Factors affecting willingness to participate in hepatitis B clinical trials among diverse U.S. populations: mitigating missed opportunities

Objective Including diverse participants in hepatitis B clinical trials is important for accurately evaluating the safety and effectiveness of new therapies. However, certain populations are underrepresented in clinical trials. Lack of trial awareness and use of inappropriate communication channels are barriers to participation among people living with hepatitis B (PLWHB). This study aimed to identify factors influencing willingness to participate in clinical trials among PLWHB of Asian, African, and Pacific Islander descent. Methods This qualitative study involved 10 ethnically and racially diverse U.S. communities, representing populations impacted by the disease. In total, 36 individuals (PLWHB, ≥18 years old) participated in this study, with 30 participating in focus groups and six participating in interviews. Communities included Somali, West African, Black, White, Chinese, Filipino, Korean, Vietnamese, Chuukese and Marshallese. Focus groups and semi-structured interviews were conducted in participants’ preferred language. Data were analyzed using inductive content analysis. Results Barriers were identified and categorized into the Socio-Ecological Model of Health’s institutional, cultural, interpersonal, and individual-level themes. Institutional factors included researchers’ qualifications, physician trust, and access to supportive services. Cultural factors surrounded the roles of respect, distrust, and community involvement. Altruism and familial influences constituted the interpersonal level. Individual factors included anticipated treatment outcomes, knowledge gaps, and time constraints. Conclusion Challenges to clinical trial participation faced by PLWHB are multifaceted but can be effectively addressed through coordinated, multilevel approaches. Intersectional strategies can improve patient-centricity in clinical trials, enhancing participant diversity.