Approaching the community about screening children for a multicentre malaria vaccine trial

Abstract

Community sensitisation, as a component of community engagement, plays an important role in strengthening the ethics of community-based trials in developing countries and is fundamental to trial success. However, few researchers have shared their community sensitisation strategies and experiences. We report on our perspective as researchers on the sensitisation activities undertaken for a phase II malaria vaccine trial in Kilifi District (Kenya) and Korogwe District (Tanzania), with the aim of informing and guiding the operational planning of future trials. We report wide variability in recruitment rates within both sites; a variability that occurred against a backdrop of similarity in overall approaches to sensitisation across the two sites but significant differences in community exposure to biomedical research. We present a range of potential factors contributing to these differences in recruitment rates, which we believe are worth considering in future community sensitisation plans. We conclude by arguing for carefully designed social science research around the implementation and impact of community sensitisation activities.

Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya

“…[6,7]. Empirical studies have also suggested that for health research, the Ministry of Health (MoH) and other key health providers are often important key communities to include [8]. Even where there is clarity on which key communities to engage with, how representatives of those communities should be selected, and how researchers should work with those communities to ensure that their contribution is recognised but their independence from researchers is maintained, is far from straightforward [6].…”

“…It was agreed that the provision of health and other services and care could instead be considered as part of research design (including ancillary care) and benefit sharing. Even where CE is considered as primarily about communication, engagement activities can cover a wide range of interactions including those aimed at consulting with community members about what should be done in studies, through those aimed at sensitising community members about research or specific studies, to activities aimed at ensuring communities receive feedback of individual test results or overall study findings [8,10]. These activities are often part of formally organised communication strategies and activities of research institutions.…”

“…A fundamental challenge in practice for formal CE strategies is that researchers’ goals of CE are often implied rather than clearly articulated [5,8]. This is an important challenge because many CE initiatives have diverse goals, which may be in tension with each other, and because all CE has the potential to have a negative impact, at the very least through taking up people’s time, but also through unintended perverse outcomes such as making some individuals feel obliged to take part in research through peer pressure, or raising expectations that cannot be met [1,6,16,19,20].…”

“…Such research needs to go far beyond documenting simple consent rates: participation in research is only one possible goal of CE, and achieving this goal can compete with other goals such as strengthening understanding of the trial and its’ implications for individual participants. Moreover, participation rates are also influenced by many factors beyond CE [8]. …”

Therapeutic research in low-income countries: studying trial communities

“…Relationships and conditions of great importance to health in different social worlds can be ignored if they do not easily fit into the universal statistical frameworks of evidence-based medicine and the institutional requirements of bioethics 2 5. In reports of research involving children, there is a lack of information on implementation processes, which would help in applying findings to different settings 6 7. Using qualitative methods, social scientists take up these matters with a commitment to widen the focus beyond ethics to ethos, that is, the study of values and perceptions as reflected in practice.…”