Research
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:
Clinical science
Caring for a severely ill infant in Kilifi
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.
Childhood illness
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.
FEAST
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/
Clinical Trials Facility
Clinical Trials Facility building
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:
- Support, guidance and scientific input from the point of setting the question and trial design to the final report.
- Project management, financial administration and trial coordination
- Full range of in-house SOPs and SOP writing to adapt to sponsor/protocol requirements.
- Centralized budget, staff and resource management
- Fully integrated clinical trial laboratory and coordination with other KEMRI laboratories and clinical services
- Planning and coordination of community engagement and wider communication planning with the units Social and Behavioral Research Group
- A DSS mapped catchment area for the district hospital
- Full data management and statistical support as needed
- Trial monitoring and quality management, regulatory support and safety reporting.
About CTF
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.
Our Vision:
To be a global centre of excellence for the conduct of clinical trials.
Our Mission:
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 Staff:
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.
Why clinical trials?
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.
A word from the head of the Clinical Trials Facility
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
Approval process for conducting a trial
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.
> STEP 1:
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.
Quality policies and SOPs
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:
1. Administrative
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
Current and planned clinical trials
| 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 | Roma Chilengi Patricia Njuguna | |
| 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 | Roma Chilengi | |
| 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 | |
| FEAST: | 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 | |
Neuroscience
Using electrodes to record electrical activity of the brain for diagnosis of epilepsyThe 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
- Case control study of children admitted with acute seizures
- Randomised control trial of fosphenytoin to prevent seizures in children admitted with an acute encephalopathy
- Use of adjunctive therapy such as albumin, pentoxifylline and magnesium sulphate in children admitted with cerebral malaria
- Role of neuronal antibodies in causing seizures
- Role of viruses causing encephalopathies in children admitted to rural hospitals in Africa
- Diagnosis and outcome of bacterial meningitis in district hospitals
- Causes and consequences of neonatal jaundice
- Risk factors and role of magnesium sulphate in the neonatal tetanus
- Causes and consequences of neonatal sepsis
- Pattern of neuro-cognitive involvement in children infected with HIV
- Neuro-cognitive outcome of children admitted with severe malaria, pneumococcal meningitis and acute encephalopathies
- Role of event related potential (ERP) in assessing brain damage following malaria, bacterial meningitis and other acute encephalopathies
- Role of ERPs in HIV encephalopathy in children
- Prevelance and risk factors of neurological impairment in children
- Prevalence, incidence and mortality of epilepsy in adults and older children
Epidemiology
Conducting homestead interviewsSince the inception of the programme epidemiological research has had a strong focus on malaria. This remains a major interest, both in Nairobi through the Malaria Public Health and Epidemiology group and in Kilifi where parasitological and clinical surveillance over twenty years provides a unique framework for understanding the current fall in transmission and concurrent epidemiological transition. More recently the work of a number of groups dorming the epidemiology cluster in Kilifi have exapnded around the linked systems of demographic and health facility surveillance. These activities have allowed us to describe the rates, patterns and trends of morbidity and mortality associated with a range of specific diseases. The scientific objectives of the group focus on three main themes: (1) the burden of bacterial diseases (with an emphasis on the pneumococcus) and the effects of vaccines; (2) the burden, epidemiology and control of common viral diseases (including respiratory syncitial virus and rotavirus); (3) and the burden and consequences of host genetic conditions. In addition, we have established a range of key strategic partnerships with networks that include GAVI, INDEPTH, PneumoCarr and MalariaGEN.
Health systems and policy research
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:
- Improving the delivery of care. After initial work on the quality of hospital care in 2002, work on means to improve services for newborns and children began in earnest in Nairobi in 2004. By 2006 the scope of work spanned evidence synthesis (see www.ichrc.org) to inform development of national hospital guidelines that drew heavily on programme work, meningitis surveillance (www.netSPEAR.org), vaccine cost-effectiveness analysis, and conduct of a 3 year trial in which hospitals were randomised to receive a multi-faceted intervention or a control intervention with evaluation using quantitative and qualitative methods. By 2009 the scope of research initiated had broadened further to include national and international methodological work on measurement of quality of hospital care, economic evaluation of complex health interventions and pragmatic clinical work evaluating case management guidelines.
- Consortium for Research on Equitable Health Systems. In 2005 a new stream of health systems work funded by the UK's Department for International Development (DFID) was initiated under the auspices of the Consortium for Research on Equitable Health Systems (CREHS) (see www.crehs.lshtm.ac.uk/index.html).CREHS aims to generate knowledge to help strengthen health systems policies and interventions in ways which preferentially benefit the poorest. In Kenya CREHS staff are working on a range of health systems issues, including health care financing, human resources, policy implementation, and scaling up of key interventions.
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.
Child Newborn Health Group (CNHG)
Training to provide effective, evidence-based care to children and newbornsFor many years biomedical research has focused on defining what the best therapeutic products are or optimizing approaches to care. However, the reality is that such research is rarely translated into practice, especially in low income settings. Thus, one of CNHG'S major aims is to understand and evaluate the quality of care and the development and implementation of clinical practice guidelines. The single largest area of work focuses on rural, Kenyan district hospitals and their ability to provide effective, evidence-based care to seriously ill children and newborns. Research includes quantitative and qualitative evaluation of health system performance and the roles of health workers, including, for example, evaluation of adherence to guidelines, explorations of health worker motivation and barriers to implementing best practice care.
Further areas of work are also focused on helping to meet local research needs and build capacity and have a relatively broad scope including:
- Examining the value of research from an ethical perspective
- Economic evaluation of new childhood vaccines
- Promoting bacterial disease surveillance in East Africa (www.netspear.org).
- Evidence review and synthesis to inform development of national treatment guidelines (www.ichrc.org). This work is conducted in collaboration with the Ministry of Health in Kenya and, hopefully, with the proposed Kenyan Branch of the South African Cochrane Collaboration.
In the future research in clinical epidemiology to tackle questions identified as of major importance by rural clinical, providers will be initiated to promote improved child and newborn survival.
Collaborators:
- University of Nairobi,
- Ministry of Medical Services / Ministry of Public Health and Sanitation,
- University of Witswatersrand,
- London School of Hygiene and Tropical Medicine,
- University of Oxford,
- WHO-Geneva and WHO-Kenya
Malaria Public Health and Epidemiology Group
Percentage of children under five sleeping under an ITN by 2007The epidemiology of malaria in Africa is in transition with evidence of declining transmission and disease burdens. This has been a presumed consequence of expanded intervention coverage due to improved international donor financing. However all is not equal and there remain disparities in intervention coverage, neglected populations and constraints to further reductions due to biological and political vulnerabilities.
There has been very little scientific effort to rigorously document this change using validated metrics of infection risk, intervention coverage and disease outcome. At a time when transmission and disease burdens are in decline, with targets set for elimination or low stable endemic control, a renewed emphasis on the basic epidemiology of malaria is paramount. Furthermore new approaches to delivering effective control and disease management are required to maximize the renewed international effort to finance malaria programmes in Africa.
These include innovative ways of financing anti-malarial drugs, accessing medicines in rural areas, improving the way medicines are prescribed, increasing universal coverage of insecticide treated nets and adaptations of intervention suites to meet the special needs of urban, pastoralist and school aged populations. Over the period 2011-2016, the Malaria Public Health and Epidemiology Group in partnership with regional national disease control programmes aim to tackle key issues of optimizing intervention delivery to meet unmet needs and provide credible evidence of impact.
Projects under MPHEG include:
- Malaria Atlas Project - Africa
- Modelling the changing infection risks and malaria burdens in Kenya
- Improving the surveillance of paediatric malaria in Kenya & Uganda
- The cost-efficiency of sampling malaria risk and markers of infection prevalence
- Epidemiology of malaria transmission in neglected, semi-arid areas of Africa
- Malaria risks in Nairobi
- Human population movement and vulnerability to importation of malaria
- Mapping inherited blood disorders in Kenya
- Malaria control in school children
- Access to Artemisinin-based combination therapies (ACTs) through the private sector
- Improving malaria case-management practices in the public sector
- Innovation for public engagement
Pathogen biology & basic science
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.
Social and behavioural research
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:
Students of Shariani Secondary School discuss the meaning of the KEMRI Logo.
- Application of ethical research principles for biomedical research in low income countries. Initiated with studies around community understanding and views of the research centres' activities in Kilifi, a large scale communication strategy for the center has evolved. The communication strategy, research around implementation and impact, and consideration of the generalisability of findings, are supported by an advisory board with experts from the region in policy, communication, community engagement, and ethics.
- Access to health care at household and district levels. Initial research exploring household vulnerability to health costs in Kilifi is now being carried out in four districts across Kenya. Future research will include documenting the impact of Kenyan health financing mechanisms on equity in access.
- Assessing malaria medicine retailer programmes in Kenya (Wellcome Trust and WHO/TDR funded). Following initial and highly promising pilot programmes in Kilifi, the Ministry of Health incorporated private retailer programmes into the national malaria control strategy in 2001. A study is currently comparing the implementation and impact of retailer programmes in four districts.
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.
- Capacity building in social science is built into all of the above research, with additional activities including:
- Formal training opportunities at collaborating institutions
- In-house workshops for social scientists working in KEMRI and in other Kenyan institutions.
- The formation of two networks of social scientists within the KEMRI-Wellcome Trust Programme.
Viral Epidemiology and Control
First Symposium on Medical and Veterinary Virus Research Held in Nairobi
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
another pcvis
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.
| Figure 1 |
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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.
| Figure 2 |
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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.
Recent Publications
- Immunizing children at birth offers hope for preventing severe pneumococcal disease in young infants Full Paper
- Malaria prevention strategies could substantially cut killer bacterial infections Full paper