“现在推进有色人种参与临床试验！”的发展：基于网络的随机对照试验方案

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

作者信息

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

机构信息

NYU Grossman School of Medicine, New York, NY, United States.

University of Pittsburgh, Department of Biomedical Informatics, Pittsburgh, PA, United States.

出版信息

JMIR Res Protoc. 2020 Jul 14;9(7):e17589. doi: 10.2196/17589.

DOI:10.2196/17589

PMID:32673274

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7388047/

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.

摘要

背景

与白人受试者相比，有色人种参与临床试验的比例仍然较低。本方案描述了“现在推进有色人种参与临床试验！”（ACT Now!）的开发情况，这是一个根据文化定制的网站，旨在影响有色人种参与临床试验的决策。

目的

这项整群随机研究旨在测试一个根据文化定制的网站在提高有色人种的知识水平、自我效能感以及参与临床试验意愿方面的效果。

方法

ACT Now!是一项随机试验，包括两组：（1）干预组（n = 50），可访问根据文化定制的网站；（2）对照组（n = 50），访问标准的临床招募网站。在接触与其分配组（干预组或对照组）相对应的网站之前和之后，将测量临床试验知识水平以及参与临床试验的意愿。将在基线、干预后1个月和3个月随访期间进行调查。网站架构和框架设计将参考相关文献和该领域的专家意见。将使用双尾t检验进行统计分析，检验效能为80%，α水平为0.05，以提高干预后3个月的临床试验知识水平、自我效能感以及参与临床试验的意愿。

结果

我们将设计一个根据文化定制的网站，为社区利益相关者提供影响力，以提高种族和族裔群体的临床试验知识水平、自我效能感以及参与临床试验的意愿。ACT Now!通过使用社区指导委员会（CSC）采用基于社区的参与式研究方法。CSC在研究构思、开发、实施和招募过程中提供意见。CSC关系有助于在有色人种社区中建立信任。ACT Now!有潜力通过一个易于访问的基于网络的网站填补有色人种参与临床试验方面的空白。本研究于2017年7月获得资助，并于2017年春季获得机构审查委员会批准。截至2019年12月，我们已招募了100名参与者。数据分析预计于2020年6月完成，预期结果将于2020年秋季发表。