The Ebola epidemic in 2014 and 2015 in the West African countries of Guinea, Liberia and Sierra Leone was unprecedented in its size, over 28,000 people were infected and around 11,000 died [1]. In Sierra Leone, as of April 2016, 14,124 cases were registered, 3,956 of whom died [2]. As the epidemic took hold in Sierra Leone, Guinea and Liberia, reports were rife of instances of community resistance to medical intervention, communities’ mistrust and avoidance of healthcare centres, and stigmatisation of health workers and survivors [3–6].

Wilkinson and Leach argue that such resistance and mistrust must be understood through consideration of a long history of structural violence [7]. First as a central port in the Atlantic slave trade and then as a mining colony for the British Empire, a substantial proportion of Sierra Leone’s encounters with outsiders were primarily extractive [8, 9]. The country’s postcolonial past was similarly marred by years of oppressive and corrupt rule, which deprived the majority of the population of access to education, employment and basic healthcare services [10, 11] This was followed by a brutal ten year civil war (1991–2002), in which rebelling factions fought against authorities as symbols of a “rotten system”, but in the process all sides of the conflict systematically perpetrated violence against the civilian population [12–15]. Following the war and up until the Ebola epidemic erupted in 2014, the country was undergoing a long and difficult process of post-war reconstruction, during which citizens, government and foreign partners were attempting to build trustworthy governance structures at national and local level [10, 16]. The continuing poverty (Sierra Leone is ranked 181^st in the Human Development Index) and inequalities experienced by citizens and this deep rooted historical legacy of distrust in government and outside agencies can help explain challenges faced by those attempting to contain the spread of the Ebola virus [7].

The nature and rapidity of the spread of the disease also made clear the importance of understanding the socio-cultural dimensions of disease and the historical context which shapes them [7]. The initial response to the outbreak was undertaken by national government, national and international non-governmental organisations (NGOs), followed by the global UN led responses. Whilst prioritizing treatment centres, international organisations also focused their responses on surveillance, case management, safe burials, contact-tracing and community sensitization [17]. At first, interactions with communities focused on “sensitisation”, emphasising that local populations lacked knowledge on Ebola and that “traditional practices” spread disease [18]. As Chandler et al note, these strategies paid “little attention to the historical, political, economic, and social contexts in which they are delivered…[and] they reinforce external perceptions that local beliefs and practices are barriers to be overcome through persuasion or counterbalanced with incentives” ([18], p.1275).

As the epidemic developed and lessons were learned, examples emerged of changes in the engagement of local populations, as some aspects of the response adapted to deal more effectively with socio-cultural dimensions, taking seriously the importance of understanding communities’ needs and constraints and building trust. For example, safe burials that prevented people from washing dead bodies were made more acceptable by seeking the approval of local leaders, discussing the practices with the family of the deceased, burying the body in the presence of the community and including components of burial rituals such as Muslim shrouds on coffins [19]. The Ebola response’s learning curve was thus characterized by a gradual move away from attempts to correct misinformation towards the engagement of communities. In a recent analysis of the epidemic, Laverack and Manoncourt found that in a context of fear, mistrust and resistance, due to both the structural and political context as well as experiences of poor quality health care, utilising bottom up approaches to communication, which included a respect for local knowledge, was more effective [17]. As anthropologists working in these contexts have argued throughout the epidemic, rather than viewing customs and culture as barriers of resistance, it is more useful to consider how culture can adapt, something that, as Richards et al suggest, ought to be done in continuous consultation with local communities [20]. Reflecting on the West African Ebola epidemic, Abramowitz et al highlight how “under conditions of extreme stress, culture can be flexible and supple in response to extreme circumstances and the arrival of new information (such as public health messages), and make allowances in extraordinary conditions” ([21], p.4). The Ebola epidemic, in other words, rendered evident the benefits of engaging deeply with affected countries’ social, cultural and political context in order to understand communities’ response to the disease and to work with them to find ways to deal with crises.

The speed with which the epidemic grew and its extent demanded not only a rapid and coordinated response from international agencies and local authorities, but also called for the fast-tracked development of vaccines and other potential preventative and treatment technologies. This required the establishment of prophylactic vaccine trials in an epidemic context, which presents particular challenges for both the communities and the trialists. The setting up of such trials requires learning lessons from the historical and political context and from the experiences of the response to the outbreak, as described above, especially in terms of rooting communication strategies on deep understanding of socio-cultural contexts as adaptable and dynamic and on effective and active engagement of community members. In addition, the setting up of trials can benefit from learning from anthropological research on clinical trials related to other stigmatised diseases in resource poor contexts.

There is a growing body of work that is exploring complex political economy and social justice questions that emerge in communities where clinical trials are taking place [22–24]. These address broader ethical questions beyond the focus on informed consent. Molyneux and Geissler, for example, argue that this often does not take into account broader issues of inequities in wealth, health status and health care resources between the researchers and the researched ([24]; see also [22, 23, 25]). Dugas and Graham similarly suggest that standardised consent processes may be inadequate in contexts where translation is required, where socio-economic inequalities are stark and where collective consent may be important alongside individual consent [26]. Beyond these issues, there has been a growing body of research on the local effects of medical research on participants and their communities [24, 27–29]. Such research has revealed the salience of social relations developed between researchers and participants as well as the prevalence of rumours and concerns [28–36]. This body of research provides a foundation for developing strategies for engaging local populations and participants in a meaningful way grounded in the specificities of ethics and social relations in resource-poor contexts.

Given the nature of the Ebola epidemic, and the specific fears and concerns that the disease invokes, as well as the political history of Sierra Leone, the setting up of a vaccine trial during the Ebola epidemic required having an in-depth understanding of the epidemic and its effects as well as building trust within communities. With the prospect of such new encounters with biomedicine for people in communities with very little (and often no) experience of medical research, there is also an urgent need to determine what rumours, concerns, fears or mistrust emerge from dialogues with community members and individuals involved in vaccine trials and the ways in which such actors can be engaged in addressing these and building trust.

This paper discusses the role of social science (anthropology) and community liaison in supporting the establishment of the EBOVAC-Salone prophylactic Ebola vaccine trial in Kambia District, Northern Sierra Leone, during July to August 2015, towards the end of the Ebola epidemic. Through an exploration of notions of power, fairness and trust emerging from analysis of the Sierra Leonean context and through ethnographic research, the paper discusses three situations in which the EBOVAC-Salone social science and community liaison teams worked together to ensure effective communication, to develop appropriate recruitment strategies and to address rumours about the trial.

In December 2014, the Innovative Medicines Initiative (IMI) awarded funding from the Ebola + programme to a consortia of research institutions to support the development, manufacturing and deployment of a prime-boost prophylactic Ebola vaccine regimen, in partnership with private industry [37]. A portion of the IMI2 funding awarded to the EBOVAC1 consortium is being used to implement the EBOVAC-Salone study in Sierra Leone. In addition to EBOVAC-Salone, IMI2 has also funded the related EBODAC (Ebola Vaccine Deployment, Acceptance and Compliance) consortium whose objective is to conduct community engagement and communication to support the prime-boost Ebola vaccine trials and roll-out of vaccines, if proven effective.

The EBOVAC-Salone study aims to assess the safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo prime-boost regimen in a population affected by Ebola. The study is being carried out in Kambia District in Northern Sierra Leone. Stage 1, an open label, safety and immunogenicity study of the prime boost vaccine in 43 healthy adults aged 18 years or older has completed the vaccination phase. The first participants to volunteer for the study were screened for eligibility on 20 September 2015 and vaccination began on 8 October 2015. In stage 2, a randomised, controlled, safety and immunogenicity study, 688 individuals will be screened and will be randomised to the prime boost vaccine or a control vaccine.¹ Adults, adolescents and children aged one year or older will be included in this trial. Plans for additional stages are being finalized in consultation with the Sierra Leonean authorities and international health agencies. EBOVAC-Salone is coordinated by the London School of Hygiene &Tropical Medicine (LSHTM) working in partnership with Sierra Leone’s Ministry of Health and Sanitation and the College of Medicine and Allied Health Sciences. The EBOVAC-Salone study is one of several vaccine trials set up in West Africa during and in the immediate aftermath of the epidemic [38, 39].

Engagement with the community in Kambia in the run-up to stage 1 of the EBOVAC-Salone study was conducted by a community liaison team and a social science team. The two teams were recruited locally.

The community liaison team, comprising nine locally-recruited staff, supervised by two LSHTM staff members, was responsible for implementing EBOVAC-Salone’s community engagement strategy. The team was complemented by an external communications manager who monitors rumours and concerns about the trial beyond the Kambia District and also provides information about the trial at national and international levels.

EBOVAC Salone was the first vaccine trial of any kind to have taken place in the study area, and the country as a whole has had limited experience of medical research. The community liaison team members thus received background training on clinical trials, with a particular emphasis on the difference between communication to support clinical trials and communication and social mobilisation for routine or proven interventions. The community engagement strategy for Stage 1 involved engaging with all levels of the community – from elected and traditional leaders to individual households - through a variety of channels. These included undertaking one-to-one engagement with key stakeholders, holding public meetings in partnership with influential civil society leaders, organising community meetings supported by local and traditional leaders, conducting house-to-house sensitisation visits, and hosting radio chat shows and phone-ins on local radio within Kambia District.

A Participant Advisory Group (PAG) was also set up, serving as a means through which study participants were encouraged to openly discuss their experiences of participating in the EBOVAC-Salone study with each other. The purpose of the latter group was to address concerns, share views, expose perceived barriers to enrolment and to share information where necessary. This group is entirely participant-led and at the first meeting the participants elected a Chairman and representative committee. For Stage 1, trial participants were invited to join the group by field workers who visited their homes in the initial seven days following vaccination. The frequency, structure and agendas of these meetings were decided by the group members themselves. The PAG is continuing to support stage 2, where 99 participants have enrolled to date.

The social science team was made up of four locally recruited research assistants, a data analyst and a transcriber, led by an LSHTM social scientist based in Kambia. The team was responsible for conducting anthropological research to examine community and participant perceptions and experiences of the EBOVAC Salone vaccine study, including any rumours and concerns around the trial and the vaccine. In addition, the team explored the socio-cultural context and perceptions of illness and disease in the community where Stage 1 was taking place. The methods used for this research were: ethnographic observation, focus group discussions, in depth interviews, and exit interviews with participants as they completed their visit to the vaccination clinic. Ethical approval for this study was granted by the ethics committees of LSHTM and Sierra Leone.

Ethnographic observations were carried out in key areas in Kambia and trial clinics to explore community dynamics; social interactions around the clinic; community narratives about EVD and the clinical trials; and to trace any ongoing rumours and concerns emerging at community level. Focus group discussions were carried out with both community members and with trial participants to discuss perceptions and experiences of the trial. In depth interviews were carried out with 6 Stage 1 Participants and 16 Stage 2 participants, interviewed after prime and boost vaccination, and with approximately 20 key stakeholders in Kambia. At the time of writing the Stage 2 research was ongoing. The data for Stage 1 was analysed through thematic and framework analysis. Framework analysis was used to answer the specific research objectives. A coding tree was developed according to the key research questions. Interview transcripts were coded according to this coding tree. Thematic analysis was used to develop emerging themes not identified by the research objectives.

The insights for this paper are based primarily on the ethnographic research carried out in Kambia in the three months preceding the opening of the trial. As the epidemic continued to ravage the country, and as Kambians lived under military curfew and constant news of Ebola cases, the trial team was renovating clinics, building laboratories and holding high-level conversations with key stakeholders. During the preparation phase for Stage 1, ethnographic encounters in local markets, attaya² bases, poyo³ bars, shops and okada⁴ parking grounds enabled the research team to develop a rich and complex picture of Kambia’s community dynamics, the everyday struggles and concerns of its inhabitants during the outbreak, their beliefs and fears about medical intervention and their views on the study that was about to open in their town.

During the preparation phase, the social science and community liaison teams developed a feedback system to inform rapidly research-driven communication strategies. Weekly meetings had three main purposes. Firstly, the social science team provided feedback on community engagement plans based on their research on the socio-cultural context, local community dynamics and perceptions of the vaccine trial. Secondly, the meetings brought up any issues encountered by the trial team or the community liaison staff that required further research by the social science team, such as the design of the recruitment strategies outlined below. Thirdly, the social science team reported on any rumours or concerns identified in the community. These rumours and concerns were communicated to the community liaison team anonymously in order not to breach confidentiality and to maintain the independence of the social science research. Following feedback, the community liaison staff brainstormed strategies to respond to concerns or rumours. Such strategies depended on the specific issue raised, but usually involved considering different and creative avenues for discussion with the community on the issue, reviewing messaging to actively engage with the issue at hand, and determining who the best person in the team was to respond and through which channel. When an urgent or potentially harmful rumour had been identified, this was reported immediately to the trial manager in Kambia and to the principal investigators.

This section of the paper discusses three examples of challenges faced by the trial team during the set-up phase of the study. These case studies reflect how lessons gained from knowledge of the country’s context, the experiences of the Ebola response and knowledge gained during previous trials helped inform the community engagement strategies and responses to issues as they came up. The examples are arranged through three key themes: power, fairness and trust. Each case study begins with a reflection on the context facing the trial team, then offers insights from the ethnographic research and finally considers the implications for community engagement strategies. These case studies elucidate the importance of research-driven mobilisation strategies, as well as the inevitable limitations on trialists’ ability to engage with all aspects of complex community dynamics.

Carrying out vaccine trials in the context of an infectious disease epidemic with high mortality in a developing county recovering from years of internal conflict brings significant challenges. The EBOVAC Salone trial was set up during the Ebola outbreak as affected populations were trying to make sense of the disease and its devastating impact on families and communities. In addition, the epidemic has laid bare, and sometimes exacerbated, mistrust in the healthcare system, elected officials and external health interventions. In order to understand some of the concerns surrounding the trial, it was crucial that the teams took into account how the Ebola epidemic has affected social relations and power as well as local ideas about the Ebola response, including interactions with Western medicine and experiences of community engagement. Even more broadly, it was important for the two teams to work together to engage effectively with the community dynamics and power constellations highlighted by anthropological research. Such understandings of the community in which the trial was being set up have helped the teams to ensure that communities and participants are given an opportunity to voice concerns and to work with them to address mistrust. Knowledge of contested power, for example, allowed the team to listen to the voice of “small leaders” and to take into account their potential to disengage from the trial.

This paper has offered illustrations of how social science and community liaison team worked in concert to shape engagement strategies and volunteer recruitment mechanisms. The examples discussed here show the value of research-driven communications and offer important lessons for future trials. Firstly, they demonstrate the importance of real-time social science research in the setting up of a vaccine trial. Social science researchers can act as independent “eyes and ears of the trial”, listening to fears, concerns and suggestions. Secondly, an in depth understanding of community power dynamics highlights the importance of diversifying communication methods and avenues for engagement. As shown by the concerns of the “small” community leaders, contestations of power can be muted and hidden but can nonetheless affect the relationship between the vaccine trial and the community. As such, using a variety of communication channels, rather than relying solely on established leadership, can ensure messages reach different sectors of the community. Thirdly, an understanding of community dynamics and local social norms through ongoing dialogue can help inform the set-up of a trial from the start as evidenced by the establishment of a public lottery for volunteer recruitment. Finally, a focus on listening to and understanding rumours revealed deeper concerns about health interventions stemming from histories of mistrust, rather than simply being “misunderstandings”.

This paper reveals that lessons learned from ethnographies of other trials about political and social inequities, social relations and rumours and concerns have been heeded. However, they also highlight very specific and local concerns in the context of the Ebola epidemic, which can only be revealed by on-going and “close to the ground” social science research and effective and dynamic community engagement.

More information on the EBOVAC Trial can be found at: http://www.ebovac.org and https://clinicaltrials.gov/ct2/show/NCT02509494?term=EBOVAC&rank=1.