The findings of this study provide insight on the delivery of a community engagement programme primarily from the perspective of the individuals delivering it. The CLT felt their role was to explain the trial and its importance to the community, recruit participants and to address any rumours or misconceptions the community had about the trial (CLT004). They did this through a variety of activities including one-to-one stakeholder meetings, group area meetings, public performances and radio jingles (CLT002, CLT009, CLT010). The SST served two functions. The first was to support the trial through power mapping to understand the community’s leadership structure, community household mapping to collate geographic locations, and ethnographic research to explore rumours and concerns circulating in the targeted community (SST001, SST002, SST004). The second was to produce independent research on the social aspects of the trial to understand what factors led people to participate in the trial and their experiences as participants (SST001). Finally, the Participant Advisory Group (PAG) was a group of trial participants that served in an auxiliary capacity to the trial. They held their own meetings to discuss grievances and concerns and reported their priorities for action back to the trial (CLT004).
SST and CLT members that were interviewed brought up a number of challenges faced in recruiting participants for the trial. It was often difficult to locate people because they did not know their addresses or because they had businesses or farms that kept them out of the house all day. Due to the community members’ busy schedules, the CLT would conduct their house-to-house visits early in the morning or late in the evenings and would ask organization leaders to book times that worked best for their members for area meetings (CLT002, CLT003, CLT004, CLT007). From the perspective of the CLT, many in the community were unwilling to listen to anything relating to Ebola because of residual fear of the disease based on their community’s recent experiences with it (CLT001) or could be unwilling to attend meetings or discuss the trial because “people’s minds are very fixed from what they told them [during the outbreak]” (CLT008). This perception of an unwillingness to learn about the vaccine was verified during FGDs in Mambolo and Kambia (FGD001, FGD002). Local community leaders in Kambia explained that they did not trust this vaccine when they first heard of it because of the experiences they had during the outbreak where they were also told there was no medicine to cure Ebola (FGD002). These were some of the sources behind the hesitancies that the SST and CLT would need to address.
Interestingly, both teams described themselves as a bridge between the trial and the community. This could be because both teams felt they were a mechanism that ensured that the voices of the community were raised and heard by the clinical trial team. While both teams viewed themselves in this similar capacity, they carried out this role in different ways. While the CE program structure had a few mechanisms for feedback (Figure 1), CLT and SST members typically described a flow of information that is represented in Figure 2.
This section describes four characteristics of the CE program and the dynamic presented above that were uncovered throughout the interviews.
The Four R’s
Trial team members expressed positive impressions of their work in the community, citing the high number of trial participants as evidence of their success. When asked about how the CE work of the trial had been successful, both individual team members and FGD participants pointed to the importance of trust. As one CLT member said:
If people do not have confidence in you, […] you will not succeed. Yes, the first thing is confidence building – trust. People need to have trust in you that presented the message. If they do not have trust in you, even when you present the message, they will sit down and listen to you, [but] these people do not accept the messaging. . . (CLT008)
Throughout the interviews, four concepts emerged relating to the activities of both the CLT and SST: reciprocity, relatability, relationships, and respect. These were not formal principles that staff were trained on, but they helped establish the trust between the community and the trial staff through their delivery and influenced the success of the CE.
4.1 Reciprocity
There were several ways through which this CE model established a reciprocity that created effective engagement. The first was the CLT-SST feedback loop that allowed for any issues in the community to be both heard and addressed. Another avenue that created this reciprocal relationship was the exit interviews conducted by SST members at the clinic. These conversations, that occurred at the end of a participants’ visit to the clinic, allowed the SST to bring information from the trial participants back to the trial – both the CLT and clinic staff. This forum was also appreciated by the community members:
One thing I love about them whenever you go there for the marklate [vaccine] immediately after taking the marklate [vaccine] they have an interview room where they will take you and whatever you say there is secret. They give you confidence to ask questions… (FGD002)
This opportunity to provide confidential feedback, including potentially negative feedback or criticism, on their experience built trust among the community members towards the trial. This sentiment also echoed an SST member’s comments on how their team provided an aspect of care – an opportunity for feedback and follow up – typically missing from the hospitals and health care system in Sierra Leone (SST001). Trial participants were also able to discuss and provide feedback on the trial through the established PAG. This group contributed to the trial by bringing participants together to discuss with each other their grievances. This group was completely independent of the trial, with the ability to bring certain issues to the trial’s attention.
Reciprocity could also be seen in the format of area meetings held by the CLT. At these meetings, community members had an opportunity to ask their own questions after the trial staff presented their information. In addition to answering questions, CLT members would interact with meeting attendees to keep them engaged and interested. A CLT member explained:
We ask them questions – how are they getting the message. We tell them ‘ask us questions.’ If they don't ask us we say okay we will ask you. We interact. . . We will ask them the questions. . . How many marklates [vaccines] are they giving you? They tell us. If they make a mistake we correct them. (CLT003)
By consulting local authorities, the trial teams were able to improve the trial procedures to make them more acceptable to participants. One challenge they faced in May 2018 was how the holy fasting month of Ramadan would affect trial participation. A CLT member explained that they approached this challenge by reaching out to the religious leaders for advice on what they thought the appropriate response to questions about what the religion says about observing the month of Ramadan and participating in a trial that involves injections or drawing blood (CLT010). This inclusion demonstrated both a respect (another one of the four principles) for local leaders and beliefs as well as reciprocity as the community contributed directly to the functioning of the trial. The overlap between reciprocity and respect was also clear in the practice of providing refreshments during meetings. An SST member that observed area meetings in both trials described the importance of these:
This model of providing the refreshment for people plays a very big role because we have this type of reciprocity. If I give you, you should be able to give me in return. Whichever way - I am sacrificing my time, I am sacrificing my business, I am sacrificing my other economic activities to come and listen to you to help to promote your agenda. What do I stand to gain in return? (SST001)
This concept of exchange is not unusual or unexpected (51), but it could be a delicate matter to apply in a way that does not coerce or bribe research participants. This CE approach could be adopted in future trials to support finding the balance between these issues.
4.2 Relatability
Another theme that became apparent in interviews was the relatability of the trial team members with the community members. Most of the EBOVAC-Salone and PREVAC CLT and SST members were recruited locally. The CLT and SST staff could relate to their target audiences as they shared the same cultural and social norms, appearance, language, and terminology. The first impression from appearance was agreed to be an important first step in being able to engage with the community. A CLT member explained the importance in dressing modestly because:
If you dress as if you are the president of this country, some of these stakeholders will not even talk to you. They will say that these are the people that are eating the country's money so we see no reason for us to listen to them . . . That's why you need to put yourself in that moderate manner so that maybe when you go there they will think that all of us, we are equal. (CLT004)
Another form of relatability comes from using local institutions and infrastructures for the project. For example, the use of a local town crier demonstrated respect for that institution while reaching community members in a way to which they were accustomed. In using these existing systems of communication, it was vital to consider language. A common language (Krio, Temne, Susu or Fula depending on the setting) not only allowed for conversations to take place, but also facilitated a better understanding, comfort, and trust between the two parties (CLT004).
In addition to speaking the same language, CLT and SST members needed to account for some of the scientific terminology used to explain the trial. An SST member highlighted the need to break down complicated or scientific terminology into relatable terms (SST001). One example of this that was observed throughout the interviews was the use of the word “marklate” instead of “vaccine” or “injection.” Between 1988 and 1990, there was a national campaign to eradicate polio from the country (54). This large-scale campaign and the “polio marklate” were relatable experiences for the community members. Because the people were more familiar with that word, it became a term frequently used by both trial staff and community members to refer to the Ebola vaccines. Another example was that there was no local term for meningitis. Instead, a CLT member said they would explain the condition and its symptoms without calling it ‘meningitis’ as this was not a familiar word (CLT003). Employing appropriate language and terminology could be a considerable challenge when discussing nuances in a ‘naïve community’ with no experience in biomedical research.
Relevant examples and simple metaphors were another way the CLT members related to community members in order to convey their message. When community members questioned the extensive screenings required before administering the vaccine, CLT members explained how a doctor in a hospital would run tests to confirm diagnosis if they were ill because this was an experience with which they were familiar (CLT005). A vaccine trial was a new experience in the community and so the CLT needed to explain that they were testing the vaccine being administered. A CLT member said they would mention existing vaccines that the community knew and would explain that these vaccines went through similar processes around the world before they could be dispensed in their own communities (CLT010).
Focus group participants confirmed that the CLT members gave clear information with a relatable football metaphor that they could understand (FGD002). One SST member described the value of this strategy to justify why staff members were not taking the vaccine:
People want to hear not just explanations, but practical examples. That will force them to believe. For example, you set up the scenario of a footballer and a referee. In a football match, you cannot be referee and at the same time, play the match. What will happen if you play a foul that leads to a penalty kick – would you blow that whistle? Any time this kind of example is made, you will see people laugh. You will see them nodding their heads, nodding their heads in acknowledgement. (SST001)
Finally, this relatable demeanor and language was complimented with visual aids. To respond to the concerns over blood sampling, the CLT brought the test tubes used at the clinic to the area meetings. They filled a test tube with water and poured the tube’s contents into their hands to demonstrate the small volume that would be collected. In each FGD, participants recalled this display when asked about the type of information they received at area meetings.
4.3 Relationships
The next principle highlighted throughout the interviews was the emphasis on relationships in these communities. Both staff and community members expressed the value of family and friend relationships in Sierra Leone. Two CLT members explained their roles would not have been as effective had they been strangers to the local community because the fact that the people knew and trusted them was important in delivering their messages about the trial (CLT005, CLT003). This high value on relationships was why it was important for trial staff to be recruited locally. Local residents hired for CE work had already established both relationships and reputations within the community that primed them for effective trial message delivery. Multiple SST members agreed that local staff was important for the trial to succeed (SST001, SST004).
An additional benefit of local staff was the connections they brought. A CLT member explained that their “relationship between we the community liaison and the paramount chief, the heads of different areas, is very cordial because most of the stakeholders, they are our parents” (CLT008). This was acknowledged by community members as well and given as one of the reasons they trusted them. In Mambolo, an FGD participant explained:
Some of them are related to stakeholders here, some came from ruling houses, so as a matter of fact, there is that trust […] that confidence in them and like the previous speakers said, some of them are our former school pupils and some of them have attained higher education. So, with all of that, there is that confidence and trust to accept whatever information they brought us. (FGD001)
This speaker mentioned the value of not only the CLT members’ relatives’ reputations but also their own. Growing up and interacting with the community throughout their lives gave them the credibility to approach their neighbors for the purpose of the trial.
This idea was echoed in a Kambia FGD as well:
We trust them because they are native born of Kambia and we know them. We know that they cannot take us somewhere where we will lose our lives... Everyone is related to each other and they cannot contribute to trouble for each other. Brothers and sisters always bring good thing for each other. So, that is why once I see them, I am always ready to listen to them. (FGD002)
This agreement featured another example of the strong sense of family and relationships in these communities that was apparent in observing community area meetings and FGD dynamics. This attitude and regard for others as “uncle, auntie, son, daughter” demonstrated both respect and a high regard for interpersonal relationships. For example, community members referred to elders or local authorities as “ma” or “pa” and to younger people as their own children. As one CLT member said, “When the people see me, they build up confidence because I am their son” (CLT008).
4.4 Respect
Respect is interwoven throughout the activities and examples of the other three principles and is an underlying factor in any engagement. The CLT and SST members needed to trust and respect the work of their colleagues. This was a common challenge in the beginning of the trial, with some SST members describing an initial tension between the CLT, SST, and clinical teams. One SST member explained this tension as a result of providing feedback on aspects of the trial that could include the behaviors of trial staff such as an error made in the clinic or a confusing statement described at a community meeting (SST005). These comments on actions trial staff did or did not take could then be perceived as a personal attack (SST001, SST002). Addressing this issue took time and patience; another SST member explained that more frequent training sessions and checkpoints between the different teams mitigated the tension (SST003). The mutual respect that eventually developed at these meetings allowed the teams to move forward together.
Trial team members stressed the importance of demonstrating respect to the community members in the areas they worked. A CLT member provided this scenario to illustrate the overlap between relationships, reputations, and respect:
First of all, one thing about community people, if you are indigene of this place, make sure you have respect for people. You need to have respect. . . Now when you have respect, here is a village area, so when you greet somebody you do not call them by names, you call them my uncles, my auntie, my grandmother. With that respect, when they see you my son, my daughter, have this bucket go and find water for me. My son, please come and help me pound this rice. My son, today I have work in my farm, please go and help me. From that, people build up confidence in you. That you are a son or a daughter that have respect for them. (CLT008)
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 (CLT009, CLT010). Community members and local leaders agreed that these behaviors and how the staff carried themselves showed that the trial teams respected them. In one FGD, community members explained that a disrespectful person would not be accommodating and approachable, but the CLT and SST staff were always polite and encouraging (FGD002). Another participant expressed an appreciation for the way trial team members were receptive to any comments they wanted to share and would respond in a respectful tone and manner (FGD002).
In addition to this behavior at the area group meetings, community members felt the time trial team members would take to visit them at their own homes to answer questions demonstrated their respect (FGD003). Ensuring confidentiality in these one-on-one conversations became another way to show respect the community members. When an SST member heard a rumor or concern that needed to be corrected, they only reported the area where the rumor was circulating rather than the individual that conveyed it (SST003). This respect for privacy encouraged community members and trial participants to continue to be open with their feedback or criticism of the trial when speaking with the SST.
When asked if the community members respected the trial team members in return, there was a resounding unanimous agreement. When questioned why they respected the trial team members, one participant aptly reported:
Because this is just like if you don’t want yourself to be slapped by someone, don’t slap anyone [laughing…]. So if you respect somebody, somebody will respect you in return. They have already given us our own respect, why don’t we give them the same respect? (FGD002)
Respecting the existing power hierarchies and structures of the community was imperative for the program because of the high respect community members had for their local authorities and leaders. The CLT understood that it was crucial for important stakeholders to be actively involved in order for the rest of the community to be willing to listen (CLT008). An SST member further explained that “the local authorities must not be seen to be sidelined. They must be seen to be taking the center stage, because our people impose high trust on these local authorities” (SST001). This respect for local leaders also aided the trial when a key leader of Kambia became a participant of the trial. Community members in both Kambia and Mambolo cited this example as one of the reasons they believed that the trial was not malicious. Seeing an individual of such high status and regard taking the vaccine had a noticeable influence on the perceptions of the trial.
The trial team members exhibited their respect for the local leaders not only by reaching out to them first, but also by having them set the times and terms of their meetings. They also made sure to acknowledge the relevant customs and traditions in the community. One CLT member gave the example of bringing a small token to the chief as a sign of respect to him and to the local customs (CLT010). While this custom would be a sign of respect in this community, in some settings, it could also be misconstrued as a bribe. This is one example of a challenge in maintaining a balance between respecting customs and practicing appropriate research ethics.