Although under-represented in HCV-related research studies, this cohort of Black patients living with HCV reported that they would be willing to participate in research if given the opportunity. Patients had greater WTP if they perceived personal and community benefits from their participation and if they felt more knowledgeable and confident in their understanding of research. In our study, perceived barriers, trust in doctors, health literacy, prior participation in research and demographic variables such as age, education level and cirrhosis status were not associated with WTP.
We found variability in WTP depending on the type of research being conducted or the research scenario described. Patients were less willing to participate in research involving randomization of treatment condition or procedures such as biopsies and medical device implants. These results are consistent with another study of Black patients finding high willingness to participate overall with lower willingness to participate in randomized controlled trials of medications. In research conducted with Black breast cancer patients, concerns specific to participation in randomized controlled trials included loss of control over treatment choice and preference for FDA-approved medications, which may explain lower WTP in this type of research. We conducted post hoc analyses to identify factors associated with WTP in research not involving in a randomized controlled trial, but the results were similar to our original findings. Given the importance of increasing the proportion of non-White patients in drug registration trials for HCV and other liver diseases, we conducted additional post hoc analyses to attempt to identify participant characteristics associated with different levels of WTP (low, neutral, high) in randomized controlled trials of medications (Tables S1 & S2). None of the sociodemographic or other attitudinal factors helped to predict different levels of WTP in drug randomized controlled trials. Across all characteristics evaluated, 50%–68% of the cohort reported lower WTP and less than a quarter reported higher WTP in drug randomized controlled trials. Future qualitative studies (interviews, focus groups) are needed to better understand beliefs, attitudes and barriers driving participation specifically in drug trials.
Participants who felt more knowledgeable about research or perceived greater benefits of research participation were more willing to participate in research, and these results are consistent with prior research.[17,38] Our findings are consistent with research identifying misconceptions about clinical trials, which is common across many different populations[39,40] in the United States, not only the Black community.[41–43] While greater than 85% of participants were aware of informed consent procedures and voluntary participation, most participants were unaware that clinical trials often involve random assignment to a treatment or control group, and many participants did not know some clinical trials could utilize placebo controls.
Participants in this study provided valuable recommendations to improve engagement of members of the Black community in research. These included greater community outreach, clear communication about research activities, race concordance with research staff/investigators and increased communication from healthcare providers about research opportunities. When our quantitative results are viewed in the context of participants' recommendations to increase participation, a key driver of racial disparities in research participation may not be patients' WTP but rather a deficit in community-based outreach and education on the part of research sponsors and investigators. Therefore, Black patients may be under-represented in HCV-related research because they may experience greater difficulties accessing healthcare resources[44,45] or are less likely to be approached to participate compared with White people. Prior research has shown, among patients approached to participate, Black patients do not differ from White patients in their WTP in clinical trials. Access to research opportunities within the Black community and structural barriers to health care may, therefore, play a critical role in racial disparities in research participation. Additionally, participants in this study indicated research professionals were not adequately engaging with the Black community in certain locations (eg Black churches, community centres, social media platforms). Since recruitment for health/medical research traditionally occurs in healthcare settings, racial disparities in access to and utilization of healthcare services[44,45] arising from systemic racism may explain under-representation in research. Sponsors and investigators should consider devoting adequate resources to participant recruitment outside of healthcare settings to bolster representation of racial and ethnic minorities in research.
Findings from this study and others have implications for engagement of Black patients in clinical trials and health/medical research broadly. Our findings suggest discussions about the benefits of research participation and strategies to increase patients' confidence in their understanding of research activities could improve WTP. Focus groups with Black breast cancer patients identified variation in knowledge and understanding of cancer clinical trials, and to bridge this gap, patients recommended researchers engage the Black community through assets such as churches and informed community leaders (ie those with prior experience of clinical trials). Participants in the current study echoed similar recommendations. Another study found role-playing and call-and-response sessions aimed at dispelling myths and providing facts about clinical research were educational interventions that increased favourable attitudes about clinical research and WTP. Community engagement activities could build capacity related to knowledge of scientific methods and study designs, so once research opportunities present themselves, people feel more knowledgeable and confident to make an informed decision.
Taken together, community outreach and educational activities could be worthwhile methods to increase knowledge and positive attitudes about clinical research and increase participation. Study sponsors and investigators should, therefore, devote resources to community-based programmes aimed at education and recruitment. Our qualitative findings indicate some participants would prefer to participate in studies led by Black investigators or where they were recruited by Black research staff. Recruitment and retention of racially diverse research teams may improve recruitment of Black research participants. Care should be taken to ensure that race concordance is not used solely as a symbolic gesture, but instead as one aspect of holistic relationship-building based on cultural humility and self-reflection on racism within research settings.
This study is not without limitations. Almost three-fourths of participants in this study had previously participated in at least one observational study, and these patients may have a more positive view of research participation compared with patients who have never participated. Our sample included few patients with low WTP scores, and thus, making it difficult to know what barriers exist for those who are not willing to participate in studies. By participating in the current study, patients are at least somewhat willing to participate in health/medical research. Therefore, these findings may not reflect the broader population of Black patients living with HCV nor those who are not engaged in academic hepatology centres, and trust in doctors may be higher in this sample relative to the community at large. However, a strength is that participants were recruited from eight clinical sites across the United States. This study did not collect measures to assess racism and access to research opportunities, so these phenomena could not be studied empirically here. Finally, only Black and African American participants were recruited, so differences in WTP across racial and ethnic groups could not be assessed.
In summary, this study found Black patients with HCV are willing to participate in research depending on the type of research study. Patients are more willing to participate whether they perceive greater benefits of participation or have greater confidence in their understanding of research conduct. Lower WTP in randomized controlled drug trials may limit generalizability of research findings and remains a significant issue for research sponsors and investigators conducting trials of medications for chronic liver disease. Misconceptions or lack of knowledge about randomization procedures, such as treatment and control group assignment, are present and may explain lower WTP in randomized controlled trials. Qualitative findings indicate robust opportunities for research professionals to engage Black community members. Research sponsors and investigators should consider developing or expanding community-based outreach and education activities to improve equitable knowledge of and access to research opportunities for members of the Black community.
CI, Confidence Interval; HCV, hepatitis C virus; WTP, willingness to participate.
This study was funded by Merck, Sharp and Dohme Inc., Kenilworth, NJ, USA. Additional support for this project was funded, in part, by the National Center for Advancing Translational Sciences (NCATS) for the North Carolina Translational and Clinical Sciences Institute through Grant Award Number UL1TR002489.
The authors would like to thank the UNC HCV Patient Engagement Group for their assistance with survey item selection. We would also like to thank Dr. Adrian M. Di Bisceglie at St. Louis University, St. Louis, MO for assistance with recruitment. We appreciate Dr. Paul Stewart for his consultation with statistical methodology for this study.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
J Viral Hepat. 2021;28(7):982-993. © 2021 Blackwell Publishing