Clinical trial NCT03243071: Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach
Official title: Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recruitment
Keywords: Medical Care
Racial Discrimination
Poor Health Literacy
Medical Care Disparities
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose pf this study is to evaluate the comparative effectiveness of a culturally and linguistically tailored clinical trial literacy website in increasing likelihood of participating in clinical trials. To achieve this objective,a randomized group design will address the following patient-centered outcomes: willingness to enroll in clinical trials and behavioral intent as well as likelihood of referring others to enroll in such trials) before and after exposure to a culturally-tailored clinical trial literacy website. Health literacy will be measured both before and post exposure to tailored messages. Participants will be randomized into two groups. The intervention group (n=50) will have access to culturally tailored website. Participants in the control group (n=50) will have access to NYU 's standard trial participation website.

Detailed description: Compelling evidence demonstrates racial/ethnic disparities in health and healthcare in the United States. These disparities arise from various factors including unequal access to adequate medical care, perceived racial discrimination, and poor health literacy.The Center for Healthful Behavior Change (CHBC) has been involved in numerous initiatives to eradicate health disparities and have implemented NIH-funded interventions to address inequities in health. Interventions targeting patient-centered outcomes have been suboptimal because of inadequate infrastructure to support equitable contributions from stakeholders (patients, providers, and community leaders) in all aspects of the research process. This is crucial to promote sustainable effects regarding minority patients' ability to make informed decisions about participating in existing clinical trials. This study will address this gap, bringing together academic investigators and important stakeholders to develop a website providing access to culturally tailored videos to enhance awareness of clinical trial, health literacy, thus promoting participation in existing clinical trials.

Eligibility criteria: Inclusion Criteria:

* Self-reported race/ethnicity as African American, African, Caribbean American or black men and women
* accessible by telephone
* no plans to move away from the region within the year following enrollment; consent to participate.

Exclusion Criteria:

* Progressive medical illness in which disability or death is expected within one year
* impaired cognitive or functional ability, which would preclude meaningful participation in the study
* stated intention to move within the same year of enrollment.

Primary outcomes:
measure: ACTNOW! Clinical Trial Knowledge Assessment Score
timeFrame: Baseline
measure: Clinical Trial Knowledge Assessment Score
timeFrame: Month 1
measure: Clinical Trial Knowledge Assessment Score
timeFrame: Month 3
measure: ACTNOW! Self-Efficacy Score
timeFrame: Baseline
measure: Self-Efficacy Score
timeFrame: Month 1
measure: Self-Efficacy Score
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Girardin Jean-Louis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung A, Seixas A, Williams N, Senathirajah Y, Robbins R, Newsome Garcia V, Ravenell J, Jean-Louis G. Development of "Advancing People of Color in Clinical Trials Now!": Web-Based Randomized Controlled Trial Protocol. JMIR Res Protoc. 2020 Jul 14;9(7):e17589. doi: 10.2196/17589.