Faculty Bibliography

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/BACKGROUND:ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:DERR1-10.2196/17589.

PURPOSE OF REVIEW/OBJECTIVE:In this current review, we describe the benefits of community-based and "precision and personalized population health" (P3H) approaches to assessing and addressing sleep health problems and sleep-related cardiovascular diseases (CVD) among vulnerable populations such as racial/ethnic minorities, the elderly, and the socioeconomically disadvantaged. RECENT FINDINGS/RESULTS:Very few sleep health programs utilize a community-based or P3H approach, which may account for low estimates of sleep health problems, related CVD outcomes, and inadequate healthcare infrastructure to address sleep-related health outcomes at the community and population level. We describe community-based and P3H approaches and programs as solutions to accurately capture estimates of sleep health and reduce burden of sleep health problems and corollary CVD outcomes at the level of the community and population. Specifically, we describe seven critical steps needed to successfully implement a community-based and P3H approach to address sleep health problems. Community-based and P3H approaches are effective strategies to assessing and addressing sleep health problems and related health conditions.