Inclusive community engagement in infectious disease clinical trials in South Africa (The Engaged Trials project)

The Engaged Trials Project aims to enhance community engagement in clinical trials in South Africa (SA). South Africa has a disproportionate burden of infectious diseases, like HIV/AIDS and tuberculosis. Clinical trials are crucial for developing effective prevention and treatment strategies to combat these diseases and reduce their impact on people’s health. However, successful trials require not only scientific rigor but also effective community engagement to build trust, collaboration, and relevance. Community engagement is a priority for the United Nation’s Sustainable Development Goals (SDGs), particularly those related to health and well-being (Goal 3), reducing inequalities (Goal 10), and fostering partnerships (Goal 17). Yet, inadequate community engagement in trials often leads to low participation rates, delays in trial completion, and mismatches between trial outcomes and community priorities. To address these challenges, the Engaged Trials project draws on insights from the “Strengthening Community Engagement in TB and HIV Vaccine Trials in South Africa” (CETH) project. The CETH project identified barriers, facilitators, and strategies for effective community engagement. Building on the foundation laid by the CETH project, the Engaged Trials project aims to explore the feasibility of a community engagement intervention and test its implementation at two International AIDS Vaccine Initiative (IAVI) partnering sites in South Africa. The project will collaborate closely with local community members and trial staff to co-design, implement, assess, and learn from a contextualised community engagement intervention. By applying a mixed-methods approach underpinned by human-centered design, implementation research, and integrated knowledge translation, the project aims to ensure that community engagement practices are inclusive, ethical, culturally sensitive, and contextually relevant. This innovative approach will not only enhance the quality and reliability of trial data but also foster trust, collaboration, and empowerment within trial sites and surrounding communities. By prioritising community engagement, the Engaged Trials project has the potential to revolutionise clinical trial practices in SSA, ultimately improving health outcomes and contributing to the achievement of the SDGs. Through collaborative efforts and inclusive practices, the project aims to set a new standard for community engagement in clinical trials, with far-reaching implications for global health research, society, and partnerships.