hands4health: Hand Hygiene, Water Quality and Sanitation in Primary Health Care Not Connected to Functional Water Supply System: a Cluster-randomized Controlled Trial in Mali and Burkina Faso
Phase: NA
Conditions: Hand Hygiene Behavior, Hand Hygiene Effectiveness
Sponsor: Swiss Tropical & Public Health Institute

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Study Protocol 
(Epi & non-clinical studies) 
 
“hands4health: Hand hygiene, water quality and sanitation in primary health care  
not connected to functional water supply system: a cluster-randomized controlled trial in 
Mali and Burkina Faso” 
 
 
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 
Date 
17.01.2023 
Project Leader / 
Responsible 
PD 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 the 
h4h project and 
lead at FHNW 
 
Bruno Pascual 
Terre des 
hommes 
Lausanne 
WASH Advisor  
WASH 
coordinator at 
Terre des 
hommes 
Lausanne 
 
Aboubacar Ballo 
Terre des 
hommes Mali 
 Regional advisor  Lead of Terre 
des hommes 
Mali 
 
Kamboulbé Dah 
Terre des 
hommes 
Bourkina Faso 
WASH 
Responsable 
Lead of Terre 
des hommes 
Burkina Faso 
Dr. 
Anna Gamma 
Ranas Ltd. 
Senior Behaviour 
Change Expert 
Behaviour 
Change work 
package Mali 
and Burkina 
Faso 
Dr. 
Jan Hattendorf 
Swiss TPH 
Scientific Project 
Leader 
Statistician 
 
Anaïs Galli 
Swiss TPH 
PhD Candidate 
Investigator 
 
Meleesa 
Naughton 
Skat Foundation 
Water specialist 
Knowledge 
broker 
 
The project leaders are qualified individuals by education and training and 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 primary health 
care not connected to functional water supply system: a cluster-randomized 
controlled trial in Mali and Burkina Faso 
 
The following project leaders have approved the protocol version [1 (dated 17.01.2023)], 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, dated 17.01.2023) 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 center/site) 
 
Signature 
 
 
 
 
Name  
Mirko Winkler 
Date of Signature 
(DD.MM.YYYY) 
Title 
PD Dr. 
Institution 
Swiss Tropical and Public Health Institute 
Address 
Kreuzstrasse 2 
4123 Allschwil 
Phone 
+41612848339 
 
 
 

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Local Project Leader at local center/site Mali 
Signature 
 
 
 
 
Name  
Aboubacar Ballo 
Date of Signature 
(DD.MM.YYYY) 
Title 
 
Institution 
Terre des hommes Mali 
Address 
Cité du Niger 
Phone 
+ 223 91 57 96 08/ 76471935 
 
 
Local Project Leader at local center/site Burkina Faso 
Signature 
 
 
 
 
Name  
Kamboulbé Dah 
Date of Signature 
(DD.MM.YYYY) 
Title 
 
Institution 
Terre des hommes Burkina Faso 
Address 
01 BP 2212 Ouagadougou 01 
Phone 
+22676712626 
 
 
Statistician 
Signature 
 
 
 
 
Name  
Jan Hattendorf 
Date of Signature 
(DD.MM.YYYY) 
Title 
Dr. 
Institution 
Swiss TPH 
Address 
Kreuzstrasse 2 
4123 Allschwil 
Phone 
+41612848193 
 
 
 
 
 

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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 
13 
2.1 
The effects of hand hygiene on health .................................................................................................................................... 13 
2.2 
Hand hygiene in health care settings ...................................................................................................................................... 13 
2.2.1 
WASH in health care facilities 
13 
2.2.2 
Health care-associated infections 
13 
2.2.3 
Hand hygiene of HCWs (HCWs) 
14 
2.3 
The hands4health project ....................................................................................................................................................... 14 
2.3.1 
Gravit’eau handwashing station 
14 
2.3.2 
Behavioural change intervention 
15 
2.3.3 
Capacity development and training for chlorination of water storage 
16 
2.3.4 
LoRaWAN technology 
16 
2.3.5 
WASH FIT 
17 
2.3.6 
The management of WASH infrastructure at facilities 
17 
2.4 
Study setting: WASH in humanitarian emergencies ................................................................................................................ 18 
3 
Objectives and purpose 
20 
3.1 
Study rationale and objectives ................................................................................................................................................ 20 
3.1.1 
Study rationale 
20 
3.1.2 
Primary objective 
20 
3.1.3 
Secondary objectives 
20 
3.2 
Additionally to the primary objective, the h4h project aims to address the following secondary objectives and research 
questions: ......................................................................................................................................................................................... 20 
3.2.1 
Explorative objectives 
21 
3.3 
Scientific justification of study population ................................................................................................................................ 21 
4 
Study design 
21 
4.1 
Primary endpoint .................................................................................................................................................................... 25 
4.2 
Secondary endpoints .............................................................................................................................................................. 26 
4.3 
Measures to minimize bias ..................................................................................................................................................... 26 
4.4 
Study duration and duration of participant’s participation ........................................................................................................ 28 
4.4.1 
Schedule of events 
30 
4.5 
Amendments .......................................................................................................................................................................... 31 
4.6 
Withdrawal and discontinuation .............................................................................................................................................. 31 
4.7 
End of project ......................................................................................................................................................................... 31 
5 
Selection of study participants 
31 
5.1 
Recruitment ............................................................................................................................................................................ 31 
5.2 
Inclusion criteria...................................................................................................................................................................... 32 
5.3 
Exclusion criteria .................................................................................................................................................................... 32 
5.4 
Criteria for discontinuation of study ......................................................................................................................................... 33 
5.4.1 
Discontinuation of individual participants 
33 
6 
Statistics 
34 
6.1 
Hypothesis.............................................................................................................................................................................. 34 
6.1.1 
Primary hypothesis 
34 
6.1.2 
Secondary hypotheses 
34 
6.2 
Determination of sample size .................................................................................................................................................. 34 
6.3 
Description of statistical methods ............................................................................................................................................ 35 
6.3.1 
Datasets to be analysed, analysis populations 
35 
6.3.1.1 
Primary Analysis 
35 
6.3.1.2 
Secondary Analyses 
35 
6.4 
Handling of missing data ........................................................................................................................................................ 35 
7 
Description of data management 
35 
7.1 
Specification of source documents ......................................................................................................................................... 35 
7.2 
Data recording and source data .............................................................................................................................................. 37 
7.3 
Confidentiality and coding ....................................................................................................................................................... 38 
7.4 
Retention and destruction of study data and biological material .............................................................................................. 38 
7.5 
Data security, access, archiving and back up ......................................................................................................................... 38 
8 
Quality control and quality assurance 
39 
8.1 
Supervision / Continuous Checks ........................................................................................................................................... 39 
8.2 
Confidentiality, data protection ................................................................................................................................................ 39 
8.3 
Translations - Reference language ......................................................................................................................................... 39 
8.4 
Storage of biological material and related health data ............................................................................................................. 39 
9 
Ethical considerations 
39 
9.1 
Independent Ethics Committee (IEC) ...................................................................................................................................... 39 
9.2 
Risk-benefit ratio ..................................................................................................................................................................... 40 
9.3 
Participant information and consent ........................................................................................................................................ 40 
9.4 
Participant confidentiality ........................................................................................................................................................ 41 
9.5 
Participants requiring particular protection .............................................................................................................................. 41 
9.6 
Participant compensation ....................................................................................................................................................... 41 
9.7 
Damage coverage / Insurance ................................................................................................................................................ 41 

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9.8 
Other aspects ......................................................................................................................................................................... 41 
10 
Funding 
42 
11 
Dissemination of results and publication policy 
42 
11.1 Dissemination to scientific community; incl. lead in publications .............................................................................................. 42 
11.2 Information of community and policy makers .......................................................................................................................... 42 
12 
References 
43 
13 
Appendices 
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 
DAG 
Directed Acyclic Graph 
DALY 
Disability-Adjusted Life Year 
Eawag 
Swiss Federal Institute of Aquatic Science and Technology 
EPFL 
Ecole Polythechnique Fédérale de Lausanne 
FACET 
Facility and Evaluation Tool for WASH in Institutions  
FGD 
Focus Group Discussion 
FHNW 
Fachhochschule Nordwestschweiz 
HAI 
Health Care-Associated Infection 
HCF 
Health care facilities 
HCW 
Health Care Worker 
HRO 
Ordinance of Human Research with the Exception of Clinical Trial (Switzerland) 
ICF 
Informed Consent Form 
IDP 
Internally Displaced People 
IEC 
Independent Ethics Committee 
IoT 
Internet of Things 
IPC 
Infection Prevention and Control 
JMP 
Joint Monitoring Programme 
KII 
Key Informant Interview 
LMIC 
Low and Middle-Income Country 
LoRaWAN 
Low-Power, Wide Area Networking Protocol 
NGO 
Non-Governmental Organization 
Kofam 
Koordinationsstelle Forschung am Menschen (Federal Office of Public Health’s (FOPH) 
portal for human research in Switzerland) 
ODK 
Open Data Kit 
PHCF 
Primary Health Care Facility 
RANAS 
Risk, Attitude, Norm, Ability and Self-regulation 
SDC 
Swiss Agency for Development and Cooperation 

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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 
WASH 
Water, Sanitation and Hygiene 
WASH FIT 
Water and Sanitation for Health Facility Improvement Tool 
WHO 
World Health Organization 
 
 
 

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IV. 
Synopsis 
 
Project Leader 
PD Dr. Mirko Winkler 
Study Title 
hands4health: Hand hygiene, water quality and sanitation in primary 
health care not connected to functional water supply system: a cluster-
randomized controlled trial in Mali and Burkina Faso 
Short Title/Study ID 
Hand hygiene intervention in primary health care 
Protocol Version and 
Date 
Version 1, 17.01.2023 
 
 
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 
On the African continent, more than half of the population does not have 
access to a handwashing facility with water and soap at home. This 
inaccessibility contributes to the spread of communicable diseases, such 
as diarrhea. Countries affected by humanitarian emergencies are 
particularly vulnerable to water shortages and a lack of hygiene. This lack 
is particularly problematic in health care settings to avoid health care 
associated infections. Data about hand hygiene or the success of hygiene 
interventions in primary health care facilities (PHCFs) in conflict settings is 
scarce. Therefore, the “hands4health” project will collect data about hand 
hygiene in PHCFs and then administer a hand hygiene intervention 
package containing handwashing stations and behaviour change in 
PHCFs bordering conflict regions in Mali and Burkina Faso. 
Objective(s) 
Primary objective: 
Evaluate the effects of the comprehensive h4h handwashing intervention 
on hand hygiene in PHCFs in Mali and Burkina Faso. 
 
Secondary objectives: 
1) Assess hygiene-related risks, attitudes, norms, abilities and self-
regulation (RANAS) behavioural factors of health care providers 
2) Assess the impact of the h4h intervention package on hygiene-
related RANAS behavioural factors of health care providers 
3) Explore perceived effects on health and wellbeing of the 
hands4health intervention package in PHCFs 
Primary Endpoint 
Secondary Endpoints 
The primary endpoint of this study will be good handwashing practice 
defined as health care workers (HCWs) who wash their hands with water 
and soap almost always in the five critical moments of the World Health 
Organization assessed by structured handwashing observations. Critical 
moments are: 
i) 
Before touching a patient 
ii) 
Before clean/aseptic procedures 
iii) 
After risk/exposure to body fluids 
iv) 
After touching a patient 
v) 
After touching a patient’s surroundings 
The secondary endpoints in the survey are:  
 
A) Self reported handwashing practice answered for each critical 
moment on a Likert scale ranging from almost never to almost 
always.  

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B) Number of total coliforms and E.coli colony-forming units (CFUs) 
per hand before handwashing. 
C) Hygiene-related health outcomes which are summarized in table 
3. The health outcomes will be reassessed with local experts of 
the respective countries 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, two 
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 and 6 are qualitative focus group 
discussions (FGDs) and interviews and will take place after the second 
round of data collection in Modules 1-3. For Module 2, only a maximum of 
10 HCWs per facility will be observed. 
Inclusion/Exclusion 
Criteria 
Study participants will be HCWs of the PHCFs which were chosen to be 
included in this study.  
 
Inclusion criteria Modules 1-3: 
PHCFs were chosen based on accessibility for the study teams, not 
having a water source directly connected to the building of the facility, 
having a maternity ward, having at least five employees and being 
impacted by conflict. All of the HCWs who are present in the PHCFs of the 
day of data collection will be invited to participate in the project for 
Modules 1 and 3. 
 
 HCWs must fulfil all the inclusion criteria: 
- 
Minimum age of 18 years 
- 
HCWs, men and women, who are in direct (body) contact with the 
patients 
 
 
Exclusion criteria Modules 1-3: HCW participants must not fulfil any of 
the following exclusion criteria: 
- 
HCWs, whose primary occupation is not in the PHCF of the h4h 
project 
- 
Suffering from any skin conditions not allowing the HCW to use 
soap or alcoholic hand rub 
- 
Refusals to participate 
 
Inclusion/Exclusion criteria Module 4: As the data will be collected on 
the health care facility level, all facilities in the project will be included. 
 
Inclusion criteria Module 5:  
- 
HCWs of the intervention facilities 
- 
Minimum age of 18 years 
 
Exclusion criteria Module 5: Refusals to participate. 
 
Inclusion criteria Module 6:  
- 
The participant needs to be: 
a) a stakeholder within the community, state, region or country of 
the intervention who’s position is related in any way to WASH in 
HCFs 
b) working in one of the intervention PHCFs. They do not need to 
be HCWs, they can also be hygiene technicians or in a leading 
position of the facilities. 

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- 
Minimum age of 18 years 
 
Exclusion criteria Module 6: 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: Combined RANAS and knowledge, attitudes and practice 
(KAP) 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, (v) Module 5:FGDs and 
(vi) Module 6: 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 9 months. Module 5 and 6 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 a minimum of 20 health care facilities 
per country. With political instability and other factors which might lead to 
a loss of follow-up, we increased the sample size to 24 health care 
facilities per country. This will lead to 48 health care facilities in total. We 
estimate a median of 6 HCWs working in the facilities and a mean number 
of 5 observed handwashings per person. This would lead to about 384 
participants in the entire study. 
 
For Modules 1 and 3, all HCWs who are present during data collection 
and eligible will be asked to participate in the study. For Module 2, the 
observations a maximum of 10 HCWs per PHCF will be followed in order 
to avoid disturbing the daily routines of the PHCF too much. Module 4 
follows the sample size calculation of the cRCT design, hence 24 PHCFs 
will be monitored. For Module 5, 6-10 FGDs will be administered and for 
Module 6, 10-20 interviews. 
Study Duration 
14 months 
Study Schedule 
January 2023 of First-Participant-In (planned) 
March 2024 of Last-Participant-Out (planned) 
Investigator(s) 
Prof. Dr. Mirko Winkler and Anaïs Galli 
Swiss Tropical and Public Health Institute 
Kreuzstrasse 2 
4132 Allschwil 
Phone: +41612848339 
mirko.winkler@unibas.ch and anais.galli@swisstph.ch 
 
Aboubacar Ballo 
Terre des hommes Mali 
Cité du Niger 
Rue 24, Porte 118 
BP 1311 Bamako, Mali 
Phone: + 223 91 57 96 08/ 76471935 
aboubacar.ballo@tdh.ch 
 
Kamboulbé Dah 
Terre des hommes Burkina Faso 
01 BP 2212 Ouagadougou 01 
Phone :  
kamboulbe.dah@tdh.ch  
 
Meleesa Naughton 
Skat Foundation 
St. Leonhard-Strasse 45 Benevolpark 

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9000 St.Gallen 
Phone 
meleesa.naughton@skat-foundation.ch 
Study Centre(s) 
Multinational: Mali, Burkina Faso  
Statistical Analysis 
incl. Power Analysis 
To determine the required sample size, we run a series of simulations 
using the software R. Assuming a mean number of six staff members 
(range two to nine) per health facility and a mean number of five times a 
person was supposed to wash their hands (SD=5) and an intra cluster 
correlation coefficient of 0.15, we need to enrol 10 health facilities in each 
trial arm to detect difference of 15%-points (30% control versus 45% 
intervention) with 81% power at a two-sided 5% significance level. To 
account for potential loss to follow-up we aim to enrol in total 24 health 
facilities. 
 
Baseline characteristics will be summarized using descriptive statistics. 
The difference between two study arms at follow-up will be investigated 
using mixed effect logistic regression models with random intercepts for 
health care facilities using the available case population analysed 
according to the intention-to-treat principles. In the primary analysis only 
the intervention will be included as predictor.  
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 Institute 
of Public Health (INSP) in Mali, and the Comité d’Ethique pour la 
Recherche en Santé (CERS) in Burkina Faso. 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 
The effects of hand hygiene on health 
Globally, about 3.3% of deaths are attributable to effects of insufficient water, sanitation, and 
hygiene (WASH), of which 53% occur in sub-Saharan Africa (1). Similarly, 4.6% of the global 
disability-adjusted life years (DALYs) can be attributed to inadequate WASH (1). These numbers 
are likely to be underestimating the true effects of WASH on the global burden of diseases, as they 
only stem from quantifiable effects. Examples are malaria, diarrheal diseases, soil-transmitted 
helminthiasis, and Schistosomiasis, which are often neglected or not representatively reported (1). 
Moreover, important health outcomes such as mental health or maternal and neonatal adverse 
health effects are not included in the calculations for the health effects attributable to insufficient 
WASH. 
 
Despite recent efforts to increase hygiene during the coronavirus disease 2019 (COVID-19) 
pandemic, one third of the global population lacked access to basic hygiene in 2020 (2).  Basic 
hygiene is defined as having a handwashing facility on premises with water and soap (3). On the 
African continent, more than half of the population did not have access to basic hygiene and 28% 
did not have any handwashing facility (3). When considering the regions of Africa, West African 
countries have the worst access to basic hygiene services, with 35% of the population not having 
any handwashing facility. Within the countries, inequalities persist between geographic regions and 
urban and rural areas (3). 
Hand hygiene is crucial to sustain individual and community health. Without proper hand hygiene, 
pathogens can be easily transmitted from faecally contaminated hands (e.g. after using the toilet, 
changing diapers, handling animal products) to other people’s hands, eyes, and mouths (4). 
Hence, inadequate hand hygiene can increase the risk for transmission of diarrheal, respiratory, 
and skin diseases (5-7). Scientific literature reviews report that handwashing education can reduce 
diarrheal disease prevalence by 23-40% (4-6), respiratory disease prevalence by 16-21% (4, 7), 
and school absenteeism due to gastrointestinal diseases by 29-57% (8). 
 
2.2 
Hand hygiene in health care settings 
2.2.1 
WASH in health care facilities 
One fourth of health care facilities in the world do not have access to basic water services (9). The 
global baseline report of the United Children’s Fund (UNICEF) and the  WHO Joint Monitoring 
Programme (JMP) in 2019 stated that from the 55 mostly low-and middle-income countries 
(LMICs) which offered data about handwashing facilities at the point of care, only 43% had fully 
functional stations with soap (10). The likelihood of not having a handwashing facility doubles if the 
health care facility is a PHCF (9). A study conducted in 14 LMICs found that 37% of sampled 
health care facilities had water with E.coli contaminations, exceeding the WHO guidelines (11). 
2.2.2 
Health care-associated infections 
Health care-associated infections (HAIs) are the most common adverse health effect occurring in 
health care settings (12). These infections lead to prolongation of hospital stays, disability, the 
spread of anti-microbial resistant bacteria, excess deaths generating high individual and societal 
costs (13). LMICs are disproportionately affected by HAIs with a prevalence ranging from 5.7-19% 
in mixed patient populations of hospitals (12, 14).  
 
Beyond improving community health, proper hand hygiene is also crucially important in health care 
settings. A systematic literature review reports that multi-component hand hygiene campaigns 
resulted in a median effect of 49% (12.7-100%) reduction of HAIs (15). The World Health 
Organization (WHO) strongly promotes good hand hygiene practices in health care with guidelines, 
toolkits, and the WHO Multimodal Hand Hygiene Improvement Strategy (16). There is a lack of 

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studies investigating single-component interventions, rendering it difficult to estimate the true effect 
of hand hygiene alone (15, 17). 
2.2.3 
Hand hygiene of HCWs (HCWs) 
Global estimates about hand hygiene of HCWs are scarce. The WHO estimates that in high-
income countries hand hygiene compliance in health care settings hardly surpasses 70% (18). In 
LMICs, only 9% of critically ill patients are treated with best practices in hand hygiene (18). In sub-
Saharan Africa, handwashing prevalence at critical moments differs across countries with about 
20% in Burkina Faso (19, 20), 8% in Mali (21), 15% in Uganda (22), and 55% in South Africa (23). 
The low prevalence in these studies were explained with a lack of knowledge and insufficient 
infrastructure. 
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 and PHCFs 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 (24). 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, (ii) a behaviour change intervention from Ranas Ltd., a spin-off company of the 
Swiss Federal Institute of Aquatic Science and Technology (Eawag), (iii) capacity development and 
training for chlorination of water storage  by Fachhochschule Nordwestschweiz (FHNW), (iv) the 
low-power, wide area networking protocol (LoRaWan) technology (only for Mali) and (v) the Water 
and Sanitation for Health Facility Improvement Tool (WASH FIT) 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, 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 graywater disinfection methods. The behavioural change intervention will be designed and 
lead by Ranas Ltd. The NGO Terre des hommes (Tdh) will support the intervention and all data 
collection with local teams and expertise and cooperates with Green Cityzen to test the LoRaWan 
technology.  The Swiss Tropical and Public Health Institute (Swiss TPH) will lead the efficacy 
assessment of the project. 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 PHCFs of the project countries, 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 (25). 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 is treated using gravity in a grease trap and by the gravity-driven membrane filtration. 
The membrane module contains ultrafiltration membrane that removes pathogenic 
microorganisms. In health care facilities, 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 color, the water needs to be replaced about once 
a month and the filter needs to be replaced every five to eight years (25).  

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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 is 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 facility, inside or outside, etc.). So far, the station has been tested in a 
laboratory at FHNW, in 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 
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 (26). 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) (26). The RANAS approach consists of four 
phases: (i) identification of potential behavioural factors through an explorative phase with 
qulitative 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 their own behaviour change activity catalogue which will 
be thoroughly piloted before implementation. The RANAS approach has been applied successfully 
in a variety of settings to change hygiene behaviour (27-30). 

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Figure 1: RANAS model for systematic behaviour change (26) 
2.3.3 
Capacity development and training for chlorination of water storage 
Chlorination of drinking water and handwashing water is mandatory in the health care facilities. 
However, the staff does not always have an understanding of the procedure of chlorination and the 
monitoring of the concentrations of residual chlorine in the water. Additionally, HCFs might be 
missing tools for the chlorination and monitoring processes. The staff needs to be able to ensure 
water is chlorinated regularly and properly and require: 
- 
hardware to dose and monitor chlorine to be available 
- 
existing and functional supply chain for chlorine products 
- 
knowledge on how to dose the chlorine, measure concentrations and  
- 
knowledge on how to dose the chlorine. 
FHNW support the Tdh team to choose the equipment to dose and monitor chlorine concentration 
considering the forms of chlorine available on the local market. During the training of trainers 
workshop we will train the teams and representatives of the health authorities on these aspects 
and discuss with them the possibility of training the staff of the facilities and supporting the overall 
maintenance of infrastructure to introduce controlled chlorination. The Tdh and Cesvi teams will 
train the staff of the facilities afterwards and review the management systems to ensure the long 
term supply chains are functional and there is quality control and monitoring in place.      
2.3.4 LoRaWAN technology 
The Graviteau project is looking for a solution to monitor the Gravit'eau handwashing station to 
ensure that the service is provided. Greencityzen is supporting us to deploy Internet of Things (IoT) 
solutions in health centres to secure the water supply. The LoRa-based solution has proven to be a 
viable concept. The Greencityzen HummBox IoT platform also allows the integration of third-party 
sensor information (https://www.greencityzen.fr/home/). 

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2.3.5 WASH FIT 
The WASH FIT process is a risk-based approach to improving and sustaining WASH and 
biomedical waste management infrastructure and services in health facilities in LMICs developed 
by the WHO and the United Nations Children’s Fund (UNICEF) (31). The WASH FIT process is an 
improvement tool that should be implemented consistently and regularly, with the objective of firstly 
helping health facility staff and administrators prioritise and improve their services and secondly, 
supporting national, regional or district level efforts in health care improvement (31). 
 
The Wash FIT methodology includes behavioural changes for infection prevention and control 
(IPC) such as hand hygiene, biocleaning of equipment and surfaces, medical waste management; 
changes in infrastructure, and maintenance and repair.  
 
The main goal of the h4h project is to empower the PHCFs covered by this study in the 
participatory (technical staff, Community health Associations, local authorities, communities) and 
sustainable management of WASH services in general and in the ownership of the Gravit'eau 
system by PHCF managers in particular. 
The implementation of the WASH Fit approach by Tdh and the health authorities will include the 
following 5 steps of the classic WASH Fit approach by WHO and UNICEF) (31): 
 
o Setting up the WASH Fit team (technical staff, Community health Associations, local authority, 
communities); 
o Conducting the initial assessment; 
o Identification and prioritization of improvement actions; 
o Development and implementation of the progressive improvement plan; 
o Ongoing monitoring of the effectiveness of the plan and its periodic review. 
 
2.3.6 The management of WASH infrastructure at facilities 
The support in the management of the WASH system in each institution will be carried out 
according to improvement plans resulting from the WASH Fit process led by the PHCFs. In this 
context, regular visits of a technician, trained and equipped with proper tools under the supervision 
of the WASH Fit committee could be delivered. The visits 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 facility managers on budget planning for the maintenance of WASH 
equipment 
● 
Providing timely repairs (e.g. plumbing fixtures and water supplies, latrines, handwashing 
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 
 

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2.4 
Study setting: WASH in humanitarian emergencies 
This project will take place in Mali and Burkina Faso in rural areas from the year 2021 to 2024. 
Both countries are located in the West African Sahel zone and are known for their political 
instabilities (32, 33). In recent years, jihadists and other radical groups have been terrorizing the 
population leading to a rise in internally displaced people (IDP) (32, 33). Additionally, these 
countries were affected by the impact of the COVID-19 pandemic threat has swept the world (34). 
This state of emergency impacts various determinants of health, such as WASH. 
 
The right to water and sanitation is a human right which is expressed as an international law and 
has to be upheld by affected states during conflict situations (35). Poor WASH has been identified 
as one of the key risk factors for communicable disease outbreaks in humanitarian emergencies 
(36). In these situations, sanitation infrastructure is often overburdened, water quality is poor, the 
water quantity is insufficient, and crowding occurs (37). During acute emergencies, globally 40% of 
children’s deaths in camps are attributable to diarrheal diseases (38). 
 
Hand hygiene promotion is often included in campaigns by NGOs and the United Nations during 
emergencies. However, these campaigns are mostly administered at community household level 
and do not target people in health care (39, 40). 
In Mali, the project will take place in the region of Ségou in the sanitary districts of Markala, 
Macina, San, and Tominian (Fig. 2). The official language in Mali is French and in the study 
regions, most people speak and understand Bambara (32). 
 
In Burkina Faso, the study takes place in the Boucle du Mouhon region and in the provinces of 
Mouhoun, Nayala, and Sourou. Apart from the official language French, the people in the study 
provinces mostly speak and understand Moré or Dioula (33). Information about potential project 
health care facilities assessed in a pilot phase of the h4h project can be seen in Table 1. 
 
In both countries, the areas studied are affected by armed extremist groups, but humanitarians are 
not targeted and Tdh has security and humanitarian access experts who ensure adequate security 
standards are met based on a localised risk analysis. Security management is ensured by focusing 
on the accessibility and acceptance of interventions including this project. In addition, the potential 
of armed groups moving further into the study regions provokes worries about maintaining access 
to water sources, which are already scarce. 
 
 

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Figure 2: Map of potential health care facilities assessed in a pilot phase of the h4h project in the provinces of 
Markala, Macina, San, and Tominian in Mali, and in the provinces of Moughon, Nayala, and Sourou in Burkina 
Faso.  
Table 1: Health care facility information assessed during a h4h pilot phase* 
Characteristic 
Measure 
Mali (n=60) 
BF1 (n=53) 
BF2 (n=48) 
Number of employed staff  
Median 
6.0 
8.0 
5.0 
Number of outpatients during 
the busiest month 
Median 
365.0 
470.0 
651.0 
Total number of births during 
the busiest month 
Median 
19.0 
17.0 
18.0 
Water source which is not 
directly accessible in the 
building 
Percentag
e 
65.0 
86.8 
83.3 
* Due to security concerns in the facilities of the first pilot phase in Burkina Faso (BF1), a second 
pilot phase (BF2) took place in more accessible facilities. Both are displayed in the table. 

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3 
OBJECTIVES AND PURPOSE 
 
3.1 
Study rationale and objectives 
 
3.1.1 
Study rationale 
Despite increased awareness about the importance of hand hygiene in the post-COVID-era and 
global efforts to improve WASH, data gaps about access to basic hygiene persist, especially in 
rural sub-Saharan Africa (3). Hand hygiene in health care facilities is crucial for the prevention of 
HAIs. Unfortunately, data about HAIs in LMICs is scarce due to the lack of diagnostic facilities, 
patient records, and necessary expertise of HCWs in HAI control and surveillance (12, 13). The 
few available data on HAIs are usually collected in tertiary care settings (hospitals) because patient 
follow-up is much easier with in-patients and HAIs can better be distinguished from community-
acquired infections (41). Consequently, there is a big data gap on the occurrence of HAIs in 
primary health care settings in LMICs (13). Overall, HAIs in LMICs are estimated to be higher than 
in high-income countries because infection control measures rarely exist, staff lack the necessary 
training, insufficient infrastructure and hygiene material and the health facilities are often 
overcrowded by populations with high prevalence of infectious diseases (13). The most commonly 
reported HAI in LMICs is the surgical site infection, caused by unhygienic procedures of the HCWs 
(12).  
 
Hand hygiene interventions have been proven to be effective in reducing a variety of infections in 
community, school and health care settings (4, 7, 8). However, information about additional 
benefits of these interventions is rarely available. Evidence about satisfaction, saving of costs or 
other resources, and the number of patients visiting the PHCFs would be important indicators for 
the success of an intervention. 
 
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 (37, 39). In conflict settings, hand hygiene is mostly being investigated in community 
settings, but not in health care facilities where infections can easily spread (39, 40). 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 (37). 
Finally, data on handwashing interventions in complex emergencies is rarely shared publicly and 
therefore is not being used to inform other handwashing campaigns (37). 
The Gravit’eau handwashing station is a promising invention to increase access to water in 
settings suffering water scarcity and humanitarian crisis. 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 (25). For scaling up the use of Gravit’eau, scientific evidence about its 
impact and potential barriers for implementation are much needed. 
 
3.1.2 
Primary objective 
Evaluate the effects of the comprehensive h4h handwashing intervention on hand hygiene in 
PHCFs in Mali and Burkina Faso. 
 
3.1.3 
Secondary objectives 
 
3.2 
Additionally to the primary objective, the h4h project aims to address the following 
secondary objectives and research questions:  
 
1) Assess hygiene-related risks, attitudes, norms, abilities and self-regulation (RANAS) 
behavioural factors of health care providers 
RQ 1.1: What is the level of hygiene-related RANAS behavioural factors of health care 
providers? 

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RQ 1.2: What is the current water and hygiene infrastructure of the health care facility? 
RQ 1.3: Are hygiene-related RANAS behavioural factors associated to selected 
independent variables (demographic indicators, previous training, water infrastructure, 
etc.)? 
 
2) Assess the effect of the h4h intervention package on hygiene-related RANAS 
behavioural factors of health care providers 
RQ 2.1: Can the h4h intervention package be associated to a change in hygiene-related 
RANAS behavioural factors of health care providers? 
RQ 2.2: Which factors promote the uptake of the intervention? 
RQ 2.3: Does the change in hygiene-related RANAS behavioural factors differ between the 
two study countries? 
 
3) Explore perceived effects on health and wellbeing of the hands4health intervention 
package in PHCFs 
RQ 4.1: What are the perceived potential effects of the h4h intervention package? 
RQ 4.2: How can the h4h intervention be further improved to fit the local needs? 
RQ 4.3: What are potential barriers for district / region / country-wide implementation of the 
h4h intervention? 
RQ 4.4: What are the potential opportunities for district / region / country-wide 
implementation of the h4h intervention? 
RQ 4.5: How did the HCWs perceive the implementation of the h4h intervention package? 
3.2.1 
Explorative objectives 
1) Assess effects of the h4h intervention package on health outcomes and absenteeism 
RQ 3.1: What are the differences in hygiene-related health outcomes of patients in the 
health care facilities receiving the h4h intervention compared to control facilities? 
RQ 3.2: What are the differences in absenteeism due to disease in HCWs over time in the 
two arms of the h4h study? 
3.3 
Scientific justification of study population 
The study countries were both chosen because they have been affected by ongoing conflicts 
caused by armed extremist groups over the past years (32, 33) while suffering severe water 
shortages (42, 43). In Mali, the region of Ségou hosted in May 2022 35’702 IDP. This is the highest 
number of IDP in a still accessible region of Mali. Mopti, Tombouctou, and Gao hosted more IDP 
but are not secure enough to visit (44). Additionally, the region of Ségou was described in the last 
WASH cluster report of Mali as one of the regions with one of the highest needs for water acces 
while having only very few NGOs working in the area (42). In 2019, Tdh`s evaluation in 60 Health 
centres in the Ségou Region showed that 59% had no WASH service and 34% had limited service. 
Similary, the Boucle du Mouhoun region in Burkina Faso is one out of six regions affected by a 
water crisis in the country (43). Boucle du Mouhoun hosted in February 2022 almost 81’000 IDP. 
PHCFs were chosen as study clusters for several reasons: (i) NGO interventions usually focus on 
communities and do not specifically target health care facilities (39, 40), (ii) access to water in 
health care facilities is crucial to avoid the spread of HAIs (15), (iii) research about HAIs in PHCFs 
of LMICs is very scarce (41). Finally, (iv) if HCWs can protect themselves from infections, the 
health care facility is more likely to have a sufficient number of staff members, who can then deliver 
their service to the population. Tdh has established offices in Mali and Burkina Faso supporting 
health and WASH interventions in health care facilities to complement its maternal, newborn and 
child health programme. Tdh collaborates closely with local authorities and most relevant 
stakeholders who expressed their support to this project. 
4 
STUDY DESIGN 
The overall project will follow an multi-center cluster-randomized controlled trial (cRCT) design 
(Figure 3). Prior to this study, the Facility and Evaluation Tool for WASH in Institutions (FACET) 

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has been used to assess the WASH infrastructure of the PHCFs in the study regions. From these 
PHCFs 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 collaborators who carefully assessed the 
security situation around the facilities. The Tdh collaborators then chose 24 facilities which are 
most probable to still be accessible for data collection within the next year. These 24 PHCFs will 
then be distributed into two arms (intervention vs. control) with stratified randomization using 
computer-generated randomization code provided by an statistician not involved in any field 
activities. The intervention arm will receive the full intervention package (handwashing station, 
behavioural change intervention, capacity development, management support, chlorination training 
and WASH FIT). The control arm will receive nothing for the duration of the intervention (9 
months). Afterwards they will receive the same intervention package with potential improvements 
identified in the former intervention group.  
 
In the chosen PHCFs all HCWs present at the day of data collection who fulfil the inclusion criteria 
will be asked to participate in the study. We aim to have as many of the HCWs in all of the Modules 
1 and 3 as possible. For Module 2, only a maximum of 10 HCWs per facility will be observed. 
 
  
 
The methods to achieve the different objectives of this project are summarized in Table 2. 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 KAP 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, (v) Module 5: Focus Group Discussions (FGDs) and (vi) 
Module 6: Key informant interviews (KIIs). 
 
 
Figure 3: Consort flow diagram of the PHCF selection for the h4h cRCT in Mali 

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Table 2: Overview of different project modules and analysis by objective 
Module 
Objective 
Analysis 
Module 1: Combined 
RANAS and KAP survey 
SO1: Hygiene-related RANAS 
behavioural factors of HCWs 
at baseline 
- Descriptive statistics, 
multiple linear and logistic 
regression models 
Module 2: Structured 
handwashing observations 
SO1: Hygiene-related RANAS 
behavioural factors of HCWs 
at baseline 
SO2: Impact of h4h 
intervention on hygiene-
related RANAS behavioural 
factors of HCWs 
- Descriptive statistics, 
multiple linear regression 
models and logistic 
regression models 
 
Module 3: Microbiological 
analysis of hand rinse 
samples 
SO1: Hygiene-related RANAS 
behavioural factors of HCWs 
at baseline 
SO2: Impact of h4h 
intervention on hygiene-
related RANAS behavioural 
factors of HCWs 
- Analysis of E. coli and total 
coliforms 
- Descriptive statistics, 
multiple linear regression 
models 
Module 4: Diary approach 
for pre-defined health 
outcomes 
EO1: Effects of h4h 
intervention package on 
health outcomes and 
absenteeism 
- Descriptive statistics 
Module 5: Focus Group 
Discussions  
SO3: Perceived effects of the 
h4h intervention package 
- Framework methodology 
Module 6: Key informant 
interviews 
SO3: Perceived effects of the 
h4h intervention package 
- Framework methodology 
 
 
The Swiss TPH assessed the health care worker’s understanding of hygiene and expected positive 
and negative impacts of the intervention with Gravit’eau with focus group discussions (FGDs) in 18 
facilities in Mali and 9 facilities in Burkina Faso (more facilities are still being investigated). Local 
collaborators from Tdh and the regional ministries of health 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: 
 
Module 1: Combined RANAS and KAP 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 (43). If needed, this survey will be enriched with additional questions to 
assess knowledge and self-reported handwashing practices of the participants. The survey will be 
administered to HCWs three times in total; as a baseline survey before the intervention package, 
about two 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. 
 
Module 2: Structured handwashing observations: Structured handwashing observations are 
perceived as a gold standard method to assess handwashing behaviour (12, 44). 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 HCWs three times at the same time points 

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as the survey in Module 1. In this study, two scenarios for structured observations are suggested. 
They will be chosen according to what functions better and is deemed more appropriate by our 
local collaborators during the piloting phase. Scenario 1 is a structured handwashing observation 
by a trained observer, whereas scenario 2 is the observation of a consultation room with a camera 
at the ceiling. 
 
Scenario 1: A trained observer from a Tdh team, who normally works in the health care facilities 
with a different function will visit the facility under the pretence of their usual function. They will be 
equipped with an observation tool and will follow a healthcare worker for a minimum of one hour at 
the peak time for patient visits. The observer will not declare that he/she is observing handwashing 
practices. Consent will be obtained at a health care facility level, from the director of the health 
care facility. To avoid making patients feel uncomfortable during sensitive procedures, such as 
giving birth, only patient visits containing physical examination, injection, and blood sampling will 
be observed and the patients will be asked for their oral consent prior to entering a room with them. 
 
Scenario 2: A small camera will be placed at the ceiling of a consultation room in a way that heads 
are only seen from above and patient’s remain unrecognizable. At the beginning of the study, the 
HCWs will be informed that the cameras will operate several hours a day to observe their quality of 
care. They will be asked to give consent prior to the installation of the cameras. In addition, each 
patient will be informed before entering the consultation room and they will be asked for their 
consent as well. The recordings of 1 hour intervals during peak time of patient visits will be 
analysed by a researcher from the h4h team. 
 
Module 3: Microbiological analysis of hand rinse samples: Hand rinse samples of HCWs will 
be collected after 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 (28, 45). 
 
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 
(45). 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 (45). 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 (45). 
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 and log10 
transformed (45). 
 
Module 4: Diary approach for pre-defined health outcomes: Longitudinal data on hygiene-
related health outcomes of patients and disease-related absences of HCWs will be collected during 

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9 months after the intervention in both of the study arms from the cluster-randomized controlled 
trial with a diary approach (Table 3). Every time a pre-defined health outcome takes place at facility 
level, this outcome will be reported in a diary by the director of the PHCF (or someone who was 
appointed by the director). No patient names or birth dates will be recorded to keep this data fully 
anonymous. For each health outcome the director will report when it happened, if applicable how 
long it took, if applicable the number of days of treatment, if known the reason for the outcome and 
if it was an infection the outcome (recovered, death, unknown) (Table 3). These health outcomes 
either occur directly at the health care facility, if the facility offers inpatient care, or are reported if 
the patients report their outcome after a visit (e.g. by calling or re-visiting the facility). The diary 
consists of one table per month containing all of the different health outcomes and subcategories. 
Consequently, the HCWs can keep track of these outcomes with a minimal administrative effort. 
The local study team is still discussing if a paper table, which will be collected once a month will be 
used, or if alternatively, the team sends the doctor in charge once a month a mobile survey to fill in 
the data.  
 
Module 5: Focus Group Discussions: The FGDs will be used to capture the common norms and 
beliefs of the HCWs. This tool offers many insights in shorter time compared to other qualitative 
methods such as participatory observation (46, 47). Data will be collected by a small local team 
with experience in qualitative data collection and if the security situation allows, by the Swiss TPH 
PhD student in autumn 2023. The team containing at least one moderator and one observer/note 
taker will be trained by the PhD student prior to data collection. A field research journal will be used 
throughout the study to take structured notes and observations of the FGDs. The discussions will 
be audio recorded and then transcribed into the local language and translated to French or English 
for further analysis. 
 
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) (48).  
 
Module 6: Key informant interviews: The KIIs will engage with other stakeholders outside of the 
health care facilities who have an influence on the intervention areas of the project. Some of these 
key informants will have been identified through the Theory of Change analysis, while others will 
be suggested by local partners. Individual interviewees were chosen as a tool to gain the insights 
of these stakeholders, such as people from the ministry of health or the mayor, so that their status 
does not influence other participant’s freedom of speech (47). The KIIs can be additionally used to 
inquire further about questions or topics which came up during the FGDs. Further, the format of 
interviewing can also be used on the health care facility level, in case not enough participants are 
available for a FGD. 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 to French or English 
for further analysis. In some instances, interviews may be carried out remotely (online) from 
Switzerland, in French, 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) (48). 
 
4.1 
Primary endpoint  
 
The primary endpoint is the number of times a participant performs good handwashing practice 
with soap at critical moments assessed by structured handwashing observations over half an hour 
to an hour per HCW. The number of critical moments serves as denominator. Critical moments are 
defined by the WHO as: 
 

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i) 
Before touching a patient 
ii) 
Before clean/aseptic procedures 
iii) 
After risk/exposure to body fluids 
iv) 
After touching a patient 
v) 
After touching a patient’s surroundings 
 
4.2 
Secondary endpoints 
 
The most important secondary endpoints in the survey are: 
 
A) Self reported handwashing practice to answer for each critical moment on a Likert scale 
ranging from almost never to almost always.  
B) The log-transformed number of total coliforms and E.coli CFUs per hand before 
handwashing. 
C) Hygiene-related health outcomes which are summarized in table 3. The sum of each 
outcome variable seperately per facility will be used as a measure for statistical 
analysis. The health outcomes will be reassessed with local experts of the respective 
countries to assure feasibility before the start of the intervention. 
Table 3: Hygiene-related health outcome variables for Module 4. 
Outcome variable 
Details 
Absenteeism of health care worker 
 
Record of the event 
 
Number of days absent 
 
Reason for absence 
Maternal mortality 
 
Record of the event 
 
If known, reason of passing 
Neonatal mortality 
 
Record of the event 
 
If known, reason of passing 
Neonatal sepsis(49) 
 
Record of the event 
 
Number of days treated 
 
Outcome (healthy, unknown, death) 
Umbilical cord infection 
 
Record of the event 
 
Number of days treated 
 
Type of infection 
 
Outcome (healthy, unknown, death) 
Wound infection after stitching of 
surgical procedures 
 
Record of the event 
 
Number of days treated 
 
Outcome 
 
 
Covariates were assessed with a directed acyclic graph (DAG) with RANAS variables as exposure 
variables and good handwashing practice as outcome variable (Appendix). Covariates for 
estimating the total effect of RANAS on good handwashing practice are age, education, sex, socio-
economic status, previous training in hygiene, handwashing practices, position in the health care 
facility, and the water infrastructure of the health care facilities. 
 
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 

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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 KAP 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 with the exception of one question about their last training on 
handwashing. To reduce the desirability bias, the people administering the survey will not lable 
themselves clearly as Tdh staff members, because local people know that Tdh often delivers 
humanitarian aid in the region and might want to impress the Tdh team. 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 correspondent of 
Tdh, the staff will be asked to comply to 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 two months after the 
intervention and nine months after the intervention. For Module 5, the proportion of reported health 
outcomes per year will be correlated with the health care facility four times during the survey year. 
 
For Module 2, the handwashing observations, a Hawthorne effect is to be expected. Once the 
participants notice that they are being observed, they might change their behaviour accordingly. 
We will not be able to completely eliminate this bias. However, by not declaring that the observer is 
part of the h4h project, the participants will not know that the observer is focussing on 
handwashing behaviour. In scenario 1 of the observation technique, a bigger Hawthorne effect is 
expected, as people can ignore a camera more easily than an observer who constantly takes 
notes. However, we expect that with scenario 2 more handwashing opportunities or actions will not 
be clearly visible because the HCW or patient might obscure the view from the camera by their 
position in the room. 
 
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 a quality control.  
 
In Module 4, the reporting of pre-defined health outcomes, different biases might arise. Depending 
on how dutifully the HCWs report and on the severity of the outcomes, a detection bias might 
occur. We will test for this bias by correlating the health care facility with the proportion of reported 
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 patients does not report back after suffering any form of 
infection they contracted at the health care facility. For example, if neonatal sepsis occurs, patients 
might directly go to a tertiary health care facility instead of a PHCF. We are aware that this module 
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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 good hand hygiene in PHCFs. If these differences can be 
demonstrated on a local level, motivating local HCWs 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. 
 
In case a facility has 25% higher negative health outcomes than the average of all facilities, the 
regional Ministry of Health will be consulted to check if this is usual. If not, the study will have to be 
stopped in this facility. 
 
4.4 
Study duration and duration of participant’s participation 
HCWs will be regularly approached for data collection. First, the data collection phase starts with 
the observations and is then followed by the Ranas questionnaire and the hand-rinse samples 
(Figure 3). For practical reasons, the hand-rinse samples can be taken right after the 
questionnaire.  
The observations will take approximately 30 minutes to one hour per HCW depending on how 
many patients visit and hence how many handwashing opportunities arise. The questionnaire will 
take a maximum of 40 minutes and the hand-rinse samples about 10 minutes. This means that for 
the Ranas questionnaire and the hand-rinse samples together with the informed consent, the 
participant will be asked for about an hour of his/her time. 
 
Entering the pre-defined health outcomes in the diary over the course of the year will not take 
much time of the HCWs. To write down an event will take the HCW about two minutes per event. 
Figure 4: 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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Finally, the HCWs of the 12 intervention facilities 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 health care 
facilities 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 facilities 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 and Northern EC 
guidelines. 
 
4.6 
Withdrawal and discontinuation 
Participants may stop their participation at any time and withdraw their consent. Local staff is 
recruited and employed by Tdh and has to follow the terms and conditions of the local Tdh 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 staff due to any reason out of their control including pandemics, 
natural hazards or deterioration of security situation 
 
Political constraints restricting access to the health care facilities 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, Terre des hommes 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 (HCFs). For the surveys (Module 1) and the microbial testing (Module 3), all HCWs in 
the intervention facilities will be targeted. For the handwashing observations (Module 2), a 
maximum of ten HCWs will be followed. If a PHCF has more than ten HCWs, they will be selected 
at random by drawing blindly their names from a closed bag. The patients who will be in contact 
with the HCWs during the observation period will all be asked to participate and to allow the 
observer to watch the interaction with an oral informed consent. 
 
For the FGDs (Module 6), HCWs from the intervention arm of the h4h study will be invited to 
participate. If more than 3-4 HCWs are present at the day of the FGD, they will be selected 
randomly and asked for their consent to participate. In addition, the potential of inviting patients or 
their care takers will be explored in order to assess if the h4h intervention brings noticeable 
changes and improvements on the level of quality of care. Structures of hierarchy and gender in 
the health care facilities will be identified with the local partners to avoid mixing strongly differing 
hierarchies in mini groups of 3-4 participants. The group size of HCWs will be kept small as the 
participants should all have high expertise in hand hygiene in the intervention group (46). 
Depending on the hierarchical levels and if patients will be invited for discussion, one to four FGDs 
will take place per facility. If the FGDs are only done with HCWs, 6-10 FGDs per country will take 

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place or until saturation1 is reached. In case interviews are held within the HCFs instead of FGDs, 
we expect to have 10-20 interviews or until saturation is reached. 
 
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 HCWs of the PHCFs which were chosen to be included in this study. 
PHCFs were chosen based on accessibility for the study teams, not having a water source directly 
connected to the building of the facility, having a maternity ward, having at least five employees 
and being impacted by conflict. All of the HCWs who are present in the PHCFs of the day of data 
collection will be invited to participate in the project for Modules 1 and 3. 
 
Inclusion criteria Modules 1-3: HCWs must fulfil all the inclusion criteria: 
- 
Minimum age of 18 years 
- 
HCWs, men and women, who are in direct (body) contact with the patients 
 
During the handwashing observations, health workers will consult with patients. In order to protect 
patients, they must meet these inclusion criteria for an observer to be allowed into the consultation 
room with them: 
- Minimum age of 18 years or be accompanied by a legal guardian 18 years or older. 
- Going to the SSE for a physical examination, injections/vaccinations or blood test. 
- Oral consent to enter the room with them 
 
Inclusion criteria Module 4: As the data will be collected on the health care facility level, all 
facilities in the project will be included. 
 
Inclusion criteria Module 5:  
- 
HCWs of the intervention facilities 
- 
Minimum age of 18 years 
 
Inclusion criteria Module 6:  
- 
The participant needs to be: 
a) a stakeholder within the community, state, region or country of the intervention who’s 
position is related in any way to WASH in HCFs 
b) working in one of the intervention PHCFs. They do not need to be HCWs, they can also 
be hygiene technicians or in a leading position of the facilities. 
- 
Minimum age of 18 years 
 
5.3 
Exclusion criteria 
 
Exclusion criteria Modules 1-3: HCW participants must not fulfil any of the following exclusion 
criteria: 
- 
HCWs, whose primary occupation is not in the PHCF of the h4h project 
- 
Suffering from any skin conditions not allowing the HCW to use soap or alcoholic hand rub 
- 
Refusals to participate 
 
 
Exclusion criteria Module 5: Refusals to participate. 
 
 
                                                 
 
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Exclusion criteria Module 6: 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. 
Changing work situation 
3. 
Long-lasting absence of at least 6 months 
4. 
Death 
5. 
Inaccessibility of the HCF 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 handwashing intervention 
package increase the hand hygiene of HCWs in PHCFs in Mali and Burkina Faso? 
 
H1.1= The comprehensive h4h handwashing intervention increases hand hygiene in primary HCWs 
in Mali and Burkina Faso. 
 
H0.1= The comprehensive h4h handwashing intervention will have no effect on hand hygiene of 
primary HCWs in Mali and Burkina Faso. 
 
6.1.2 
Secondary hypotheses 
 
Depending on the secondary objective, different secondary hypotheses were formed: 
 
H1.1= Hygiene-related RANAS variables will differ between participants based on their 
demographic indicators, previous training, and the water structures available in the health care 
facilities. 
 
H0.1= Hygiene-related RANAS variables will not differ between participants based on their 
demographic indicators, previous training, and the water structures available in the health care 
facilities. 
 
H1.2= Hygiene-related RANAS variables of health care providers in the intervention facilities will be 
significantly better compared to the health care providers in the control facilities. 
 
H0.2= Hygiene-related RANAS variables of health care providers will be the same in health care 
providers of intervention and control facilities.  
 
H1.e= Hygiene-related health outcomes will be significantly less frequent in intervention health care 
facilities compared to control health care facilities. 
 
H0.e= Hygiene-related health outcomes will be the same in intervention health care facilities and 
control health care facilities. 
 
6.2 
Determination of sample size  
To determine the required sample size, we run a series of simulation using the software R. 
Assuming a mean number of six staff members (range two to nine) per health facilitry and a mean 
number of five times a person was supposed to wash their hands (SD=5) and an intra cluster 
correlation coefficient of 0.15, we need to enrol 10 health facilities in each trial arm to detect 
difference of 15%-points in the proportion of handwashing during the five criticall moments of the 
WHO (30% control versus 45% intervention) with 81% power at a two-sided 5% significance level. 
To account for potential loss to follow-up we aim to enrol in total 24 health facilities. 
 
For Modules 1 and 3, all HCWs who are present during data collection and eligible will be asked to 
participate in the study. For Module 2, the observations a maximum of 10 HCWs per PHCF will be 
followed in order to avoid disturbing the daily routines of the PHCF too much. Module 4 follows the 
sample size calculation of the cRCT design, hence 24 PHCFs will be monitored. For Module 5, 6-
10 FGDs will be administered and for Module 6, 10-20 interviews. 
 

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6.3 
Description of statistical methods  
Baseline characteristics will be summarized using descriptive statistics. The difference in the 
observed proportion of always handwashing in the five critical moments as defined by WHO  
between two study arms at follow-up will be investigated using mixed effect logistic regression 
models with random intercepts for health care facilities. In the primary analysis only the 
intervention will be included as predictor. 
 
6.3.1 
Datasets to be analysed, analysis populations 
For the primary analysis we will use the available case population of HCWs which will be analysed 
according to the intention-to-treat principles.  
 
6.3.1.1 
Primary Analysis 
 
Module 1: Combined RANAS and KAP survey: The data will be summarized using descriptive 
statistics. Associations of RANAS behavioural factors with good handwashing practices and health 
care worker’s characteristics 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 health care facilities models will be 
applied.  
 
Module 3: Microbiological analysis of hand rinse samples: For investigating factors associated 
to E.coli and total coliform prevalence on HCWs hands, random effect linear regression models will 
be applied. 
 
Module 4: Diary approach for pre-defined health outcomes: . The sum of each outcome 
variable separately per facility will be used as a measure for statistical analysis. To quantify the 
intervention effect on hygiene-related health outcomes, random effect linear regression modelling 
will be used. 
 
Modules 5 and 6, 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). 
 
 
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 
Because imputation of missing data in cluster randomised trials is challenging, no imputation of 
missing data will be done.  
 
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 

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List of health care 
facilities 
Produced during the pilot 
phase of the h4h project 
with a Facility and 
Evaluation Tool for WASH 
in Institutions 
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 health 
care facility and scanned 
Destruction of paper form and storage of 
the scan on the password-protected 
secure server of Terre des hommes. 
Electronic case 
report form (CRF) for 
the Ranas and KAP 
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.  
Electronic CRF for 
the structured 
handwashing 
observations 
(scenario 1) 
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. 
Electronic videos of 
handwashing 
observations 
(scenario 2) 
Will be collected with a 
video camera which will be 
collected by the Tdh 
research teams from the 
study site. 
Video material will be stored 
electronically in a password-protected 
secure server at Swiss TPH, Switzerland 
and during the study duration on a 
password-protected  Swiss TPH Laptop 
of the local study coordinator. The 
material on the video tape will be directly 
deleted after the transfer to the secure 
server. 
Electronic CRF for 
the microbiological 
handrinse 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 Laptop of the person 
responsible for data entry. 
Paper & 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-
protected Tdh Laptop. 
Electronic storage in password-protected 
secure server at Swiss Tropical and 
Public Health Institute, Switzerland and 
during the study duration on a password-

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FGD notes from the field 
journal will be collected 
protected  Tdh Laptop of the person 
responsible for 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 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 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 
reporting 
Data will be collected 
continuously in the health 
care facilities by HCWs on 
monthly sheets of paper. 
Once a month, Tdh staff 
then collects these paper 
sheets. 
First in a locked cabinet at the health 
care facility and after pick up by Tdh in a 
locked cabinet at the Tdh office. 
Electronic CRF for 
the diary approach of 
hygiene related 
health outcome 
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 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 health outcome 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 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 healthcare facilities, 

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electronic CRFs for the handwashing observations, the microbiological analysis, and the health 
outcome diary, 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. Each time someone works at one of these documents, they have to store it under an 
updated name with a new version number and date. 
 
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 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 video and 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 on paper will be kept in a folder, locked at the study site for 10 years. After 10 years 
electronic data will be deleted and the papers will be shredded and disposed of. The participant 
identification list and the paper informed consent forms after scanning will be immediately 
destroyed after the end survey to guarantee anonymity after the survey. 
 
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 over night. The next morning, the bleach solution will be emptied 
into the waste 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 the 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.  
Data is stored on the server of the study centre and back up.  
All study data must be archived for a minimum of 10 years after study termination or premature 
termination of the study. 
 

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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 (Anaïs Galli) 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 Module 5, 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 French.  
 
The survey questions and important key words of the FGD guide will be translated to Bambara, 
Moré and Dioula by the Tdh staff in Mali and Burkina Faso. The Swiss TPH staff will then come 
together with the local Tdh staff for a back translation to French and check if the meaning of the 
words is still appropriate. 
 
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 health care facilities, 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 Retention 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 following IECs will be asked for approval: the Ethikkommission 
Nordwest- und Zentralschweiz (EKNZ) in Switzerland, the National Institute of Public Health (INSP) 
in Mali, and the Comité d’Ethique pour la Recherche en Santé (CERS) in Burkina Faso. 
 

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9.2 
Risk-benefit ratio 
With the h4h intervention the health care facilities 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 HCWs precious time at work and water can be saved at the health care 
facility level to be used as drinking or cleaning water. With the Ranas behaviour change program, 
the HCWs will receive valuable information on how to maintain a good hand hygiene during their 
work. This knowledge together with the available infrastructure will enable the HCWs to better 
protect themselves and their patients against infections. In addition, the HCWs can transfer their 
knowledge to new staff or their families and communities. Finally, if the intervention helps to foster 
a better hygiene at health care facility level, the facility might become more attractive to patients 
and offer a better quality of care. 
 
The control health care facilities will not receive any form of intervention during the the year where 
the intervention package is being tested in the intervention facilities. 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 health care facilities, and the 
patients clearly outweigh the potential risks for study participants. Moreover, the risk of contracting 
Covid-19 is already a daily risk for HCWs 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 
according to the guidelines referred to, and answer all questions regarding this study, prior to 
obtaining informed consent.  
 
In the case of illiterate participants, an impartial witness will be called to make sure that the 
participant understood the information and agrees. This witness must be independent from the 
research being conducted and cannot be influenced unfairly by the researchers. For example, a 
literate relative of the participant is eligible as impartial witness. Both, the participant and the 
impartial witness must sign the ICF. If the participant does not have a signature, a fingerprint will 
be sufficient. 
 
For the handwashing observations, the regional directory of health and HCWs in the pilot facilities 
will be consulted if it is appropriate to receive the signed consent at the end of the study 
retrospectively in order to avoid any Hawthorne effect. Patients who visit the health care facility 
during the observation time will be asked for their consent orally, as no patient-related data will be 
collected. If children visit the facility during this time, their guardian has to give oral consent. 
 
If retrospective consent is not appropriate in the respective country setting, the directors of the 
health care facilities will be informed and asked for consent at health care facility level at least two 
weeks prior to the data collection. Their written consent will be sought without letting them know, 
when exactly the observer will visit.  
  

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9.4 
Participant confidentiality 
The Investigators must ensure that the participant’s confidentiality will be maintained. HCWs will be 
identified on the Case Report Forms with a unique participant ID composed of initials of the study 
country, a number of the health care facility, and a letter from a to z (e.g. BF-01-a). Patients of the 
HCWs will not be identified, only their gender and age group will be recorded. 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 HCWs and patients cannot come to the facilities anymore, the study 
would be stopped in the affected location. 
 
Children under the age of 18 are a vulnerable group which will be a part of the study during the 
structured handwashing observations and potentially also during the FGDs. Children are being 
considered in this study because most of the patients visiting PHCFs are usually children who are 
accompanied by their guardians or elderly people (50). To protect the children, their guardian has 
to sign a written ICF and will be accompanying the child during the whole patients visit while the 
structured handwashing observations take place. If FGDs are held with patients, the child’s 
guardian will be asked about their perception of the quality of care. The child will not have to 
actively participate at the FGD. 
Neither during the handwashing observations, nor during the FGDs, any particular risk for the 
children is expected. 
 
9.6 
Participant compensation 
Participant compensation has been defined with the local partners from Tdh. Participants in the 
modules 1- 4 will not be compensated individually. Participants attending the focus group 
discussions and interviews will be offered a snack at the end of the work (water, drink, sandwich). 
In case a participant is obliged to travel especially for a study-related activity and outside his/her 
working time at the PHCF, his/her transport will be reimbursed. 
 
9.7 
Damage coverage / Insurance 
Field staff and collaborators visiting the countries are insured by Tdh Lausanne. For the study 
participants there is no insurance as the project risk class is A. 
 
9.8 
Other aspects 
Tdh workers are allowed to assist health care facilities with transport, in case an emergency patient 
needs to be transportet to the nearest hospital. Tdh does have official evacuation documents for 
this instance.  
 
Field workers will be briefed before their deployment to the health care facilities about the sensitive 
nature of this study setting. They will be informed that they might encounter emergencies and see 
people in a very bad health state. In case that a field worker needs psychological support, Tdh will 
arrange this.  
 
For the security of the field workers, Tdh has a security department which is responsible for 
security protocols and updates concerned staff about the safety of visiting certain areas. 
 

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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 authorities, policy makers and local key 
stakeholders will be informed with webinars, sector events and workshops. Former health care 
facilities  which have participated in the study will be informed about the results by the local 
implementation partners from Tdh. 
 
 

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13 APPENDICES 
 
We recommend listing the main appendices (without version nr and date) and to create for each a 
separate document)