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

JMIR Research Protocols
Alicia ChungGirardin Jean-Louis

Abstract

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. 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. 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, se...Continue Reading

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