The Irish Forum for Global Health, November 6th 2018 Sheila Garry Clinical trials in outbreak settings – learnings from the EBODAC project in Sierra Leone The Irish Forum for Global Health, November 6th 2018 Sheila Garry

What is EBODAC ? EBODAC is a consortium of partners supporting communications, community engagement and enabling technologies for the EBOVAC- Salone vaccine trial. EBOVAC is investigating the safety and immunogenicity of a candidate prime-boost Ebola vaccine in Kambia District in Sierra Leone The EBODAC project supports the EBOVAC and PREVAC clinical trial programmes, ensuring vaccine acceptance and compliance. EBODAC consortium: World Vision Ireland, London School of Hygiene and Tropical Medicine, Janssen Pharmaceutica and Grameen Foundation.

Background 2014/16 unprecedented ; outbreak of Ebola Virus Disease in Sierra Leone, Guinea and Liberia – 11,300 lives lost No vaccines or drugs available Rapid mobilisation in outbreak context to establish clinical trials , presenting many ethical, scientific and logistical challenges Risk – that sensitivities and realities of trial participants and communities could be neglected. Focus of presentation: EBODAC project - learnings from its community engagement.

Clinical trials in an outbreak setting - Ethical Challenges Research priority setting Prioritisation of participants ……with epidemic as a backdrop. Household lottery system used by EBOVAC to schedule visits and invitations to participate Informed consent –ensure people understand….. Perception of risk vs benefit? Community involvement – recognising the social context of clinical trials

Social, cultural and political context. Recognise the important role of social scientists – establish rapid anthropological aspects Critical to establish mutual understanding of agendas, expectations, procedures and priorities in decisions to conduct a trial in a particular community ‘Community’ is not a homogenous entity. Don’t assume communities are fearful of clinical research! Explain roles, link to community engagement workers.

Community engagement in practice – learning from EBODAC Getting started………….. Vital to work through national authorities – formal ethical and regulatory bodies. Engagement with community is critical in any prospective trial site Don’t approach communities with a pre-determined trial protocol (even in emergency context)

Trials and interventions – very different messaging Community exposure to development research Vs medical research Development processes = expectations. Questions = projects Development – can have a broader focus. Medical = very specific.

Addressing rumour Actions Rapid Social anthropological studies to establish likely points of confusion Communications strategy should be cognisant of : Emergencies and outbreaks – public fear and anxiety Rumours around how disease spreads…..protection that works……possible cures Vital to keep track - Deploy social scientists on a daily mission in the community to collect possible rumours however small they may be Monitoring of media Early brainstorming sessions to identify possible points of confusion Develop clear, simple responses to anticipated concerns and start addressing them from the source

Enabling technology Minimise person to person contact in outbreak but maximise coverage EBODAC - biometric tools for unique identification of participants Iris scanning and digital fingerprinting MOTECH system provided pre-recorded reminders to participants in their own language. IVR; contextual prevention messaging. Mobile training for front line health workers; no workshops, classrooms Collaboration with MoH and government, local leaders including religious leaders. Community engagement a key to success

Overcoming barriers to using technology Research the area- landscape, phone use Community engagement and sensitisation strategies essential Battery operated biometric kits. Connectivity challenges Robust training for staff. EBODAC using MOTS a mobile training supports tools - interactive training modules in line with local curriculum in local languages. Partnerships with local and international companies

Conclusions Even in outbreak situations it is possible to structure community engagement activities so participants are at heart of research Collaboration between clinical teams, community engagement experts and social scientists is vital Experience allowed for insights into addressing rumours. Can be mitigated by advance sensitisation and clear communication. Enabling technologies work well with vital adjustments re the operating context (e.g. local language use) The EBODAC programme has contributed to preparing communities for future Ebola outbreaks and vaccination strategies. HSS – capacity building, MOTS training GAP analysis