An advanced cookstove intervention to prevent pneumonia in children under 5 years old in Malawi: a cluster randomised controlled trial

Lead Research Organisation: Liverpool School of Tropical Medicine
Department Name: Clinical Sciences

Abstract

Malawi has one of the highest rates of death among infants and the under fives (69 and 110 per 1000 live births respectively in 2009) despite having made progress towards meeting the Millennium Development Goal of reducing child mortality. Pneumonia is the leading cause of death and one of the commonest causes of morbidity with around 298 per 1000 children under the age of 5 diagnosed with pneumonia every year and a case fatality rate between 2.7 and 13.2 per 1000. Exposure to smoke produced when biomass fuels (animal or plant material) are burned in open fires is a major avoidable risk factor for pneumonia. In Malawi, where at least 95% of households depend on biomass as their main source of fuel, biomass smoke exposure is likely to be responsible for a substantial burden of this disease.

Effective strategies for reducing smoke exposure exist (e.g. ventilation, improved stoves, cleaner fuels, behaviour modification) but are out of reach for the majority due to a wide range of largely poverty-related factors. The Global Alliance for Clean Cookstoves was launched in 2010 to tackle this energy poverty issue through public private partnerships. A central aim of the alliance is for 100 million homes to adopt clean and efficient stoves and fuels by 2020. However, there is very limited evidence to assess the potential benefits of such an approach.

We have conducted preparatory and pilot work in sub Saharan Africa to determine which of the currently available advanced cookstoves would be most suitable for use in a trial in Malawi in terms of improvements in combustion efficiency, reduced emissions and ability to cook local dishes. We have gone to considerable lengths to involve local communities in the development of this proposal.

We are now in a position to be able to study an efficient and locally acceptable advanced cookstove that substantially reduces smoke emissions in a trial to address three principal research questions:

1) Can an advanced cookstove intervention that substantially reduces biomass smoke exposure relative to an open fire prevent pneumonia in children under 5 years old in Malawi?
2) How affordable and cost effective is the intervention from household, healthcare system and societal perspectives?
3) What can be learned from trial participants and non-participants about adoption of the intervention that could inform effective implementation of the trial findings in the future?

High quality clinical trial evidence about the health and economic impacts seen when households adopt advanced cookstove technologies is needed to inform policy and decision makers across commercial, health, development and community sectors at local, regional and international levels. The results of this trial will be relevant to local policy makers in Malawi who will have new efficacy, economic and qualitative data to guide decisions about funding advanced cookstove programmes for improving child health; to regional commercial, non-governmental and governmental organisations in sub Saharan Africa manufacturing and distributing advanced cookstove solutions; and to international (e.g. World Health Organisation (WHO)) decision and policy makers by contributing new evidence about the health and economic impacts of an advanced cookstove intervention of broadly generalisable relevance to areas of the world where biomass fuel use is common. We have established local (e.g. community leaders), regional (e.g. commercial and non-governmental organisations and Malawi Ministry of Health) and international (e.g. WHO and Global Alliance for Clean Cookstoves) links that will allow us to disseminate the findings of the trial effectively at all levels to a wide range of stakeholders, policy and decision makers.

Technical Summary

Trial type: Prevention.
Design: Village-level cluster randomised controlled trial with two arms of equal size.
Interventions: Experimental - The Philips fan-assisted stove with user training (replacing open fires). Control - Continuation of traditional cooking methods (open fire).
Randomisation: By matched pairs of villages using computer-based system stratified by district to trial arms in a 1:1 ratio.
Target population: Children up to 4.5 years old in Malawi allowing for a minimum of 6 months data collection before a child's 5th birthday. The trial will be broadly inclusive. HIV infection will not be an exclusion criterion.
Duration of treatment period and follow-up: 24 months from randomisation.
Primary outcome measure: Incidence of pneumonia in children under 5 years of age diagnosed by blinded physicians or medical officers using the WHO Integrated Management of Childhood Illness (IMCI) pneumonia assessment protocol.
Economic, social, qualitative measures: Analyses will be carried out to explore factors that may be relevant for scale up of the intervention in the future.
Sample size and potential power of the trial: Randomisation will be at the village level with an expected average number of children per village of 85 (77 after allowing for 10% loss to follow up). The between cluster CV has been set at the conservatively high level of 0.10. The latest data from Malawi suggest that around 9% of control group children will develop pneumonia severe enough to require treatment at a healthcare facility every year. We are using a highly conservative estimate of 5% (allowing for impact of pneumococcal vaccine). A sample of 59 villages per group will give 80% power to detect a 20% reduction in risk in the intervention group from 5% to 4% (a=0.05).
Consumer involvement: Villagers, local stove producers and community leaders in Blantyre and Balaka districts have been involved with the development of this trial proposal through community engagement meetings.

Planned Impact

Research participants: The research is expected to provide direct benefits to trial participants: a quarterly allocation of maize or pigeon peas, access to a mobile phone, access to antibiotics for pneumonia if indicated but unavailable at the local health facilities and two advanced cookstoves either at the beginning or end of the trial. Reduced fuel consumption is a potential additional ongoing benefit. Participation in the trial is at village-level and may therefore have further positive effects on welfare and social cohesion.
Local staff: We plan to employ a number of local people through this grant with many other local people involved indirectly. The training and experience gained should lead to improved work opportunities in the future. In addition there will be immediate financial benefits for individuals receiving a salary. Such financial benefits typically extend widely beyond these individuals to families and home villages.
Women and children living in poverty in developing countries: Should we see a reduction in childhood pneumonia from an effective biomass smoke exposure reduction intervention in this trial, this finding will be relevant across populations of people who cook using open fires living in the developing world well beyond the immediate trial setting. The benefits of adopting clean cookstove technologies could extend beyond health effects to economic, quality of life and well-being effects.
Local, national and international policy and decision makers: High quality clinical trial evidence about the health and economic impacts seen when households adopt advanced cookstove technologies is needed to inform policy and decision makers across commercial, health, development and community sectors at local, national and international levels. The results of this trial will be relevant to local policy makers in Malawi who will have new efficacy, economic and qualitative data to guide decisions about funding advanced cookstove programmes for improving child health; to regional commercial, non-governmental (NGO) and governmental organisations in sub Saharan Africa manufacturing and distributing cookstove solutions with uncertain health benefits; and to international (e.g. DFID, WHO and Global Alliance for Clean Cookstoves) decision and policy makers by contributing new evidence about the health and economic impacts of an advanced cookstove intervention of broadly generalisable relevance to areas of the world where biomass fuel use is common.
Public Sector: We will provide regular training to local healthcare workers in the use of the IMCI pneumonia assessment protocol. This training will help maintain knowledge and skills and will hopefully have positive impacts on the management of the ill child.
Business: The new scientific knowledge including exposure-response data from this research could be exploited by businesses locally and internationally developing biomass smoke exposure reduction interventions. This could contribute to wealth creation and economic prosperity in individual developing countries.
Third Sector: Concern Universal and other NGOs implementing cookstove programmes are expected to benefit from new knowledge about exposure-response effects of biomass smoke exposure reduction strategies that could be used to guide future activities.
Other: LSTM, MLW and COM have public engagement programmes that contribute to increasing public awareness and understanding of science, economic and societal issues which we will contribute to with the results of this trial.
Environment and climate change: The widespread adoption of clean burning efficient cookstoves that consume less fuel and put less pressure on forests could contribute to environmental sustainability and protection. A cookstove intervention that has health as well as environmental benefits could be particularly valuable in the carbon trading market that could help provide funding for sustainable cookstove programmes.

Publications

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Gordon SB (2014) Respiratory risks from household air pollution in low and middle income countries. in The Lancet. Respiratory medicine

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Jary HR (2014) Feasibility of conducting a randomised controlled trial of a cookstove intervention in rural Malawi. in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease

 
Title Cooking and Pneumonia Study: Information film 
Description The video outlines the two-year study that will track around 10,000 children aged under five years who live in randomised villages in Chikhwawa and Chilumba in Malawi. The homes of the children involved in the study are randomly selected to be supplied with two clean cookstoves or to continue cooking on open fires in the traditional way. The aim is to see if the new stoves, which can reduce emissions by up to 90%, will stop the children getting pneumonia, a major cause of death in this age group. 
Type Of Art Film/Video/Animation 
Year Produced 2014 
Impact TBC 
URL http://www.capstudy.org
 
Title Photovoice CAPS film 
Description As part of a pilot study of Photovoice methodology carried out in rural Chikhwawa as part of CAPS a film of the participants was produced. This pilot study was funded by the Wellcome Trust, through an Engaging Science Grant,'The Cooking and Pneumonia Study: a focus on food' (reference, 106977/Z/15/Z). The film shows the 6 participants discussing images they have taken about food and drink. 
Type Of Art Film/Video/Animation 
Year Produced 2015 
Impact This film has been shown to the pilot study participants and the CAPS fieldworkers as part of dissemination of the results of the pilot study. This activity is also an important part of sensitising both fieldworkers and study participants to a qualitative study nested within CAPS. The film forms an important part of a publication of this pilot study and has been used in several conference presentations. This has resulted in considerable interest in the use of this methodology both within cookstove adoption studies and other fields and the development of collaborative relationships. 
URL https://vimeo.com/153926407
 
Guideline Title WHO Guidelines for Indoor Air Quality
Description Citation in WHO Guidelines for Indoor Air Quality
Geographic Reach Africa 
Policy Influence Type Citation in clinical guidelines
 
Description Input into DfID policy on household air pollution
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in advisory committee
 
Description Bill and Melinda Gates Foundation
Amount $343,147 (USD)
Organisation Andrew W. Mellon Foundation 
Sector Private
Country United States
Start 08/2015 
End 08/2016
 
Description Children's health research award
Amount £50,912 (GBP)
Organisation Medical Research Council (MRC) 
Department Medical Research Foundation
Sector Charity/Non Profit
Country United Kingdom
Start 02/2016 
End 01/2017
 
Description GCRF Research Grant
Amount £606,000 (GBP)
Funding ID MR/P022006/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 04/2017 
End 04/2019
 
Description International Engagement Award
Amount £3,000 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2015 
End 02/2015
 
Description MRC GCRF
Amount £218,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 06/2017 
End 12/2018
 
Description NIH (R56)
Amount $100,000 (USD)
Organisation National Institutes of Health (NIH) 
Sector Public
Country United States
Start 08/2014 
End 08/2015
 
Description NIHR Global Health Research Unit
Amount £7,000,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 06/2017 
End 03/2021
 
Description Newton Advanced Fellowship: Biostatistical Methods for Bayesian Analysis of Multilevel Models of Lung Health in Africa.
Amount £92,600 (GBP)
Funding ID NAF\R2\180681 
Organisation Academy of Medical Sciences (AMS) 
Sector Charity/Non Profit
Country United Kingdom
Start 12/2018 
End 12/2021
 
Description Wellcome Trust Clinical PhD scheme
Amount £455,000 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 12/2018 
End 09/2021
 
Description Biomass Reduction and Environmental Air Towards Health Effects in Africa (BREATHE -Africa) 
Organisation Liverpool School of Tropical Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Theme leader for health Effects. Teach level 1 students at the annual PATS MECOR course.
Collaborator Contribution •Draw together experts and investigators in major air pollution trials in order to share findings and plans •Harmonise specific aspects of trial methodology to ensure that exposure monitoring and health effect evaluation are comparable among active trials and those in development, as well as other research and evaluation with similar exposure and outcome assessment needs. •Optimise the opportunity to undertake mechanistic work, including testing of new biomarkers, not funded by current trials •Engage African researchers and trainees in existing and new studies by a bottom-up approach offering mentored research training and projects.
Impact The publication of a Commissioned Review for The Lancet Respiratory Medicine journal has been an early success for the Partnership. This is wide-ranging review of 'Respiratory risks from household air pollution in low and middle income countries' is available on the Lancet website. http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(14)70168-7/fulltext. CAHRD meeting [Centre for Applied Health Research & Delivery]
Start Year 2014
 
Description Malawi pneumococcal carriage and disease group 
Organisation Wellcome Trust
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution The MLW group with an interest in pneumococcal disease (originally sepsis and meningitis, then pneumococcal vaccine work, latterly mucosal responses and pneumonia) has contributed more than 50 papers on this subject including 2 major studies published in the New England Journal of Medicine. I have been involved in this group from 1999 to the present. Currently this group is led by Prof Rob Heyderman, Prof Neil French, Dr Dean Everett and Malawi-resident Wellcome Trust research staff and Fellows.
Collaborator Contribution A decade of active research, approx. £10m research funds and a major vaccine study so far.
Impact Malawi vaccination with multivalent conjugate vaccine.
Start Year 2006
 
Title Advanced cook stove 
Description Clean cook stoves offer the potential to reduced household air pollution and save lives. There are 200 untested stoves on the market, with varying efficacy in reducing HAP, and unknown effectiveness to improve health. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Market authorisation
Year Development Stage Completed 2008
Development Status Actively seeking support
Impact Can be used to charge phones, give light and generally reduced household energy poverty. 
 
Description 47th World Conference on Lung Health 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Scientific presentation on the challenges of implementing new models of care in low- and middle- income countries which generated discussion .
Year(s) Of Engagement Activity 2016
 
Description African Utility Week 2016 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Presentation about the potential for clean energy solutions to improve health and save lives in Africa which was followed by questions and discussion and potential areas for future collaborative work.
Year(s) Of Engagement Activity 2016
 
Description American Thoracic Society Conference 2015 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Participation in American Thoracic Society Task Force Workshop and preparation of a report about the adverse health effects of household air pollution.
Year(s) Of Engagement Activity 2015
 
Description BBC News coverage of Cooking And Pneumonia Study programme of work 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Coverage of the story of the Cooking And Pneumonia Study (CAPS) by BBC News Science Reporter Victoria Gill who visited the study location in Malawi and prepared reports that were shown widely on BBC News outlets. This generated considerable global interest in the study and the topic of household air pollution and the adverse health effects associated with this.
Year(s) Of Engagement Activity 2014
URL http://www.bbc.co.uk/news/health-30448559
 
Description COPD conference presentation 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited talk as Long Investigator at the COPD11 conference on 'learning from global studies'. Following this I was invited to participate in a Global Initiative for Chronic Obstructive Lung Disease (GOLD) meeting on how to make the international GOLD guidelines more relevant to LMIC populations. An output from this meeting was the drafting of a position statement.
Year(s) Of Engagement Activity 2018
 
Description Cambridge University Visit 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Seminar delivered at Cambridge University Hospitals' Respiratory Research event about household air pollution and lung disease in Africa. Questions and discussion followed. Opportunities for future clinical and academic collaboration explored.
Year(s) Of Engagement Activity 2017
 
Description Community activities in conjunction with the IUATLD Conference 2016 in Liverpool 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact As part of Community Commons activity at the 47th Union International Conference of Lung Health held in Liverpool, activities related to air pollution and cookstoves were held immediately outside the conference entrance and inside in the community area.

The display was organised in conjunction with firefighters from Operation Florian and young adults from a local college. There were sessions at various times showing the immediate risks from fire and how these can be mitigated and the longer term risks to lung health from cooking using biomass.

Young people from the local college build replica African houses and also carried out other in-school activities. In addition Florian, the college and Kevin Mortimer (CAPS Co-PI and BREATHE Health Effects theme lead) participated in a joint presentation session inside the conference arena.
Year(s) Of Engagement Activity 2016
URL http://liverpool.worldlunghealth.org/updates/the-union-world-conference-opens-with-fiery-display-of-...
 
Description Community engagement activities (Malawi) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact All communities participating in the Cooking And Pneumonia Study we consulted about the study which sparked questions and discussion.

The communities have asked us to return. We are planning additional engagement activities to explore community-identified research priorities for the future
Year(s) Of Engagement Activity 2014
 
Description Conference (The Union 2016) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Raising awareness about the global health problem of household air pollution to a wide range of audiences through engagement with community activities of the 2016 World Lung Health Conference.
Year(s) Of Engagement Activity 2016
URL http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(16)30413-1/abstract?cc=y=
 
Description Ethiopian Thoracic Society Conference 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Invited talk on the effects of air pollution on lung health at the 2nd annual meeting of the Ethiopian Thoracic Society which generated interest in the topic and discussion of potential future research and collaboration in this area.
Year(s) Of Engagement Activity 2016
 
Description Global Health Film Festival 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Contributed to the development and implementation of a Workshop at the Global Health Film Festival: "Research in Focus - the role of video film in global health research". Discussion followed and interest was expressed in further Workshops being held at the Festival in the future.
Year(s) Of Engagement Activity 2018
 
Description MRC Unit The Gambia talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Talk to academic audience at the MRC Unit in The Gambia about the Cooking And Pneumonia Study which led to questions and discussion about opportunities for future collaboration.
Year(s) Of Engagement Activity 2017
 
Description Presentations at meetings in Nepal 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Invited talks in Nepal - at Patan Hospital and the Institute of Medicine - on "Household air pollution and the improved cookstove: a story of smoke and mirrors?" These talks led to discussion and meetings particularly focused on opportunities to collaborate in the future
Year(s) Of Engagement Activity 2018
 
Description School Visit (Liverpool) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact Involved Liverpool Life Sciences UTC students in discussing Malawi-based work and preparing for community participation in The World Lung Health Conference in Liverpool 2016
Year(s) Of Engagement Activity 2016
 
Description Smart Villages Webinar 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Participation as panelist in seminar: Healthy villages are smart villages: Health, energy, and development which generated questions and discussion and potentially influenced future decision making.
Year(s) Of Engagement Activity 2017
 
Description Warwick University Visit 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Talk to Doctoral students at Warwick University Medical School about 'life post PhD' which led to questions and discussion.
Year(s) Of Engagement Activity 2017