Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964478
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2023-07-19
Brief Title:
Hands4Health A Multi-component Intervention on Hand Hygiene Well-being in Schools in Nigeria Palestine H4H
Sponsor:
Swiss Tropical Public Health Institute
Organization:
Swiss Tropical Public Health Institute
Study Overview
Official Title:
Hands4Health Hand Hygiene Water Quality and Sanitation in Schools Not Connected to a Functional Water Supply System a Cluster-randomized Controlled Trial in Nigeria and Palestine
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
H4H
Brief Summary:
The aim of this study is to assess the impact of the hands4health hand hygiene multi-component intervention on students and teachers in primary schools with limited access to water in Nigeria and Palestine To evaluate the effects of the intervention the investigators will involve the participants in the included schools in the following data collection methods including i a survey regarding their thoughts behaviours and practices related to handwashing at school ii structured observation of their handwashing behaviour iii hand rinse sample collection to check for bacteria on their hands iv absenteeism tracking through a daily journal to record the reasons for any absences with a specific focus on identifying if they are related to hygiene-related diseases and v discussions and interviews to gather their perspectives on the perceived impacts of the intervention on their health and well-being
The investigators will collect data using these methods before the intervention starts a few months after it begins and again one year later The schools will be randomly divided into two groups one group will receive the intervention activities including handwashing stationrehabilitation of water sanitation and hygiene infrastructure behavioural change intervention capacity development and management support The other group will not receive any intervention until the end of the study By comparing the two groups the investigators will determine if the intervention had any impact on health determinants including hygiene infrastructure handwashing knowledge behaviour beliefs etc
The investigators will collect data using these methods before the intervention starts a few months after it begins and again one year later The schools will be randomly divided into two groups one group will receive the intervention activities including handwashing stationrehabilitation of water sanitation and hygiene infrastructure behavioural change intervention capacity development and management support The other group will not receive any intervention until the end of the study By comparing the two groups the investigators will determine if the intervention had any impact on health determinants including hygiene infrastructure handwashing knowledge behaviour beliefs etc
Detailed Description:
The overall project will follow a multi-center cluster-randomized controlled trial cRCT design Prior to this study a group of schools in the studys target areas were surveyed by the Tdh in Nigeria and Cesvi in Palestine using the Facility Evaluation Tool for WASH in Schools FACET WINS which is a monitoring tool for WASH delivery services in schools From these schools a subsample was identified which fulfils certain inclusion criteria see Eligibility This subsample was handed over to the local Tdh and Cesvi collaborators who carefully assessed the security situation around the schools The Tdh and Cesvi collaborators then selected 26 facilities per country which are most probable to still be accessible for data collection within the next year These 26 schools will then be allocated to the two arms intervention vs control with covariate constrained stratified randomization using computer-generated randomization code provided by a statistician not involved in any field activities The intervention arm will receive the full intervention package see multi-component intervention in primary schools The control arm will receive nothing for the duration of the intervention 12 months Afterwards they will receive the same intervention package with potential improvements identified in the former intervention group
Objectives of the study
Primary objective Evaluate the effects of the H4H multi-component intervention on hand hygiene of primary school students in Nigeria and Palestine
Secondary objectives
Evaluate the effects of the H4H multi-component on the well-being of primary school students in Nigeria and Palestine
Assess the effect of the H4H multi-component package on hygiene-related risks attitudes norms abilities and self-regulation RANAS behavioural factors of primary school students
Explore the associations of personal physical and social contextual factors with hand hygiene and the well-being of primary school students in Palestine
Explore the perceived impacts of the H4H multi-component package on the health and well-being of primary school students
Explorative object Assess the effect of the H4H multi-component package on hygiene-related health outcomes and absenteeism incidence of primary school students in Nigeria and Palestine
In the schools the investigators selected 50 eligible students from each school from one or two classes within the age group of 10-12 years using random sampling If a school had a single class consisting of 50 students within the studys target age group the investigators selected the sample from that class However if no class with the target age group had more than 50 students the investigators randomly selected two classes from within the target age group and selected the sample from these classes For different data collection modules the investigators randomly selected subsets from the 50 previously selected students
The modules of the study incudes qualitative and quantitative data approaches in order to enable a triangulation of the overall project results The following modules will be used in the cRCT and the overall project i Module 1 Combined RANAS and well-being survey ii Module 2 Structured handwashing observations iii Module 3 Microbiological analysis of hand rinse samples iv Module 4 Diary approach for health outcomes and absenteeism v Module 5 personal physical and social contextual factors survey vi Module 6 Focus Group Discussions FGDs and vii Module 7 Key informant interviews KIIs
Local collaborators from Tdh and Cesvi and the regional Ministries of Education MoE were involved from the studys kick-off meeting onwards and are regularly being consulted in bi-weekly meetings and additional ToC workshops led by Skat Foundation The data collection methods for each module will be described in further detail
i Module 1 Combined RANAS and well-being survey The survey will be developed through RANAS approach that targets the underlying psychological factors that are postulated as important precursors for effective behaviour change by the model These factors include handwashing-related perceived risks attitudes norms abilities and self-regulation The well-being of the participants will be assessed in the survey using the KINDL tool which is designed to measure health-related quality of life in children and adolescents by looking into different domains of well-being eg physical mental and school The survey will also contain questions assessing the perceived sufficiency and safety of the water supply satisfaction with the available infrastructure for handwashing and obstacles to water access The survey will be administered to a randomly selected subset of 25 students per primary school three times in total as a baseline survey before the implementation of the intervention package about three months after the intervention and about a year after the baseline survey with the software Open Data Kit ODK Central version 202231 on Android tablets Informed consent forms will be obtained from the participants guardians before the day of data collection In addition oral assent will also be obtained from the participants at the beginning of the interview for filling out the survey
ii Module 2 Structured handwashing observations The observations will be administered three times at the same time points as the survey in Module 1 To be able to assess individual behaviours and link them to data collected using other tools all of the students in the classes selected for the study will be assigned coloured badges with their unique IDs Students will be informed that they are randomly assigned the colours However the data collector will agree with the school teachers on a specific colour to be assigned to the 50 students selected for the study from these classes The observation will start at 900 am 60 minutes before the breakfast break and end at 1200 pm 90 minutes after the break The data collector will pilot the observation process before the intervention and in coordination with the school staff
The occurrence of handwashing with soap will be observed for each of the two critical handwashing events after using the toilet and before eating for each included student To observe handwashing before eating studys primary outcome the investigators will engage participants in a painting activity followed by a popcorn snack which should prompt handwashing During snack time observers stationed at handwashing points will document who washes their hands Observations will also include other handwashing opportunities such as after toilet use Outcomes will indicate whether or not handwashing with soap occurred at these key events with some considerations for unforeseen field complications If feasible the investigators will observe the handwashing steps of students who do wash their hands Consent for observation will be obtained at a school level from the principal of the school as well as from the parents
iii Module 3 Microbiological analysis of hand rinse samples This module focuses on the microbiological analysis of hand rinse samples from a random subset of 12 students three times at the same time points as the survey in Module 1 and observation in Module 2 The modified glove juice method is the process used for that and it involves shaking and massaging participants hands in 350 mL of clean water contained in a 710 mL Whirl-Pak bag NASCO Corp Fort Atkinson WI followed by drying The bags with samples are kept on ice and processed within four hours Using membrane filtration the investigators will detect E Coli and total coliforms colony-forming units CFUs This will involve filtering the bag contents through a 47-mm-diameter 045 µm cellulose filter applying the filter to growth media and incubating it at 35C 05C for a duration of 24 hours the investigators plan to filter 100 mL per bag however the exact amount of mL will be established during piloting as the volume used is dependent on the degree of bacterial contamination on the hands The investigators will utilize compact dry plates to detect Ecoli and total coliforms and the detection limits will be calculated based on the filtrate volume and Whirl-Pak volume The lower detection limit of CFUs will be calculated by dividing 1 CFUplate 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 CFUsplate by the filtrate volume and then multiplying it with the Whirl-Pak volume For analysis CFUs per hand will be normalized and log10 transformed
iv Module 4 Diary approach for health outcomes and absenteeism incidence The approach uses a diary method to track hygiene-related health outcomes and absenteeism post-intervention The key measure is hygiene-related absenteeism tied to conditions like diarrhea respiratory and skin infections helminth infections head lice and trachoma A teacher in each school will record daily absences and reasons in an electronicpaper diary To account for the cluster design the investigators will separately calculate hygiene-related absenteeism rates for each medical condition in each school by dividing the number of absences by student-weeks yielding rates per 100 student-weeks
v Module 5 personal physical and social contextual factors survey The cultural and contextual factors that may influence students handwashing and well-being will be covered in this survey Given the unique stressors of military occupation in Palestine its crucial to understand these conditions impact on life beyond school The investigators will analyse determinants of hygiene behaviour before starting the intervention providing insight into how to maximize effectiveness for broader hygiene interventions in Palestine The study uses a cross-sectional baseline design with an initial assessment conducted before school randomization Parents of the 50 included students will complete a survey assessing household hygiene services their hygiene knowledge and habits and their childs hygiene behaviour
vi Module 6 Focus Group Discussions FGDs The FGDs generate extensive data quicker than individual interviews The investigators will conduct 10 gender-separated FGDs in the selected schools during autumn 2023 This separation also encourages open free-speaking environments without fear of teasing or embarrassment Each group will consist of 5-8 students ensuring a fair representation from each class participating in the study To avoid dominance issues the investigators will ensure all students within a group are of the same age Furthermore there will be 5 FGDs specifically designed for 5-8 teachers from schools involved in the intervention The team conducting the FGDs ideally including the SwissTPH PhD student will consist of a moderator and a note-taker FGDs will be tape-recorded transcribed and translated into English for analysis with observations noted in a field research journal Analysis will be conducted using MaxQDA VERBI Software Marburg Germany or NVivo software QSR International Melbourne Australia
vii Module 7 Key informant interviews KIIs The key informant interviews will be with education ministry stakeholders school committee members and community leaders to gain detailed insights into specific issues and proposed solutions This data will be collected in autumn 2023 providing depth that FGDs might miss due to group dynamics Interviewers trained similarly to those for FGDs will audio record interviews with transcripts translated into English for analysis using either MaxQDA VERBI Software Marburg Germany or NVivo software In some cases interviews may be conducted remotely in English
Objectives of the study
Primary objective Evaluate the effects of the H4H multi-component intervention on hand hygiene of primary school students in Nigeria and Palestine
Secondary objectives
Evaluate the effects of the H4H multi-component on the well-being of primary school students in Nigeria and Palestine
Assess the effect of the H4H multi-component package on hygiene-related risks attitudes norms abilities and self-regulation RANAS behavioural factors of primary school students
Explore the associations of personal physical and social contextual factors with hand hygiene and the well-being of primary school students in Palestine
Explore the perceived impacts of the H4H multi-component package on the health and well-being of primary school students
Explorative object Assess the effect of the H4H multi-component package on hygiene-related health outcomes and absenteeism incidence of primary school students in Nigeria and Palestine
In the schools the investigators selected 50 eligible students from each school from one or two classes within the age group of 10-12 years using random sampling If a school had a single class consisting of 50 students within the studys target age group the investigators selected the sample from that class However if no class with the target age group had more than 50 students the investigators randomly selected two classes from within the target age group and selected the sample from these classes For different data collection modules the investigators randomly selected subsets from the 50 previously selected students
The modules of the study incudes qualitative and quantitative data approaches in order to enable a triangulation of the overall project results The following modules will be used in the cRCT and the overall project i Module 1 Combined RANAS and well-being survey ii Module 2 Structured handwashing observations iii Module 3 Microbiological analysis of hand rinse samples iv Module 4 Diary approach for health outcomes and absenteeism v Module 5 personal physical and social contextual factors survey vi Module 6 Focus Group Discussions FGDs and vii Module 7 Key informant interviews KIIs
Local collaborators from Tdh and Cesvi and the regional Ministries of Education MoE were involved from the studys kick-off meeting onwards and are regularly being consulted in bi-weekly meetings and additional ToC workshops led by Skat Foundation The data collection methods for each module will be described in further detail
i Module 1 Combined RANAS and well-being survey The survey will be developed through RANAS approach that targets the underlying psychological factors that are postulated as important precursors for effective behaviour change by the model These factors include handwashing-related perceived risks attitudes norms abilities and self-regulation The well-being of the participants will be assessed in the survey using the KINDL tool which is designed to measure health-related quality of life in children and adolescents by looking into different domains of well-being eg physical mental and school The survey will also contain questions assessing the perceived sufficiency and safety of the water supply satisfaction with the available infrastructure for handwashing and obstacles to water access The survey will be administered to a randomly selected subset of 25 students per primary school three times in total as a baseline survey before the implementation of the intervention package about three months after the intervention and about a year after the baseline survey with the software Open Data Kit ODK Central version 202231 on Android tablets Informed consent forms will be obtained from the participants guardians before the day of data collection In addition oral assent will also be obtained from the participants at the beginning of the interview for filling out the survey
ii Module 2 Structured handwashing observations The observations will be administered three times at the same time points as the survey in Module 1 To be able to assess individual behaviours and link them to data collected using other tools all of the students in the classes selected for the study will be assigned coloured badges with their unique IDs Students will be informed that they are randomly assigned the colours However the data collector will agree with the school teachers on a specific colour to be assigned to the 50 students selected for the study from these classes The observation will start at 900 am 60 minutes before the breakfast break and end at 1200 pm 90 minutes after the break The data collector will pilot the observation process before the intervention and in coordination with the school staff
The occurrence of handwashing with soap will be observed for each of the two critical handwashing events after using the toilet and before eating for each included student To observe handwashing before eating studys primary outcome the investigators will engage participants in a painting activity followed by a popcorn snack which should prompt handwashing During snack time observers stationed at handwashing points will document who washes their hands Observations will also include other handwashing opportunities such as after toilet use Outcomes will indicate whether or not handwashing with soap occurred at these key events with some considerations for unforeseen field complications If feasible the investigators will observe the handwashing steps of students who do wash their hands Consent for observation will be obtained at a school level from the principal of the school as well as from the parents
iii Module 3 Microbiological analysis of hand rinse samples This module focuses on the microbiological analysis of hand rinse samples from a random subset of 12 students three times at the same time points as the survey in Module 1 and observation in Module 2 The modified glove juice method is the process used for that and it involves shaking and massaging participants hands in 350 mL of clean water contained in a 710 mL Whirl-Pak bag NASCO Corp Fort Atkinson WI followed by drying The bags with samples are kept on ice and processed within four hours Using membrane filtration the investigators will detect E Coli and total coliforms colony-forming units CFUs This will involve filtering the bag contents through a 47-mm-diameter 045 µm cellulose filter applying the filter to growth media and incubating it at 35C 05C for a duration of 24 hours the investigators plan to filter 100 mL per bag however the exact amount of mL will be established during piloting as the volume used is dependent on the degree of bacterial contamination on the hands The investigators will utilize compact dry plates to detect Ecoli and total coliforms and the detection limits will be calculated based on the filtrate volume and Whirl-Pak volume The lower detection limit of CFUs will be calculated by dividing 1 CFUplate 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 CFUsplate by the filtrate volume and then multiplying it with the Whirl-Pak volume For analysis CFUs per hand will be normalized and log10 transformed
iv Module 4 Diary approach for health outcomes and absenteeism incidence The approach uses a diary method to track hygiene-related health outcomes and absenteeism post-intervention The key measure is hygiene-related absenteeism tied to conditions like diarrhea respiratory and skin infections helminth infections head lice and trachoma A teacher in each school will record daily absences and reasons in an electronicpaper diary To account for the cluster design the investigators will separately calculate hygiene-related absenteeism rates for each medical condition in each school by dividing the number of absences by student-weeks yielding rates per 100 student-weeks
v Module 5 personal physical and social contextual factors survey The cultural and contextual factors that may influence students handwashing and well-being will be covered in this survey Given the unique stressors of military occupation in Palestine its crucial to understand these conditions impact on life beyond school The investigators will analyse determinants of hygiene behaviour before starting the intervention providing insight into how to maximize effectiveness for broader hygiene interventions in Palestine The study uses a cross-sectional baseline design with an initial assessment conducted before school randomization Parents of the 50 included students will complete a survey assessing household hygiene services their hygiene knowledge and habits and their childs hygiene behaviour
vi Module 6 Focus Group Discussions FGDs The FGDs generate extensive data quicker than individual interviews The investigators will conduct 10 gender-separated FGDs in the selected schools during autumn 2023 This separation also encourages open free-speaking environments without fear of teasing or embarrassment Each group will consist of 5-8 students ensuring a fair representation from each class participating in the study To avoid dominance issues the investigators will ensure all students within a group are of the same age Furthermore there will be 5 FGDs specifically designed for 5-8 teachers from schools involved in the intervention The team conducting the FGDs ideally including the SwissTPH PhD student will consist of a moderator and a note-taker FGDs will be tape-recorded transcribed and translated into English for analysis with observations noted in a field research journal Analysis will be conducted using MaxQDA VERBI Software Marburg Germany or NVivo software QSR International Melbourne Australia
vii Module 7 Key informant interviews KIIs The key informant interviews will be with education ministry stakeholders school committee members and community leaders to gain detailed insights into specific issues and proposed solutions This data will be collected in autumn 2023 providing depth that FGDs might miss due to group dynamics Interviewers trained similarly to those for FGDs will audio record interviews with transcripts translated into English for analysis using either MaxQDA VERBI Software Marburg Germany or NVivo software In some cases interviews may be conducted remotely in English
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None