Evidence-informed trial recruitment planning: an integrative review of infectious disease trials in Africa

Persistent recruitment and retention challenges undermine trial feasibility, particularly in infectious disease trials. While regulatory frameworks like ICH-GCP and WHO-GCP emphasize ethical trial conduct, they provide limited operational guidance. This integrative review aimed to establish a baseline of the practical guidance available for planning clinical trial recruitment in infectious disease trials in Africa. We conducted an integrative review to examine trial recruitment across four framework levels: macro (contextual and systemic factors), trial sponsor, site investigator, and individual participants. Searches included peer-reviewed and grey literature. Data were extracted and coded using both deductive (framework-guided) and inductive (theme-emergent) approaches to identify alignment and gaps. The searches returned a total of 1091 documents, of which 60 were included; predominantly, these were peer-reviewed articles focused on HIV and Ebola. At the macro level, studies emphasized community engagement but rarely addressed broader policy environments, such as national regulatory systems or donor-driven priorities. Sponsor-level findings highlighted communication strategies, ethical tensions in trial design, and the importance of community advisory structures, though practical project management approaches were largely absent. At the investigator level, the literature stressed the need to tailor communication to local language, literacy, and cultural norms, and to strengthen local ethics review and infrastructure. At the individual level, personal motivations, psychosocial beliefs, and health literacy strongly shaped willingness to participate, but gaps remained in understanding, negotiating autonomy, and using resilience strategies. Across all levels, “how-to” recruitment guidance was minimal, with few CRO or NGO documents providing operational recruitment strategies. The integrative review demonstrates a lack of practical operational guidance to support recruitment planning in low-resource settings. Templates and tools to fill this gap are needed to provide structured, actionable guidance that aligns with existing evidence. Future research and investment in trial recruiting tools and processes would be beneficial. This protocol was registered in Open Science Framework (OSF) Registries. Cevasco, K., & Pyche, C. (2025, May 14). Trials Recruiting Plan Template Evaluation. Retrieved from osf.io/uhncs.