Bridging the divide: A mixed methods study of the multilevel challenges and driving factors influencing the likelihood of clinical trial participation among individuals of African descent

Abstract

Background: Clinical trial participation is pivotal to medical advancement, the improvement of health outcomes, and the reduction of health inequities. However, research has highlighted notable gaps in clinical trial participation across racial and ethnic groups. This study aims to disclose the challenges and driving factors associated with the self-reported likelihood of clinical trial participation for African Americans residing in metropolitan Atlanta, Georgia.

Methods: The Health Equity Framework guided this phenomenological concurrent mixed methods study. Purposive and snowball sampling were utilized for recruitment with African Americans intentionally oversampled to fulfill the study’s objectives. Recruitment methods included advertisements through social media, emails, flyers, and participation in community meetings and events. Quantitative data was collected through electronic surveys (n=145) while qualitative data was collected through semi-structured interviews (n=12). Quantitative data was analyzed via bivariate and multivariate methods. Statistical significance was assigned at a p-value of 0.05. Content and thematic analysis were completed for qualitative data. Quantitative and qualitative study results were evaluated for convergence.

Results: Chi-square analysis revealed statistically significant associations between race and two challenges: interference with work commitments (p-value=<.001) and the identification of no perceived barriers to clinical trial participation (p-value=.020). Fisher’s analysis also revealed a statistically significant association between race and the inability to obtain childcare. Two driving factors revealed statistically significant associations with race via Fisher’s analysis: full financial coverage for treatment (p-value=.020) and childcare while participating in the clinical trial (p-value=.049). In addition, Spearman analysis revealed moderate, statistically significant positive associations between the likelihood of clinical trial participation and three driving factors: altruism, receiving a new treatment for a medical condition before it is available to the general public, and the proposed treatment being more effective than the standard approach (all p-values <.001). Mann-Whitney analysis revealed small differences in the likelihood of clinical trial participation levels for race and gender, and larger differences for residence in the city of Atlanta, Georgia; identification as married or widowed; and the presence of health insurance via mean rank comparison. Mann-Whitney analysis also revealed statistically significant differences between the likelihood of clinical trial participation and four Health Equity Framework variables: clinical trial awareness (p-value=.011), previous clinical trial participation (p-value=<.001), previous experience in a clinical trial (p-value=.003), and presence of a primary care physician or nurse practitioner (p-value=.008). Kruskal-Wallis analysis revealed that the likelihood of clinical trial participation differed across study participants according to their perceptions of whether local, state, and federal policies provide them with the adequate resources needed to be healthy (p-value=.011). Multiple linear regression analysis utilizing race and all statistically significant clinical trial participation challenges and driving factors revealed a statistically significant model (p-value=<.001) with the identification of no perceived barriers to clinical participation (p-value=.027), receiving a new treatment for a medical condition before it is available to the general public (p-value=<.001), and clinical trial treatment being fully covered (p-value=.016) reported as statistically significant, positive predictors regarding the likelihood of clinical trial participation. Conclusion: The clinical trial participation decision-making process is a multifaceted process shaped by structural, individual, social, and physiological factors. This study’s quantitative and qualitative findings identify key perceptual and experiential determinants impacting the likelihood of clinical trial participation for residents of metropolitan Atlanta, Georgia. Study findings, coupled with published literature, further generated 5 actionable recommendations to increase clinical trial participation in the African American population and advance health equity.