An Exploration of the Intersection of Clinical Trials and Health Literacy: A Scoping Review

This scoping review synthesizes findings from 25 articles examining health literacy (HL) and clinical trials (CTs). Key factors contributing to low HL include poverty, limited education, older age, and limited English proficiency. Three thematic categories emerged: 1) barriers to recruitment and participation, 2) perceptions and comprehension of CT processes, and 3) interventions to improve knowledge and participation. Health literacy was found to influence willingness to participate in CTs, with higher HL associated with greater participation, especially in lower-burden trials. Misconceptions about CTs were prevalent among underserved populations. Interventions such as animated videos and simplified consent forms showed mixed effectiveness. A mapping exercise revealed gaps in existing HL frameworks, including provider bias and lack of target population involvement in trial design. Addressing these gaps through inclusive, culturally responsive strategies may improve comprehension, trust, and participation among underserved populations. Further research is needed to refine and evaluate HL interventions across CT contexts.