Development of “Advancing People of Color in Clinical Trials Now!”: Web-Based Randomized Controlled Trial Protocol

Abstract

Background Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of “Advancing People of Color in Clinical Trials Now!” (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. Objective This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. Methods ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. Results We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. Conclusions ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. Trial Registration ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401 International Registered Report Identifier (IRRID) DERR1-10.2196/17589

Reporting of Participant Race and Ethnicity in Published US Pediatric Clinical Trials From 2011 to 2020

“…However, journals’ websites did not explicitly state when these policies were put into place. Articles reporting stakeholder involvement in trial design were less likely to enroll a diverse population in single-state studies; this finding may have been associated with the encouragement of greater representation of participants of racial and ethnic minority groups, which in turn may have led to lower diversity indexes.…”

Development and Evaluation of the Clinical Trial HEalth Knowledge and Beliefs Scale (CHEKS)

“…Participants’ rights and safety, as well as the process and procedures of clinical trial research, funding, setting and benefits, were identified as critical areas to ensure patient understanding. These topic areas were agreed upon as survey items to include in the CHEKS tool given the historical mistrust of research and typical misconception of clinical trials only being pharmaceutical in nature [ 11 , 12 , 26 ]. Our approach is consistent with the literature, with our patient-centered input to the instrument development for key content areas guided by the literature, literacy level and cultural appropriateness guided by the CSC, data collection, troubleshooting user access processes, and survey ease of use administered online.…”

“…In addition, our measure could be used as part of pre/posttest research analysis to determine how the research community is faring in improving recruitment and participation in trials from all communities. Examples of such interventions include the development of a tailored website to increase participant willingness to enroll in clinical trials [ 11 ], to understand knowledge content areas to bolster and beliefs or misconceptions to clarify.…”

“…Unethical research conducted in human populations throughout history has contributed to grave mistrust, particularly among Black, Indigenous, and People of Color (BIPOC). Moreover, institutional racism, and lack of transparency, awareness, culturally and linguistically appropriate research measures, tools, and research studies are a few of the driving factors behind BIPOC patient mistrust and low rates of clinical trial participation [ 11 ]. Choi and colleagues found that fear, lack of trust, and patient safety concerns were barriers to clinical trial research patient enrollment in Korea [ 12 ].…”

Precision Recruitment and Engagement of Individuals at Risk for Diabetes and Hypertension in Clinical Trials (PREDHICT): A Randomized Trial for an E-Persuasive Mobile Application to Inform Decision Making about Clinical Trials

“…In sum, a decentralized clinical trial can address the knowledge, access, and navigation limitations of traditional centralized clinical trials [14][15][16][17][18][19][20]. Decentralized trials have demonstrated value in enhancing participant diversity, recruitment, and retention rates and providing more representative real-world data for improved generalizability of study findings [20].…”