Community Engagement,
Communications, and Technology for
Clinical Trials in Outbreak Settings

Authors:
London School of Hygiene & Tropical Medicine: Beth Smout, Will Schulz, Heidi Larson
Johnson & Johnson Global Public Health: Annik Willems, Paula Mc Kenna

Thanks To:
Grameen Foundation: Monica Amponsah
Johnson & Johnson Global Public Health: Anneleen Vuchelen (on behalf), Romain Rutten, Serge Masyn
Map Project: Karoline Beronius
PREVAC Guinea: Dr. Alexandre Quach
World Vision: Robert Kanwagi, Magnus Conteh
Zoetic Science (an Ashfield company, Macclesfield, UK): Morgan McKenzie, Patrick Hoggard
Participants in the EBODAC Symposium, Dakar, 2017

Illustrations: Sam Bradd (Drawing Change)

 

Produced by the members of the EBODAC Consortium:
LSHTM | Janssen Pharmaceutica NV. | World Vision | Grameen Foundation

 

1. Introduction

The 2014-2016 Ebola outbreak devastated communities across Guinea, Liberia and Sierra Leone, claiming more than 11,000 lives[i]. No specific vaccine or drug was available to either treat or prevent Ebola Virus Disease (EVD), leading multiple international research groups to rapidly mobilise themselves and work to establish clinical trials of both candidate Ebola vaccines and treatments in the midst of the epidemic. The ethical, scientific and logistical challenges of setting up rapid and robust clinical trials in such a context were significant, creating the risk that the sensitivities, anxieties and realities of potential trial participants and communities risked being considered as an afterthought rather than placed at the heart of the research itself[ii]. From establishing basic lines of communication in the midst of chaos, to meeting the ideals of ethical standards in highly compromising environments, every aspect of clinical research becomes more difficult when the illness a trial drug is meant to prevent or treat is actively circulating in the trial area, creating fear and anxiety and consuming already-scarce resources.

Kambia Town Area Chiefs at sensitisation meeting. Credit: Elizabeth Smout (LSHTM).

Yet if the 2014-16 West African Ebola outbreak is any indication, then we can expect this to be the working model for some of the most crucial medical research in years to come.  It is necessary, therefore, to carefully examine the challenges trialists have faced in the Ebola outbreak, and identify ways to mitigate them, so as to ensure research can continue being conducted in outbreak contexts at a high level of scientific rigor, cultural acceptability, and ethical propriety.

The international community’s initial slow and uncoordinated reaction to the emerging crisis has received considerable criticism from multiple expert panels established to evaluate the global emergency response to Ebola[i] [iii] [iv] [v] [vi] [vii]. Included among their findings was a generalised failure to understand or consider the socio-cultural and political context within which the response was occurring until a late stage, and often only when facing resistance.

Paul Farmer writes that the outbreak raised questions regarding the relationship between “contagion, lethality, stigma and long neglect”[viii]. After decades of structural violence across the region,[ix] a lack of trust between communities and international and national actors posed challenges for community engagement efforts. This served as the backdrop to both overt and covert resistance towards the response and public health interventions[viii] [x] [xi], compounded by negative messages which focused on the disease having no available cure and a high mortality rate7. In general, community engagement throughout the crisis has been criticised for its one-sided, top-down approach, focusing on the delivery of information to elicit behaviour change and to “correct” misperceptions rather than engaging in dialogue to understand people’s perceptions, concerns and fears.

Despite numerous reflections and recommendations related to community engagement in the Ebola response, only one expert panel has identified any findings or recommendations around engaging communities specifically for clinical trials taking place during an outbreak.[xii] This document has therefore been prepared as a repository for the knowledge gained during the Ebola outbreak.  It draws upon the experiences of the EBODAC (EBOla Vaccine Deployment, Acceptance and Compliance) Consortium, who have been supporting communications and community engagement for the EBOVAC-Salone Ebola vaccine trial, investigating the safety and immunogenicity of a candidate prime-boost Ebola vaccine in Kambia district, northern Sierra Leone, in consultation with other individuals and groups involved in both Ebola and non-Ebola clinical trials.

References

[i] World Health Organization. 2016. Ebola Situation Report 30 March 2016. Web. Available here (Accessed 20 Nov 2017)

[ii] Rojek AM, Horby PW. 2016. Modernising epidemic science: enabling patient-centred research during epidemics. BMC Medicine 14(1):212. Available here

[iii] Fielding J, Allen T, Chu B, Galdo J, Gayle H. 2016. Report of the Independent Panel on the U.S. Department of Health and Human Services (HHS) Ebola Response. U.S. Department of Health and Human Services. Available here (Accessed 13 Mar 2017)

[iv] World Health Organization. 2015. Report of the Ebola Interim Assessment Panel – July 2015. Available here (Accessed 13 Mar 2017)

[v] International Rescue Committee. 2016. The Ebola Lessons Reader: what’s being said, what’s missing and why it matters. IRC: New York. Available here (Accessed 13 Mar 2017)

[vi] Moon S, Sridhar D, Pate MA, Jha AK, Clinton C, Delaunay S, Edwin V, Fallah M, Fidler DP, Garrett L, Goosby E, Gostin LO, Heymann DL, Lee K, Leung GM, Morrison JS, Saavedra J, Tanner M, Leigh JA, Hawkins B, Woskie LR, Piot P. 2015. Will Ebola change the game? Ten essential reforms before the next pandemic. The report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola. The Lancet 386(10009):2204-2221. Available here (Accessed 20 Nov 2017)

[vii] Global Health Crises Task Force. 2016. Protecting Humanity from Future Health Crises. Report of the High-Level Panel on the Global Response to Health Crises, 25 Jan 2016. Available here (Accessed 13 Mar 2017)

[viii] Farmer P. 2014. Diary. London Review of Books 36(20):38-39. Available here (Accessed 10 Mar 2017)

[ix] Wilkinson A, Leach M. 2014. Briefing: Ebola–myths, realities, and structural violence. African Affairs 114(454):136-148. Available here (Accessed 20 Nov 2017)

[x] Fairheard J. 2016. Understanding Social Resistance to the Ebola Response in the Forest Region of the Republic of Guinea: An Anthropological Perspective. African Studies Review 59(3):7-31. https://doi.org/10.1017/asr.2016.87

[xi] Yamanis T, Nolan E, Sheplers. 2016. Fears and Misperceptions of the Ebola Response System during the 2014-2015 Outbreak in Sierra Leone. PLoS Neglected Tropical Diseases 10(10): e0005077. Available here

[xii] Keusch G, McAdam K, et al. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. National Academies of Science Engineering and Medicine. Available here (Accessed 20 Nov 2017)

 

 

 

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement EBODAC (grant nr. 115847). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

Recommended Reading

Keusch G, McAdam K, et al. 2017. National Academies of Science Engineering and Medicine.
Yamanis T, Nolan E, Shepler S. 2016. PLoS Neglected Tropical Diseases 10(10): e0005077.
Fairheard J. 2016. African Studies Review 59(3):7-31.
Wilkinson A, Leach M. 2014. African Affairs 114(454):136-148.
Farmer P. 2014. London Review of Books 36(20):38-39.
Global Health Crises Task Force. 2016. Report of the High-Level Panel on the Global Response to Health Crises, 25 Jan 2016.
Moon S, Sridhar D, Pate MA, Jha AK, Clinton C, Delaunay S, Edwin V, Fallah M, Fidler DP, Garrett L, Goosby E, Gostin LO, Heymann DL, Lee K, Leung GM, Morrison JS, Saavedra J, Tanner M, Leigh JA, Hawkins B, Woskie LR, Piot P. 2015. Lancet 386(10009):2204-2221.
International Rescue Committee. 2016.
World Health Organization. 2015.
Fielding J, Allen T, Chu B, Galdo J, Gayle H. 2016. U.S. Department of Health and Human Services.
Rojek AM, Horby PW. 2016. BMC Medicine 14(1):212.
World Health Organization. 2016.
S Vong, R Samuel, P Gould, H El Sakka, BJ Rana, V Pinyowiwat, S Bezbaruaha & R Ofrina. 2016. WHO Bulletin. 94: 913-924.
Vinh-Kim Nguyen. 2014. Cultural Anthropology. Ebola in Perspective.
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