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

Alicia Chung, Azizi Seixas, Natasha Williams, Yalini Senathirajah, Rebecca Robbins, Valerie Newsome Garcia, Joseph Ravenell, Girardin Jean-Louis, Alicia Chung, Azizi Seixas, Natasha Williams, Yalini Senathirajah, Rebecca Robbins, Valerie Newsome Garcia, Joseph Ravenell, Girardin Jean-Louis

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://ichgcp.net/clinical-trials-registry/NCT00102401.

International registered report identifier (irrid): DERR1-10.2196/17589.

Keywords: eHealth; health care disparities; health communication.

Conflict of interest statement

Conflicts of Interest: None declared.

©Alicia Chung, Azizi Seixas, Natasha Williams, Yalini Senathirajah, Rebecca Robbins, Valerie Newsome Garcia, Joseph Ravenell, Girardin Jean-Louis. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 14.07.2020.

Figures

Figure 1
Figure 1
Study diagram illustrating participant flow throughout the study cycle.
Figure 2
Figure 2
Landing page screenshot of study including subheading menus and cartoon animation describing clinical trials.
Figure 3
Figure 3
Joseph Ravenell, MD describing the different types of clinical trials, including community-based research.

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