How Can Community Engagement in Health Research Be Strengthened for Infectious Disease Outbreaks in Sub-Saharan Africa? A Scoping Review of the Literature

"The need for accurate and culturally sensitive communication with relevant community stakeholders about a trial is widely recognised as a critical preliminary step in the research process..."

The growing number of clinical trials around emerging diseases has sparked calls for improved community engagement (CE), especially in emergency situations. Although CE is increasingly recognised as core to the science and ethics of health research, there are concerns that CE in clinical trials does not always address political and economic issues related to involving people from resource-poor communities. With a focus on health research for infectious disease outbreaks in Sub-Saharan Africa, this scoping review seeks to describe how CE has been conceptualised and understood in the literature and what conclusions research teams have reached on the effectiveness of CE in these settings.

Adopting the World Health Organization (WHO) definition of CE as "a process of developing relationships that enable stakeholders to work together to address health-related issues and promote well-being to achieve positive health impact and outcomes", the researchers undertook an iterative process that led to inclusion of 59 papers in the scoping review.

As a window into the literature, the paper details the CE activities undertaken in six clinical trials conducted during the West Africa Ebola outbreak between 2014 and 2016, exploring what the literature describes as "working" or not and why, as well as any lessons suggested. Papers on CE activities for Ebola treatment and prevention trials in Sierra Leone, Liberia, and Guinea included either vaccine trials (four) or treatment trials (two). The vaccine trials aimed to recruit healthy volunteers and had the strongest focus on CE as part of their recruitment strategy and associated need to engage with a wide area of local residents.

Table 2 in the paper summarises the set-up, aims, and mechanisms of these CE strategies and activities. For example, EBOVAC-Salone's vaccine trial Phase III incorporated a CE approach, informed by prior and ongoing qualitative research, which involved dedicated social science team and community liaison teams working to understand intra-community power dynamics. The teams concluded that local understandings of fairness can inform the recruitment strategy design and that rumours can be addressed through "active dialogue" rather than efforts to correct misinformation. This emerging understanding was used to support and adapt CE over the course of the trial.

The researchers then describe the scope covered by a wider relevant literature on CE, including research accounts that reference CE activities and commentaries and analyses of what constitutes good practice for CE. They observe that the value of CE is often framed in terms of encouraging support for the trial, and the language used to describe this tends to be linked to promotion, enhancement, and sensitisation. For example, the instrumental value of CE is recognised for overcoming challenges to both the outbreak research and the public health response, in addressing rumours and changing core risk behaviours (e.g., those around "unsafe" burial practices), and in introducing new measures like contact tracing and quarantine. One published report included in the review provides an overview and analysis of the various aspects of research and development for Ebola vaccines, offering general CE recommendations that can be applied to health research.

Drawing on these findings, the researchers offer an analysis of major elements of CE that are central to "effectiveness" or good practice in infectious disease studies:

1. Communicating to build collaborative relationships - "[C]ommunication can serve a range of purposes, from more 'one-way' or outreach forms of communication to more 'bi-directional' or participatory forms-supporting learning and consultation....Unpacking the explicit and implicit aims of communication methods - particularly in the context of setting up a new trial, perhaps in a research-naïve community - can lay the groundwork for continued communication strategies that are cognisant of their multiple effects." To that end, the researchers provide several examples from the literature of each of these (often overlapping) types of communication in the context of trials. For instance, all trials included elements of communication reaching individuals or specific groupings of potential participants or "influencers". The communication at STRIVE (a Phase III vaccine trial involving frontline health workers in Sierra Leone), with the help of social mobilisation experts (SMEs), were responsible for ensuring voluntary, informed participation. The approach to understanding a potential participant's decision-making was based on a tailored social ecology model, which shows how an issue can be influenced at multiple societal levels.
2. Producing contextual knowledge - "The use of formative research prior to and for the purpose of informing trial design and implementation is a core part of CE strategy." Having provided several examples, the researchers identify the need for further research to examine "the specific intentions and aims of the formative research - to prime the setting or to ask open-ended questions about the ethical, social, cultural and historical feasibility of conducting trials in the setting?"
3. Learning lessons over time - "Knowing and understanding whose feedback is getting incorporated and why is an important step in mapping out the effectiveness of CE strategy." Examples from trials illustrate how incorporating findings and creating feedback loops can contribute to building a sustaining legacy for communities (especially in view of longstanding structural inequities that characterise settings in which outbreaks are likely to arise).

Based on this analysis, the researchers argue that:

• Communication approaches should be multifaceted and tailored to context, while including elements that build collaborative relationships between partners.
• Social science research (formative and ongoing) is a critical component in guiding the shape and content of CE during an outbreak and ensuring that the collaborative relationships researchers aim to build are well-founded, meaningful, and durable.
• It is important to commit to learning lessons from ongoing experiences during an outbreak so that research teams can flexibly adapt and sustain those collaborative relationships, which are at the heart of the research enterprise.

In sum, this review suggests that "good practice in CE in the context of outbreak research (and potentially for research in general) is underpinned by bi-directional communication, the careful longitudinal incorporation of social science research into planning, and ensuring that structures are in place to support meaningful feedback and adaptation of research practice on the ground. This includes efforts to ensure that CE has an enduring legacy from research, for the benefit of a widely defined community."

In conclusion: "Going forward, the additional work needed in order to further knowledge in assessments of CE will be to consider broader implications of CE on an aggregate level....The importance of documenting and sharing lessons learnt to improve CE practice remains paramount as current epidemics continue.... deeper understanding through more comprehensive reporting of the mechanisms of CE would provide stakeholders with a benchmark for assessing the ethical principles around CE and offer a tangible, on-the-ground opportunity to enact them."