Understanding gender dynamics, consent experiences, and community engagement in clinical trials in the context of a Lassa fever vaccine trial in Ghana

Introduction: Clinical trials often overlook social dynamics that influence participant experiences and outcomes. Gender affects research participation, with men and women approaching clinical trials differently due to social, cultural, and personal factors. A recent Phase 1 study in Kintampo districts, Ghana highlighted this challenge, with only one woman among 18 participants consenting to join. Traditional text-based consent may present varying accessibility across participant groups, and alternative approaches like audio-visual methods could enhance understanding. The Lassa vaccine trial (ViTaL02), a Phase 1 study, will evaluate the safety and immunogenicity of ChAdOx1 LassaJ among healthy volunteers. This study provides an opportunity to examine gender dynamics, consent experiences, and community engagement to improve clinical trial implementation through a social science study running concurrently. Methods: This exploratory mixed-methods study examines gender dynamics, consent experiences, and stakeholder engagement within the ViTaL02 trial in the Kintampo districts of Ghana across three phases. Phase 1 assesses existing gender-related factors and evaluates three information delivery methods (textual, audio-visual, combined text-pictorial). Phase 2 explores participant lived experiences. Phase 3 will focus on post-trial analysis and policy implications. Data collection will aim to include 71 in-depth interviews, 6 focus group discussions, 120 information delivery surveys, and 30 participant observations using pragmatic and purposive sampling to ensure gender representation. Results: Submissions for scientific and ethics reviews are imminent in Kintampo Health Research Centre, Ghana and Oxford University, UK. The study is expected to start in the last quarter of 2025. This study will generate insights into gender-specific experiences and evaluate the effectiveness of different consent approaches in the context of the Lassa vaccine trial. Conclusion: This study will inform recommendations for improving participation in clinical trials, community engagement, improving trial design, and developing effective dissemination strategies for policy stakeholders in sub-Saharan Africa and similar settings.