Promoting acceptability and participation in the INTEGRATE Lassa fever clinical trial: Exploration of community perceptions through mixed methods research

Introduction: Lassa fever (LF) is endemic in Nigeria, with Ondo and Edo States serving as epicenters of recent outbreaks. The INTEGRATE clinical trial seeks to identify effective treatments for LF. However, trial participation could be hindered by community sociocultural beliefs, misconceptions, or mistrust. This study explored community knowledge, attitudes, and perceptions surrounding LF and clinical trials in Ondo and Edo States, to inform the design and implementation of a culturally responsive community sensitisation strategy to promote acceptability and participation in the clinical trial. Methods: An exploratory mixed methods design was employed across selected communities in both States, engaging 150 purposive sampled community leaders and members. Quantitative data were first collected using a structured questionnaire and analyzed descriptively with SPSS and R software. Qualitative insights were then gathered from a subset of participants to explore sensitive issues through semi structured interviews, and thematically analyzed using MaxQDA. Findings were interpreted within each state’s sociocultural context to ensure their relevance. Results: Participants generally demonstrated good knowledge of Lassa fever (LF); 91% identified eating food contaminated with rat excreta as a risk factor. However, 13%attributed LF to witchcraft and 11% to divine punishment. Belief in spiritual and traditional cures coexisted with confidence in biomedical treatments. Willingness to participate in LF clinical trials was driven by the promise of quality, free care. Some also viewed participation as a way to serve their community. However, concerns around the clinical trial process—such as randomisation, efficacy, and safety—were key barriers. Notably, 77.3%would only participate if clearly informed, and 36% required family approval. Conclusion: These findings highlight the need for context-sensitive communication strategies that address spiritual beliefs, clarify clinical trial processes, and build trust in biomedical care. Tailored sensitisation could dispel misconceptions and enhance trial acceptability, supporting LF treatment advancement in Nigeria and beyond.