The precarious state of community engagement in African clinical trials: A systematic review of funding, workforce gaps, and the path to institutionalization

Abstract

Community engagement (CE) is an ethical imperative for clinical trials, yet it is often treated as a peripheral activity rather than a core scientific requirement. In light of the Africa CDC's mandate to achieve 60% local vaccine production by 2040, establishing robust community engagement frameworks within African clinical trials is vital. We systematically synthesized evidence on CE approaches, with a focus on funding and sustainability, utilizing the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) checklist. Peer-reviewed research articles on CE in clinical trials across Africa published from January 2000 to February 2026 in English or French were retrieved from eight databases: MEDLINE, EMBASE, CINAHL, Cochrane Library, WHO Afro Library, African Journals Online databases, Scopus, Web of Science, and Global Health, alongside gray literature, reference lists, EDCTP reports, and Africa CDC documents. Study quality was appraised using the Mixed Methods Appraisal Tool (MMAT), and spatial analysis was performed using R with the sf and ggplot2 packages. Thirty studies met the inclusion criteria. Analysis revealed a dependency trap with approximately 90% of clinical trials in sub-Saharan Africa estimated to be funded by external international donors, creating a sustainability gap where essential trial components, such as community engagement and laboratory infrastructure, often dissolve upon the conclusion of a specific grant. We identified three primary typologies: instrumental (recruitment-focused), ethical (compliance-focused), and collaborative (partnership-focused). Findings show that while robust CE correlates with improved recruitment and social value, the reliance on uncompensated community labor and indirect funding models threatens the long-term viability of the African trial ecosystem. Transitioning from extractive CE to institutionalized CE is critical for Africa's vaccine sovereignty, requiring funding models to shift toward direct, ring-fenced budgets to ensure pandemic preparedness and ethical integrity.