Guidance on stakeholder engagement practices to inform the development of area-wide vector control methods.

These recommendations on practices for stakeholder engagement build on the knowledge and experience of practitioners and subject-matter experts from a large variety of fields. They aim to provide teams involved in the development of area-wide vector control methods with guidance on how to design community and stakeholder engagement programmes as part of their development pathway. Area-wide vector control methods are not new in concept [1]. For example, the use of natural predators for biocontrol of agricultural pests or public intervention for the treatment of water bodies with larvicides are current area-wide applications. Thus, new approaches under development—such as those using sterile-male techniques, Wolbachia, or gene drive—can build upon well-established development pathways. These methods offer the benefit of providing vector control for all inhabitants of a specific treated area without individual or group biases related to economic means, level of education, etc. Although this benefit can be a great advantage, multiperson or community-applied interventions may not offer individuals the chance to ‘opt out’ of a home or area receiving the intervention [2]. There may be aspects of the research in which individuals can choose to participate or not (for example, during the collection of mosquitoes or other insects from houses), but the research or technique developed will, at some stage, require the deployment of the tools in selected sites, and residents of those sites may not be able to ‘opt out’ of these phases in the same way that individuals can decline to be part of a vaccine field trial. Therefore, although these methods may differ greatly in scope and impact, the processes for their development and use share commonalities that provide a basis for asserting a broadly applicable framework for engagement. The framework set out below attempts to leverage these commonalities to provide a starting point that may be useful to a very wide variety of projects working in this field while retaining sufficient flexibility to be tailored as appropriate to local circumstances Some methods, such as gene drives and environmentally persistent Wolbachia methods, involve modifications to vector species that could persist and disseminate through a population over time and space. This means that the scale of the human communities affected can be quite large fairly early on in the development process and may persist or increase over time. Thus, testing of area-wide vector control methods does not conform to the familiar clinical trial model employing individual informed consent [3], and a different set of research ethics considerations is required. Trial authorisation by the hosting community and, potentially, peripheral communities that may be affected may be necessary. Therefore, identification of key stakeholders and community representatives is vital, and early and ongoing engagement with them is essential. This type of engagement can enable the sharing of knowledge, experience, and perceptions between the project and its stakeholders to help ensure that the pathways for development respond to the expectations of communities and other stakeholders, that the tools developed are ultimately effective and appropriate and meet the needs and preferences of users and other potential beneficiaries, and that accountability is established for trial outcomes and eventual disease mitigation. The recommendations may serve not only for projects involved in the development of new area-wide vector control methods but also as a benchmark to shape the expectations of a wider range of stakeholders, including project funders, communities, the media, and policy makers and regulators, about what projects will and should deliver. More broadly, shared recommendations can help facilitate the alignment of approaches of different projects and provide a clear pathway for other projects entering the field. These recommendations also describe ways in which projects can engage with stakeholders to meet other requirements for their research, including community acceptance for specific activities or phases of the research that may be necessary for the research to be able to proceed. However, the ability to implement these recommendations hinges on the availability of appropriate funding. Many of the suggested activities and approaches will be resource intensive. Therefore, funders are encouraged to make adequate supplies available for stakeholder engagement at every stage of the development process.