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Vicki Marsha,∗, Dorcas Kamuyaa, Yvonne Rowab, Caroline Gikonyoa, and Sassy
Molyneuxa
aKEMRI Wellcome Trust Research Programme, Kilifi, Kenya.
bOxfam, Kenya.
Abstract
There is wide acknowledgement of the need for community engagement in biomedical research,
particularly in international settings. Recent debates have described theoretical approaches to
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identifying situations where this is most critical and potential mechanisms to achieve it. However,
there is relatively little published experience of community engagement in practice. A major
component of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme
is centred on Kilifi District General Hospital and surrounding community of 240,000 local residents.
Documented community perceptions of the research centre are generally positive, but many indicate
a low understanding of research and therapeutic misconceptions of its activities. As in other settings,
these misunderstandings have contributed to concerns and rumours, and potentially undermine
ethical aspects of research and local trust in the institution. Through a series of consultative activities,
a community engagement strategy has been developed in Kilifi to strengthen mutual understanding
between community members and the Centre. One important component is the establishment of a
representative local resident network in different geographic locations commonly involved in
research, to supplement existing communication channels. Early implementation of the strategy has
provided new and diverse opportunities for dialogue, interaction and partnership building. Through
the complex social interactions inherent in the community engagement strategy, the centre aims to
build context specific ethical relations with local residents and to strengthen understanding of how
ethical principles can be applied in practice. Evaluations over time will assess the effectiveness and
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sustainability of these strategies, provide generalisable information for similar research settings, and
contribute to debates on the universality of ethical principles for research. This paper aims to
summarise the rationale for community engagement in research, drawing on published literature and
local findings, to outline the process of community engagement in Kilifi and to describe issues
emerging from its development and early implementation.
Keywords
Kenya; Community engagement; Bioethics; Ethical research
Introduction
Increasing recognition of the need to consider the ethical implications of biomedical research
participants as members of a wider community, and not just as individuals, has led to active
international debate on the value, goals and practicalities of involving communities in many
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aspects of the planning and conduct of research. (Dickert & Sugarman, 2005; Emanuel,
Wendler, Killen, & Grady, 2004; Gollust, Apse, Fuller, Miller, & Biesecker, 2005; Newman,
2006; Quinn, 2004; Strauss et al., 2001; Weijer, Goldsand, & Emanuel, 1999; Weijer & Miller,
2004). Although key ethical principles for biomedical research are well recognised, the primary
rationale for community engagement is premised on widely acknowledged challenges in
contextualising and applying these principles in different research environments (Belmont,
1979; CIOMS, 2002; Emanuel et al., 2004; Nuffield Council on Bioethics, 2002; Quinn,
2004).
ethical aspects of research and local trust in the institution (Molyneux, Peshu, & Marsh,
2005).
involvement in biomedical research has come from studies on aboriginal communities, HIV/
AIDS, emergency medicine, international research and, more recently, genetic diversity
(AIATSIS, 2002; Emanuel et al., 2004; HGDP, 1999; Morin, Maiorana, Koester, Sheon, &
Richards, 2003; Weijer & Miller, 2004). Authors point to four main goals for community
involvement: protection, respect, empowerment and partnership building (Dickert &
Sugarman, 2005; Foster et al., 1999; Lavery, 2004; Marshall & Rotimi, 2001; Morin et al.,
2003; Quinn, 2004; Sharp & Foster, 2000; Weijer & Miller, 2004).
views into the development of informational aspects of research (Strauss et al., 2001).
According communities rights to comment on the planning and conduct of research affecting
them is empowering; it demonstrates respect, provides opportunities for maximising benefits
for communities and increases mutual understanding (Lavery, 2004). Greater mutual
understanding may strengthen research processes. It may also increase community uptake of
any products of that research (Dietrich & Schibeci, 2003; Sharp & Foster, 2000). Increasing
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It is reasonably argued that community involvement may not be appropriate in all types of and
settings for research (Weijer & Emanuel, 2000), but the relevance of community involvement
has been increasingly articulated for international research (Diallo et al., 2005; Doumbo, 2005;
Emanuel et al., 2004; Weijer & Miller, 2004). The importance of affording greater protection,
respect and empowerment to communities that participate in international research is
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underlined by the differences in social and cultural norms, values, goals, resources and
technological understanding between researchers and typical participant communities
(Doumbo, 2005; Leach & Fairhead, 2006; Mitchell et al., 2002; Molyneux, Wassenaar, et al.,
2005). Weijer stresses the importance of empowerment as an ethical requirement in research
involving vulnerable, oppressed and non-majority groups (Weijer & Miller, 2004). Lavery
(2004) points to the need for consultation and negotiation to ensure more equitable distribution
of the benefits of research in low and middle income countries. Community engagement may
provide a mechanism for retaining a shared institutional memory for researcher–community
interactions over time. This is arguably of particular importance in long-term international
research centres, where formal governance may provide less representation, and therefore
protection, to individuals.
community consultation and approval to full partnership, where the latter implies greatest
community empowerment (Sharp & Foster, 2000). Similarly, a summary of public
participation techniques by the New Economic Foundation in the United Kingdom describes
a hierarchy of methods ranging from non-participatory techniques of manipulation, through
“tokenistic” approaches of placation, informing and consultation, to power sharing strategies
of partnership and delegated or citizen power (New Economic Foundation, 1999). Using this
model, community engagement mechanisms towards the bottom of this “ladder of
participation” could include information dissemination about planned research, while activities
at the top might provide legally constituted representative community groups powers of veto
in relation to proposed research.
Weijer and Sharp's analysis that potential forms of engagement are predicated on specific
community characteristics provides a helpful conceptual framework (Sharp & Foster, 2000;
Weijer, 2004; Weijer & Emanuel, 2000). “Consultation with consent” is only achievable in
research (in particular, risk-benefit analyses) to be important factors in gauging the importance
of community involvement (Ernst & Fish, 2005). However, there is wide consensus that
community representatives can potentially be involved in a broad range of activities in research,
from protocol development (including the process of providing information and obtaining
consent), to research conduct, reviewing access to data and samples, and dissemination or
publication of research findings (Marshall & Rotimi, 2001; Quinn, 2004; Sharp & Foster, 2000;
Weijer & Miller, 2004).
Probably the most prominent mechanism for community engagement in international research
has been the use of Community Advisory Boards (CAB), defined as “being composed of
committee members who share a common identity, history, symbols and language, and
culture” (p. 1940) (Strauss et al., 2001). Marshall describes CABs as an example of a strategy
“safeguarding the interests of local populations, through the establishment of a solid foundation
that supports a relationship based on trust and engagement with community members” (p. 243)
(Marshall & Rotimi, 2001). Of key importance is the establishment of a relationship that is
sustained over time, specifically beyond the lifetime of any specific research project. However,
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a major challenge to the CAB model has been identifying stakeholders with legitimate interests
– that is, avoiding politicisation and ensuring authentic community representation (Dickert &
Sugarman, 2005; Foster et al., 1999; Marshall & Rotimi, 2001; Mills et al., 2005; Sharp &
Foster, 2000). Underpinning these difficulties are debates on how to define the community
(Ernst & Fish, 2005; UNAIDS, 2006), balancing remuneration and independence of members
(Morin et al., 2003), the need for resources to train and sustain CAB activities, and resolving
differences between community-level and individual decisions (Quinn, 2004; Sharp & Foster,
2000). Given the importance of lead researchers in negotiating solutions to many of these
potential challenges, the effectiveness of the CAB has been described as being determined by
the relationship between a principal investigator and the community (Sharp & Foster, 2000).
Examples of politically powerful community representatives have emerged in HIV/AIDS
research, highlighted recently in three studies on HIV prophylaxis in Cameroon, Cambodia
and Nigeria where the actions of activists representing community interests led to a cancellation
of research in planning or in progress (Mills et al., 2005). The authors describe that “the issues
raised by activists, academics and the research community highlight the poor communication
between these stakeholders and the need for mutual understanding of values” (p. 1403).
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the balance of power between researchers and community representatives is negotiated (Diallo
et al., 2005; Dickert & Sugarman, 2005; Quinn, 2004; Sharp & Foster, 2002). A specific need
has been identified for more carefully designed studies on the impact of such collaborative
efforts on research design and implementation, to understand how representative community
groups work to guide, speak for and protect their communities (Sharp & Foster, 2000). Given
that current ethical principles are founded on a notion of equity between researchers and
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The Kenya Medical Research Institute (KEMRI) Centre for Geographical Medicine Research,
Coast (CGMRC) is one of 10 research centres in Kenya administered by KEMRI, a parastatal
organisation under the Ministry of Health. A collaborative research programme was set up in
Kilifi between KEMRI CGMRC and the Wellcome Trust in 1989, and currently attracts support
from several international funding agencies. The centre has developed a strong international
reputation for its wide-ranging interdisciplinary research covering clinical, basic science,
epidemiological and public heath aspects of major childhood and adult diseases, focused
primarily on concerns for coastal Kenya. A key feature of the programme has been its deliberate
development within a District Hospital, with research being carried out in a “real world
environment” serving a rural community. The research centre provides support to the hospital
to ensure a good standard of care is available to those using the departments where research is
conducted, regardless of their involvement in research. The additional resources include
medical and clinical officers, paediatric drugs and equipment and a paediatric intensive care
ward. Within the community, clinical services are supported at specific government health
centres and dispensaries. A Demographic Surveillance System (DSS) has been established in
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the area surrounding the hospital. Approximately 240,000 people are included, accounting for
around 80% of all paediatric hospital admissions. Homes within the DSS are visited three times
a year to collect information on residence, migration, births and deaths. A map showing the
hospital and DSS area is shown in Fig. 1. The centre is represented in the District Development
Committee, a coordinating group for all district government departments, such as health,
education and social services.
By 2001, parents were signing consent for over 4000 children per year to be involved in clinical
studies at the research centre ranging from purely observational research to the testing of new
procedures and drugs. Thousands more community members were consenting verbally or in
writing to interviews and procedures in community-based research. Every study carried out by
the programme has always been scrutinised in advance by local and independent national and
international scientific and ethical review committees. The existing methods of community
engagement included consultation with local administrative leaders (chiefs) in advance of all
Input from an external advisory group (five experts in ethics, health policy and
communication) on strategic planning for the overall communication strategy,
including community engagement;
• A 2-day consultative workshop for external advisors, community representatives, a
member of the District Health Management Team (DHMT) and KEMRI researchers
to develop a draft communication strategy;
• Wide consultation on the draft communication strategy with centre staff, community
members and the DHMT to develop the working draft that currently provides a guide
for implementation of the community engagement strategies outlined in this paper.
encapsulates the breadth of the term as commonly used is “a group of people sharing a common
interest – for example, cultural, social, political, health and economic interests, but not
necessarily a particular geographic association” (Brown & Tandon, 1983). Within the centre's
communication strategy, the community was defined as the normal residents of the DSS area,
but mechanisms for effecting authentic representation of this heterogeneous population were
not clear.
Civil administration in Kenya is conducted through the Office of the President, a government
department with tiers at national, provincial, district, divisional, locational and sublocational
levels. The DSS area covers, approximately, half the district, including 3 divisions divided into
14 locations. Amongst these, project specific CABs had been established in the past in four
locations, with members selected by chiefs. Further potential channels for engagement within
these locations included local councillors, Village Development Committees (VDCs) and
community-led Dispensary Health Committees (DHCs) associated with rural health facilities.
Each presented challenges to community representation either through their own selection
documentation of the types, activities and membership was hindered by a lack of resources for
monitoring.
We conducted a survey of all active CBOs in 10 DSS locations without a CAB, using the social
services database and a snowballing technique involving chiefs, assistant chiefs and CBO
members. At least two members of each CBO were interviewed together, using a semi-
structured questionnaire to gather information on the membership and functioning of the group.
We identified 569 groups, one-third of which were unregistered, with a median active
membership of 16 people (Inter Quartile Range10–22) across an area with a population 98,117,
giving a ratio of 1 active CBO member to, approximately, 11 people in the community. This
ratio, and the range of membership and activities (shown in Fig. 3), supported our proposal
that this channel might provide balanced and accurate community representation. A further
advantage was that it would supplement, and not duplicate, existing channels of communication
with higher profile community groups, such as the chief's office, VDCs and DHCs. The CBO
network was therefore chosen as the basis for identifying representative community members
in these 10 locations, as described below.
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by the research centre and the Ministry of Health, to seek community endorsement for the
nominated individuals, and disseminate information on the KCR's roles. Nominees from the
CBO selection process were all endorsed as KCRs. In three locations where pre-existing active
CABs had precluded nominations by CBO representatives, the individuals were not endorsed.
The main reasons for their rejection were their perceived lack of geographic representation or
political bias. Chiefs in these locations countered that difficulties in finding volunteers had led
to uneven geographic coverage. Later consultation with wider leadership groups representing
all geographic areas of these locations led to the nomination and later public endorsement of
new KCRs. Since endorsement, quarterly and ad hoc community-based meetings between
KCRs and KEMRI liaison staff have begun to strengthen existing communication channels.
Through this linkage, there has been greater feedback on community concerns and
recommendations to KEMRI (including providing advice on specific aspects of research
planning), and dissemination of information on different aspects of KEMRI's work in the
community.
Emerging issues
The value of qualitative formative and action research—The value of rigorous
qualitative research in developing a community engagement strategy (Newman, 2006) is
strongly borne out by our experiences. Qualitative studies in 2001 and 2004 brought out clearly
the mix of communication, environmental and institutional policy issues, including power
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Action research methods have been used throughout the development and implementation of
the community engagement strategy, described as ‘a (usually cyclic) process by which change
and understanding can be pursued at the one time, with action and critical reflection taking
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place in turn. The reflection is used to review the previous action and plan the next one’. In the
latter cycles of action research, methods, data and interpretation are continually reshaped in
the light of the understanding developed in the earlier cycles. Involvement of the community
in action research to identify representatives, activities, channels and messages has
strengthened the potential effectiveness of these components and has been a critical step in
demonstrating the centre's commitment to community involvement. Building on a wide
consultative process, research staff perspectives of the community engagement strategy have
evolved towards seeing greater community involvement as a fundamental way in which the
centre could strengthen certain ethical aspects of research, as described elsewhere (Emanuel
et al., 2004).
The role of an external advisory group—The external advisory group provided technical
support, objectivity and perspectives on generalisability in developing the overall
communication, and community engagement, strategies. There is an obvious risk of bias
(inadvertent or otherwise) in using an internal process to develop strategies to strengthen ethical
aspects of research. Although a protocol for this work was routinely reviewed and approved
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by local, national and international scientific and ethical review bodies, the nature of action
research implies that continuing objective, technical advice is an important part of this
overview. The technical expertise of the external advisory group brought an increased depth
of understanding of the issues behind KEMRI-community relations and greater coherence to
the strategies developed to address them. The group were important in advocating a move away
from early concepts of simple communication activities, such as the production and
dissemination of print materials, towards a broader communication strategy cross-cutting all
departments, including policy.
nominations and public endorsements, participatory trainings and regular meetings. Adequate
human resources (Lavery, 2004), such as time and skills, and flexibility were major challenges
for a biomedical research centre where the highly competitive nature of funding tends to limit
amounts allocated to non-research elements and tie activities to an agreed time line. On the
other hand, within a collaborative framework, the community was able to contribute resources
for many activities, such as their time in planning and advertising public meetings and provision
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Extensive pre-testing of tools, qualitative skills for interviewers, and a detailed manual to
ensure that, as far as possible, surveys can be replicated in a comparable way in the future, are
important components to such an evaluation.
common economy and shared resources; communication network; and self identity as a
community. For example, community consultation requires authentic representative voices and
effective communication within the community to underpin current and continuing
authenticity. This may be achievable in cohesive communities through existing social units
(Sharp & Foster, 2002). In the absence of authentic representation and a communication
network, Weijer suggests that less formal types of dialogue could replace community
consultation, which may be neither achievable nor needed. However, he notes that certain types
of community – specifically those that are vulnerable, oppressed or minority groups – may
require formal consultation with legitimate representatives without existing mechanisms for
achieving this. This latter situation pertains in Kilifi, and may be typical of many international
research settings, given the vulnerability implied by poverty, low access to education and unmet
health needs. Our challenge, then, was to identify how representative community voices could
be brought into discussions on research planning and debates on research ethics and
governance.
links to a wide sector within this community. There is also evidence from the endorsement
process that the CBO approach is more acceptable to community members attending public
meetings than representatives identified by chiefs, reflecting wider concerns about “how
authentically people appointed by agencies outside a group speak for the group” (CIOMS,
1991). The finding highlights the importance of public endorsement as a check for fairness,
accuracy and balance of individuals chosen to represent them. At the same time, we are cautious
of the extent to which a CBO network may function to achieve this representation, and
communicate with the wider community over time. We are also observant of the need to ensure
that the KCR network supplements existing channels for communication with local residents,
such as chiefs, KEMRI and MOH staff, rather than replace them. A single strong channel may
both lose authenticity and risk over-politicisation.
primary ownership and responsibility for setting up and maintaining the KCR structure. Given
the low understanding of research in this community, comparisons were made with local non-
governmental community development organisations where the benefits of mutual cooperation
were clear. The relative wealth of the centre, seen through resources such as four-wheel drive
vehicles, medical supplies and well-equipped buildings, initially led to demands for KEMRI
to support KCRs through the provision of offices, payments, telephones and transport. Such
demands would potentially threaten wider community perceptions about the independence of
KCRs, and call into question which “community” they represent (Morin et al., 2003). Although
these demands have reduced with greater understanding of research and the KCR role, the
challenge of providing sufficient resources for KCRs to be effective while maintaining their
perceived independence from the centre remains. The relative wealth of the research centre
forms a continuing backdrop to these negotiations. To counterbalance inequities, policies are
being developed within the research centre to strengthen inputs to local health service
provision, through bilateral discussions on MOH–KEMRI interactivity.
Community engagement is a two-way process, and the attitudes of research staff a critical
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element. A principal investigator who is willing to listen and act on feedback where necessary
is a requirement for effective engagement (Sharp & Foster, 2000; Strauss et al., 2001). In Kilifi,
research and administrative staff have expressed wide support for community engagement.
Researchers' main aims were to respect community views, respond to community concerns
(particularly those impacting negatively on recruitment) and provide systematic community
feedback of findings. For specific projects, such as long-term cohort studies on genetics and
disease, there was a perceived need for consultation on protocol development. Reservations
were voiced about community engagement in developing research agendas, and the potential
for complex explanations on highly technical areas of research to cloud fundamental ethical
issues of autonomy. A second key staff group were field workers, whose primary
responsibilities are conducting interviews, and sometimes collecting samples, from research
participants. They are recruited from the local community and represent KEMRI during their
daily work, undertaking a critical role as cultural brokers (Molyneux, Peshu, et al., 2005).
Discussions with field workers and community members highlighted issues with important
implications for interactions between them. Important examples were field workers' perceived
need to recruit adequate numbers of research participants, their empathy with participants'
interest in individual benefits, and their low awareness of local and international guidelines for
ethical research conduct. Routine field worker training on research and communication has
subsequently been strengthened and expanded to include research methods and participants'
rights.
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studies to complaints about staff conduct, have been communicated to researchers and acted
upon. At the same time, community members have contributed essential resources to the
community engagement process, such as their time and local planning support for activities.
For example, in some instances KCRs have accompanied KEMRI liaison staff in visiting homes
to respond to serious concerns or complaints from community members. Beyond the practical
value that these community contributions represent, they may also chart an early shift for
ownership of the community engagement process away from the research centre and towards
the community, with implications for the balance of power between these parties.
Since partnership models of engagement are based on mutual understanding and shared
decision-making and benefits, these examples of changes in institutional policy to benefit the
community and community contributions to benefit the research centre may plausibly be
described as reflecting a partnership. However, researchers perceived research review
processes as less easy to adapt to this level of power sharing, a view acknowledged by other
authors (Marshall & Rotimi, 2001; Morin et al., 2003; Quinn, 2004; Sharp & Foster, 2000;
Weijer, 2004). A consultative model (that is, listening to and incorporating community
perspectives) may offer a more effective strategy for research review, and is the approach
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currently followed in Kilifi. In this situation, inputs from broader groups of stakeholders
representing community views have also been essential. Particularly key groups have been
chiefs and MOH staff, illustrating the mutually supportive and often interdependent roles of
these channels. Our use of both partnership and consultative models in community engagement
illustrates the subtlety of the concept of power sharing. Community engagement in Kilifi has
involved complex interactions and negotiations leading to a mix of outcomes that aim to satisfy
the main requirements of involved parties. In future, after planned evaluations of KCR
functioning, it may be important to ensure that the views of KCRs are also directly visible to
the national ethical review body to ensure that consultation provides fair consideration of
community interests (Ernst & Fish, 2005).
Conclusions
King et al. introduced the concept of a relationships paradigm for research in place of a model
based on universal ethical principles, or “principalistic model”. He wrote “The moral principles
held to govern research with human subjects remain current and meaningful, but make sense
only in context. Thus the ethics of human subjects research may be universal but is at the same
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time deeply particularized, so that what autonomy or informed consent or even benefit and
harm means depends on the circumstances” (p. 921) (Quinn, 2004). The recently proposed
additional ethical principle of “respect for communities” and guidelines on when and how to
establish mechanisms for community engagement move the debate towards ways of defining
goals, identifying characteristics and avoiding pitfalls in understanding a local context for
ethical principles. We have drawn on this body of opinion to develop and begin to implement
mechanisms for community engagement in a busy biomedical international research centre in
Kilifi. Emerging issues in the process of development and early implementation have been
described in this paper. Key elements of building trust and mutual understanding with
community representatives have been shared ownership of the liaison processes and flexibility
in power sharing. Local representatives have considered their inputs into institutional policy
to be critical and their recommendations in these areas have been adopted. Community input
into research review has emerged as a consultative process, although this may evolve over time
with greater community understanding of research. Through the complex social interactions
inherent in the current community engagement strategy, the centre aims to build context
specific ethical relations with local residents and to strengthen understanding of ways in which
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ethical principles can be applied in practice. Evaluations over time will assess the effectiveness
and sustainability of these strategies, provide generalisable information for similar research
settings, and contribute to debates on the universality of ethical principles for research.
Acknowledgements
We are grateful to local residents, Area Chiefs and Assistant Chiefs, faith-based leaders and schoolteachers in Kilifi,
staff at KEMRI and the District Health Management Team in Kilifi district for their active participation in this work.
Francis Kombe, Johnson Masha and Richard Rimba were critical team members who supported research and
implementation activities in this work. We strongly acknowledge the support of the external advisory board for the
project; Professors Doug Wassenaar and Nhlanhla Mkhize, Professor Lucy Gilson, Mr John Muturi and Mr Oby
Obyerodhyambo. This work was conducted with financial support from the Kenya Medical Research Institute
(KEMRI) and the Wellcome Trust Bioethics for Medical Research Programme, UK. The paper is published with the
permission of the Director, KEMRI.
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Fig. 1.
Kenya, Kilifi district and the research study area (the DSS area).
Fig. 2.
Steps to developing a community engagement strategy.
Fig. 3.
Types of Community-based organisations in 10 locations in Kilifi district. SHG = self help
group; FMG = farmers group; SCS = social or cultural group; WMG = women's group;
CSA = credit and savings group; YTG = youth group; CHW = community health workers;
DHC = dispensary or health centre committee; TBA = traditional birth attendant; and
OTH = other.
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