The CETH study: strengthening community engagement in TB and HIV vaccine trials in South Africa

The CETH study, led by EDCTP Career Development Fellow Dr Bey-Marrie Schmidt (South Africa), was designed to investigate the multi-level factors influencing community engagement (CE) in infectious disease clinical trials within sub-Saharan Africa. CE is recognised as an ongoing process that encompasses the entire life-cycle of a clinical trial (CT). It necessitates the active involvement of communities through participatory approaches and sustainable partnerships with key stakeholders.

Objectives and methodology

This study aimed to develop a comprehensive framework for enhancing community engagement in infectious disease clinical trials in sub-Saharan Africa. A diverse array of data collection strategies was employed throughout the project to explore the factors that inform CE at various levels. The initial stage comprised a Cochrane qualitative evidence synthesis alongside telephone interviews. In the second stage, qualitative case studies were conducted at two clinical trial sites in South Africa, specifically focusing on HIV and TB. Additionally, collaborative research was undertaken, which included an interactive webinar engaging CE/CT stakeholders on a global scale. Qualitative data analysis techniques were consistently applied throughout the study, with some findings detailed in the article “An unclosed loop: Perspectives of community engagement in infectious disease clinical trials in sub-Saharan Africa” and the project webpage.

Key findings and lessons learned

The study revealed several valuable lessons regarding community engagement. Notably, barriers included the exclusion of communities from the CE and CT dialogue during early research stages and a general lack of solicited community input throughout the research process. Furthermore, it was evident that local contexts and socio-cultural factors shaping CE were frequently overlooked in the planning of CE/CT procedures. On the other hand, facilitators of CE were identified, such as the incorporation of cultural nuances and empowering communities through effective dissemination of information regarding the significance of clinical trials.

Recommendations for enhanced community engagement

A pivotal strategy for improving CE practices in clinical trial research involves the active involvement of various community stakeholders throughout the CT/CE planning process. It is essential to view the community as a multifaceted entity shaped by social, historical, and cultural dimensions. Employing multicomponent, transdisciplinary, and creative/arts-based methods may serve as valuable instruments for fostering sustainable community engagement in research.