Späth, CarmenSchmidt, Bey-Marrié2026-07-062026-07-062026Späth, C. and Schmidt, B.M., 2026. A qualitative study on community engagement at two clinical trial sites in South Africa. Discover Social Science and Health.10.1007/s44155-026-00419-1https://hdl.handle.net/10566/24842Background: Community engagement (CE) and building collaborative relationships with stakeholders is an ethical imperative for public health research. Understanding the pathways to effective CE through reviewing barriers, facilitators and strategies, can inform the conceptualisation of strategies that foster beneficial collaboration between clinical trial (CT) staff and communities. The aim of this qualitative case study was to identify and describe the factors affecting CE at two infectious disease CT sites in South Africa (SSA), from the perspectives of various CE stakeholders. Methods: We purposively selected two case studies in the Western Cape Province (South Africa), with a total of 17 participants. Case study 1 (TB trial site) had 4 CT staff/community advisory board members (CABs) who were individually interviewed (Zoom), including a senior research officer/principal investigator, a research officer, a CAB coordinator/researcher and a site manager. A further 4 CAB members were part of two in-person group interviews. Case study 2 (HIV trial site) entailed two in-person group interviews and four individual interviews, and participants included a community liaison officer, fieldworkers, CAB members, a clinical research worker and a doctor. Thematic analysis was used to generate themes and findings. Results: From Case study 1 it was evident that staff viewed CE as outreach, with successful activities having been implemented; staff positioned CABs as responsible for CE and its challenges; and there was an overlap between roles of CT staff/CABs (leading to role-confusion). Case study 2 revealed that CABs were allies to CT staff and that the selection of CABs were tied to those individuals who could encourage access to participants and who are respected by communities; staff mentioned that approaching communities in a considerate manner aided effective CE. Moreover, at both sites, it appeared to be necessary to improve CE strategies through trial literacy, collaboration and reduced role-confusion. Conclusion: Approaching communities considerately, building connections among staff/CABs and addressing role-confusion are some factors affecting CE in CT research. CE and relevant roles should be clearly defined. Efforts to support effective CE in CT research depend on approaching communities in respectful and culturally appropriate ways.enCase studyClinical trialsCommunity engagementArticle