Community Engagement Before Initiation of Typhoid Conjugate Vaccine Trial in Schools in Two Urban Townships in Blantyre, Malawi: Experience and Lessons.

BACKGROUND: To determine the efficacy of a new typhoid conjugate vaccine in an endemic setting in sub-Saharan Africa, the Typhoid Vaccine Acceleration Consortium is conducting a phase-3 randomized controlled trial in Blantyre, Malawi. This article describes community and stakeholder engagement activities before and during the trial, challenges, and lessons learned. METHODS: In October 2017, Malawi-Liverpool Wellcome Trust (MLW) organized a wide range of community engagement activities, including meetings with Ministry of Health and Education officials at the district and facility level, local community leadership, and parent teacher association groups. We engaged media outlets to include local and international television, radio, and print media. Community members were informed directly through a study jingle played via loudspeaker from a van and by community-based activities.To review engagement activity effectiveness: The MLW team met to discuss progress and challenges; and a focus group discussion (FGD), consisting of trial staff, sought feedback from the community on each engagement modality. RESULTS: The school-based vaccine campaign increased community participation exceeding recruitment targets to date (on average, >200 children/day). CONCLUSIONS: The FGD concluded that the van and local activities improved awareness and turnout for the trial, but prior engagement with local government and community leadership is an essential mechanism to provide details of the study, answer questions, communicate the value of the study, and address safety concerns. Effective community engagement is essential in a large intervention trial. Multiple channels of communication are required to reach the community and deliver information needed for participation and provide opportunity for dialogue with the trial team.

Questionnaires for Lung Health in Africa across the Life Course.

Respiratory infections remain a leading cause of morbidity and mortality in many low and middle-income countries but non-communicable disease rates are rising fast. Prevalence studies have been primarily symptom-focused, with tools developed in countries in the Global North such as the United States and the United Kingdom. Systematic study in sub-Saharan African populations is necessary to accurately reflect disease risk factors present in these populations. We present tools for such studies, developed as part of the International Multidisciplinary Programme to Address Lung Health and TB in Africa ('IMPALA'), which includes lay representatives. At a preliminary meeting, the adequacy and suitability of existing tools was discussed and a new questionnaire set proposed. Individual questionnaires were developed, and an expert panel considered content and criterion validity. Questionnaires underwent a cross-cultural adaptation process, incorporating translation and contextual 'sense-checking', through the use of pre-established lay focus groups in Malawi, before consensus-approval by project collaborators. The complete set of research questionnaires, providing information on lung health symptoms and a relevant range of potential risk factors for lung disease, is now available online. In developing the tools, cultural and contextual insights were important, as were translational considerations. The process benefitted from a foundation in expert knowledge, starting with validated tools and internationally respected research groups, and from a coordinated collaborative approach. We present and discuss a newly devised, contextually appropriate set of questionnaires for non-communicable lung disease research in Africa that are now available in open access for all to use.

'We are the eyes and ears of researchers and community': Understanding the role of community advisory groups in representing researchers and communities in Malawi.

Community engagement to protect and empower participating individuals and communities is an ethical requirement in research. There is however limited evidence on effectiveness or relevance of some of the approaches used to improve ethical practice. We conducted a study to understand the rationale, relevance and benefits of community engagement in health research. This paper draws from this wider study and focuses on factors that shaped Community Advisory Group (CAG) members' selection processes and functions in Malawi. A qualitative research design was used; two participatory workshops were conducted with CAG members to understand their roles in research. Workshop findings were triangulated with insights from ethnographic field notes, key informant interviews with stakeholders, focus group discussions with community members and document reviews. Data were coded manually and thematic content analysis was used to identify main issues. Results have shown that democratic selection of CAG members presented challenges in both urban and rural settings. We also noted that CAG members perceived their role as a form of employment which potentially led to ineffective representation of community interests. We conclude that democratic voting is not enough to ensure effective representation of community's interests of ethical relevance. CAG members' abilities to understand research ethics, identify potential harms to community and communicate feedback to researchers is critical to optimise engagement of lay community and avoid tokenistic engagement.