Willingness to Participate in Research Among Black Patients With Liver Disease

A National Cross-sectional Study

F. Hunter McGuire; Kat André; Minyone L. Bradsher; Dawn Harrison; Richard K. Sterling; K. Rajender Reddy; Marina Serper; Carol E. Golin; Nancy Reau; Joseph K. Lim; David R. Nelson; Souvik Sarkar; Donna M. Evon


J Viral Hepat. 2021;28(7):982-993. 

In This Article

Abstract and Introduction


In the United States, Black people are disproportionately diagnosed with hepatitis C virus (HCV) compared with White people but are under-represented in HCV studies. In this US-based cross-sectional telephone survey study, we assessed willingness to participate (WTP) in health/medical research and attitudes and beliefs that may influence WTP among Black patients with HCV. Two hundred participants who had current or prior HCV diagnosis and self-identified as Black or African American were recruited from a national HCV cohort study and an outpatient hepatology clinic. WTP responses ranged from 1 (not at all willing) to 5 (very willing). Multivariable models were used to identify factors associated with the overall mean WTP score. In addition, an open-ended question solicited strategies to help increase research participation from the Black community. Overall, participants reported moderate WTP in research (Mean [95% Confidence Interval (CI)] = 3.78 [3.68, 3.88]). Of 13 types of research presented, participants reported lowest WTP for randomized controlled trials of medications (Mean [95% CI] = 2.31 [2.11, 2.50]). The initial multivariable model identified higher subjective knowledge of research as positively associated with WTP (Parameter estimate [95% CI] = 0.15 [0.02, 0.27]). Sensitivity analyses also identified higher perceived benefits of research as an additional factor associated with WTP. Qualitative findings indicate that greater community-based outreach efforts would increase accessibility of research opportunities. When given the opportunity to participate, Black participants with HCV reported moderate WTP in health/medical research. Research sponsors and investigators should employ community-based outreach to expand access and awareness of research opportunities.


Black people living in the United States are disproportionately diagnosed with hepatitis C virus (HCV) compared with White people.[1] Since 2011, direct-acting antiviral regimens have improved treatment efficacy and reduced treatment-related adverse events for patients with HCV.[2–12] Despite comprising 23% of the HCV-diagnosed population,[13] Black patients made up only 2%–22% of patients enrolled in pharmaceutical industry-sponsored clinical trials of HCV direct-acting antivirals.[2–12] Low levels of participation in HCV-related health and biomedical research can make it difficult to generalize efficacy, safety and other study findings to Black people living with HCV.[14]

Across a variety of health conditions, most prior research on racial disparities in research participation has focused on understanding willingness to participate (WTP) in health/medical research studies; however, the degree to which WTP drives actual research participation has been challenged.[15] Prior studies have found that negative attitudes towards research,[16,17] perceived health risks,[18,19] lack of knowledge about research conduct,[17,20,21] health literacy[19,22,23] and lack of trust in doctors[16,20,24] may play a role in determining WTP in research. Lack of trust in doctors conducting research stems from historical abuses and community trauma, such as the Tuskegee syphilis study.[20] Additional factors beyond WTP, including systemic racism, proximity to medical centres, and access to health care, limit access to and availability of research opportunities for Black people.[15]

No prior research has been conducted with Black individuals with liver disease to understand attitudes and perceptions related to participation in health/medical research. This knowledge could enhance ways to incorporate the patient's voices into drug development and pharmaceutical industry-sponsored clinical trials.[25] Using a national cohort of patients with current or prior HCV infection who self-identified as Black or African American, this mixed-methods study aimed to (1) evaluate WTP in various types of research; (2) assess attitudes, perceptions and other factors potentially associated with WTP in research; (3) identify factors associated with WTP in research; and (4) elicit feedback on strategies to increase Black patients participation in research.