Representatives of the health care system can be important players to include in community engagement strategies in clinical trials. CHWs are clearly an important group to consider interacting within community- based trials given their position at the interface between health care systems and local communities. Furthermore, as in our setting, engagement with CHWs is likely to be recommended by community members and representatives. Beyond simply being informed of research as part of community sensitisation activities, CHWs can be given the more proactive roles they had in this trial, such as introducing trial team members to community members, assisting the trial team with identification of potential participants, sharing information about the trial, and responding to trial- related concerns in the community.
Echoing some of the debates expressed in the wider literature, our experience suggests that having CHWs work with other frontline staff performing similar roles has potential practical and ethical benefits and challenges. Studies benefit from working with and learning from well-known and respected individuals in the study communities, who in turn appreciate being given financial support (where this is given) to conduct activities that appear to be particularly related to their training and that increase their visibility locally. As discussions nationally continue on what support CHWs should be given by the Ministry of Health to roll out the community strategy, and where the funds to support this should come from,19
CHWs are expected to continue performing their roles either on an entirely voluntary basis, or with the support of locally active governmental or non-governmental organizations. Offering some compensation for CHWs to be involved in research-related activities, as was done for this trial, appeared to assist in keeping CHWs motivated and active over the course of the trial, as was envisioned by MoH staff and community elders who recommended their involvement. The importance of ensuring that there is adequate motivation for CHWs, whether it is extrinsic or intrinsic, and financial or non-financial, is widely recognised internationally.20
It is feasible that the financial contribution offered by the trial to CHWs in our context assisted in some small way the implementation of the national community strategy in the trial communities. Involvement of CHWs in community engagement was also perceived by trial staff to assist indirectly with ensuring that expected numbers of participants were recruited into the trial through encouraging potential participants to come and hear about the study, and to strengthen relationships and trust more broadly between the trial team and the communities in which the research was being conducted. Given that strengthened science and appropriate levels of trust are often included as ethical goals of community engagement strategies,21
engagement of CHWs in the ways described in this paper, could be described as a potentially important element of a wider set of community engagement activities. Although the roles of CHWs evolved over time, leading to differences across the three sites in the nature of how CHWs were involved, this is to some extent inevitable, given community engagement can never be a pre-fabricated set of activities applied uniformly across all settings, but rather a dynamic and ever changing set of negotiated relationships.22
However, there are clearly dilemmas associated with involving CHWs and other frontline research staff. Firstly, although there was a clear distinction maintained between employees and CHW volunteers, with the former having more diverse roles and training (in research, ethics, and trial details), there was some indication of overlaps in roles, of tensions between CHWs and fieldworkers, and of conflicts among CHWs themselves. In particular there were suggestions that CHWs were undermining study-related information provided to potential participants by fieldworkers, and exerting some pressure on participants to visit health care facilities for further information in order to increase their own reimbursements. These findings could be interpreted as indicating both vertical exploitation – where CHWs were being encouraged by researchers to exploit their social connections and status in the community – and horizontal exploitation, through CHWs seeking to gain income and influence in their communities.23
However, both of these forms of exploitation were eased by excluding CHWs from any final information giving or consenting for the trial; roles which were performed individually by carefully trained study clinicians. CHWs were also inadequately trained to understand and share key trial messages, and may therefore have been simply ill-informed or unable to give correct information or answers to community members. Furthermore, as community members with a keen interest in health care, CHWs may have been less interested in their own gains than in ensuring that households had the opportunity to access what were indeed significant health related benefits associated with trial participation for participants. Given the high degree of poverty and unemployment levels in the trial communities,24
the inadequate resources allocated to support CHWs by Ministries of Health and NGOs in Kenya as elsewhere (noted above), and the significant health-related burdens and costs facing low income households in these communities, these challenges and tensions between interface staff and volunteers are not surprising or unreasonable, including to fieldworkers. These findings suggest the importance from the outset of carefully considering (and discussing and re-considering) the roles, training and support systems of CHWs and how these relate to those of FWs. In so doing, it should be recognised that fieldworkers themselves also face many similar ethical and practical challenges in their roles at the interface, with their level of embeddedness in the particular study communities influencing their familiarity with local social networks and norms, and therefore the way in which they experience and handle these challenges.25
A second dilemma associated with including CHWs in the trial, possibly motivated by the hope of remuneration or future employment in the research programme, was some indication that their involvement might have impacted negatively on their pre-existing CHW roles in the community. This was possibly more likely where CHWs were not already highly active and with clear roles and relationships within the community. This would be plausible either through CHWs spending significant amounts of time on trial-related activities, or through undermining their relationship with community members through repeated visits to homes as part of their mobilization efforts. In both cases, extrinsic incentives might also have begun to crowd out CHWs intrinsic motivation such as social recognition, knowledge gain, and the opportunity to make a social contribution.26
More broadly therefore, engagement of CHWs in this way can potentially undermine rather than support CHW programmes which are ultimately intended to benefit community health, with the possibility of this depending on pre-existing dynamics of the cadre. Clearly this would operate against the ethical gains of working with CHWs described above, and against community leaders’ initial motivation for suggesting CHWs involvement in the trial. Specifically it would potentially undermine fair benefits in research through reducing benefits to communities during and after trials, and potentially cause harm or disadvantage through undermining community engagement in local health care systems. It was beyond the scope of our study to explore this in depth, or the long term implications of CHW involvement in this trial. However, this finding suggests the need to recognise differences among CHWs, and to consider and monitor such potential perverse outcomes of engaging with CHWs, in future trials, and more specifically of different CHW reimbursement strategies. Depending on the context, careful discussion and agreement with Ministry of Health and NGO managers and implementers is likely to be important.
Another potential challenge in paying some level of remuneration to CHWs, although not identified as a challenge in this study, is that other community leaders and representatives who are informed about a trial and who typically help to raise and respond to community concerns, might also be keen to receive some financial support for any involvement they (perceive themselves) to have in the trial. The dilemma with providing motivation for other community ‘volunteers’ (for example chiefs and elders, and women's group representatives), as for CHWs, is the possibility of crowding out any sense of intrinsic motivation. For all groups, there is also a concern that increasing motivation of community members has to be balanced against the need to ensure that they maintain an independence from researchers in a way that facilitates critical and meaningful dialogue. On the other hand there should be recognition of community members’ contributions, and efforts to minimise trial costs – in time and especially financially – for community members. Challenges in achieving an appropriate balance have been regularly observed for community advisory boards. Where there is no motivation, or independence and dialogue is compromised, the potential of community engagement to strengthen research relationships and ethical practice is undermined. This opens up the possibility to identify other forms of motivation that minimise such limitations, including for example providing appropriate training or exposure to health care research.