University of Bath (Enria); London School of Hygiene and Tropical Medicine (Lees, Smout, Mooney, Greenwood, Watson-Jones, Larson); College of Medicine and Allied Health Sciences (COMAHS), University of Sierra Leone (Tengbeh, Leigh); Mwanza Intervention Trials Unit, National Institute for Medical Research (Watson-Jones)
"...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."
This paper explores the establishment of a clinical trial of an Ebola vaccine candidate in Kambia District, Northern Sierra Leone, during the epidemic and analyses the role of social science research in ensuring that lessons from the socio-political context, the recent experience of the Ebola outbreak, and learning from previous clinical trials were incorporated in the development of community engagement strategies. The Ebola vaccine projects - EBOVAC1, EBOVAC2, EBODAC, and EBOMAN - are a series of trials and associated projects which aim to assess a novel prime-boost preventive vaccine regimen against Ebola Virus Disease (EVD). Through a case study of the EBOVAC-Salone prophylactic Ebola vaccine trial in Kambia District, Northern Sierra Leone, during July to August 2015, the paper suggests ways in which research can be used to inform communication strategies before and during the setting up of the trial. It explores notions of power, fairness, and trust emerging from analysis of the Sierra Leonean context and through ethnographic research to reflect on several situations in which social scientists and community liaison officers worked together to ensure successful community engagement.
The "background" section of the paper examines the dynamics - including the key communication-related elements - of the Ebola epidemic in 2014 and 2015 in the West African countries of Guinea, Liberia, and Sierra Leone. As the epidemic took hold, 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. 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. The Ebola response's learning curve was thus characterised by a gradual move away from attempts to correct misinformation towards the engagement of communities.
In this context, 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. 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 2 teams were recruited locally. The community liaison team members 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 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: 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. The social science team was made up of 4 locally recruited research assistants, a data analyst and a transcriber, led by a London School of Hygiene & Tropical Medicine (LSHTM) social scientist based in Kambia. The insights for this paper are based primarily on the ethnographic research carried out in Kambia in the 3 months preceding the opening of the trial. Ethnographic encounters in local markets, attaya (Chinese gunpowder tea) bases, poyo (palm wine) bars, shops, and okada (commercial motorbike) 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."
Weekly meetings involving the social science and community liaison teams had 3 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. Thirdly, the social science team anonymously reported rumours or concerns to the community liaison team. Following feedback, the community liaison staff brainstormed strategies, which 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.
A section on "power" considers the pitfalls of considering communities as homogeneous and shows the importance of understanding intra-community power dynamics when engaging communities. In brief, a few days after one of the community meetings about the EBOVAC Salone Trial, a small group of "stakeholders" who had attended one of the meetings approached the social science team to ask if they could meet at one of their homes to tell their story in exchange for the promise of absolute confidentiality. They recounted how they felt that their position as respected leaders in their community had been undermined and that, as a consequence, their ability to mobilise their communities to participate in the trial was curtailed. This experience revealed that, whilst community engagement meetings appeared to be received positively in Kambia, such manifest support could not be assumed to translate into community-wide acceptance. Internal struggles over status and economic resources, as well as mistrust and disputes over rightful loci of authority, must be taken into account.
A section on "fairness" shows how local understandings of what is fair can help inform the design of volunteer recruitment strategies. In Sierra Leone, conversations around fairness often revolve around the widespread assumption that access to resources relies on having a strong sababu, that is, a connection with people in positions of power. In the initial stages of trial design, which this paper focuses on, engaging with local ideas of fairness was an especially important in trialists' discussions surrounding the design of a volunteer recruitment strategy. Given assumptions that access to resources is assumed to be based on "connectocracy", there was the potential that, given the limited number of participants required, people could have assumed that the "big ones" were picking themselves and those they knew. In consideration of these and other concerns, and after extensive consultation with the principal investigators, trial sponsor, and the trial manager, the community liaison team opted for a public lottery of household numbers followed by individual visits through which people would be offered the opportunity to volunteer in the vaccine trial.
A section on "trust" highlights how historically rooted rumours can be effectively addressed through active dialogue rather than through an approach focused on correcting misinformation. In the context of a history of oppressive rule and conflict (discussed in the paper), the epidemic was accompanied by a plethora of stories and rumours that exposed the lack of confidence in government authorities, medical practitioners, and external agencies. Examples include: the widespread belief that Ebola was a man-made, population control strategy in view of the next Presidential elections; that people were killed inside ambulances by being asphyxiated by chlorine; or that new cases were fabricated in order for Ebola response workers to profit from the protracted crisis. While maintaining a commitment to the confidential nature of research conversations, the social science team alerted the community liaison team when these fears and articulations of mistrust emerged. The community liaison team responded by visiting areas such as the town's market, where the idea of the vaccine being "Ebola Phase Two" had taken root. Being aware of the particular nature of anxieties surrounding blood donation in the context of the Ebola outbreak meant that the community liaison team encouraged debates and conversations through community meetings, one-on-one conversations, and radio shows. They provided explicit information about the destination and use of blood samples and the fact that samples could be destroyed if the participant so wished once the study was over. They also invited questions, challenges, and suggestions. Representatives of different societal groups who had previously attended community engagement events hosted their own meetings, which the community liaison team attended as guests, encouraged open and often heated debates, and also enabled the creation of spaces for expressing and confronting anxieties rather than simply rejecting them as misinformation.
"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'."