The research agenda of the programme is led by 31 principal investigators (researchers with their own funding), of which 23 are Wellcome funded and 14 hold Wellcome Fellowships. Research falls into five major disciplines: Clinical sciences, Epidemiology and Demography, Pathogen Biology, Public Health Policy and Health systems, and Social and Behavioural research. To take account of geographical distribution there are eight functional reporting groups or clusters. There is considerable interaction within and between divisions and functional reporting groups with a number of overarching programmatic activities involving many groups.
More information on the KEMRI-Wellcome Research Programme research areas:
What is it?
The Malaria Public Health (MPH) Cluster is focused around four main research areas: a) the epidemiology of malaria transmission in space and time; b) the impact of malaria and its control on disease outcomes; c) the translation of epidemiological evidence into better disease control design and financing; and d) operational research to improve the quality of malaria case management and drug resistance surveillance. Our focus is on Africa with specific research collaborations with those responsible for malaria control in Kenya, Uganda, Djibouti, Sudan, Somalia, Namibia, Malawi, Madagascar, The Gambia, Nigeria and Democratic Republic of Congo. Ensuring a translation of research into regional policy involves working in partnership with the World Health Organization’s regional technical and advocacy agencies, bi-lateral donors and the African Leaders for Malaria Alliance.
MPH involves staff from a range of backgrounds including epidemiology, demography, public health, operational research, human geography and clinical medicine. The cluster is currently directed by Professor Bob Snow with five research units each managed by a senior scientist.
Bob has worked in Africa since 1984. He is Professor of Tropical Public Health at the University of Oxford and directs the MPH in Nairobi. His work began with the first clinical trials of Insecticide-treated bed nets in The Gambia and he has since developed a large programme of work in Kenya on the public health burden of malaria in Africa and understanding ways in which this can be reduced through scientifically proven methods of intervention, effective partnerships with African governments and appropriate financing. He has published over 350 articles on malaria, is a technical advisor to the Kenyan Government and sits on a number of international malaria advisory panels. He is supported by the Wellcome Trust (UK) as a Principal Fellow and was made a Fellow of the Academy of Medical Sciences in 2008.
Catherine holds diplomas in Business Management and ICT from the Kenya Institute of Management and City & Guilds respectively. She began her career in 2009 as a Finance and Administration manager at the Centre for Heritage Development in Africa (CHDA) a non-profit organization . In July 2011 she joined Mondeas Limited a media company as an Administrative Coordinator. She joined MPH in April 2012 as the Personal Assistant to Professor Bob Snow and provides wider administrative support to the MPH group, she is currently the senior administrative assistant to the cluster.
Abdisalan Mohamed Noor (known as Noor) graduated with a BSc (Hons) in Surveying from the University of Nairobi in 1999. Following a GIS internship at the International Research on Livestock Institute he joined the MPH in 2000 and was involved in developing a spatial infrastructure of health services in Kenya. He completed his PhD on spatial models of access to and use of government health services in Kenya in 2005 with the Open University, UK and the University of Oxford. He was awarded a Wellcome Trust Research Training fellowship in 2007 to investigate the spatial and socio-economic determinants of access to and use of health interventions among rural African communities, particularly understanding and modelling the dynamics of insecticide treated net uptake. Noor is an honorary lecturer at the University of Nairobi, Department of Geospatial Engineering & Space Technology, Technical Advisor the Kenyan Government’s National Malaria Control Programme and supports other Ministries of Health in the region notably in Somalia, Djibouti and Northern Sudan. In 2009 Noor was awarded one of the most prestigious regional science awards, the African Union Young Scientist of the Year award. Noor’s research interests now include new important elements of changing malaria risk in Africa – the definition, measurement and spatial modeling of malaria risk in areas of exceptionally low transmission. For this work Noor was awarded a five-year Intermediary Fellowship by the Wellcome Trust UK in 2010. He is currently the head of the geo-spatial modeling unit of MPH, an honorary Visiting Fellow at the Nuffield Department of Medicine, University of Oxford and serves on the KEMRI/Wellcome Trust Research Programme’s Executive Strategic Development Committee. He is currently the Chairman, National Council for Population & Development.
Emelda graduated with a BSc (Hons) in Chemistry and Biochemistry from Egerton University, Kenya in 2001 and joined KEMRI-Wellcome Trust-Kilifi Unit the same year as a research assistant involved in a large field epidemiological project studying various aspects of RSV infection. Emelda completed her PhD in 2007 from the Open University, UK, and the University of Warwick on infectious disease epidemiology examining the transmission dynamics of RSV infection, in particular the characterization of patterns of infection of this virus and associated disease within the community. Emelda joined the MPHEG in 2007 with a specific interest in developing research questions related to measuring the spatial and temporal heterogeneity in P. falciparum risk and how this relates to global malaria disease burdens. In 2008 she was awarded a Wellcome Trust Research Training fellowship to study the changing clinical epidemiology of malaria in East Africa. Her interests continue to be anchored in measuring the impact of scaled malaria control with the best possible statistical techniques and supporting regional Ministries of Health. In 2011 Emelda won a prestigious fellowship to spend a year at the Institute of Health Metrics, University of Washington, Seattle. Emelda is head of the Epidemiological Impact & Surveillance Unit of MPH examining the clinical malaria epidemiological transition in Africa and is an Honorary Fellow of Nuffield Department of Clinical Medicine, University of Oxford and serves on the programmes Higher Degree Committee (HDC).
Judy holds a Bachelor's degree in Dentistry (University of Nairobi) and an MPH (Hebrew University, Israel). She began her career in epidemiology working as part of the KEMRI/Wellcome Trust Collaborative Programme in Kenya. In 2002 she was awarded a Wellcome Prize studentship to undertake a DPhil at the University of Oxford in modelling the spatial risks of Plasmodium falciparum in East Africa. When she completed her DPhil in 2005 she moved to the International Research Institute for Climate and Society (IRI) in New York where she was an Associate Research Scientist with IRI's Africa Program until 2011. Her research interests continue to involve building the capacity of the health sector in Africa to use climate information effectively for decision-making in the control of climate sensitive diseases. Judy serves on the Scientific Advisory Committee of the World Wide Anti-malaria Resistance Network (wWARN) and the External Technical Advisory Group for AvecNet, a project on 'Targeting malaria by hitting the vector' that is led by the Liverpool School of Tropical Medicine and sponsored by the European Union. Judy was appointed in June 2012 to head the policy interface unit of the MPH malaria epidemiology work working with regional partners and national governments.
Caroline graduated with a B.Sc. (Hons) in Geomatic Engineering from the Jomo Kenyatta University of Agriculture and Technology (JKUAT) in 2006, and holds a Masters in Environmental Planning and Management from the University of Nairobi. She has been involved in various GIS projects at the Regional Centre for Mapping of Resources for Development (RCMRD) and establishing Roads network database at Gath Consulting Engineers. She joined MPH in August 2007 as a research assistant and has been involved in the mapping of Anopheles vector distributions globally as well as database assembly for mapping of malaria prevalence for Africa. She is currently pursuing an Open University PhD examining the effects of changing patterns of urbanization on malaria transmission in Africa over the last 100 years.
Victor graduated with a BSc (Hons) in Surveying from the University of Nairobi in 2006. He immediately joined MPH as a research intern and later as a research assistant working on various projects with application to GIS, developing spatial databases of health facilities in Kenya, malaria and fever prevalence in Somalia amongst others. He was awarded a Wellcome Trust Masters fellowship in 2009 to study applied GIS (health) and remote sensing at the School of Geography, University of Southampton. His interests include applied spatial epidemiology and model based approaches in disease mapping, the application of remotely sensed data in health and participatory web-based health GIS (PPGIS) platforms. He recently won a Commonwealth Fellowship to pursue a PhD supervised between MPH and the University of Southampton to explore optimized ways of defining Health Information System (HMIS) data to define malaria incidence in low transmission setings.
Deepa graduated with a BSc (Hons) in Business Mathematics and Statistics from the London School of Economics in 2007 and following research statistical internships at UN HABITAT and the University of Washington’s HIV projects in Kenya, gained interest in statistical and mathematical modeling of infectious diseases. In October 2009 she completed an MSc in Modern Epidemiology from Imperial College London and joined MPH in January 2010. She is currently undertaking a co-supervised PhD between MPH and the University of Florida to develop data sets and models of human population movement in relation to the threats posed by human migration and mobility on malaria elimination ambitions in the African countries.
Damaris graduated from the Egerton University in 2006 with a BSc in Biomedical Science and Technology. She completed an MPH in 2009 and MSc in Medical statistics in 2011 at the University of Nairobi. She began her career as a research assistant with United Nations Children's Fund in 2006 and later joined United Nations Environment Programme in 2008 as a research Analyst. In 2011 she joined MPH as a research officer in GIS and Medical statistics. She is involved in assembling data on malaria and under nutrition in Somalia and statistical analysis to investigate the association between malaria and poor nutrition, and provide evidence to international agencies tasked to respond to the dual emergencies of disease and famine in Somalia. Damaris’ research interest is in Bayesian geostatistical methods to explore risk factors for under-nutrition and anemia in Somalia and will expand these research themes to support a PhD thesis in 2013.
Clara holds a Bachelor of Science degree in Environmental Science/Biology from Edinboro University of Pennsylvania and obtained her MSc in Geography and Environmental Resources in 2010 from Southern Illinois University at Carbondale, USA. While in the USA, she worked as an environmental intern and volunteer for government and non-profit organizations participating in the development of environmental education programs as well as recycling and cleanup activities. She joined MPH in October 2011 as a GIS research officer working on projects related to the historical distributions of malaria in Africa, traveling to regional and international library archives for data collection and developing GIS applied products for the group.
Punam graduated with a BSc (Hons) in Mathematics, Operational Research, Statistics and Economics from the University of Warwick in 2009. During her final years, she concentrated her studies towards medical statistics and mathematical biology - population dynamic models; volunteering to work with clinical data at the Aga Khan hospital in December 2008. In October 2010 she completed an MSc in Modern Epidemiology at Imperial College London. She joined MPH in January 2011 as a research officer working on the assembly of historical malaria data and descriptions of control in Africa and the Arabian Peninsula.
Viola graduated with a B.Sc. (Hons) in Computer Science from Jomo Kenyatta University of Agriculture and Technology (JKUAT) in 2011. She has been involved in various GIS and application development projects as an applications developer including projects for several Kenyan Local Authorities including County Council of Makueni and the Municipal Council of Nakuru. She joined MPH in May 2012 and is currently involved in a number of data analyses of malaria prevention intervention coverage regionally.
Jacob completed his Bachelor of Arts degree in Geography at Moi University in 2007. He then worked with the Kenya National Bureau of Statistics and briefly with KEMRI-CDC in Kisumu. Jacob joined MPH in September 2011 as an Assistant Research Officer, specializing in GIS, after completing a research internship at the African Population and Health Research Center. His major interests areas are spatial epidemiology, spatial analysis and the application Of GIS and remote sensing in health research. Jacob currently works on a project mapping the locations of health facilities and the health work force in Kenya.
Ambrose completed his medical degree at Makerere University in 1992 and his Masters in Epidemiology from the London School of Hygiene and Tropical Medicine in 1996. He was awarded a PhD from the University of Antwerp and Institute of Tropical Medicine for his work on intensity of transmission and spread of antimalaria drug resistance in 2004. Between 1996 and 2011 Ambrose held senior positions within the Ugandan Ministry of Health, the Medicines for Malaria Venture (MMV) and was the field coordinator for the multi-country malaria clinical trial supported by the European & Developing Countries Clinical Trials Partnership (EDCTP). He received a senior fellowship in 2007 from EDCTP to conduct a capacity strengthening project for pharmacovigilance of antimalarial drugs in Africa. He sits on several international advisory boards including the international Ethical Review Board of Médecins Sans Frontières, the World Health Organization and is a permanent member of the Global Fund Technical Review Panel. His work on drug resistance surveillance over the last 15 years has shaped malaria treatment policy in Africa which was recognized in a special profile in Lancet, 2010, 375:1428. Ambrose joined the MPH in 2011 as the Regional Scientific Director, World Wide Antimalaria Resistance Network (wWARN) for East Africa and leads this initiative to build the regional capacity and science behind the epidemiology of antimalarial drug resistance. Ambrose holds an appointment at the University of Oxford and heads the unit on Drug & Case-management surveillance unit of the MPH.
Rachel graduated from the University of London (University College London) in 1993 with a BSc (Hons) in Biochemistry. She completed an MSc in 1997 in Medical Microbiology from the University of British Columbia and a PhD from Open University in collaboration with Birmingham University in 2008. In 2010 she obtained a Graduate Certificate in Emerging Infectious Disease Epidemiology from the University of Iowa, USA. She began her career as a graduate research assistant with Department of Pathology and Laboratory Medicine, University of British Columbia in 1994, and later joined Nairobi Hospital and International Medical for a short spell, before joining KEMRI-Wellcome Trust Research Programme in Kilifi as a graduate research officer in the Respiratory Syncytial Group in 2001.She went on to work at the KEMRI/US Army Medical Research Unit-Kenya as a senior research officer in 2008 for 2 years and then moved to KEMRI/Centers for Disease and Prevention Collaborative Programme in 2010 as an Epidemiologist/Influenza program head-Kisumu. She has now re- joined the KEMRI-Wellcome Trust as the East Africa Regional Liaison Scientist in the WWARN program.
Dejan is an epidemiologist within Malaria Public Health and Epidemiology Group at KEMRI/Wellcome Trust Research Programme in Nairobi, Kenya. Since 1997 he has been working in several African countries as medical doctor, health programme manager and researcher monitoring and evaluating translation of malaria case-management policies into practice. His current research interest is on the use of mobile phones to improve health workers’ adherence to malaria guidelines, patients’ adherence to treatments, and availability of medicines at rural health facilities. Dejan is affiliated to the University of Oxford (UK), Boston University (US), and is also a technical advisor to the Kenyan Government’s Division of Malaria Control.
Sophie completed her first degree in Education and completed a Masters in Population Geography at Kenyatta University in 2002. She was involved in evaluation of community development projects for two years before being awarded a scholarship by the Katholischer Akademischer Ausländer-Dienst (KAAD) to pursue her PhD studies at the Rheinischen Friedrich-Wilhelms-Universitaet Bonn, Germany in 2006. Her PhD work focused on human ecology and disease models in the study of behavioral, socioeconomic and micro ecological factors associated with malaria in south Kisii district, Kenya. She was awarded her PhD in 2009. Sophia joined MPEHG in March 2010 on a one year Post Doc internship programme working on a variety of quantitative analyses related to malaria case-management in Kenya and Sudan. She was appointed to a research scientist position in February 2011 and has developed a series of studies to investigate the applications of SMS text messaging for effective diagnostic and anti-malarial drug management supply in conjunction with the Kenyan Ministry of Health.
Gabriel graduated with a B.Ed Sc. (Hons) in Double Mathematics (Statistics Option) from Egerton University in 2007, and currently undertaking a Masters in Biometry (Biostatistics) from the University of Nairobi. He has worked for Barclays Bank of Kenya as a data manager and the Institute of Development Studies (IDS) of the University of Nairobi as a research assistant. He joined ICIPE as a Graduate Fellow attached to the biostatistics unit in 2001. Gabriel is a Member of the International Biometric Society (IBS).He joined MPHEG in June, 2012 working under the malaria case management cluster.
Charles is a public health entomologist with over 20 years’ experience in the conduct of entomological studies in Kenya, Ethiopia and Eritrea. His focus has been the study of malaria vectors and has worked on the large-scale evaluation of insecticide-treated bednets, insecticide resistance, and integrated vector management (IVM) strategies. Charles has developed and implemented vector surveillance systems at local and national scales. Charles serves on various national and international technical committees. He maintains a keen interest in translating research into policy and practice and played an important role in the formulation of national policy on IVM. He is the current President of the Pan African Mosquito Control Association (PAMCA), an association of African entomology professionals dedicated to Improving human health through suppression of mosquitoes and mosquito borne diseases.
Luna holds a PhD in Molecular Entomology from Kenyatta University and a Diploma in Leadership and Management for Strathmore University and is currently a Principal Research Officer and Head of the Biotechnology Research Programme at the Kenya Medical Research Institute, KEMRI. She has extensive experience in biomedical research in different aspects of vector biology including population genetics, insecticide resistance and vector ecology. In 2008, Luna was appointed as a Young Affiliate member of the Academy of Sciences for the Developing World, TWAS. She is a member of the Pan African Mosquito Control Association (PAMCA), Kenyan Chapter and a member of the interim organizing committee.
Joseph Mwangangi graduated with BSc (Zoology, Botany and Geography) from Kenyatta University in 1997. He joined KEMRI in 1998. Mwangangi graduated with PhD degree in Medical Entomology from Kenyatta University in 2007. His research interest is in malaria vector biology and ecology, novel approaches to the control of vector borne diseases and the monitoring of insecticide resistance. His current research interests include IVM within a community based model, empowering communities and public health stakeholders in disease control. He is TWAS Young Affiliate Fellow for Academy of Sciences for the Developing World (TWAS) and the TWAS Regional Office for Sub-Saharan Africa (TWAS-ROSSA) for period 2011 - 2015. He is an Official for the PAMCA, Kenyan Chapter and member of coordinating committee for PAMCA.
Damaris holds a Bachelor of Science degree in Biochemistry and Masters in Biotechnology from the University of Mysore, India. Currently she is pursuing a PhD in Molecular Medicine with Jomo Kenyatta University of Agriculture and Technology. Her PhD work focuses on population genetics and insecticide resistance of malaria vectors in Western Kenya. Damaris joined KEMRI, Centre for Biotechnology Research and Development, Molecular Entomology laboratory in the year 2006 as an Assistant Research Officer and later as a Research Officer within the same department. She is involved in various projects encompassing monitoring of insecticide resistance, mapping of malaria vectors and studying of behavior changes of mosquitoes in relation to vector control systems in Kenya. Damaris is a member of the Pan African Mosquito Control Association (PAMCA)
See MPH Organogram here.
Spatial epidemiology unit: Head, Dr Abdisalan M Noor
Mapping 100 years of changing intensity of P. falciparum transmission in Africa
Developing novel methods to map the risks of P. falciparum infections in areas of low transmission intensity using combinations of community and facility-based data
New methods to estimating malaria intervention coverage from sparse point data from multiple sources to inform sub-national health decision making
Mapping the risks of malnutrition and coincidence with malaria and human resilience in Africa
Modeling and mapping the seasonality of clinical malaria in Africa as new tools for national malaria control programmes
Mapping the changing spatial distributions of Plasmodium malariae in Africa
The temporal effects of urbanization on P. falciparum prevalence in Africa since 1960
Quantifying the threats posed by human population movement to malaria elimination and control with special reference to three regions: African Islands, North Africa and the Arabian Peninsula
Estimating the malaria burden and coverage of prevention among African pregnant women
Improving malaria case-detection and hot-spot surveillance in the Republic of Sudan, Djibouti and Kenya
Revisiting the malaria selection hypothesis of sickle cell trait in East Africa using receptive endemicity
Reviewing the pathways from control to elimination on the Arabian Peninsula: challenges for a malaria free peninsula
Modeling the threats and challenges to malaria elimination in Jazan Province, Kingdom of Saudi Arabia
Vector Public Health Unit: Head, Dr Charles Mbogo
Insecticide resistance monitoring in Western & Nyanza provinces
Integrated Vector Management in urban settings
National malaria vector surveillance
Vector database assembly and time-space modeling: East & Southern Africa
Epidemiological impact & surveillance unit: Head, Dr Emelda Okiro
The impact of changing malaria transmission on all-cause child mortality in Africa 1970-2010
The role of malaria and its control in the spatial and temporal patterns of child survival in East Africa
Monitoring the changing clinical epidemiology of hospitalized paediatric malaria in Kenya, Uganda and Malawi
Policy impact unit: Head, Dr Judy Omumbo
Understanding how malaria maps, data and indicators are used by national governments in Africa: qualitative and quantitative studies
Developing digital archives of malaria control information at health decision making units across Africa
Establishing regional information platforms and Repositories Open Access Data for malaria control and elimination
Improving the use of national malaria information to guide and finance sub-national disease control: applying decision making tools to mapped data in ten countries
The history of pre-RBM malaria control with special reference to chemoprophylaxis and implications for current drug-based prevention policies in Africa
Drug & Case-management surveillance unit: Head, Dr Ambrose Talisuna
Monitoring the implementation and effectiveness of new parasite-based diagnosis out-patient malaria case management guidelines in Kenya
The operational impact of SMS technologies to improve drug management and commodity supplies and health information reporting in Kenya
Clinical trials of the effectiveness of SMS reminders on patients’ adherence to antimalarial treatments and post-treatment review
The effectiveness of SMS based reporting of adverse drug events and quality of medicines
Developing spatial risk analysis models to provide insights into high level hot-spot analysis for future surveillance programs in Africa.
Pilot studies of pragmatic early warning and detection systems for emerging artemisinin resistance in East Africa
Factors affecting early parasitological response to ACTs in Africa: a) pooled analysis of individual patient data; b) trends of the parasite clearance profile for hospitalized patients with severe malaria receiving intravenous artesunate monotherapy; c) Monitoring trends of the parasite clearance profile and efficacy of ACTs in East Africa
Links with other clusters/groups:
Over the next five years linkages are proposed between the health care financing and health information research themes within the HSSR cluster and the malnutrition interest groups within the Clinical Sciences cluster.
Clinical research is in many senses the “engine room” of the overall programme, with bed side and clinic based research linking into epidemiological surveillance, basic science and health systems research as well as research on ethics and communication. Clinical surveillance over 20 years at Kilifi District Hospital (KDH) has generated a unique database of around 80,000 consecutive paediatric admissions. Having such a comprehensive data source led naturally to the recognition that children entering hospital often have multiple interacting pathologies and that a focus on the severely ill patient was more appropriate than on any single disease entity.
A key aim of clinical research is to provide the evidence base for prevention and treatment. We have identified key clinical correlates with poor outcome across a range of clinical syndromes and helped refine and develop existing national and international guidelines. Alongside the clinical epidemiology and pathophysiological research at Kilifi we have conducted large numbers of clinical trials in Kenya and beyond, in both in patients and out patients. Our clinical trials facility (CTF) provides cross programme support and coordination to ensure the highest possible compliance with national and international regulatory requirements and ethical standards.
Large-scale studies of paediatric admissions are helping to clarify the spectrum of diseases affecting young children in Kilifi, and pointing the way to improved treatments for the severely ill.
The KEMRI-Wellcome Programme is closely linked to Kilifi District Hospital, which sees more than 5000 paediatric admissions a year. This link provides the basis for a comprehensive clinical surveillance system and underpins the Programme's activities into severe childhood illnesses. Although the children's ward is run and maintained by the District Hospital, extra staffing and resources come via the Programme.
Intensive studies of severely ill children are carried out in a separate well-equipped high-dependency unit. Clinical studies provide a clear description of the nature and importance of life-threatening syndromes within the context of a rural African hospital. The high-dependency unit also provides facilities for sophisticated research to be carried out safely, and has been selected for multi-centre clinical trials.
One of the earliest and most substantial pieces of work carried out at Kilifi was a landmark series of studies mapping out local patterns of disease - an area that, somewhat surprisingly, was not well researched in the African context.
The FEAST trial is a large randomised controlled trial in African children hospitalised with severe illness examining whether the addition of rapid fluid infusion (fluid resusciation or expansion) at admission to hospital standard case management improves survival compared to standard management alone.
More specifically, the trial has been designed with the aim of resolving the current debate over:
a) Whether rapid correction of intravascular volume, using colloidal or electrolyte solutions, is safe and improves both survival and neurological outcome in children with severe falciparum malaria; and
b) Whether this approach is preferable to slow restoration of total body water deficits, as suggested by other clinical researchers and currently recommended in international guidelines.
Why is this trial important?
In sub-Saharan Africa case fatality rates in hospital for severe infections in children remains at 15-30%. In this region well over a million children die of severe infection in hospital each year. Currently, antimalarial and antimicrobial drugs are the mainstay of treatment, however most deaths occur early, due to the complications of severe illness, and before definitive treatments have time to act. In this situation doctors have to rely upon supportive therapies to treat complications to try to improve outcome. Defining which are the best life-saving treatments has been frustrated by the lack of clinical studies.
Rapid fluid infusion to correct fluid deficits is a standard supportive treatment and practised routinely for the emergency management of children with severe illness. Currently, reticence to adopt this approach remains and thus in African hospitals children are managed with little fluid or no additional fluid. If the benefits of rapid fluid infusion were shown, then FEAST trial could potentially save thousands of lives of young children annually.
For more information see http://www.feast-trial.org/
The Clinical Trials Facility (CTF) of the KEMRI-Wellcome Trust Research Programme was set up in 2007 to provide a global standard trial centre within the collaborative programme. Based in Kilifi, our role is to work from the point of setting the research question through to analysis and reporting to help ensure all trials run at the unit meet International quality standard. The core aim of using this facility is to enhance the way trials are organised, as an optimum environment for developing highly skilled African trialists.
We have an in-house monitoring team that is trained and with membership to the Institute of Clinical Research and/or Association of Clinical Research Professionals. These are assigned to monitor specific trials. Monitoring ensures all trials comply with ICH-GCP and are thereby being conducted to high ethical standards whilst collecting high quality data.
Some of our trials are externally sponsored and so also receive external monitoring visits from the sponsors. Others are fully in-house trials and for these our monitors provide full cover.
At the KEMRI-Wellcome Trust facility in Kilifi, clinical trials conducted through the Clinical Trial Facility benefit operationally from the following:
Brief History of CTF
The Kemri-Wellcome programme in Kilifi has a long history of conducting clinical trials in illnesses that bring high disease burden and mortality in the community with which we work. We have a good balance of locally led 'academic' type clinical research and product development / drug registration trials. We have built up considerable experience from phase I through to evaluating real-life effectiveness in phase IV trials.
All trials are conducted to ICH-GCP and we manage them through a central system that shares resources and skills. Our Staff work across different trials where possible, and this gives them better opportunity to learn and allows us to share practices and materials. In addition the continuity this brings makes planning possible which enables us to properly resource all our trials and support the career development of our staff.
The clinical trial laboratory within the Kemri-Wellcome programme has full GCLP accreditation and our unit has been audited by the various regulatory bodies from the US and Europe. We work closely with the unit's research laboratory bringing a wide range of in-house expertise such as microbiology, immunology and pharmacology. The hospital also serves as a well-mapped Demographic Surveillance Site (DSS) where a census is conducted three times a year. This is of great benefit for planning and conducting trials.
To be a global centre of excellence for the conduct of clinical trials.
To ensure that our clinical trials capture high quality data and are conducted to the highest ethical standards. We strive to develop a cadre of skilled African clinical trialists to govern and lead our own research agenda.
CTF team comprises of highly skilled cadre of trialists and team members, which includes: Data team, Internal monitors, coordinators, lab team, pharmacy team, quality team and clinical team. Dr Patricia Njuguna is the acting Head of the Clinical Trials Unit. Below is an attachment that elaborates the organization of CTF unit.
It is important to continue doing research because "even the best proven prophylactic, diagnostic and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality." (Declaration of Helsinki Intro Paragraph 6).
"The collection, analysis and interpretation of information obtained from research involving human beings contribute significantly to the improvement of human health." (CIOM11).
Our team of relentless clinicians, scientists and other highly qualified personnel put all their effort to provide quality clinical trials that are result oriented and respect motivated under the ICH/ GCP guidelines. Compassion and respect are our driving forces.
We are delighted to welcome you to our site. At the Clinical Trials Facility, quality standards are our obsession and we do go out of our way to ensure that this is reflected in all aspects of our work. The CTF enjoys the very rare privilege of being set in custom designed, state of the art buildings and endowed with the most wonderful group of hard working individuals one could dream of.
Please take time to run through the various sections of this site which will be revealing, but it is only the tip of the iceberg. We are situated on the hospital grounds of the rural District of Kilifi. Thanks to ICH-GCP, location does not matter anymore in research, but rather the quality of the work that is done.
Our business is to ensure that all clinical trials bearing the KEMRI-Wellcome Trust Research Programme logo meet the globally acceptable standards for conducting clinical trials. Our scientists leading the various fields of research are indeed world class, and have contributed significantly to current scientific evidence in field of tropical disease epidemiology, fluid management, care for the severely ill child, nutritional aspects as well a respiratory disease. When any of these programmes have need for conducting clinical trials, they come to the CTF. We also conduct clinical trials supported by external collaborators such as pharmaceutical industry, universities and other philanthropies.
At CTF we offer expertise for the design, regulatory/ethical aspects, implementation, monitoring and clinical data management. With a pool of experienced study coordinators, clinical monitors and data managers, we ensure that all aspects of an individual study comply to GCP and local regulatory requirements. We have recently implemented an quality assurance programme that ensures that we have a structured framework for maintaining our quality standards. We are also proud of the complement of clinical laboratories that are GCLP accredited.
Please come visit us whenever your road leads to the coast of Kenya.
Dr Patricia Njuguna
Acting Head of the Clinical Trials Facility
All research involving human participants is subject to regulation and approval by KEMRI, Ministry of Health and/or secondary Institutional Review Boards. It is the responsibility of the Principal Investigators to familiarize themselves with these policies and regulations prior to commencing any research and be aware of any changes thereafter. A record of decisions of the technical committees and any responses should be maintained in the main study file.
There are multiple steps of review before a trial can begin with an average turnaround time of about 6 months.
KEMRI Kilifi review committees
KEMRI Kilifi Programmet Management Committee (PMC) - (Meetings held every first Friday of the month)
The Kilifi PMC reviews all concepts intended for trial implementation. The concept proposal is written in standardized format. This review involves an overview of the study i.e. investigators, funding, study objectives, population, study design, duration and strategic implications and how protocol fits in the whole program. The concept is reviewed for potential interaction with ongoing or planned studies. After PMC approval the study can start the protocol approval processes described below. If the protocol is still in early development, the team can continue the protocol development process and later submit the protocol as described below at a later date.
> STEP 2
KEMRI Kilifi Scientific Review
KEMRI Wellcome Trust Kilifi - Scientific Centre Committee (SCC) Meetings held every first Friday of the month after PMC and KEMRI Wellcome Trust Kilifi - Consent and Communications Committee (CCC).
This committee does an indepth review of protocols which must be presented in a standard structured format, unless the sponsors/collaborators require a different format. The committee goe through a systematic review of all aspects of the proposed trial (Protocol, Investigator Brochure, Questionnaires, CRF, Information sheet and Lay Summary). The standard form has been developed to facilitate ethics and science review at the Kilifi SSC and anticipate areas of ethical and scientific discussion.
Protocols must be submitted to Kilifi SCC at least two weeks before the meeting. As per KEMRI guidelines, Kilifi SCC provides thorough review to protocols generated at the centre and ensure that protocols receive appropriate scientific and ethical input. The KEMRI Wellcome Trust Kilifi unit has two committees for this purpose, the SCC which mainly reviews scientific integrity and ethics and the CCC which reviews consents After review at the Kilifi SCC, the informed consent is reviewed by the Kilifi CCC on the following Tuesday. Where the Kilifi SCC decision is favorable to continue IRB/ERC reviews, the investigator will complete a KEMRI Forwarding Form for submission to KEMRI SSC. In addition to the protocol, informed consent and translations (except if exempt), and where applicable, Investigator Brochure, any recruitment material including videos for approval by KEMRI IRB/ERC.
> STEP 3
KEMRI Nairobi Scientific Review
A protocol approved by the Kilifi SCC is submitted to the KEMRI Nairobi SSC through the Centre Director using the official KEMRI Forwarding Form. KEMRI also specifies who qualifies as an investigator. These reviews are also conducted monthly at pre-scheduled meetings. (The dates for their meetings are available upon request)
The decision of the KEMRI SSC may be to approve the protocol and forward it to KEMRI ERC or obtain the investigator's specific responses to reviewer comments before approving the protocol. After review by KEMRI SSC, the protocol is given a KEMRI SSC study number which should be referenced for any future correspondence with KEMRI.
The investigator may notify the KEMRI SCC if there are
any new amendments to the protocol. Depending upon the changes required you may need to change the version of the protocol or informed consent.
> STEP 4
KEMRI Ethics Review Committe
KEMRI ERC meetings are held monthly, usually two weeks after KEMRI SSC meetings and their meetings schedule is also available upon request. KEMRI Nairobi ERC reviews all research protocols that involve human subjects. The KEMRI ERC mainly reviews the ethical aspects of the protocol, storage of samples, exportation of samples, future research and also any other aspects of the proposal relevant to KEMRI. The decision of the ERC may be approval to start the study or further correspondence with the investigator prior to approval.
After receiving the KEMRI ERC approval non-clinical trial research may be able to recruitment, however, clinical trials involving medicinal products must go through the fifth and final review.
> STEP 5
Pharmacy and Poisons Boards Review
Pharmacy and Poisons Board Expert Committee on Clinical Trials (ECCT) reviews and approves all clinical trials in Kenya and providing import licenses for study drugs. A checklist of required documents and schedule of meetings is available on the web site http://www.pharmacyboardkenya.org/. They PPP does not have a fixed submission schedule, but generally completes their review within about a month.
After approval - (Continuing Review and Renewal Request)
After receiving all approvals as required for the study, field or hospital recruitment activities may then start. Please check the expiry dates of the approvals. Usually approvals are given for one year or less depending on the type of research. Approvals are subject to renewal upon submission of annual Continuing Review Report and request for approval renewal.
It is the responsibility of the PI to report any changes in research activity and provide amendments and consent form changes to KEMRI for approval prior to initiating these changes unless the changes impact on safety of participants.
Failure to comply with regulatory authority policies and regulations can result in study suspension, termination and possible disciplinary action on the part of the investigator.
We have developed in house standards and policies which are available on our intranet or upon request by interested parties. Their purpose is to govern and assure quality is achieved and maintained, and that all regulatory requirements are adhered to. These sets of policies and standard operating procedures (SOP) are reviewed and updated regularly and currently they include:
POL- 001 Health and Safety
POL- 002 Training
POL- 003 Quality Improvement
POL- 004 Clinical Lab Management
CTF's SOPs cover the following areas:
SOP 1.0 Preparation, Approval, Review and Issue of clinical trial SOP
SOP 1.1 CTF Standard of operation
SOP 1.2 Pharmaceutical product management and accountability
SOP 1.3 Preparing a trial budget and contract
2. Regulatory and QA
SOP 2.0 Protocol generation and submission
SOP 2.1 Informed consent
SOP 2.2 Consent on HIV screening
SOP 2.3 Participant confidentiality
3. Clinical Trial conduct
SOP 3.0 Study initiation procedure
SOP 3.1 Good documentation practices
SOP 3.2 Adverse/ Serious Adverse Events (AE/ SAE)
SOP 3.3 Phlebotomy
SOP 3.4 Ongoing trial management
SOP 3.5 Monitoring
SOP 3.6 Data entry and management
SOP 3.7 Community engagement and MOH liaison
SOP 3.8 Study close out
|SHORT TITLE||FULL TITLE||PRINCIPLE INVESTIGATOR|
|RTSS MAL055||A phase III, double blind (observer-blind), randomized controlled Multi-centre study to evaluate, in infants and children, the efficacy of the RTS,S/ASO1E candidate vaccine against malaria disease caused by P.falciparum infection,across diverse malaria transmission settings in Africa|
|CTX||Randomized, double-blind, placebo controlled trial of Cotrimoxazole prophylaxis among HIV-uninfected children with severe malnutrition||Jay Barkley|
|Trap Vac||Safety and immunogenicity of heterologous prime-boost with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults in a malaria endemic area||Roma Chilengi|
|Ferroquine||A phase II , parallel group, double-blind, randomized study assessing the efficacy, safety and pharmacokinetics profiles of Ferroquine associated with Artesunate and a single-blind dose level of Ferroquine alone in a 3-day treatment of uncomplicated malaria due to Plasmodium falciparum in an immune symptomatic African adult and paediatric population|
|NNJ||The causes, interventions and neurodevelopmetal outcome of neonates admitted with severe hyperbilirubinemia to a kenyan rural hospital||Michael Mwaniki|
|FOSCOM||A randomized double blind placebo controlled trial of fosphenytoin for prevention of seizures in children with acute non-traumatic encephalopathies||Charles Newton/ Samson Gwer|
|Endotox||Endotoxaemia in severe and complicated malnutrition||Kathryn Maitland|
|PRISM||Reactogenicity and immunogenicity of 10-valent pneumococcal conjugate vaccine in children||Laura Hammit|
|MAL059||An extended follow-up of a phase II b vaccine trial with RTS,S/ASOIE in Kilifi district, Kenya||Ally Olotu|
|PrEP||A pilot study of Pre-Exposure Prophylaxis (PrEP) to evaluate safety, acceptability, and adherence in at-risk populations in Kenya, Africa (IAVI E001)||Eduard Sanders|
|ARIEL||A Phase II, open-label trial to evaluate pharmocokinetics, safety, tolerability and antiviral activity of DRV in comination with low dose ritonavir (DRV/rtv) in treatment-experienced HIV-1 infected children from 3 years to < 6 years of age||Robrt Kimutai|
The Neuroscience programme in Kilifi, Kenya aims to investigate the causes, the consequences and burden of neurological conditions in a rural tropical area, mainly affecting children. Children with neurological conditions are assessed, either on admission to hospital, after discharge from hospital or in epidemiological surveys in the community.
Clinical pathophysiology studies are conducted on children admitted with acute seizures, malaria, bacterial meningitis and neonatal conditions such as sepsis, jaundice and tetanus. Outpatients with HIV infection and epilepsy are studied. Further studies on the genetic susceptibility and immunological basis of these conditions are determined. The neurocognitive consequences of these conditions are assessed by cultural appropriate psychological assessment and event related potentials. The follow up of cohorts of children with these conditions and epidemiological surveys allow us to assess the burden of neurological conditions in this community.
Specific studies include
Epidemiology and Demography (ED) Cluster is involved in epidemiological studies that focus on issues relevant to the local population. ED is the largest cluster with over 180 employees. The cluster supervises and manages the Kilifi Health and Demographic Surveillance System (KHDSS), part of the core research platform of the Programme which avails data for studies across the Programme. In addition to this, the cluster has three distinct groups; Viral Epidemiology Control (VEC), Invasive Bacterial Diseases (IBD), Human Genetics Factors (HGF).
Weak health systems have increasingly been highlighted as major barriers to achieving global health goals. Work within the programme tackling this area is multidisciplinary, with strong links to other research areas within KEMRI/Wellcome Trust and international collaborators. It is focused around understanding and influencing provider and household behaviours, and developing and evaluating interventions and policies to strengthen research and service provision.
Two key areas of health systems research are centred in our Nairobi offices:
Both these streams of work have helped build close links between the programme and the Ministry of Public Health and Sanitation and the Ministry of Medical Services and, in the more clinical areas, with the University of Nairobi.
Many other groups within KEMRI/Wellcome Trust also have a strong focus on health systems and policy issues, including work of the Social Behavioural Research group, and the Malaria Public Health and Epidemiology group.
The Health Services Research Group has evolved from the Child and Newborn Health Group and spans a multi-disciplinary team based in Nairobi that has close links to the Ministry of Medical Services, The Ministry of Public Health and Sanitation, the University of Nairobi, College of Health Sciences and the Kenya Paediatric Association.
In 2011 a formal Memorandum of Understanding to underpin and guide joint research and capacity development was signed by the KEMRI-WTRP, the Ministry of Medical Services and the University of Nairobi, College of Health Sciences, creating the Health Services, Implementation Research and Clinical Excellence (SIRCLE) Collaboration.
The KEMRI-WTRP’s Health Services Research Group is the main programme partner in this collaboration based on its work in a number of areas including:
Top Image: Participants at the Child Health Evidence week 2010, L-R: The 2010 National Paediatric Guidelines produced after the Child Health Evidence Week, The training team at the start of the Mulifaceted Intervention Research Study and A Hospital Nurse being trained in 'best-practice' care and use of national guidelines.
Health Services, Implementation Research and Clinical Excellence Collaboration
The Health Services and Implementation Research and Clinical Excellence (SIRCLE) Collaboration brings together policy-makers from government and academics from the University of Nairobi and the KEMRI-Wellcome Trust Research Programme (KEMRI-WTRP). This new collaboration aims at building research capacity in health systems research in Kenya.
Health systems research is a poorly developed field in many lower-income countries including Kenya. There are particular difficulties in ensuring that routine service delivery reflects contextually appropriate, evidence-based, best practices. This in turn reflects our poor understanding of how to introduce, reinforce and continually update good practices amongst health workers. The challenge of implementation.
SIRCLE’s work therefore aims to bridge the evidence – policy – practice gaps in Kenya with an initial focus on areas of relevance to Maternal, Newborn and Child Survival, addressing Millennium Development Goals 4 & 5 [Reducing maternal and child mortality rates], and referral care services provided by rural hospitals.
The main strategic objectives of the SIRCLE Collaboration are:
SIRCLE Progress and Plans 2011 – 2013
SIRCLE’s work is overseen by a Board of Management, with representatives from the three partner institutions and led by a Senior Researcher and an Academic Manager. SIRCLE recruited 6 trainees in August and September 2011 who now form a research team with individual supervisors and mentors drawn from amongst senior staff from the three partner institutions.. Four of the trainees will undertake distance based MSc Training to support their research skill development and two have individualized research training plans. This team will tackle themed research projects over a 2.5 years period
After a joint workshop with the Ministry of Medical Services in November 2011 the SIRCLE researchers were asked to develop tools and approaches for assessing the quality of hospital care. The tools developed in partnership with MoMS will allow SIRCLE to support the Ministry of Medical Services to evaluate Level 4 and 5 hospital services in surveys to be conducted in June and July 2012.
Surveys will be of two types:
Reports on these hospital assessments will be available in September 2012.
The role of molecular and immunological sciences within the programme is twofold: first to support the development of new approaches to prevention and treatment of infectious diseases and second to provide tools for epidemiological and clinical studies. Studies fall to either side of (but do not include) product development. Thus they include early stage work on target identification (for vaccine or drugs) or mechanisms of pathogenesis, or later stage work around implementation, for example in examining correlates of protection in or the effect of interventions on pathogen populations.
Malaria has historically provided a major focus and more recently similar approaches have been developed for a range of invasive bacterial and viral pathogens. Kilifi provides high quality laboratories and a critical mass for much of this work. An important part of work on bacterial pathogens takes place in Nairobi, in collaboration with the KEMRI Centre for Microbiological Research ( CMR) and we propose to extend this capacity. Strategically key to all these areas is our long term collaboration with several groups at the Sanger centre, which brings state of the art rapid mass sequencing technologies to bear on important real world problems.
Over the years a large social science research programme has evolved within the KEMRI-Wellcome Trust Collaborative Research Progamme. The focus of social and behavioural research (SBR) has been around three key inter-related areas:
SBR researchers in Kilifi are increasingly linked with researchers in the Consortium for Research on Equitable Health Systems (CREHS) group in Nairobi. CREHS work on strengthening health system policies and interventions to preferentially benefit the poor. Current studies are examining the implementation of IMCI in Kenya to promote health and health system equity, and evaluating the introduction of health facility funds in Kenya. Future research will be around mechanisms to motivate and retain health workers, particularly in "hardship areas", and documenting approaches to expand access to ACT through retailers.
The above research programme has been funded primarily by The Wellcome Trust, MIM/TDR and DFID. External scientific support and mentorship to this programme has been primarily through collaborators based at The Centre for Health Policy at Wits University, the Health Economics Unit in University of Cape Town, the Health Policy Unit at the London School of Hygiene and Tropical Medicine, SARETI at the University of Kwa Zulu Natal, and the Ethox centre in Oxford University. In addition to the SBR/CREHS groups, there are also social scientists working in primarily epidemiological or clinical studies, either as research assistants or as PhD students. For example there are social scientists involved in HIV vaccine trials, and in epilepsy and genetics studies in Kilifi. In Nairobi social science research beyond the CREHS group includes exploring the research-policy-practice interface, and health worker motivation around quality of health care provided in hospitals.
The 1st Medical and Veterinary Virus Research in Kenya (MVVR-K) symposium was held in Nairobi 8-9 September 2011. The two day symposium brought together over read more
The Pneumoccocal Conjugate Vaccine Impact Study (PCVIS) is a large-scale before-after study of the effectiveness of the 10-valent pneumococcal conjugate vaccine (PCV10) in the routine childhood immunisation schedule in Kenya.
The project will compare the incidence rates of invasive pneumococcal disease, radiologically proven pneumonia, and all-cause admissions to hospital in the period before vaccine introduction and the period after vaccine introduction taking account of secular trends in major confounders including HIV, malnutrition, malaria and bed net use. The project is restricted to the residents of the Kilifi Health and Demographic Surveillance System (KHDSS) and the endpoint events will be defined among admissions to Kilifi District Hospital.
The project will compare the incidence rates of invasive pneumococcal disease, radiologically proven pneumonia, and all-cause admissions to hospital in the period before vaccine introduction and the period after vaccine introduction taking account of secular trends in major confounders including HIV, malnutrition, malaria and bed net use. The project is restricted to the residents of the Kilifi Health and Demographic Surveillance System (KHDSS) and the endpoint events will be defined among admissions to Kilifi District Hospital.
PCV10 was introduced into Kilifi District in January 2011. Population-based surveillance for invasive pneumococcal disease was initiated in 2002. The project aims to estimate not just the changing incidence of disease among the population as a whole but the effect of vaccine introduction on children who were not vaccinated - the 'indirect vaccine effect'. In 2009 a system of vaccine monitoring was established to record all immunizations against the KHDSS population register; linkage of the vaccines database to the hospital IPD database will permit an individual-based analysis of the rate of IPD taking account of immunisation status.
As some of the indirect effect of vaccine will be observed amongst adults, the project has also been estimating the incidence of IPD in adults since 2008. A subsidiary aim of study is to calculate the cost effectiveness ratios associated with the new vaccine programme.
The project began in March 2008 and is funded by the Global Alliance for Vaccines and Immunizations (GAVI Alliance) through the PneumoADIP. It is collaboration with the Division of Vaccines and Immunization in the Ministry of Public Health and Sanitation.