The results presented here relate to earlier work looking at the experience of caregivers of pediatric participants in malaria vaccine clinical trials.(3)
Eleven interviews were conducted with members of the research team. Respondents had various roles in the research team but all were involved with the RTS,S malaria vaccine clinical trial. The average length of an interview was 53 minutes, with the shortest being 28 minutes and the longest 2 hours.
In the interviews, respondents described their experience in the community and overall impressions with great detail. Respondents described communities as dynamic and outlined the experiences they had when working in community systems. In particular, challenges associated with blood draws, rumours and misconceptions arose, as well as the ways in which they dealt with these. Often a foundation of trust and continuous communication were reported to be key for clinical trials to work in a community and through complexity theory this foundation can be used to embrace the non-linearity of the system and effectively work in it. Below we present the alignment with these descriptions and CAS, as well as the indicators that when a clinical trial is initiated in a community they merge, and they exhibit interconnectedness and interdependence and behave as one cohesive system.
Communities are complex adaptive systems
The ways in which respondents defined community was strongly aligned with attributes related to unpredictability, non-linearity and emergence associated with complex adaptive systems. When discussing work in the communities, respondents described a dependency on a complex array of factors. Throughout the interviews, researchers brought up their definitions of community from their perspective, in particular the diversity across various communities and the ways in which this impacted the trial.
P11 Working with communities is dynamic. There are pros and cons about working with communities. But it depends on how you conduct yourself in the community and how you engage the community.
P10 It depends on the social make-up of the area where you are. For example, we had more withdrawals from the central area than from the more rural outlying clinics.
Challenges of working in CAS
The impact of misconceptions around adverse events and risks was reported by all respondents, which could vary depending on the community context. These misconceptions arose out of contextual factors within the community system, as there are multiple factors acting on the community simultaneously to the trial procedures. These also indicate the merging of two independent systems (trial and community) displaying significant interdependence. The challenge in dealing with this was also raised, particularly in sensitive cases when a participant has died from causes not related to the vaccine study. Here the community blames the powerful clinical trial for an event where helplessness is experienced in the community, indicative of a power imbalance and linked to the hierarchy characteristic of CAS. The non-linearity and complexity of working in CAS settings was evident, as well as the experience for the researcher being a part of the community system and then having to return to an unpredictable scenario.
P08: If for example after a participant dies, it becomes another challenge altogether because a participant can die from another cause. But then people sometimes feel that in a way you contributed to that. But you see those who are participating at least they know because they went through the whole treatment procedure and everything so then they understand. But now the whole community, even when you are going to visit these compounds you feel when you are going you are not really sure of what can take place, because you are going, and you don’t know if maybe some people will turn wild and attack you or something. But then it never happened, really, actually, it never happened.
The interviews revealed consistently that there are many concerns from the community with regards to blood draws and transfusions, illustrating that communities are not operating in isolation, instead they are imbedded in contextual histories where clinical trials were, at times, exploitative. This overlapped with religious motives for denying medical intervention such as blood transfusion or oxygen for a sick child enrolled in the clinical trial. Many of the communities have rooted beliefs around blood, arising out of these historical research experiences.
P08: The main issue in the community is about blood samples that we take, that one is a major issue. People want to know “what are you doing with the blood?”
There are multiple factors that play into the consent process and it is rarely the person who consents (frequently the mother) who has the only say in the child’s participation. The concerns around blood or other misconceptions are often heightened in those family or community members who haven’t gone through the formal consent process. Different communities have varying employment realities, which contributes to the social make-up and transience of fathers at a given moment in time. This is not predictable and adds a layer of complexity to operating in a community.
P02: Some homes you had the father, or the head of the household, who does not want anything to do with vaccine research because of the perspectives. So they would be hostile. And threatened, “leave my home, I don’t want my children in those studies, you’re taking blood for what? You’re making money with our blood!”
In a few cases it was highlighted that external research projects being conducted in the area interfered with the perception of the research study. In particular, it was noted how some researchers bypassed community engagement processes. As the community did not necessary distinguish between research institutions due to the overlap of activities, this generated further broad suspicion around medical research.
P11: University students that don’t know how to do it and they’re in a hurry to get their data. They just say, take these 200 shillings, I want to remove the blood of the child. And the community kept on thinking it was us.
It was widely reported that having local staff was necessary for effective community engagement and necessary for an understanding by the trial team of the sociocultural norms and economic contexts unique to the participants. However, it was also acknowledged that in the event of an employment termination there could be a disruptive impact on the community-trial relationship. These explicit demands by the community for more reciprocity from the clinical trial was indicative of the community’s experience with the power imbalance. The economic and power inequity was seen as a particularly delicate issue for the research team, in line with the hierarchal nature of CAS.
P02: There are instances where the family would say “My daughter was looking for a job but you never hire people here from this community, you want to bring people from outside to come and work for you” so probably a percentage of your field team should come from the community, because now the community relates, they know these people, these people live amongst them, there is no way they can bring something bad to them.
P02: We have a family around the community, one of their children was hired here but because of negligence, he used to miss, he lost his job. So the family was mad at the organization so they would go around the community and discourage people from engaging with us.
How researchers work in complex adaptive systems
It was cross-cutting across respondents how important it was to understand the people in the community, show concern and express gratitude for their participation. This was an important aspect to working harmoniously in the community through strengthening the communication and comprehension. At times, the researchers identified the power imbalance within the CAS between the clinical trial and the community, feeling that more needed to be done for the community and the participants.
P02: Think about their needs and don’t treat them as a subject, treat them as someone who has sacrificed their time who has put aside some of the things they were supposed to do to come to the clinic.
P07: You get to learn their challenges, or their fears, or their reservations. And then you get to explain why you are doing what you are doing at that time point and why you are planning to do it or why you are not planning to do it.
Understanding the role of community leaders, especially elected leaders, attributed to positive opinion of the trial within the community – as they can have a major impact in the community and determine the directionality of the engagement. It requires careful engagement by the research team, as it is necessary for the success of the trial to have the chief’s support.
P05: And the chiefs, those ones you must have on your side, before you try anything. Because if they decide you treated them disrespectfully that study is not going onwards, they’ll say don’t enroll, they’re doing this, maybe they’re selling blood.
Being aware of the norms and subsequently approaching misperceptions in accordance with those norms was reported as being a continual iterative learning process. For instance, addressing power dimensions and sending the appropriate staff member to provide clarification in challenging situations. A few respondents clearly identified how important it is to have members of research team that are culturally versed and sensitive to local norms. Without this there can be implications on perception of the study, without the researcher themselves being aware of it.
P05: He is familiar what not to do. Maybe when you enter a household, how you should enter, who you must see before you start seeing. You can’t just enter a homestead and just start talking to anyone you want, it’s inappropriate.
Frequently it was reported that staff should not only be properly trained, but also selected based on their fit within the community norms. This was seen as key to maintaining a trusting and strong relationship with community members.
P11: You must know who your staff are. Others are outgoing, others are introverts. You can’t send an introvert to the village, they will be closed. The villagers will not share with them.
Respondents often brought up the role that trust plays in communicating with the community and maintaining harmony. The ways in which this was built was through consistent and transparent communication, as well as adhering to the proposed study protocol without surprising the community with new procedures.
P09: Trust is in the core of the understanding between the staff and the community.
Hosting information sessions that are inclusive to all members of the community (not only those who consent and the participants) was reported to be a positive contribution to the trial perception and addressing information gaps. It is helpful to have regular sessions where all can attend and have access to information updates to avoid a powerful voice having a misconception or information gap.
P11: Communicate and talk to them at every level. Right from the time they come to the clinic. To not be tired of communicating, communicate all the time.
Informing the community about research findings was also highlighted by the respondents. Especially in the long-term view of the research study and supporting future recruitment was identified to be tied closely to ongoing engagement and keeping the community informed.
P01: I think people want to know where you have reached, because especially if it is not a perfect vaccine, for the lack of another word, then people will need to come back again, provided that the disease remains a problem, to come back again to the community. That’s a major challenge, especially for large studies.
The introduction of a new research project, in this case a new vaccine, required a lot of clarification and engagement. Especially ongoing involvement of the community to raise understanding and comfort with the new tool. The nature of this involvement was dependent on the community the research team was working in.
P08: What I have learned in this community, is that if there is a vaccine that is injected, a lot of mobilization needs to be done. Because you find that in these areas there are not many vaccine trials that previously had been done so people don’t really know how the vaccine trial is done, especially one that is injected.
The establishment of the Community Advisory Board (CAB) was reported to be beneficial as a tool for staying aware of the community developments. Having regular meetings allowed the clinical trial team to address misconceptions and information gaps, as well as adapt appropriately to new situations.
P01: I would not start a study without telling the CAB, it would almost be suicide. If something goes wrong, even if you don’t know who to tell, you see then you have already told them “oh remember the study, we discussed, oh this is what is happening” or they already know about it, so if they hear a rumour they can tell the people, we heard, but that is not really it.
A number of respondents identified the need to translate informed consent forms into contextually-sensitive language. It was reported that certain words translate poorly into the local language, with the consequence of creating community suspicion towards the researchers.
P04: Allowing the use of more latitude with how we translate, meaning it should not be word-for-word, which is what they tend to look at, but it should be more context.
Despite the various ways in which challenges were addressed and the overall benefits attributed to the clinical trial working in the community, a few respondents called for more to be done. These researchers felt that with the power of the clinical trial and the benefits received, the community needed to benefit more and the trial needed to do more in return and acknowledge this power discrepancy.
P02: Being an organization working in a community, you should give back to that community. You should show concern, don’t just collect data and forget about them.
P07: Different communities have different expectations, it is really challenging because when we are starting the trial the new satellite facilities were looking forward to us doing much facility improvement.