Lessons learned from engaging communities for Ebola vaccine trials in Sierra Leone: reciprocity, relatability, relationships and respect (the four R's)

Sara Dada, Gillian McKay, Ana Mateus, Shelley Lees, Sara Dada, Gillian McKay, Ana Mateus, Shelley Lees

Abstract

Background: Building trust and engaging the community are important for biomedical trials. This was core to the set up and delivery of the EBOVAC-Salone and PREVAC Ebola vaccine trials in Sierra Leone during and following the 2014-2016 West African Ebola epidemic. Local community liaison teams (CLT) engaged with the community through public meetings, radio chat shows, and other activities, while a social science team (SST) assessed community members' and participants' perceptions and regularly updated the clinical team to adapt procedures to improve the acceptability and compliance of the trial. The objective of this study was to examine the community engagement (CE) program in these trials and to identify potential barriers and facilitators.

Methods: Fifteen CLT and SST members participated in in-depth interviews and 23 community members attended three focus groups to discuss the Ebola vaccine trials and their experiences and perspectives of the CE activities.

Results: A key aim of the CE program was to build trust between the community and the trial. Four main principles (the "four R's") evolved from the discussions with team members and the community that influenced this trust: reciprocity, relatability, relationships and respect. The CLT and SST ensured reciprocal communication between the trial team and the community. The CLT delivered key messages from the trial, whilst the SST completed ethnographic research in the field to uncover rumors and perceptions of the trial in the community. These ethnographic findings were shared with the CLT and addressed in targeted messaging to the community. Both the CLT and SST approached the communities in an egalitarian manner, by dressing modestly, speaking local dialects, and using relatable examples. Appreciation and understanding of the importance of interpersonal relationships and respect for the people, their customs, and traditions also played a large role in the CE program.

Conclusion: These findings provide an in-depth understanding of how interdisciplinary community liaison and social science teams can work with a clinical team to strengthen trust. The four R's suggest the ways in which trust relations are central to CE and confidence in vaccine trials, and could offer an approach to CE in vaccine trials.

Keywords: Community engagement; Disease preparedness; Ebola; Sierra Leone; Vaccine trials.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Community Engagement Structure . The trial’s community engagement structure, highlighting the interactions between the different parties. Source: EBOVAC trial community engagement diagram – Tom Mooney
Fig. 2
Fig. 2
“Bridges of Information”. The flow of information in the community engagement program of the vaccine trial based on descriptions from interview participants

References

    1. Wilkinson A, Parker M, Martineau F, Leach M. Engaging ‘communities’: anthropological insights from the west African Ebola epidemic. Philos Trans R Soc B. 2017;372(1721):20160305. doi: 10.1098/rstb.2016.0305.
    1. Ahmed SM, Palermo A-GS. Community engagement in research: frameworks for education and peer review. Am J Public Health. 2010;100(8):1380–1387. doi: 10.2105/AJPH.2009.178137.
    1. Dickert N, Sugarman J. Ethical goals of community consultation in research. Am J Public Health. 2005;95(7):1123–1127. doi: 10.2105/AJPH.2004.058933.
    1. Aggett S. Turning the gaze: challenges of involving biomedical researchers in community engagement with research in Patan, Nepal. Crit Public Health. 2018;28(3):306–317. doi: 10.1080/09581596.2018.1443203.
    1. MacQueen KM, Bhan A, Frohlich J, Holzer J. Sugarman J, the ethics working group of the HIVPTN. Eval Community Engage Global Health Res. 2015;16:44.
    1. Tindana PO, Singh JA, Tracy CS, Upshur REG, Daar AS, Singer PA, et al. Grand challenges in Global Health: community engagement in research in developing countries. PLoS Med. 2007;4(9):e273. doi: 10.1371/journal.pmed.0040273.
    1. Holzer JK, Ellis L, Merritt MW. Why we need community engagement in medical research. J Investig Med. 2014;62(6):851–855. doi: 10.1097/JIM.0000000000000097.
    1. Moreno-John G, Gachie A, Fleming CM, Napoles-Springer A, Mutran E, Manson SM, et al. Ethnic minority older adults participating in clinical research: developing trust. J Aging Health. 2004;16(5 Suppl):93s–123s. doi: 10.1177/0898264304268151.
    1. Attree P, French B, Milton B, Povall S, Whitehead M, Popay J. The experience of community engagement for individuals: a rapid review of evidence. Health Soc Care Community. 2011;19(3):250–260. doi: 10.1111/j.1365-2524.2010.00976.x.
    1. McCoy DC, Hall JA, Ridge M. A systematic review of the literature for evidence on health facility committees in low- and middle-income countries. Health Policy Plan. 2012;27(6):449–466. doi: 10.1093/heapol/czr077.
    1. Fregonese F. Community involvement in biomedical research conducted in the global health context; what can be done to make it really matter? BMC Med Ethics. 2018;19(Suppl 1):44. doi: 10.1186/s12910-018-0283-4.
    1. Yarborough M, Edwards K, Espinoza P, Geller G, Sarwal A, Sharp R, et al. Relationships hold the key to trustworthy and productive translational science: recommendations for expanding community engagement in biomedical research. Clin Trans Sci. 2013;6(4):310–313. doi: 10.1111/cts.12022.
    1. Marsh V, Kamuya D, Rowa Y, Gikonyo C, Molyneux S. Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya. Soc Sci Med (1982) 2008;67(5):721–733. doi: 10.1016/j.socscimed.2008.02.007.
    1. Lavery JV, Tinadana PO, Scott TW, Harrington LC, Ramsey JM, Ytuarte-Nuñez C, et al. Towards a framework for community engagement in global health research. Trends Parasitol. 2010;26(6):279–283. doi: 10.1016/j.pt.2010.02.009.
    1. Gikonyo C, Bejon P, Marsh V, Molyneux S. Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Soc Sci Med (1982) 2008;67(5):708–720. doi: 10.1016/j.socscimed.2008.02.003.
    1. UNAIDS/AVAC . Good participatory practice: Guidelines for biomedical HIV prevention trials 2011. 2011.
    1. Kutywayo A, Yah CS, Naidoo NP, Malotana M, Dyani S, Mullick S. Implementing the good participatory practice guidelines in the girls achieve power trial in South Africa. SAGE Open. 2018;8(4):2158244018809149. doi: 10.1177/2158244018809149.
    1. CPTR. Good Participatory Practice Guidelines for TB Drug Trials. Critical Path to TB Drug Regimens 2012. .
    1. Hankins C. Good participatory practice guidelines for trials of emerging (and re-emerging) pathogens that are likely to cause severe outbreaks in the near future and for which few or no medical countermeasures exist (GPP-EP). Geneva: World Health Organization; 2016.
    1. Hannah S, Warren M, Bass E. Global implementation of good participatory practice guidelines for biomedical HIV prevention research: charting progress and setting milestones. Retrovirology. 2012;9(2):P240. doi: 10.1186/1742-4690-9-S2-P240.
    1. Baron D, Essien T, Pato S, Magongo M, Mbandazayo N, Scorgie F, et al. Collateral benefits: how the practical application of Good Participatory Practice can strengthen HIV research in sub-Saharan Africa. J Int AIDS Soc. 2018;21(Suppl Suppl 7):e25175. doi: 10.1002/jia2.25175.
    1. Day S, Blumberg M, Vu T, Zhao Y, Rennie S, Tucker JD. Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence. J Int AIDS Soc. 2018;21 Suppl 7(Suppl Suppl 7):e25174. doi: 10.1002/jia2.25174.
    1. Newman PA, Rubincam C, Slack C, Essack Z, Chakrapani V, Chuang D-M, et al. Towards a science of community stakeholder engagement in biomedical HIV prevention trials: an embedded four-country case study. PLoS One. 2015;10(8):e0135937. doi: 10.1371/journal.pone.0135937.
    1. Mack N, Kirkendale S, Omullo P, Odhiambo J, Ratlhagana M, Masaki M, et al. Implementing good participatory practice guidelines in the FEM-PrEP Preexposure Prophylaxis Trial for HIV Prevention among African Women: A focus on local stakeholder involvement. Open Access J Clin Trials. 2013;5:127. doi: 10.2147/OAJCT.S45717.
    1. Fairhead J, Leach M, Small M. Public engagement with science? Local understandings of a vaccine trial in the GAMBIA. J Biosoc Sci. 2006;38(1):103–116. doi: 10.1017/S0021932005000945.
    1. Marsh VM, Kamuya DM, Mlamba AM, Williams TN, Molyneux SS. Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya. BMC Med Ethics. 2010;11(1):13. doi: 10.1186/1472-6939-11-13.
    1. Statement on the 1st meeting of the IHR Emergency Committee on the 2014 Ebola outbreak in West Africa: World Health Organization; 2014 [Available from: .
    1. Gire SK, Goba A, Andersen KG, Sealfon RSG, Park DJ, Kanneh L, et al. Genomic surveillance elucidates Ebola virus origin and transmission during the 2014 outbreak. Science. 2014;345(6202):1369–1372. doi: 10.1126/science.1259657.
    1. Ebola Situation Report - 30 March 2016: World Health Organization; 2016 [Available from: .
    1. Pandey A, Atkins KE, Medlock J, Wenzel N, Townsend JP, Childs JE, et al. Strategies for containing Ebola in West Africa. Science. 2014;346(6212):991. doi: 10.1126/science.1260612.
    1. Galvani AP, Ndeffo-Mbah ML, Wenzel N, Childs JE. Ebola vaccination: if not now, when? Ann Intern Med. 2014;161(10):749–750. doi: 10.7326/M14-1904.
    1. Frieden TR, Damon I, Bell BP, Kenyon T, Nichol S. Ebola 2014 — new challenges, new global response and responsibility. N Engl J Med. 2014;371(13):1177–1180. doi: 10.1056/NEJMp1409903.
    1. Kamradt-Scott A. WHO’s to blame? The World Health Organization and the 2014 Ebola outbreak in West Africa. Third World Q. 2016;37(3):401–418. doi: 10.1080/01436597.2015.1112232.
    1. Coltart CEM, Lindsey B, Ghinai I, Johnson AM, Heymann DL. The Ebola outbreak, 2013–2016: old lessons for new epidemics. Philos Trans R Soc B. 2017;372:1721.
    1. Thiam S, Delamou A, Camara S, Carter J, Lama EK, Ndiaye B, et al. Challenges in controlling the Ebola outbreak in two prefectures in Guinea: why did communities continue to resist? Pan Afr Med J. 2015;22(Suppl 1):22.
    1. Tiffany A, Dalziel BD, Kagume Njenge H, Johnson G, Nugba Ballah R, James D, et al. Estimating the number of secondary Ebola cases resulting from an unsafe burial and risk factors for transmission during the West Africa Ebola epidemic. PLoS Negl Trop Dis. 2017;11(6):e0005491. doi: 10.1371/journal.pntd.0005491.
    1. Fang LQ, Yang Y, Jiang JF, Yao HW, Kargbo D, Li XL, et al. Transmission dynamics of Ebola virus disease and intervention effectiveness in Sierra Leone. Proc Natl Acad Sci U S A. 2016;113(16):4488–4493. doi: 10.1073/pnas.1518587113.
    1. Enria L, Lees S, Smout E, Mooney T, Tengbeh AF, Leigh B, et al. Power, fairness and trust: understanding and engaging with vaccine trial participants and communities in the setting up the EBOVAC-Salone vaccine trial in Sierra Leone. BMC Public Health. 2016;16:1140. doi: 10.1186/s12889-016-3799-x.
    1. Abramowitz SA, McLean KE, McKune SL, Bardosh KL, Fallah M, Monger J, et al. Community-centered responses to Ebola in urban Liberia: the view from below. PLoS Negl Trop Dis. 2015;9(4):e0003706. doi: 10.1371/journal.pntd.0003706.
    1. Laverack G, Manoncourt E. Key experiences of community engagement and social mobilization in the Ebola response. Glob Health Promot. 2015;23(1):79–82. doi: 10.1177/1757975915606674.
    1. Mooney T, Smout E, Leigh B, Greenwood B, Enria L, Ishola D, et al. EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country. Clin Trials (London, England) 2018;15(5):436. doi: 10.1177/1740774518780678.
    1. Shukarev G, Callendret B, Luhn K, Douoguih M. A two-dose heterologous prime-boost vaccine regimen eliciting sustained immune responses to Ebola Zaire could support a preventive strategy for future outbreaks. Human Vaccin Immun. 2017;13(2):266–270. doi: 10.1080/21645515.2017.1264755.
    1. Larson HJ, Cooper LZ, Eskola J, Katz SL, Ratzan S. Addressing the vaccine confidence gap. Lancet. 2011;378(9790):526–535. doi: 10.1016/S0140-6736(11)60678-8.
    1. Larson HJ, Jarrett C, Eckersberger E, Smith DMD, Paterson P. Understanding vaccine hesitancy around vaccines and vaccination from a global perspective: a systematic review of published literature, 2007–2012. Vaccine. 2014;32(19):2150–2159. doi: 10.1016/j.vaccine.2014.01.081.
    1. Larson HJ. Negotiating vaccine acceptance in an era of reluctance. Human Vaccin Immun. 2013;9(8):1779–1781. doi: 10.4161/hv.25932.
    1. Lancet T. Ebola in West Africa: gaining community trust and confidence. Lancet. 2014;383(9933):1946.
    1. Karamouzian M, Hategekimana C. Ebola treatment and prevention are not the only battles: understanding Ebola-related fear and stigma. Int J Health Policy Manag. 2014;4(1):55–56. doi: 10.15171/ijhpm.2014.128.
    1. Gsell P-S, Camacho A, Kucharski AJ, Watson CH, Bagayoko A, Nadlaou SD, et al. Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report. Lancet Infect Dis. 2017;17(12):1276–1284. doi: 10.1016/S1473-3099(17)30541-8.
    1. Larson HJ, Ghinai I. Lessons from polio eradication. Nature. 2011;473:446. doi: 10.1038/473446a.
    1. Shagi C, Vallely A, Kasindi S, Chiduo B, Desmond N, Soteli S, et al. A model for community representation and participation in HIV prevention trials among women who engage in transactional sex in Africa. AIDS Care. 2008;20(9):1039–1049. doi: 10.1080/09540120701842803.
    1. Tengbeh AF, Enria L, Smout E, Mooney T, Callaghan M, Ishola D, et al. “We are the heroes because we are ready to die for this country”: Participants’ decision-making and grounded ethics in an Ebola vaccine clinical trial. Soc Sci Med. 2018;203:35–42. doi: 10.1016/j.socscimed.2018.03.008.
    1. NIAID . Ebola: New Trial Launched in West Africa to Evaluate Three Vaccination Strategies: NIH: National Institute of Allergy and Infectious Diseases. 2017.
    1. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13(1):117. doi: 10.1186/1471-2288-13-117.
    1. Jalloh M, Graeff J, Jalloh S. Marklate (‘Vaccinate’): The Communication Initiative Network. 2004.
    1. MacQueen KM, Eley NT, Frick M, Hamilton C. Using theory of change frameworks to develop evaluation strategies for research engagement: results of a pre-pilot study. J Int AIDS Soc. 2018;21(Suppl 7):e25181. doi: 10.1002/jia2.25181.
    1. Okello G, Jones C, Bonareri M, Ndegwa SN, Mcharo C, Kengo J, et al. Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya. Trials. 2013;14(1):142. doi: 10.1186/1745-6215-14-142.
    1. Molyneux S, Bull S. Consent and community engagement in diverse research contexts: reviewing and developing research and practice: participants in the community engagement and consent workshop, Kilifi, Kenya, march 2011. J Empir Res Human Res Ethics. 2013;8(4):1–18. doi: 10.1525/jer.2013.8.4.1.

Source: PubMed

3
購読する