Alicia Chung|Azizi Seixas|Natasha Williams|Yalini Senathirajah|Rebecca Robbins|Valerie Newsome Garcia|Joseph Ravenell|Girardin Jean-Louis
Development of “Advancing People of Color in Clinical Trials Now!”: Web-Based Randomized Controlled Trial Protocol
New York University|New York University|New York University|University of Pittsburgh|Brigham and Women's Hospital|Morehouse School of Medicine|New York University|New York University
background participation clinical trials among people color remains low compared white subjects protocol describes development advancing people color clinical trials act culturally tailored website designed influence clinical trial decision making among people color objective cluster randomized study aims test efficacy culturally tailored website increase literacy selfefficacy willingness enroll clinical trials among people color methods act randomized trial including 2 groups 1 intervention group n50 access culturally tailored website 2 control group n50 exposed standard clinical recruitment website clinical trial literacy willingness enroll clinical trial measured exposure website corresponding assigned group intervention control surveys conducted baseline 1month postintervention 3month followup website architecture wireframing informed literature experts field statistical analysis conducted using twotailed test 80 power 05 alpha level increase clinical trial literacy selfefficacy willingness enroll clinical trials 3 months post intervention results design culturally tailored website provide leverage community stakeholders influence clinical trial literacy selfefficacy willingness enroll clinical trials among racial ethnic groups act applies communitybased participatory research approach use community steering committee csc csc provides input research study conception development implementation enrollment csc relationships help foster trust among communities color act potential fill gap clinical trial enrollment among people color accessible webbased website study funded july 2017 obtained institutional review board approval spring 2017 december 2019 enrolled 100 participants data analyses expected completed june 2020 expected results published fall 2020 conclusions act potential fill important gap clinical trial enrollment among people color accessible webbased website trial registration clinicaltrialsgov nct03243071 httpsclinicaltrialsgovct2shownct00102401 international registered report identifier irrid derr110219617589