Developing a Gap Analysis tool to improve Ebola vaccine acceptance and compliance in sub-Saharan Africa

The Ebola outbreak that began in West Africa in 2014 was unprecedented. Between January 2014 and January 2016, 28,616 confirmed, probable and suspected cases, including 11,310 deaths, were reported in Guinea, Liberia and Sierra Leone. The outbreak devastated affected populations and caused considerable disruption across the region. As of 26 December 2019, in the onging outbreak in the Democratic Republic of Congo (DRC), 3,366 cases (3,248 confirmed and 118 probable), including 2,227 deaths, had been recorded. The outbreak in DRC puts neighbouring countries including Uganda, Rwanda, Burundi and South Sudan on high alert should the outbreak spill over their borders.

Considerable progress has been made in relation to Ebola vaccines since 2014, and as of February 2020 a number of countries have licenced their use. However, experience has shown that, when a country does decide to deploy an Ebola vaccine, exceptional levels of demand-side (community-level) preparedness are key to ensuring its success. Reluctance and refusal are issues with all vaccines, but for an Ebola vaccine this is likely to be especially sensitive due to the fear and stigma surrounding the disease itself, alongside mistrust of government, local stakeholders and international organisations that oꢀen play a significant role in the deployment of Ebola vaccines. Effective communication and community engagement to inform, interact and create a dialogue with target populations could be the difference between high vaccine confidence, uptake and compliance and heightened vaccine concerns and mistrust, low uptake and compliance and even boycotts.

The World Health Organization (WHO)’s Global Ebola Vaccine Implementation Team (GEVIT) Practical Guidance on the Use of Ebola Vaccine in an outbreak response excels in providing guidance on supply-side preparedness for deployment. However, it doesn’t cover demand-side readiness well, and thus does not enable governments or implementers to systematically assess their own readiness to deploy.

In response to this need, the Ebola Vaccine Deployment, Acceptance and Compliance (EBODAC) Consortium The EBODAC Consortium (comprising the London School of Hygiene and Tropical Medicine, Janssen Pharmaceutical, World Vision Ireland and Grameen Foundation) was formed at the height of the Ebola outbreak in West Africa as part of Ebola vaccine development efforts, and in recognition of the complex social and cultural hurdles preventing Ebola vaccine acceptance and uptake. has developed the Ebola Vaccine Communication, Community Engagement and Compliance Management (3C) Gap Analysis Tool to complement the guidance provided by GEVIT, and to enable governments, in conjunction with other stakeholders, to assess their preparedness to deploy an Ebola vaccine from a demand-side perspective. How the tool was developed Development of the Ebola Vaccine 3C Gap Analysis Tool followed a consultative co-design process involving literature review, expert consultations and simulation exercises.

Literature review

The EBODAC Gap Analysis researchers The Gap Analysis Team consisted of World Vision Research Associates based in Sierra Leone, Uganda and Senegal. conducted a literature review examining global research, best practice, community engagement and compliance management in the context of the introduction of new vaccines; emergency vaccination programmes; and Ebola clinical trials and community-based responses. The review identified commonly used structures and layouts and the most frequent readiness themes, which were used to draft core components of vaccine deployment preparedness for assessment in the 3C Tool.

Co-production and expert consultation

The EBODAC team chose an iterative process of user-centric co-design in the development of the tool, specifically targeting on-the-ground experts with first-hand experience of Ebola outbreaks and responses, vaccine trials and community engagement.

The researchers worked in close collaboration with the ministries of health in Sierra Leone, Senegal and Uganda. Multidisciplinary Project Steering Committees (PSCs) were set up in each country to feed in knowledge and experience, but also because their early buy-in and feedback on user preference was vital to ensuring the tool’s acceptance and use once completed. Two-day co-production ‘jam’ events (CPJs) were held in each country in November 2018 to bring together experts, innovators, policy-makers, NGOs, community leaders and intended endusers. The CPJs and expert consultations confirmed the findings of the literature review, generated new ideas and potential solutions and flagged user preferences in the design of the tool. The research team synthesised the data gathered to produce key thematic areas for vaccine deployment preparedness to feed into a draft version of the tool.

Simulation

Key members of the health ministries in Sierra Leone, Senegal and Uganda took part in a two-day guided simulation of the use of the draft tool in September 2019. Quantitative and qualitative data captured during these events was reviewed, analysed and interpreted alongside other feedback, and incorporated into the final design.

What is the Ebola Vaccine 3C Gap Analysis Tool?

The EBODAC Gap Analysis Tool outlines potential or desired performance in communication, community engagement and compliance management. It is intended to enable a country to assess its readiness to deploy an Ebola vaccine in both non-emergency and emergency scenarios. It helps users measure their current performance against these bench-marks through a checklist and scoring system. Users can then create specific action plans or set performance targets to ‘fill the gaps’ or reach the desired end-goal. The tool has four modules:

• Module 1: Strategic 3C activities
• Module 2: Operational 3C activities
• Module 3: Integration of 3C best practices and guidelines
• Module 4: Supportive and enabling environment for 3C

Each module is broken down into three parts:

• Gap identification and scoring, which assesses readiness to implement 3C activities as countries plan for or are in the process of deploying an Ebola vaccine.
• A Prioritization Framework, which allows users to rank thematic and item-level gaps in preparedness.
• Action Planning, which allows users to analyse gaps, propose solutions and assign responsibility and timelines for putting new measures in place.

Using the Gap Analysis Tool for Ebola vaccine deployment preparedness in Uganda

A two-day simulation exercise on using the Gap Analysis Tool for Ebola vaccine deployment preparedness took place in Uganda in September 2019, involving government health officials, UN agencies, academics, NGOs and the private sector. The first day focused on using the Gap Analysis Tool to conduct an Ebola vaccine deployment preparedness assessment and gap prioritisation and action planning. On the second day, participants provided feedback to guide the EBODAC consortium in the future development of the tool.

After testing the Gap Analysis Tool, users recommended development of a shorter tool for use in emergencies or by response managers who may not have sufficient time to complete the long tool. This has since been developed and utilised to guide community engagement for the vaccine trial in the DRC. The simulation exercise identified several preparedness gaps that need to be addressed before any decision is taken to deploy an Ebola vaccine in Uganda.

Preparedness for Ebola vaccination compliance management

Vaccine compliance management concerns the systems and processes that ensure that the people targeted for vaccination actually receive it and, in the case of prime-boost vaccine regimens, that the right person receives the right vaccine at the right time. In Uganda, it was found that systems for identifying and targeting population groups to be vaccinated were inadequate, and that no system was in place for monitoring population vaccination data. The EBODAC consortium is working with the Ugandan MoH to develop and maintain a database of priority groups to be line-listed for vaccination, as well as putting procedures in place for monitoring who has and has not received the vaccine.

Preparedness for gender and vulnerable groups

The simulation exercise also revealed a lack of specific attention to gender, family and vulnerable group dynamics in Uganda’s current guidelines for Ebola responses. Anecdotal evidence from clinical trials in Sierra Leone points to the impact of gender inequality on vaccine trials; for example, some women were unable to participate in the trial when their husband refused to allow them to take necessary family planning measures. Teenage pregnancies were also an issue, especially in relation to disclosure as parents are required to be present for the consent process. EBODAC will be supporting technical reviews of Uganda’s preparedness plans with a specific focus on addressing best practices in addressing gender, family norms, inter-spousal relations and family decision-making in communication, community engagement and compliance management plans. Attention will also be paid to identifying most vulnerable populations, including those living below the poverty line, elderly people, the disabled, migrants, refugees and other marginalised groups, to ensure that vaccine deployment guidelines take into account their specific needs.

Preparedness for messaging on an Ebola vaccine

Experience has shown that addressing community-level concerns and countering the misinformation and rumours that so often surround an Ebola response is an essential element in successful vaccine deployments. Although Uganda has previous experience of combating Ebola, it does not have a central repository of approved messaging from previous responses to guide frontline health workers and other key stakeholders in their engagement with communities.

EBODAC has accrued extensive experience over the past four years in effective messaging to promote vaccine uptake, both in clinical trials and mass vaccine deployments. Technical reviews are under way of Ugandan MoH manuals for community and stakeholder engagement, mass public communication and interpersonal communication to ensure that key decisionmakers can identify appropriate channels and audiences for messaging, and that frontline staff have relevant guidance on effective messaging when engaging with individuals and communities targeted for vaccination.

Community-based qualitative research on attitudes towards Ebola vaccines is planned for this year in six study sites across Uganda. This will explore perceptions, beliefs and attitudes towards Ebola vaccines among different population groups, and will provide baseline information for developing contextspecific messages.

Conclusion

The tool is also available online at www.worldvision.ie. A shortened version has been piloted in collaboration with key stakeholders in the current Ebola outbreak response in the DRC. The initial results of this pilot have been used to generate a targeted communication and community engagement strategy to support a large-scale clinical trial of the Ad26.ZEBOV, MVA-BNFilo vaccine in Goma. A country-wide assessment of DRC’s general preparedness to deploy Ebola vaccines is planned for 2020.

A digital version of the Gap Analysis Tool is in development and will be completed in 2020. This will allow users to sign in to a country-specific dashboard and complete the tool online, while simultaneously providing real-time analytical feedback on 3C preparedness in an intuitive and user-friendly format.

Edward Kumakech works with World Vision Ireland as a Research Associate supporting the EBODAC Project. Maurice Sadlier is Programmes Director with World Vision Ireland and a member of the EBODAC Steering Committee. Aidan Sinnott is Programmes Officer – Development Programmes with World Vision Ireland. Dan Irvine is Senior Director, Health and Nutrition, with World Vision International.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement EBOVAC1 (grant nr. 115854), EBOVAC2 (grant nr. 115861), EBOMAN (grant nr. 115850) and EBODAC (grant nr. 115847). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.