Beyond individual choice: a qualitative study on attitudes and social dynamics shaping pregnant women's participation in clinical trials in Kano, Nigeria

Background: Nigeria's high rates of maternal morbidity and mortality make it a crucial setting for maternal clinical trials. Little is known about how attitudes and social dynamics between communities and the health system shape pregnant women's participation in such trials. This study explores these attitudes and social dynamics from the perspectives of women, their families, community leaders, health workers and policy-makers in Kano, Nigeria. Methods: We conducted a qualitative study across 12 public health facilities at the primary, secondary and tertiary levels. We conducted 31 in-depth interviews with previous maternal health clinical trial participants, health workers and policy makers. We also held 11 focus group discussions with research naive pregnant women, family and community members, and community health extension workers. Data were collaboratively analysed by the research team using reflexive thematic analysis. Results: The participation of pregnant women in clinical trials was viewed by all participants as a strategy to mitigate pregnancy-related risks and adverse outcomes. Within social networks, women helped each other allay concerns about the likelihood and severity of participation-related harms through observation and discussion of positive experiences. Decision-making regarding participation was influenced by household gender dynamics, with husbands providing permission and financial support. Incentives for participation were valued, and when in monetary form, helped overcome some financial barriers such as transportation costs. Establishing and leveraging trust in health workers was key to successful recruitment and retention. Mechanisms for establishing trust were relational and included clear communication, respectful care and collaboration through a shared commitment to the participant's health. As pivotal gatekeepers, health workers' attitudes to clinical trial participation were shaped by their understanding of intervention efficacy and safety, and the potential impact of the trial on maternal health in Nigeria. Conclusions: The participation of pregnant women in clinical trials in Kano, Nigeria, is shaped by intersecting social, cultural and economic factors. Collective decision-making, shaped by gender roles and social networks is critical to determining participation. Trust in health workers and positive experiences help alleviate concerns about participation-related harms. Strengthening local capacity and tailoring research processes to ensure cultural safety are essential for enhancing the conduct of maternal health trials.