Effect of urban vs rural context on effectiveness of a community intervention to prevent diarrhoea and stunting in young children in Mali

Lead Research Organisation: University of Birmingham
Department Name: Institute of Applied Health Research

Abstract

The Problem
Globally 1.7 billion diarrhoea episodes result in approximately 2 million deaths in 2010.1 Regionally, Africa has the greatest burden. Alongside poor infant feeding, diarrhoea diseases also contribute to infant malnutrition.2-4 Despite new vaccines, treatments and public health measures,3 diarrhoea and malnutrition remain considerable public health problems in low- and middle-income countries (LMIC). The period when a child starts eating solids (usually 6-24 months called complementary food (CF)), is associated with the highest rates of diarrhoea: over 50% of all diarrhoea deaths occur at 6-11 months.1 Most low-income households in LMIC cook ingredients at home or obtain food from informal street food-sellers who prepare the goods in their homes. Therefore home food handling, preparation and storage determine the scale of food contamination.

Although many studies explore the effects of improved water supply, hygiene and nutrition of infant diets on infant diarrhoea and growth development, much less attention paid to studies of food safety remain scarce. Research in this area has been too general to reduce diarrhoea through food contamination. The World Health Organisation (WHO) advocates targeted interventions to support CF safety and hygiene. Ideally CF safety needs to be accompanied with achieving optimal dietary intake for young children, which also remains a challenge in LMIC. Research shows that infant health and safety advice has limited impact on behaviour change unless accompanied by means to motivate and empower mothers in the community. Yet previous interventions targeting diet or diarrhoea have seldom drawn on cultural dramatic arts and community assets to motivate behaviour change. African communities have a particularly strong cultural heritage to underpin such potential impact.

Our Aim
We propose a low-cost, scalable, and adaptable community intervention to reduce diarrhoea and improve the growth of young children in urban-poor and rural Mali. We will assess the effects in both settings, to inform replication and scaling of the intervention, because the dynamics of community life vary in each.

Our Previous Work
We combine two complementary interventions shown to be effective elsewhere in LMIC. A trial in the Gambia (developed through former work in Bangladesh, Nepal and Pakistan) evaluated efforts to improve hygiene and safety of CF, while a trial in Kenya evaluated a community programme to improve breastfeeding and weaning food content.

Our Plan
After adaptation with communities, our intervention will empower local families to implement behaviour change. It will include campaign-like activities such as culturally relevant dramatic arts (drama, songs, stories), public meetings, certifications, and home visits, delivered by a small team: 5 days of community campaign visits dispersed during 35 days and including home visits by trained female volunteers, plus a reminder campaign day at 9 months. We will allocate 120 urban and rural sites in Mali by chance to receive the intervention, or not, and assess 27 households in each site after 15 months.

The study is designed to quantify the influence of urban vs rural context, and to examine other societal influences (e.g. household poverty, women's work, and education, etc). Using observations, interviews, discussion groups, surveys and laboratory tests we will compare the implementation of the intervention in urban-poor and rural settings. Importantly, the intervention is designed to be sustainable through peer-education among mothers and older female volunteers (demonstrated after 32 months in Gambia), thus requiring only small levels of coordination resources from central government.

Technical Summary

We will undertake a mixed-method evaluation of a low-intensity, culturally engendered, and scalable community intervention to promote food safety and hygiene and child nutrition (breastfeeding and CF content) practices. We aim to evaluate (qualitatively and quantitatively) the effect of intervention on diarrhoea and growth parameters, understand mediating factors contributing to the outcome along the causal pathway to health outcomes, and assess the role of context in the outcomes, with a particular focus on the influence of urban-poor and rural areas.
Design: Mixed-methods - qualitative/ethnography and a parallel cluster randomised controlled trial
Study duration: 36m
Trial site: Mali: cities of Bamako, Kati and Ségou and rural villages in the same provinces
Trial Management Centre: the University of Sciences, Techniques and Technologies (USTT), Bamako
Intervention: 5 days of campaign community visits dispersed across 35 days (days 1,2,17,15,35) plus volunteer home visits and a 9-month reminder campaign day
Control: 1 day campaign community activities on use of water in households and gardens
Follow-up: 15-months
Minimisation Randomisation after clusters have ratified participation and after baseline
Outcomes: Primary: Observed and reported 24-hour diarrhoea, (primary outcome is observed photographed diarrhoea during 7-9 hours home observation from early morning till afternoon)
Other outcomes include: 4 health, 3 microbiological, 4 behavioural, 1 environmental, and 3 social outcomes; all helping to explain any changes in the causal pathway to transmission of infection and growth parameters.
Sample size: 120 clusters stratified by urban and rural, ethnicity and community size, with 27 mother-child pairs in each: 90% power to estimate a 25% reduction in diarrhoea and 25% relative difference between rural/urban with interaction and 3 measurement points.
Dissemination and Capacity Building Plan will be established and monitored.

Planned Impact

A successful intervention to improve complementary food safety and hygiene and improve infant feeding has the potential to impact the health, economic and social dimensions of individual children, families and communities. This benefit can transfer to societal level benefits, and by leading to healthier and more productive populations, result in more prosperous societies. In our trial, this can be achieved for individuals participating in the intervention arms during the life of the trial. If replicated and scaled in the rest of Mali or other African and LMIC countries, this impact could be felt more widely due to reductions in the rate of preventable diseases in children (SDG3). The Community Led Total Sanitation program was one such community-wide intervention tested in Mali (reported 2014), which as the result of its beneficial effect is now being scaled at national level in Mali and adopted by other countries in the region. Robust evidence from our trial on the effect of intervention on improving health outcomes, the mediating variables along the causal pathway, and with reference to the effect of urban/rural context on these, will be important for policy makers and implementers to fund and scale up our intervention. This trial provides such evidence and will also provide ample data on other contextual factors and societal impacts that can guide policy makers on future replication and scalability. The draft intervention manual which we will update after this trial will provide important guidance for non-academic implementers to adapt and deliver the intervention in new LMICs.

These data and the new knowledge produced will be impactful for the academic community as it will answer important research questions while driving new lines of enquiry and research. Immediate academic impact is summarised in the Academic Beneficiaries section. Benefits will extend beyond the immediate researchers involved in this project because, we plan to engage other academics in Mali and more widely within our host institutions. In Mali, much needed PhD degrees will be facilitated (Capacity Building Annex), and the trials unit and laboratory facilities will be developed through training with new methodologies.
If our intervention is proven effective, it could have significant impact across the health system in Mali and other LMICs. Diarrhoea and nutritional related conditions in children are extremely common in LICs such as Mali and utilise a great deal of health system resources as well as leading to days lost from work for family members which affects family income and prosperity. Health services are often over stretched and respond to high rates of communicable diseases and child health related conditions which overwhelm them. Should our intervention be effective, the resulting reduced rates of diarrhoea and illnesses secondary to malnutrition and stunting are likely to release resources within health services in primary and secondary care, which could then be diverted to the care of other conditions.

The PtI section outlines various impactful products produced by the research, and outlines groups of individuals or systems that can benefit in the short and long term. It describes how we intend to realize these impacts. We have a dedicated work package (WP4) with Co-Is in Mali and UK jointly responsible for its delivery. At the heart of WP4 is the Communication and Dissemination Plan (CDP) which will be monitored by the WP Co-Is (OT, OPG). Individual Co-Is will have responsibility for delivering aspects of the CDP and impact related to them and the Project Management Group will monitor the progress of WP4 and CDP on a monthly basis with SMH ultimately responsible. We are confident that since we have involved national and international policy makers, academic and implementing experts from the start in the Advisory Groups we can realise impact from various aspects of our investigations at numerous levels and into the future.

Publications

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Siu J (2021) Cost-effectiveness of a weaning food safety and hygiene programme in rural Gambia. in Tropical medicine & international health : TM & IH

 
Title Maaciwara drama, song and animation 
Description 1. A song was created to weave the messages of the intervention- this was done in the local language 2. An animation depicting the key messages of the intervention was also professionally developed in the local language 3. Posters, bracelets and community recognition boards were also developed with the symbol of the project and/or key messages 
Type Of Art Performance (Music, Dance, Drama, etc) 
Year Produced 2023 
Impact 1. Better engagement/reception of the community and participants to the intervention 
 
Description Development of a policy to support the scale up of the intervention to the rest of the Gambia
Geographic Reach Africa 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
 
Description Development funds - funds for a related RCT and qualitative data exploration for a study on cross infection and interventions for pre-meal communal handwashing practices in a common bowl of water in urban and rural Mali
Amount £35,000 (GBP)
Organisation University of Birmingham 
Department Institute for Global Innovation
Sector Academic/University
Country United Kingdom
Start 01/2021 
End 01/2022
 
Description Donald Krogstad Award- (An early career fellowship awarded to our Mali trial manager for a study of microplastics in childhood stools including a conference attendance - utilising stool samples banked from MRC study and child outcome measured)
Amount $25,000 (USD)
Organisation American Society of Tropical Medicine and Hygiene 
Sector Charity/Non Profit
Country United States
Start 01/2021 
End 01/2023
 
Description GCRF Consolidation Account (2022)- Health economic data for decision making by policy makers and implementers (users) to gage cost benefit and unexpected societal benefits or harms of the intervention
Amount £29,400 (GBP)
Organisation University of Birmingham 
Sector Academic/University
Country United Kingdom
Start 12/2022 
End 03/2023
 
Description GCRF Consolidation Account (2022): - Stakeholder and public engagement to enhance adoption of intervention and its impact by the public and institutional user agencies.
Amount £42,794 (GBP)
Organisation University of Birmingham 
Sector Academic/University
Country United Kingdom
Start 12/2022 
End 03/2023
 
Description GCRF and Newton Uplift fund to support Impact development
Amount £250,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 07/2022 
End 03/2023
 
Description GCRF uplift after the ODA cuts
Amount £134,289 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 06/2022 
End 03/2023
 
Description Geostatistical design and analysis of randomised evaluations with a geographic basis
Amount £484,706 (GBP)
Funding ID MR/V038591/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 08/2021 
End 08/2024
 
Description QR Funding to support the project after the ODA cuts
Amount £200,000 (GBP)
Organisation University of Birmingham 
Sector Academic/University
Country United Kingdom
Start 07/2021 
End 03/2022
 
Description Wellcome ISSF - pilot data Award (Early career grant awarded to UK Project Manager from MRC study - Mixed methods study to collect data Expert's data on practices of pre-meal communal handwashing and communal eating from the same bowl)
Amount £19,949 (GBP)
Organisation Wellcome Trust 
Department ISSF
Sector Charity/Non Profit
Country United Kingdom
Start 09/2021 
End 09/2022
 
Title Census to improve random sampling of participants in all clusters for evaluation 
Description We undertook a comprehensive census of all eligible participants in our 120 clusters. This enabled us to have a comprehensive list for randomly sampling our participants in each cluster for evaluation 
Type Of Material Improvements to research infrastructure 
Year Produced 2023 
Provided To Others? No  
Impact This enabled us to have a comprehensive list for randomly sampling our participants in each cluster for evaluation. This enhanced the quality of our data collection 
 
Title Maaciwara data collection tools and manuals for intervention adaptation 
Description These tools were adapted and translated for use in Mali. These tools were done in consultation with researcher and other external partners on the project. These tools including questionnaires and observation forms have been piloted and used during the formative research. Afterwards these forms were further refined and used for baseline data collection. 
Type Of Material Improvements to research infrastructure 
Year Produced 2021 
Provided To Others? No  
Impact not yet. 
 
Title Maaciwara relational database-- RedCap 
Description A relational complex database was created in English and French incorporating all the data collection tools. This database was piloted and iteratively improved before using to collect baseline data. 
Type Of Material Database/Collection of data 
Year Produced 2021 
Provided To Others? No  
Impact This is an important element to ensure that we collect the right data and also to ensure appropriate quality checks of the collected data. Currently using some features of database, we are able to improve the overall quality of the database collection process. 
 
Description Drama team in Loughborough university led by Professor Mike Wilson 
Organisation Loughborough University
Country United Kingdom 
Sector Academic/University 
PI Contribution We had series of meetings which will be on-going with the Drama team in Loughborough university led by Professor Mike Wilson to help address some of the concerns of the use of drama and arts in the trial. We organise regular catch-up meetings with them.
Collaborator Contribution We had series of meeting with Drama team in Loughborough university led by Professor Mike Wilson and an NGO specialising in WASH and drama (One drop in Canada) to help address some of the concerns of the use of drama and arts in the trial. They are also offering regular assistance during the data collection and analysis and Prof Wilson's team are to co-supervise our Mali qualitative researcher who is a PhD student in our Mali university partners who will look at the role of dramatic arts in health promotion, social norm change, and behaviour change of mothers for improving maternal child health outcomes. Together we will produce the cultural/artistic outputs including animation and other material to be available free of access on-line for future programming in Africa.
Impact no outcomes yet
Start Year 2022
 
Description Microplastics stool Collection and analysis 
Organisation University of Birmingham
Country United Kingdom 
Sector Academic/University 
PI Contribution 1. Our team secured internal funding to support the processing and transport of samples to the UK 2. Our team provided secondment opportunity for a staff from our partner's organisation to visit the UK and analyse the samples 3. Our team provided financial assistance to enable the lab support energy cost of electricity due to the rapid power outages in Mali
Collaborator Contribution 1. The partner collected and processed large samples 2. The partner provided us with freezes to store samples 3. The partner provided in-kind staff time to collect, process and analyse samples 4. The partner is contributing to the manuscript write-up
Impact 1. More than 10,000 stool samples have been analysed 2. The publication is drafted and soon to be sent for publication 3. Capacity development for partner's staff in Mali 4. Enhancement of partner's laboratory
Start Year 2022
 
Description Microplastics stool Collection and analysis 
Organisation University of Science, Technology and Technology of Bamako
Country Mali 
Sector Academic/University 
PI Contribution 1. Our team secured internal funding to support the processing and transport of samples to the UK 2. Our team provided secondment opportunity for a staff from our partner's organisation to visit the UK and analyse the samples 3. Our team provided financial assistance to enable the lab support energy cost of electricity due to the rapid power outages in Mali
Collaborator Contribution 1. The partner collected and processed large samples 2. The partner provided us with freezes to store samples 3. The partner provided in-kind staff time to collect, process and analyse samples 4. The partner is contributing to the manuscript write-up
Impact 1. More than 10,000 stool samples have been analysed 2. The publication is drafted and soon to be sent for publication 3. Capacity development for partner's staff in Mali 4. Enhancement of partner's laboratory
Start Year 2022
 
Description WASH expertise in exploring and developing interventions to reduce communal handwashing 
Organisation Save the Children UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Through our Mali study we found that communal handwashing, where a group people before meals, wash hands in one bowl of water without soap and with changing the water, was a common practice in both rural and Urban Mali, and given the potential risk of this practice, we sought this collaboration/partnerships with Water Aid and Save the Children to explore the views of WASH experts regarding this practice.
Collaborator Contribution Through this collaboration, we successfully carried out a mixed methods study in 15 countries with WASH experts to explore in-depth the perceived motivations and prevalence of this practice. The data is currently analysed and a draft manuscript is been produced.
Impact Awarded a pilot data grant and also completed a mixed methods study.
Start Year 2022
 
Description WASH expertise in exploring and developing interventions to reduce communal handwashing 
Organisation WaterAid
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Through our Mali study we found that communal handwashing, where a group people before meals, wash hands in one bowl of water without soap and with changing the water, was a common practice in both rural and Urban Mali, and given the potential risk of this practice, we sought this collaboration/partnerships with Water Aid and Save the Children to explore the views of WASH experts regarding this practice.
Collaborator Contribution Through this collaboration, we successfully carried out a mixed methods study in 15 countries with WASH experts to explore in-depth the perceived motivations and prevalence of this practice. The data is currently analysed and a draft manuscript is been produced.
Impact Awarded a pilot data grant and also completed a mixed methods study.
Start Year 2022
 
Title Drama-art based community intervention 
Description The MaaCiwara intervention is a community-based drama-art based intervention delivered at an afternoon durbar with all community members and leaders. It also includes local volunteers conducting home visits after the afternoon durbar. The intervention was delivered in 4 days, day 1, 2, 17 and 35. In addition, the intervention was delivered again as a reminder after 10-12 months. 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2021
Development Status Under active development/distribution
Impact No impacts yet 
 
Description Community engagement with urban and rural communities 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other audiences
Results and Impact A formal community consultation/advisory meeting was completed in July 2023. This was to ensure better engagement with the community and provide platforms for dissemination of the trial findings at the end of the study. A total of 60 community members including leaders attended the event
Year(s) Of Engagement Activity 2023
 
Description Conference presentation 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Third sector organisations
Results and Impact We made an oral presentation at the University of North Carolina's water and health conference. The presentation of the trial formative data on the perceptions and motivations for the practice of communal handwashing was intriguing/engaging as most of the participants/key policy actors including UNICEF and WHO were engaged in discussions on the situation and the need to best design interventions to improve hand hygiene.
Year(s) Of Engagement Activity 2022
URL https://waterinstitute.unc.edu/our-work/2022-water-health-conference
 
Description Dramatic artists and local public health officers to adapt and deliver intervention. 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact To adapt the intervention to the local context, Mali and also to deliver the intervention we actively engaged with local dramatic artists and public health professionals, which are not researchers. In this engagement we had a series of meetings and practice events to adapt the intervention appropriately.
Year(s) Of Engagement Activity 2022
 
Description Engagement with government bodies, UN agencies, Embassies, NGOs and other stakeholders in Mali 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Policymakers/politicians
Results and Impact The UK PI and Mali PI/lead both have made efforts to meet as many related influential policy makers and managers that may be interested in collaborating, using our future intervention, or co-fund aspects of our work (given the ODA cuts in 2021), or generally to increase awareness and support about our project.
To date, presentations have been made or meetings held in Mali with Minister of h=Health of the transitional government of Mali, Directorate of Public Health, WHO, UNICEF, UNDP, USAID, British Embassy, Dutch Embassy, Canadian Development Programme, various university and other government departments, etc
WHO and UNICEF are looking at developing an MOU with the project for further collaborations.
We are currently having meetings with UNICEF and WHO to discuss an opportunity for them to be involved in spilled over activities from this project.
Year(s) Of Engagement Activity 2021,2022,2023
 
Description International expert advisory group (IEAG) met in 2022 and 2023 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact This group was composed of international partners and they discussed the elements of the trial and offered advice on how to implement the trial successfully.
In 2023- this group met again to provide advice on how the remaining trial activities should be executed.
Year(s) Of Engagement Activity 2022,2023
 
Description MaaCiwara Research Web Page, Social Media, updated 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact A comprehensive and on-going web page was created before the launch of the study, within the University of Birmingham's official website in order to inform people of the aims, objectives, and methods of the MaaCiwara Mali study. The progress of the study and findings of nested studies have been disseminated using this web page, including by posting of the press-release, newsletter, publications and conference abstracts.
A tweet account is also active.
Please also see the newsletters and press-release entries.
Year(s) Of Engagement Activity 2021,2022,2023
URL https://www.birmingham.ac.uk/research/applied-health/research/maaciwara-study/index.aspx
 
Description Maaciwara Newsletters 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact In the first year of the project we produced our first newsletter, detailing the progress of the project and the activities lined up for the year. We also reported on the findings of a nested feasibility trial conducted in Mali. Both printed and electronic versions were shared to all partners and collaborators internationally, including UNICEF, WHO, various embassies and potential donors in Mali, and other global partners.
The newsletter has been emailed to a raft of contacts by all co-investigators in Mali, UK and elsewhere. This brought about more enhanced engagement from our partners. We have produced 3 regular newsletters targeting stakeholders and the general public to disseminate the activities of the project and to get them more engaged in the progress of the project in Mal
Year(s) Of Engagement Activity 2021,2022,2023
 
Description Oral presentations at a national conference in Bamako 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact The effect of soap on pathogen transmission of E.Coli and coliforms into CB-HW water and on hand swabs before mealtime in households using the same water in one bowl was presented at 2023 SOMEPI/AfEA conference in Bamako. This was national conference with a good number of attendance.
Year(s) Of Engagement Activity 2023
 
Description Policy changes to scale up intervention in the Gambia 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact A meeting with the minister of health and other stakeholder was held to advance plans on scaling up the intervention to all parts of the Gambia. This has now been approved and waiting on funding for scale-up.
Year(s) Of Engagement Activity 2023
 
Description Regular Maaciwara Newsletters 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact We have produced 3 regular newsletters targeting stakeholders and the general public to disseminate the activities of the project and to get them more engaged in the progress of the project in Mali
Year(s) Of Engagement Activity 2022,2023
 
Description Research theory and delivery 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact The UK PI, Prof Lilford as part of a monitoring and support visit to Mali delivered a talk to a group of academics and postgraduate students. This one day research symposium was well attended and engaging.
Year(s) Of Engagement Activity 2022
 
Description Trial Steering and Data management committee met in 2021, 2022 and 2023 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact 2021- This group contributed in improving the study protocol and also offering suggestions on how the trial could be run effectively and monitored. The trial protocol was approval by TSC/DMC before publication.
2022- The group met again and reviewed the progress of the trial and approved the next round of data collection. There is another meeting of this group in 6 months time.
2023- This group met again and reviewed the progress of the trial, providing advice on important protocol deviations that were observed. They also made plans to review the baseline and follow-up data
Year(s) Of Engagement Activity 2021,2022,2023