Currently submitted to: JMIR Research Protocols
Date Submitted: Dec 22, 2019
Open Peer Review Period: Dec 22, 2019 - Feb 16, 2020
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Development of the Advancing People of Color in Clinical Trials (ACT Now!) Intervention: A Web-based Randomized Controlled Trial
Participation in clinical trials among people of color remains low, compared with whites. This protocol describes the development of Act NOW! (Advancing People of Color in Clinical Trials 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, compared to the standard NYU clinical trial enrollment website.
Act NOW! is a randomized trial including two 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, self-efficacy 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 post-intervention and 3-month follow-up. Website architecture and wire-framing 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 0.05 alpha level, to increase clinical trial literacy, self-efficacy and willingness to enroll in clinical trials 3-months post-intervention.
We will design a culturally tailored website and leverage 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 informed 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 to 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, online website.
A culturally tailored website may have the potential to increase literacy, self-efficacy and willingness to enroll in a clinical trial among people of color. Clinical Trial: Trial registration number NCT03243071 August 8, 2017.
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