Lessons Learned from Engaging Communities for Ebola Vaccine Trials in Sierra Leone: Reciprocity, Relatability, Relationships and Respect (the Four R's)

"How the public engages with biomedical research can influence the design, implementation strategy, level of uptake, and impact of disease control and prevention programs."

Community engagement (CE) has become an increasingly important part of biomedical research methods and procedures, especially in programmes involving vulnerable populations in low- and middle-income countries (LMICs). This qualitative study explored the relationships between trust, CE, and acceptance of a clinical trial through a look at the experiences of conducting CE for the 2 vaccine trials that were set up during and after the 2014-2016 Ebola outbreak in Sierra Leone.

The paper's authors begin by reviewing the literature on the importance of, and barriers to, CE in biomedical research. For instance, researchers can address public mistrust towards research by, through CE, demonstrating respect for the needs and priorities of the participating communities. CE can also have unintended consequences, and it can be hindered by existing power imbalances, social hierarchies, and political divisions. Studies have found that, to be successful, many CE activities rely on mutually beneficial relationships and high levels of trust between the research programme and the community. However, as observed here, few practical guidelines are available for the implementation and evaluation of CE programmes in the context of global health.

The authors provide some background on outbreaks of Ebola virus disease (EVD) in West Africa. In this context, EBOVAC-Salone and PREVAC vaccine trials' CE programmes were developed and delivered as a collaboration between the Innovative Medicines Initiative (IMI)-funded Ebola Vaccine Deployment, Acceptance and Compliance (EBODAC) and the Ebola vaccine (EBOVAC1) projects in Sierra Leone. The EBOVAC-Salone vaccine trial was implemented to test a candidate Ebola vaccine in 2015, whilst the Ebola outbreak was still ongoing in West Africa. The same basic CE approach was adopted in the PREVAC trial in Mambolo, Sierra Leone, which started approximately two-and-a-half years after the EBOVAC-Salone trial in May 2018.

In brief, the CE programme implemented in the EBOVAC-Salone trials was shaped by the importance of understanding and tailoring communications to the local context, as well as previous participatory research techniques used in HIV prevention trials in Tanzania. Because the Ebola outbreak was ongoing while these trials were developed, there was significant fear and stigma around the disease and potential vaccine. The trial recruited 2 local teams: a community liaison team (CLT) and a social science team (SST). The CLT engaged with the community through one-to-one stakeholder meetings, group area meetings, public performances, and radio jingles, while the SST assessed community members' and participants' perceptions and regularly updated the clinical team to adapt procedures to improve the acceptability and compliance of the trial.

Data were collected in Sierra Leone in May 2018, which was towards the end of the EBOVAC-Salone trial and in the first few weeks of the PREVAC trial. Fifteen CLT and SST members participated in in-depth interviews, and 23 community members attended 3 focus groups to discuss the Ebola vaccine trials and their experiences and perspectives of the CE activities. Four main principles (the "four R's") evolved from the discussions that influenced trust between the community and the trial:

1. Reciprocity - The inclusion of the independent SST and CLT served in different capacities as a bridge between the trial and the community. In addition, the CLT and SST offered an opportunity to provide confidential feedback, including potentially negative feedback or criticism, on their experience. One challenge they SST and CLT members faced in May 2018 was how the holy fasting month of Ramadan would affect trial participation. The strategy was to reach out to the religious leaders for advice, which demonstrated both reciprocity, as the community contributed directly to the functioning of the trial, and a respect (another one of the 4 principles) for local leaders and beliefs.
2. Relatability - Most of the EBOVAC-Salone and PREVAC CLT and SST members were recruited locally, meaning that they could relate to their intended audiences (trial participants) because they shared the same cultural and social norms, appearance, language, and terminology. For instance, they dressed modestly and used relevant examples, simple metaphors, and visual aids to explain concepts such as vaccine testing.
3. Relationships - Both staff and community members expressed the value of family and friend relationships in Sierra Leone. Growing up and interacting with the community throughout their lives gave CLT and SST members the credibility to approach their neighbours for the purpose of the trial, for instance. (Despite this, SST and CLT members brought up a number of challenges faced in recruitment, in part because many in the community were unwilling to listen to anything relating to Ebola due to residual fear of the disease based on their community's recent experiences with it.)
4. Respect - Respect for the people, their customs, and traditions played a large role in the CE programme. For instance, the CLT members believed they were respectful by answering the questions of community members and through greeting people in the typical custom with handshakes instead of handwaving from a distance. In addition to this behaviour at the area group meetings, community members felt the time trial team members took to visit them at their own homes to answer questions - confidentially and in a one-on-one conversation - demonstrated their respect.

The researchers note that this study considered the implementation of the CE model in an outbreak and post-outbreak setting and found that both drew on the same 4 principles. "These are qualities that have been mentioned in the existing literature on CE, but not as one comprehensive framework that could foster trust and therefore effective engagement." They indicate that the "Four Rs" could be further developed as a tool to benchmark effective CE; to do so would require additional work to ensure the creation or adaptation of appropriate indicators for monitoring. In addition, gaps in the literature also call for more in-depth research on effective models of CE for both global health emergency and disease preparedness settings.

While these concepts could aid in applying CE in other settings, they also raise considerations to be addressed. For instance, the high value of relationships in this CE programme could be problematic. In the community of Kambia, power structures were not necessarily straightforward, and it was necessary to understand these nuances in order to effectively engage with the community. It may be useful to consider how connections to family or previous relationships with local leaders could influence the dynamics of power, representation, and privileged access to staff or resources.

In short, this study has highlighted the ways in which trust relations are central to CE and confidence in vaccine trials. "If CE is as pivotal to epidemic recovery, preparedness, and response..., it is useful that this study reveals four characteristics (reciprocity, relatability, relationships, and respect) that address complex social relations between trialists and community members."