
Objective 
Analysis 
Module 1: Combined RANAS 
and well-being survey 
PO: Evaluate the effects of the 
H4H MCI on hand hygiene of 
primary school students in 
Nigeria and Palestine 
SO1: Evaluate the effects of 
the H4H MCI on the well-being 
of primary school students in 
Nigeria and Palestine 
SO2: Assess the effect of the 
H4H MCI on hygiene-related 
RANAS behavioural factors of 
primary school students 
- Descriptive statistics and 
multiple 
random 
effect 
regression models 
Module 
2: 
Structured 
handwashing observations 
PO: Evaluate the effects of the 
H4H MCI on hand hygiene of 
primary school students in 
Nigeria and Palestine 
 
- Descriptive 
statistics, 
multiple linear regression 
models 
and 
logistic 
regression models 
 
Module 3: Microbiological 
analysis 
of 
hand 
rinse 
samples 
PO: Evaluate the effects of the 
H4H MCI on hand hygiene of 
primary school students in 
Nigeria and Palestine 
- Analysis of E. coli and total 
coliforms 
- Descriptive 
statistics, 
multiple linear regression 
models 
Module 4: Diary approach 
for 
pre-defined 
health 
outcomes and absenteeism 
EO1: Evaluate the effects of 
H4H MCI on health outcomes 
and absenteeism 
- Descriptive statistics 
Module 
5: 
personal, 
physical 
and 
social 
contextual factors survey 
SO3: Explore the associations 
of personal, physical and 
social contextual factors with 
hand hygiene and well-being 
of primary school students in 
Palestine 
- Descriptive statistics, 
multivariate regression 
models 
Module 6: Focus Group 
Discussions  
SO4: Explore the perceived 
impacts of the H4H MCI on the 
health 
and 
well-being 
of 
primary school students 
- Framework methodology 
Module 7: Key informant 
interviews 
SO4: Explore the perceived 
impacts of the H4H MCI 
package on the health and 
well-being of primary school 
students 
- Framework methodology 
 
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: 
 

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Module 1: Combined RANAS and well-being survey: The survey will be developed through 
the RANAS approach and will not only include attitude and belief questions, but also target 
the underlying psychological factors postulated by the RANAS model that are important 
precursors for effective behaviour change (Mosler and Contzen 2016). If needed, this survey 
will be enriched with additional questions to assess the knowledge and self-reported 
handwashing practices of the participants. The well-being of the students will be assessed in 
the survey using the KINDL tool (Ravens-Sieberer and Bullinger 1998). It is a tool 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) (Ravens-Sieberer and Bullinger 
1998). The perceived sufficiency and safety of the water supply, satisfaction with the available 
infrastructure for handwashing, and obstacles to water access will be also assessed. The 
survey will be administered to primary school students three times in total; as a baseline 
survey before 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. 
 
Module 2: Structured handwashing observations: Structured handwashing observations 
are perceived as a gold standard method to assess handwashing behaviour in schools 
(Pickering et al. 2013; Caruso et al. 2014; Dreibelbis et al. 2016; La Con et al. 2017; Parkinson 
et al. 2018). Data from Module 1 and the observations can later be combined through a unique 
ID of the study participants. The observations will be administered with students 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 eligible 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 for the 50 selected students for the study. 
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. The 
occurrence of handwashing before eating (our primary outcome) is an opportunity that could 
be observed once for all students when break time starts. The break time included in the 
observation period is the first break for all students during a school day, and all of them use it 
for eating their brunch (as confirmed by the local teams). No matter where the station is they 
are expected to come and wash their hands before eating. For observing the occurrence of 
the other critical event and if the station was not located next to toilets, we would have two 
observers; one is next to toilets and the other one is next to the stations. Both would observe 
and then compare their results. The observations will result in a dichotomous measure, i.e. if 
the handwashing with soap for each critical event occurred or not. However, there will be 
choices like "was not visible" or "soap or water was not available" to take into consideration 
the complicated conditions in the field. 
 
If the opportunity for handwashing before eating was not possible for all students, an 
alternative scenario is proposed. In the class before the break, students will be engaged for 
30 minutes in painting activity. At the end of the activity and as a reward, students will be 
provided with a popcorn snack and will be given free time of 15 minutes so they can eat 
together the snack. They need to use their hands for eating the popcorn, so, they are expected 
to wash their hands before eating it. They will also be told they can go outside the classroom 
if they want so they would be left with the choice to wash their hands before eating if they 
want. During that time, one observer will be standing close to the handwashing stations (or 
water points before installing the Gravt’eau) and recording all the students who take the 

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opportunity and wash their hands before eating and any other handwashing opportunity, e.g. 
after using the toilet. The observation will continue during the break time (45 minutes) so as 
to cover all opportunities for handwashing before eating for students who opted not to eat the 
snack and want to have lunch during the break. Students will be asked to keep the badges 
until the end of the activity. Other handwashing opportunities will be also recorded.  
Also, if it was feasible the steps of handwashing will be observed for the students who 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. 
 
Module 3: Microbiological analysis of hand rinse samples: Hand rinse samples of 
students will be collected after administering the survey with a modified glove juice method as 
described by Pickering et al. 2010. First, the enumerators will visually assess the cleanliness 
of the participant’s hands with an observation form prompting for visible dirt in different areas 
of the hands, such as the thumb and under the fingernails (Contzen et al. 2015, Pickering et 
al. 2010 (b)). 
 
For the hand rinse sample collection, the enumerators will have to wear sterile gloves. The 
participant’s randomly selected hand will be inserted into a 69-oz Whirl-Pak bag (NASCO 
Corp., Fort Atkinson, WI) filled with 350 mL of clean water. Then, the participant has to shake 
her/his hand in the water and rub her/his thumb and fingers together for 15 seconds. 
Afterwards, the enumerator will massage the participant’s hand through the bag for another 
15 seconds. The participant will be provided with a paper towel to dry the hand, once it is 
retrieved from the bag (Pickering et al. 2010 (b)). Afterwards, the procedure will be repeated 
with the other hand. 
 
The Whirl-Pak bags containing the samples will be kept on ice in an isolation box and 
processed within 4 hours of sampling (Pickering et al. 2010 (b)). Membrane filtration will be 
used to detect colony-forming units (CFUs) of E.Coli and total coliforms. In a field laboratory, 
the content of the bags will be passed through a 47-mm-diameter 0.45 µm cellulose filter. The 
filter paper will then be placed on growth media and incubated at 35°C ± 0.5°C for a duration 
of 24 hours for E.Coli and total coliforms (Pickering et al. 2010 (b)). We plan to filter 100 mL 
per bag to detect CFUs of E.Coli and total coliforms. 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. Compact dry plates will be used for the detection of E.coli and 
total coliforms. 
 
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 the statistical analysis, the CFUs per hand will be normalized 
and log10 transformed (Pickering et al. 2010 (b)). 
 
Module 4: Diary approach for pre-defined hygiene-related health outcomes and 
absenteeism incidence: Longitudinal data on hygiene-related health outcomes and 
absenteeism will be collected over the study course (12 months) in both arms of the study. 
The main outcome of this objective is students’ hygiene-related absenteeism. Absenteeism is 
hygiene-related if the student suffered from diarrhoea, respiratory tract infections, helminth 
infections, head lice, trachoma and skin infections. For the outcome of this objective an 
electronic/paper diary will be prepared by the PhD and used in each school by one of the 
teachers on a daily basis to report the absenteeism of included students in each cluster along 
with the reason for their absenteeism (pre-defined health outcomes). To adjust for the cluster 
design effect, we will calculate the rates of hygiene-related absenteeism separately for each 
medical reason for each school. This will be carried out by dividing the number of episodes of 
hygiene-related absenteeism for each medical reason by the number of student-weeks. The 

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answer will then be multiplied by 100 to obtain rates per 100 student-weeks and will be 
presented using descriptive statistics. 
 
Module 5: personal, physical and social contextual factors survey: Handwashing 
behaviour and well-being of school children are not only influenced by the level of water 
access and psychosocial behavioural factors but also depend on culture- and context-related 
factors. The exceptional stressors forced by the prolonged military occupation in Palestine 
result in difficult personal, social and physical conditions which lead to disruption in different 
aspects of life beyond the school environment. The analysis of all possible determinants of 
hand hygiene behaviour and well-being at baseline before the start of the intervention will 
provide a better understanding of factors that potentially modify the effectiveness of an 
intervention and may need consideration for maximising effectiveness on hygiene and well-
being when implementing larger-scale WASH interventions in the Palestinian context.  
The study design will be baseline cross-sectional. This objective will be fulfilled through the 
baseline assessment conducted before randomising the recruited schools in Palestine into the 
two arms of the study. The assessment will be carried out through a survey that is self-reported 
by the parents of the students in the selected classes for the study. The survey will include 
questions related to the availability of hygiene services at the household level, evaluation of 
parents' hygiene knowledge and behaviour, and assessment of their child's hygiene behaviour 
as reported by them.  
 
Module 6: Focus Group Discussions: The FGD is a rapid and resource-efficient method of 
gathering information since all the target participants and the researcher are readily available 
at the same study site (Mack et al. 2005; Nyumba et al. 2018). There is no need to collect 
participants from different environments and prepare them in advance, rather, they will be met 
in their usual studying environment which also helps not to introduce their expectations and 
biases, including strategic group bias (Nyumba et al. 2018). Also, the concentrated nature of 
the FGD avails a large quantity of data in much less time usually needed to collect an 
equivalent number of interviews (Nyumba et al. 2018).  
10 gender-separated FGDs will take place in the included schools in the intervention arm; 5 
FGDs for each gender in autumn 2023. However, the saturation factor6 will be considered 
when conducting the discussions in the field. Each group will include students of the same 
age of the age group target (10-12) to avoid any domination of older students if the groups 
include different age groups. Using separate groups for boys and girls will help ensure 
meaningful feedback since children may feel shy speaking in front of each other and usually 
there is an increase in teasing among children at the age of 10 (Dzino-Silajdzic 2018). It is 
important for them to feel comfortable speaking their minds freely and not feel shy, 
embarrassed or worried someone will make fun of them (Dzino-Silajdzic 2018). Each FGD will 
be composed of 5-8 selected students. The selection of the students will be consulted with the 
school administration, however, selected students need to represent each participating class 
in the intervention arm of the trial. 
Additionally, there will be 5 FGDs composed of 5-8 teachers from included schools in the 
intervention arm. The teachers invited to participate in the FGDs should be permanent 
employees in the school and teach the classes included in the intervention. 
Data will be collected by a small local team with experience in qualitative data collection and 
if the security situation allows, the PhD student would join the team. The team will be 
composed of at least a moderator and a note taker who is trained prior to data collection by 
the PhD student. A field research journal will be used throughout the data collection to take 
structured notes and observations of the FGDs. The discussions will be tape-recorded and 
then transcribed in the local language and translated into English for further analysis. 
 
                                                 
6 Saturation is reached when answers of participants start repeating and no new information can be gained through additional 
FGDs. 

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Field notes, observation notes and focus group transcripts will be analysed using the 
framework method with the software MaxQDA (VERBI Software, Marburg, Germany) or NVivo 
(QSR International, Melbourne, Australia) (Gale et al. 2013).  
 
Module 7: Key informant interviews: The key informant interviews target stakeholders in 
the Ministry of Education, school committee and leaders of the community to help solicit a 
different kind of information that is deeper and more detailed about the nature of the problems 
and recommended solutions. These insights help in the triangulation of data and could not be 
gained through the FGDs as the group dynamic may not allow for asking probing and in-depth 
questions (Kumar 1989). Also, having stakeholders in the FGD may prevent other participants 
from voicing their opinions (Mack et al. 2005). The KIIs will take place in autumn 2023. 
 
Interviewers will receive the same training as for the Focus Group Discussions. The interviews 
will be audio recorded and then transcribed into the local language and translated into English 
for further analysis. In some instances, interviews may be carried out remotely (online) from 
Switzerland, in English, if it is appropriate. They will be audio recorded, transcribed, and 
translated if necessary for further analysis.  
As the FGD transcripts, the interviews will be analysed using the framework method with the 
software MaxQDA (VERBI Software, Marburg, Germany) or NVivo (QSR International, 
Melbourne, Australia) (Gale et al. 2013). 
 
4.1 
Primary endpoint  
 
The main aim of the intervention is to improve hand hygiene. So, hand hygiene will be 
assessed in this study by assessing the occurrence, frequency and technique of handwashing 
behaviour using different tools. We will operationalise our target behaviour in this study as 
handwashing with water and soap at two critical events: (i) after using the toilet and (ii) before 
eating. However, the primary outcome in this study is the occurrence of handwashing with 
water and soap before eating during 3-hours observation for one day. It is selected as the 
primary outcome since it could be objectively assessed for all included students during the 
break whether because they have the opportunity since they eat their brunch during the break, 
or because they will eat a snack provided to them on the day of data collection. 
 
4.2 
Secondary endpoints 
 
The most important secondary endpoints are: 
 
A) Good handwashing practice defined as students who wash their hands with water 
and soap after using the toilet assessed by structured handwashing observation 
B) Self-reported handwashing practice at the two critical events (before eating and 
after using the toilet) including occurrence, frequency and technique of 
handwashing behaviour will be assessed using the survey on a Likert scale ranging 
from almost never to almost always.  
C) The well-being of the students will be assessed using the KINDL tool (Ravens-
Sieberer and Bullinger 1998). 
D) The log-transformed number of total coliforms and E.coli CFUs per hand before 
handwashing. 
E) Hygiene-related health outcomes and absenteeism. The health outcomes will be 
reassessed with local experts to assure feasibility before the start of the 
intervention. 
 
Covariates are assessed with RANAS variables as exposure variables and good handwashing 
practice as outcome variable. Covariates for estimating the total effect of RANAS on good 

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handwashing practice are age, education, sex, socio-economic status, handwashing 
practices, and the water infrastructure of the schools. 
 
4.3 
Measures to minimize bias 
Different biases might arise in this project. To prevent selection bias and confounding in the 
two study arms, we will use stratified block randomization to balance the two arms with respect 
to important baseline characteristics. Due to the nature of the intervention, neither the 
participants, nor the data collectors of the study, nor the statistician can be blinded. However, 
to reduce selective counting of CFUs on the hand-rinse samples, the lab workers assessing 
the number of CFUs will be blinded. 
 
In Module 1, the RANAS and well-being survey, we expect a recall bias and a desirability bias. 
To minimize the recall bias, participants will not be asked to report any events which have 
taken place longer than a week ago. To reduce the desirability bias, the people administering 
the survey will not label themselves clearly as Tdh or Cesvi staff members, because local 
people know that Tdh  and Cesvi often delivers humanitarian aid in the region and might want 
to impress the Tdh and Cesvi teams. Additionally, to reduce any study personnel bias, the 
data collectors will all receive a training in advance. Their ID will be recorded in the survey 
form in order to be able to conduct quality control.  
 
For Modules 1 to 3, data collectors have to upload the completed surveys every night, once 
they have a stable internet connection. All of the surveys will have the data collector’s ID. The 
PhD student from Swiss TPH will control every second day how long the data collectors took 
to complete a survey, if certain answers are always the same for specific data collectors and 
the amount of missing data per survey. In addition, the GPS location of the tablet will be 
recorded to make sure that the data collection actually took place at the predefined location. 
These components will be correlated in the statistical software R (version 4.1.3) to test for 
significant differences between data collectors. In case a data collector delivers significantly 
different results which are not deemed realistic by the Swiss TPH study team and the local 
main correspondents of Tdh and Cesvi, the staff will be asked to comply with predefined rules 
once. If they still do not comply afterwards, they will be replaced. Faulty data from these staff 
members can then not be used any more for analysing the results of the H4H project. Modules 
1-3 will be repeated three months after the intervention and nine months after the intervention.  
 
For Module 2, the handwashing observations, a Hawthorne effect is to be expected (the 
tendency of individuals to modify their behaviour due to their awareness they are being 
observed (McCambridge et al. 2014)). To minimise the Hawthorne effect, students will not be 
informed of being observed and the data collector will not get closer to the student being 
observed than needed to observe soap use. However, there is a possible source of bias 
resulting from the possibility of children connecting having someone close to the handwashing 
station with the intervention. 
In Module 3, the microbiological analysis, a study personnel bias could influence the quality of 
the hand rinse samples and the accuracy of counting the CFUs. To be aware of differences 
between the data collectors, their ID will be stored during the sample collection on ODK. The 
number of CFUs per plate will be correlated with the people who collected the data to see if 
there are any significant differences between data collectors. The people counting the number 
of CFUs will be blinded and therefore do not know if the sample comes from the intervention 
or the control group. Additionally, every 10th sample will be duplicated during the data 
collection and the CFUs on every 10th plate will need to be counted additionally by another 
staff member as quality control.  
 
To enhance the reliability of the outcomes from modules (1-3), it is proposed that each school 
be visited by two teams over two consecutive days for data collection. The first team of 
observers will conduct observations and collect hand rinse samples, while the second team of 

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interviewers will visit the same school on the following day to administer the RANAS and well-
being survey to the students (as shown in Figure 3). This approach is recommended to avoid 
any potential positive impact on handwashing behaviour that may result from survey questions 
if students were surveyed first. Additionally, it will ensure that students' responses to the 
survey are not influenced as they will not be aware of being observed on the first day.  
 
 
In Module 4, students’ hygiene-related health outcomes and absenteeism will be reported by 
one of the teachers in each school. To facilitate the process, a system of automatic weekly 
messages will be generated to remind teachers of filling out the absenteeism survey, and one 
of the tdh and Cesvi staff will follow and check their submissions on the ODK centre. However, 
different biases might arise. Depending on how dutifully the teachers report and on the severity 
of the health outcomes, a detection bias might occur. We will test for this bias by correlating 
the school with the proportion of reported days of absenteeism and health outcomes over a 
year. In order to intervene in case such differences exist, we will correlate the data in each 
quarter of the study year as a form of quality control. In addition, a form of selection bias can 
happen if a certain group of students falsely report a medical reason as an excuse for their 
absence on certain days. For example, a student might report his/her reason for being absent 
is being sick with any of the predefined hygiene-related health outcomes. To minimise such 
biases, the form of absenteeism that the teachers use contains a question about the 
availability of a medical report. If there is no medical report and the teacher still questions the 
reliability of the reason for the absence, they are asked to depend on their experience and 
knowledge to judge if the student’s excuse is false or not. We are aware that this module is 
suboptimal due to the difficulty to confirm the reasons for the students’ absenteeism. However, 
this is only part of an exploratory objective. We still think that if differences can be observed 
between the two intervention arms, this module is of high importance as it would demonstrate 
the significance of the H4H MCI in schools. If these differences can be demonstrated on a 
local level, motivating local schools and the Ministry of Education for future handwashing 
interventions might become easier. 
 
To assure the quality and functioning of the Gravit’eau handwashing stations, regular integrity 
tests and water quality tests will show if the systems are still functional and capable to remove 
the bacteria. E.coli tests of handwashing water will show if there is any recontamination or any 
integrity problem. In case there is a problem, we will provide an alternative solution (e.g. bucket 
with soap) and rehabilitate the handwashing systems or dose chlorine into handwashing 
systems and repeat the test. 
Figure 3: Flow-chart of data collection activities at baseline, follow-up and endline of the project depicting 
observations, the RANAS questionnaire and the hand-rinse samples. 

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In case a school has 25% higher negative health outcomes than the average of all schools, 
the regional Ministry of Education and Ministry of Health will be consulted to check if this is 
usual. If not, the study will have to be stopped in this school. 
 
4.4 
Study duration and duration of participant’s participation 
 
Students will be regularly approached for data collection. As mentioned above, the data 
collection phase will start with observation for 50 students selected for the study, and is then 
followed by collecting hand rinse samples for 12 of them. On the second day of data collection, 
25 out of the 50 students will be interviewed with RANAS and well-being survey. The 
observations will extend for 3 hours and the hand-rinse samples will take about 10 minutes 
including oral assent. The questionnaire will take a maximum of 20-25 minutes including oral 
assent as well. The contextual factor survey is expected to take 8-10 minutes from one of the 
parents to answer. 
 
 
Entering the students’ absenteeism and the pre-defined health outcomes in the diary over the 
course of the year will not take much time of the teachers. To write down an event of 
absenteeism will take the teacher about one minute per student. 
 
Finally, some of the students and teachers of the 13 intervention schools will be asked to take 
part in FGDs or interviews. This should not take them longer than one hour. KIIs with 
stakeholders outside of the schools will also be limited to one hour. 
 

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4.4.1 
Schedule of events 
 
 
 
 
 
 
 
 

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4.5 
Amendments 
 
All of the different modules will be piloted in pilot schools of the study regions and adapted to local 
needs and circumstances. 
Substantial changes to the project set-up; the protocol and relevant project documents will be 
submitted to all of the Ethics Committees for approval according to the local EC guidelines. 
 
4.6 
Withdrawal and discontinuation 
Participants may stop their participation at any time and withdraw their consent. However, data 
obtained prior to participant’s withdrawal will be included in analysis to ensure the validity of the 
study. Data of withdrawn participants are fully anonymised once analysis is completed. Local staff is 
recruited and employed by Tdh and Cesvi and has to follow the terms and conditions of the local 
Tdh and Cesvi offices which are written in their work contract.  
The overall H4H project or specific project sites can be discontinued due to several reasons by the 
project leader, such as: 
• 
Ethical concerns (e.g. non-acceptance of proposed technical solutions) 
• 
Insufficient participant recruitment 
• 
Natural hazards (e.g. heavy floods, earthquakes) 
• 
Damage and vandalism of infrastructure, technical failure of interventions 
• 
Alternative interventions and projects at the same facilities not coordinated with us 
• 
Limited access by Tdh or Cesvi staff due to any reason out of their control including 
pandemics, natural hazards or deterioration of security situation 
• 
Political constraints restricting access to the schools or the project implementation 
 
4.7 
End of project 
The biological material from the microbiological analysis will be destroyed upon completion of data 
analysis. Health-related data will be stored in an anonymized form for a minimum of 10 years at a 
password-protected server of Swiss TPH. Photos, videos and recordings from the project will be 
stored on a password-protected server of Swiss TPH, tdh, Cesvi or FHNW. If photos or videos 
contain pictures of people, they will be asked for their oral consent. 
 
5 SELECTION OF STUDY PARTICIPANTS 
 
5.1 
Recruitment 
Recruitment will differ according to the study modules. Participants will always be recruited within 
the clusters (primary schools). For the RANAS and well-being survey (Module 1) only 25 students 
randomly selected out of the 50 students randomly selected from the classes included in the 
intervention in each school will be targeted. For the handwashing observations (Module 2) and the 
diary approach (Module 4) the 50 students randomly selected from the classes included in the 
intervention in each school will be targeted. For the hand-rinse samples (Module 3) only 12 students 
randomly selected out of the 25 students randomly selected to be targeted with the RANAS and well-
being survey will be targeted. For the contextual factor survey (Module 5), all students in the the 
classes included in the intervention in each school will be invited to participate by delivering a survey 
to be reported by one of their parents about the contextual factors that could affect hygiene practice 
of the students.  
 
For the FGDs (Module 6), 10 gender-separated FGDs will take place in the included schools in the 
intervention arm; 5 FGDs for each gender. However, the saturation factor will be considered when 
conducting the discussions in the field. Each FGD will be composed of 5-8 selected students and 
they will be asked for their consent to participate. The selection of the students will be consulted with 
the school administration, however, selected students need to represent each participating class in 
the intervention arm of the trial. 

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Additionally, there will be 5 FGDs composed of 5-8 teachers from included schools in the intervention 
arm. The teachers invited to participate in the FGDs should be permanent employees in the school 
and teach one of the classes included in the intervention. 
 
For the KIIs (Module 7), local partners will be consulted on who they see as a suitable stakeholder 
for an interview. The sampling procedure will therefore be a purposeful sampling. Interviewees will 
be contacted by the local partners. Interviews will be held until saturation is reached. 
 
5.2 
Inclusion criteria 
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, having ≤ 7000 students. 50 students within the age 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 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 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) a stakeholder within the community, state, or region of the intervention whose position is 
related 
in 
any 
way 
to 
WASH 
in 
schools 
b) working in one of the intervention schools. They can be hygiene technicians, teachers, 
school’s principal, or in a leading position in the school. 
c) Aged ≥ 18 years old 
 
5.3 
Exclusion criteria 
 
 
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) 

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- 
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 
 
5.4 
Criteria for discontinuation of study 
 
5.4.1 
Discontinuation of individual participants 
A participant can be discontinued from the study for the following reasons: 
1. 
Withdrawal of informed consent 
2. 
Moving from the included school to another school 
3. 
Long-lasting absence of at least 6 months 
4. 
Death 
5. 
Inaccessibility of the school due to a high risk security situation 
 
 
 

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6 STATISTICS 
 
6.1 
Hypothesis 
6.1.1 
Primary hypothesis 
 
The primary hypothesis stems from the research question: Does the H4H MCI make a difference in 
the hand hygiene of primary school students in Nigeria and Palestine? 
 
H1.1= There is a difference in hand hygiene between the intervention and control groups of primary 
school students in Nigeria and Palestine. 
 
H0.1= There is no difference in hand hygiene between the intervention and control groups of primary 
school students in Nigeria and Palestine. 
 
6.1.2 
Secondary hypotheses 
 
Depending on the secondary objective, different secondary hypotheses were formed: 
 
H1.1= There is a difference in well-being between the intervention and control groups of primary 
school students in Nigeria and Palestine. 
 
H0.1= There is no difference in well-being between the intervention and control groups of primary 
school students in Nigeria and Palestine. 
 
H1.2= There is a difference between hygiene-related RANAS variables between the intervention and 
control groups of primary school students in Nigeria and Palestine. 
 
H0.2= There is no difference between hygiene-related RANAS variables between the intervention and 
control groups of primary school students in Nigeria and Palestine.  
 
H1.3= There is association between personal, physical and social contextual factors and hand 
hygiene and the well-being of primary school students in Palestine. 
 
H0.3= There is no association between personal, physical and social contextual factors and hand 
hygiene and the well-being of primary school students in Palestine.  
 
H1.e= There is a difference in hygiene-related health outcomes and absenteeism between the 
intervention and control groups of primary school students in Nigeria and Palestine. 
 
H0.e= There is no difference in hygiene-related health outcomes and absenteeism between the 
intervention and control groups of primary school students in Nigeria and Palestine. 
 
6.2 
Determination of sample size  
The number of clusters (schools) and students per school was assessed by simulations using the 
software R aiming for a power of 80% at the 95% confidence level. The Intraclass Correlation 
Coefficient (ICC) was assumed at 0.2. The simulation assumed a prevalence of handwashing 
occurrence before eating during the time of observation (3 hours) taking place over one day of 20% 
in control vs 45% in intervention schools after 1 year from the baseline. Based on this assumption, 
13 schools are needed per arm with 50 students per school. However, the number of students 
assessed for different modules will differ due to the capacity limitation of assessing the 50 students 
included 
in 
each 
school. 
 
For Module 1, only 25 students randomly selected out of the 50 students randomly selected from the 
classes included in the intervention in each school will be targeted. For Modules 2 and 4 the 50 

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students randomly selected from the one or two classes included in the intervention in each school 
will be targeted. For Module 3 only 12 students randomly selected out of the 25 students involved in 
module 1 in each school will be targeted. For Module 5, all students in the the classes included in 
the intervention in each school will be invited to participate by delivering a survey to be reported by 
one of their parents. For Module 6, 10 gender-separated FGDs will take place in the included schools 
in the intervention arm; 5 FGDs for each gender. In addition, 5 FGDs targeting teachers will be 
conducted. For Module 7, 10-20 interviews will be conducted. 
 
6.3 
Description of statistical methods  
Baseline characteristics will be summarized using descriptive statistics. The difference in the 
observed proportion of washing hands before eating between two study arms at follow-up will be 
investigated using logistic mixed effect regression to adjust for potential correlation within schools. 
In the primary analysis only the intervention will be included as predictor and school as a random 
effect. 
 
6.3.1 
Datasets to be analysed, analysis populations 
For the primary analysis we will use the available case population of primary school students which 
will be analysed according to the intention-to-treat principles.  
 
6.3.1.1 
Primary Analysis 
 
Module 1: RANAS and well-being survey: The data will be summarized using descriptive statistics. 
Associations of RANAS behavioural factors with good handwashing practices and students’ well-
being with the other outcome variables from RANAS behavioural factors will be estimated using 
random effect linear regression modelling and random effect logistic regression modelling. Missing 
data will clearly be reported but not imputed. 
 
Module 2: Structured handwashing observations: To quantify the intervention effect logistic 
regression with binomial distribution with random intercepts for schools models will be applied.  
 
Module 3: Microbiological analysis of hand rinse samples: For investigating factors associated 
to E.coli and total coliform prevalence on primary school students’ hands, random effect linear 
regression models will be applied. 
 
Module 4: Diary approach for hygiene-related health outcomes and absenteeism:  The rates 
of hygiene-related absenteeism will be calculated separately for each health outcome per school. To 
quantify the intervention effect on hygiene-related health outcomes and absenteeism, random effect 
linear regression modelling will be used. 
 
Module 5: Personal, physical and social contextual factor survey:  The independent and joint 
association of personal, physical and social contextual characteristics with handwashing behaviour, 
and well-being (total score and domain-specific scores) will be analysed in the context of multivariate 
regression models that apply a variable-selection procedure that takes interactions into 
consideration to not miss those factors where the association depends on the presence of one or 
more additional variables. To assess personal profiles consisting of a combination of factors, a 
clustering approach for factors with a statistically significant association with handwashing or well-
being will be applied. 
 
Modules 6 and 7, FGDs and KIIs: FGDs and KIIs will be audio recorded, transcribed, and translated 
if necessary for further analysis. The local perception of the success and sustainability of the H4H 
intervention will be analysed using the framework method with the software MaxQDA (VERBI 
Software, Marburg, Germany) or NVivo (QSR International, Melbourne, Australia) (48). 
 
 

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6.3.1.2 
Secondary Analyses 
In a secondary analysis the models will be adjusted for known confounder and additional predictors 
imbalanced at baseline. 
 
6.4 
Handling of missing data 
No imputation of missing data will be done because loss to follow-up is usually small to moderate in 
school-based studies. 
 
 

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7 DESCRIPTION OF DATA MANAGEMENT 
7.1 
Specification of source documents 
The source documents needed in this study are listed in the table below: 
 
Source document 
Where can the source 
document be found / 
way of collection 
Storage 
List of schools 
Produced during the pilot 
phase of the H4H project 
using 
the 
Facility 
Evaluation Tool for WASH 
in Schools (FACET WINS) 
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute and FHNW 
Informed Consent 
Forms (ICFs) 
Will be signed at the school 
and scanned 
Destruction of paper form and storage of 
the scan on the password-protected 
secure 
server 
of 
Terre 
des 
hommes/Cesvi. 
Electronic case report 
form (CRF) for the 
RANAS and well-being 
survey 
Will be collected with a 
password-protected tablet 
with automatic deletion of 
data after transmission to 
server  
 
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute, Switzerland and 
during the study duration on a password-
protected  Swiss TPH Laptop of the local 
study coordinator. 
Paper and electronic 
CRF for the structured 
handwashing 
observations 
Data will be collected on 
paper and then the data 
have to be entered into a 
password-protected tablet 
with automatic deletion of 
data after transmission to 
server  
 
The paper collected will be kept in a 
locked cabinet at the tdh/Cesvi offices. 
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute, Switzerland and 
during the study duration on a password-
protected  Swiss TPH Laptop of the local 
study coordinator. 
Electronic CRF for the 
microbiological hand-
rinse samples 
Will be collected with a 
password-protected tablet 
with automatic deletion of 
data after transmission to 
server  
 
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute, Switzerland and 
during the study duration on a password-
protected  Tdh/Cesvi Laptop of the 
person responsible for data entry. 
Paper and electronic 
CRF for FGDs 
Will 
be 
read 
and 
moderated 
to 
the 
participants 
during 
the 
FGDs 
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute, Switzerland and 
during the study duration on a password-
protected  Swiss TPH Laptop of the local 
study coordinator. Paper CRF will be 
disposed at the study centre after the 
FGD. 
 
Electronic and paper 
output of FGDs 
Audio recordings of the 
FGD will be transcribed in 
a word file on a password-
Electronic 
storage 
in 
a 
password-
protected secure server at Swiss Tropical 
and Public Health Institute, Switzerland 

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protected 
Tdh/Cesvi 
Laptop. FGD notes from 
the field journal will be 
collected 
and during the study duration on a 
password-protected  Tdh/Cesvi Laptop of 
the 
person 
responsible 
for 
the 
transcription. The written paper notes will 
be stored in a locked cabinet at the study 
site. 
 
Electronic and paper 
output of KIIs 
Audio recordings of the KII 
will be transcribed in a 
word file on a password-
protected 
Tdh/Cesvi 
Laptop.  
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute, Switzerland and 
during the study duration on a password-
protected  Tdh/Cesvi Laptop of the 
person responsible for transcription. Any 
written paper notes will be stored in a 
locked cabinet at the study site. 
Participant 
identification list 
Will be obtained during the 
baseline survey 
Locked cabinet at study site (only 
accessible by field coordinator and the 
staff conducting the follow-up surveys)  
 
Paper 
or 
electronic 
CRF for spot checks of 
Gravit’eaus 
Data entry into a table on 
paper or an excel sheet at 
the study site. If previously 
collected on paper, the 
data will have to be entered 
into an excel sheet in a 
second step. 
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute, Switzerland and 
during the study duration on a password-
protected  Tdh Laptop of the person 
responsible for data collection. If the data 
is being collected on paper, storage is in 
a locked cabinet at the study site. 
Paper CRF for the 
diary 
approach 
of 
hygiene-related health 
outcome 
and 
absenteeism reporting 
Data 
will 
be 
collected 
continuously in the schools 
by the teachers on monthly 
sheets of paper. Once a 
month, 
Tdh/Cesvi 
staff 
then collects these paper 
sheets. 
First in a locked cabinet at the school and 
after pick up by Tdh/Cesvi in a locked 
cabinet at the Tdh/Cesvi office. 
Electronic CRF for the 
diary 
approach 
of 
hygiene-related health 
outcome 
and 
absenteeism reporting 
Data will be entered from 
the paper CRF to an excel 
sheet 
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute, Switzerland and 
during the study duration on a password-
protected  Tdh/Cesvi Laptop of the 
person responsible for data entry. 
Paper CRF for the 
personal, physical and 
social 
contextual 
factor survey 
Data will be collected on 
paper by students’ parents 
and the papers will be then 
sent to the school by their 
children.  Cesvi staff will 
then collect these papers 
form the school official 
First in a locked cabinet at the school and 
after pick up by Cesvi in a locked cabinet 
at the Cesvi office. 

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Electronic CRF for the 
personal, physical and 
social 
contextual 
factor survey 
Data will  be entered from 
the paper into a password-
protected 
tablet 
with 
automatic deletion of data 
after transmission to server 
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute, Switzerland and 
during the study duration on a password-
protected  Cesvi Laptop of the person 
responsible for data entry. 
 
7.2 
Data recording and source data 
Informed consent, the participant identification, the structured observation CRF, the spot check 
CRFs, and the contextual factor CRF, and the health outcome and absenteeism diary CRFs will be 
obtained on paper forms. All the forms will then be stored in a locked cabinet at the study site at the 
Tdh/Cesvi office. Participant identification will not be kept in the same cabinet as the rest of the 
forms.  
 
The survey CRF will be collected electronically using password-protected tablets from Swiss TPH 
and Open Data Kit (ODK) software (University of Washington, Seattle WA, USA). The content on 
the tablets will be deleted automatically after the transmission to the server at Swiss TPH, 
Switzerland. The server is secure and password protected. The list of schools, electronic CRFs for 
the handwashing observations, the microbiological analysis, the health outcomes and absenteeism 
diary, the contextual factor survey and the transcripts of the FGDS and KIIs will be stored on the 
same password protected Swiss TPH server. Microsoft Word and Excel documents will have a clear 
and uniform name structure including the place of data collection, date and version number to 
guarantee data traceability. The process of constantly updating data collection will not involve 
changes to the CRFs’ version number or date. Any updates to these documents must be approved 
by the ethics committee before implementation. 
 
7.3 
Confidentiality and coding 
Project data will be handled with uttermost discretion and is only accessible to authorized personnel 
who require the data to fulfil their duties within the scope of the research project. On the CRFs and 
other project specific documents, participants are only identified by a unique participant number (ID). 
The CRFs contain the ID assigned to the participant by the field staff. The name of the participant 
will be kept in a separate confidential enrolment log that matches identifying codes with the 
participants’ names and residencies during the study. This will only be accessible by the local study 
coordinator and the people conducting the survey. The document will be stored in the locked cabinet 
on site and destroyed after the end survey in order to completely anonymize participants. 
 
Biological material (the hand rinse samples) in this project is not identified by participant name 
but by a unique participant ID. Biological material is appropriately stored in a restricted area in the 
labs of Tdh and Cesvi offices and only accessible to authorized personnel for a maximum of 48h to 
be analysed.  
 
7.4 
Retention and destruction of study data and biological material 
The study data, including audio material, will be stored on the Swiss TPH server and stays there for 
a time span of 10 years after publication of the research project. The informed consent forms and 
the participant identification lists will only be kept in paper form and stored at the Tdh and Cesvi 
offices in Nigeria and Palestine, respectively, for 10 years. After 10 years all electronic data will be 
deleted and the participant identification list and the informed consent forms will be shredded and 
disposed of. 
 
Biological material, more specifically the compact dry plates containing hand-rinse samples will be 
destroyed and disposed after a maximum of 48 hours. The plates have to be disinfected before being 
disposed of in waste bins. This can either happen by a) putting them into a covered bucket containing 
1% bleach solution overnight. The next morning, the bleach solution will be emptied into the waste 

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water and the plates can be disposed in a plastic bag in any normal waste bin. Or b) the closed 
plates are placed in a pot of boiling water for a minimum of 10 minutes. After the water cools, it can 
be emptied into the waste water and the plates can be disposed in a waste bin. 
 
7.5 
Data security, access, archiving and back up 
An electronic data capture system (EDCS) will be set up which allows to accurately reflect what 
happened with the study data and the CRFs during the lifetime of the study. This includes a 
computer-generated time-stamped trail that records all actions performed on the databases (e.g. the 
individual performing an alteration). For the paper-based CRFs entries and changes need to be 
signed and dated.  
 
The EDCS contains access restrictions which makes sure that data can only be accessed by 
qualified and appropriately trained staff who are part of the study delegation, allow for checking the 
user access against the study delegation log including its documentation, and ensures that the 
Standard Operating procedures are in place.  
All data collected using the study’s CRFs is stored electronically on the password protected Swiss 
TPH server in Switzerland, while the informed consent forms and the participant identification lists 
will only be kept in paper form and stored at the Tdh and Cesvi offices in Nigeria and Palestine, 
respectively.  
All study data (electronic and paper-based) must be archived for a minimum of 10 years after study 
termination or premature termination of the study. 
 
8 QUALITY CONTROL AND QUALITY ASSURANCE 
 
8.1 
Supervision / Continuous Checks 
For the Modules 1 to 3, the electronically collected CRFs will be uploaded to the server every 
evening. The Swiss TPH PhD student (Yaman Abuzahra) will therefore be able to control the data 
collection process remotely and intervene if necessary. Additionally, there will be regular debriefings 
with the data collection staff to react to arising problems or questions. As for the start of Modules 1 
to 3, also for Modules 5 and 6, the Swiss TPH PhD student will be based close to the study locations 
if the security situation permits. Like this daily debriefings about the FGDs can take place and if the 
security situation permits, the PhD can even join the discussions to observe. In case the PhD student 
is not able to travel, a minimum of bi-weekly debriefings with the field staff will take place online via 
Zoom. 
 
8.2 
Confidentiality, data protection  
All people involved in the study will have access to the study protocol. On request, the protocol can 
be shared with other parties as well. The participant identification list used for coding is only 
accessible by the local field coordinator and the people conducting the survey in order to know whom 
they have to visit. After the end survey, the participant identification list will be destroyed and not 
accessible to anybody. The datasets and statistical code will be available to everyone involved in 
the study who needs it in the anonymized form. Data can be published and disseminated because it 
is anonymized. Also, if there are requests for the dataset or the statistical code from third parties, it 
can be shared in the anonymized form. 
 
8.3 
Translations - Reference language  
The reference language of all study documents is English.  
 
The survey questions and important key words of the FGD guide will be translated into Hausa by the 
Tdh staff in Nigeria and into Arabic by the staff of Cesvi in Palestine. The Swiss TPH staff will then 
come together with the local Tdh/Cesvi staff for a back translation to English and check if the 
meaning of the words is still appropriate. 
 

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8.4 
Storage of biological material and related health data 
Water samples and hand-rinse samples will be stored in a refrigerator for a maximum of 48 hours 
until analysis. If unfiltered water is left from schools, it will be discarded in the drain after resting for 
30 minutes with 10mg/L of chlorine. For the analysis, CFUs will be counted and the plates will be 
photographed. The pictures will be stored in the same way as other health-related data. After 
counting the CFUs and recording the compact dry plates with pictures, they have to be destroyed 
immediately to prevent any further growth of potentially harmful bacteria (see chapter 7.4 Rtention 
and destruction of study data and biological material). 
 
9 ETHICAL CONSIDERATIONS 
 
9.1 
Independent Ethics Committee (IEC) 
Any protocol amendments, the informed consent, and all other forms of participant information 
related to the study and any other necessary documents have to be reviewed by an Independent 
Ethics Committee (IEC). The Ethikkommission Nordwest- und Zentralschweiz (EKNZ) in Switzerland 
will be asked for approval.  The following IECs reviewed the submitted protocol and granted approval 
in both countries: the National Health Research Ethics Committee (NHREC) in Nigeria, and the 
Institutional Review Board (IRB) of An-Najah National University in Palestine. 
 
9.2 
Risk-benefit ratio 
With the H4H intervention, the schools will receive much-needed handwashing infrastructure. An 
added benefit of Gravit’eau is that it only has to be refilled with water about once a month. This can 
save the school community precious time at work and water can be saved at the school level to be 
used as drinking or cleaning water. With the RANAS behaviour change program, the students will 
receive valuable information on how to maintain good hand hygiene during their stay inside and 
outside the school. This knowledge together with the available infrastructure will enable the students 
to better protect themselves against infections and enhance their well-being and satisfaction towards 
the handwashing structure in their schools. In addition, the students can transfer their knowledge to 
other students in the school or their families and communities. Finally, if the intervention helps to 
foster better hygiene at the school level, the school might become more attractive to students and 
offer a better learning experience. 
 
The control schools will not receive any form of intervention during the year where the intervention 
package is being tested in the intervention schools. However, after this year, they will also receive 
an intervention package.  
 
Depending on the Covid-19 situation in the study location, a slightly increased risk of infection arises 
during the FGDs. However, by conducting the FGDs outside with the use of masks and hand 
sanitizer and by distancing, this risk will be reduced to a minimum. In addition, the Gravit’eau does 
not contain water for drinking. Health effects of regular ingestion of Gravit’eau water have so far not 
been tested. By clearly introducing the Gravit’eau as a handwashing station and by clearly labelling 
the station with signs that signify “no drinking water”, this risk will be reduced. During the piloting 
phase, the most appropriate and understandable signs will be chosen with the local staff.  
 
To conclude, the benefits of this study for the participants, the schools, and the teachers clearly 
outweigh the potential risks for study participants. Moreover, the risk of contracting Covid-19 is 
already a daily risk for the school communities and might even be reduced through better access to 
handwashing stations. 
 
9.3 
Participant information and consent 
The Investigator or his/her representative will explain the nature of the study to the participant’s 
guardian and the participants according to the guidelines referred to, and answer all questions 
regarding this study, prior to obtaining informed consent.  

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In both countries, the Ministry of Education (MoE) permits written consent from the participant's 
guardian and oral assent from the children. This approach is adopted to prevent potential confusion 
among parents/guardians that may arise from seeking written assent. The ethics committees in both 
countries have granted approval for the consent form to be signed by the participant's guardian, 
accompanied by oral assent from the children. 
In the case of an illiterate participant’s guardian, an impartial witness will be called to make sure that 
the participant’s guardian understood the information and agrees. This witness must be independent 
of the research being conducted and cannot be influenced unfairly by the researchers. For example, 
a literate relative of the participant’s guardian is eligible as an impartial witness. Both, the 
participant’s guardian and the impartial witness must sign the ICF. If the participant’s guardian does 
not have a signature, a fingerprint will be sufficient.  
 
For the handwashing observations, the survey and hand-rinse samples, the participants’ guardians 
will be asked for consent at least two weeks prior to data collection. Their written consent will be 
sought without letting them know when exactly the observers and enumerators will visit the school.  
For the handwashing observation, oral assent of children will be sought retrospectively at the end of 
the project. 
9.4 
Participant confidentiality 
The Investigators must ensure that the participant’s confidentiality will be maintained. Students will 
be identified on the Case Report Forms with a unique participant ID composed of the initials of the 
study schools and a serial number (e.g DM12). The Investigators will keep a separate confidential 
enrolment log that matches identifying codes with the participants’ names and residencies. 
 
9.5 
Participants requiring particular protection 
People in our study regions belong to a vulnerable population because they are living in close 
proximity to where violent armed groups are active. However, they are capable of judgement and do 
not apply for any tutelary authority. The H4H project cannot guarantee protection or evacuation in 
case of a deterioration of the security situation. However, if the security situation would deteriorate 
so much that the students cannot come to the schools anymore, the study would be stopped in the 
affected location. 
 
Children under the age of 18 are the study group and they are considered a vulnerable group. To 
protect the children, their guardian has to sign a written ICF agreeing their child’s participation in the 
study. In addition, the participant has to provide oral assent to participate in the study. 
There are no particular risk for the children is expected during any of the study’s modules. 
 
9.6 
Participant compensation 
Participant compensation has been defined with the local partners from Tdh and Cesvi. Participants 
in the modules 1- 5 will not be compensated individually. However, participants may receive a snack 
(popcorn) during the observation period (module 2) if this was decided to be needed for observing 
the occurrence of handwashing before eating. Also, participants attending the focus group 
discussions and interviews will be offered a snack at the end of the work (water, drink, and sandwich). 
 
9.7 
Damage coverage / Insurance 
Field staff and collaborators visiting the country are insured by Tdh Lausanne and Cesvi. For the 
study participants there is no insurance as the project risk class is A. 
 
9.8 
Other aspects 
Tdh and Cesvi workers are allowed to assist schools with transport, in case an emergency patient 
needs to be transported to the nearest hospital. Tdh and Cesvi do have official evacuation 
documents for this instance.  
 

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Field workers will be briefed before their deployment to the schools about the sensitive nature of this 
study setting. They will be informed that they might encounter emergencies. In case that a field 
worker needs psychological support, Tdh/Cesvi will arrange this.  
 
For the security of the field workers, Tdh and Ccesvi have a security department which is responsible 
for security protocols and updates concerned staff about the safety of visiting certain areas. 
 
10 FUNDING 
This project is funded by the SDC within their research programme called TRANSFORM (2020-
2030) (see supplementary files for the contract with SDC). The research team attests that there is 
no conflict of interest and that this study will be conducted independently of outside influences in 
terms of specific intellectual, financial, and proprietary agendas. 
The budget of the H4H project is available as supplementary document. 
 
11 DISSEMINATION OF RESULTS AND PUBLICATION POLICY 
Data can be shared between project partners. Whoever was responsible and or involved in the 
collection of data, has the right to publish this data. People involved in the data collection will be 
approached to be a co-author of upcoming publications if they are willing to contribute to the paper 
writing process. 
 
11.1 
Dissemination to scientific community; incl. lead in publications 
The results of the research will be presented in scientific publications, project reports, a PhD Thesis 
at conferences and potentially as a MSc Thesis. 
 
11.2 
Information of community and policy makers 
Key stakeholders have been involved in the project from the beginning with the kick-off workshop in 
2021, followed by the co-production of the theory of change. They will be approached again for 
interviews in 2023. At the end of the project sanitary and education authorities, policymakers and 
local key stakeholders will be informed with webinars, sector events and workshops. Former schools 
which have participated in the study will be informed about the results by the local implementation 
partners from Tdh and Cesvi. 
 
 

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