SBIR-STTR Award

Direct to Phase II

Lack of participation of African-Americans, Latinx communities and rural populationsleads to persistent health disparities. The National Academy of Medicine, and researchorganizations have sounded the alarm about the impact on the clinical trial enterprise,and the health of Americans in general. The national Academy recommends strategiesthat will increase access to clinical research at the point of care. The COVID-19 publichealth pandemic has revealed significant health disparities affecting America's black andbrown communities, with 2.4 to 7 times mortality rates compared to white Americans.Current vaccine trials have enrolled less than 10% Blacks. This experience mirrorsnumerous NIH studies across institutes and centers, as well as industry studies.The goal of this SBIR Fast-Track proposal is to develop the knowledge, products andprocesses needed to implement Health 360x Platform Service in real world practicesserving predominant African Americans, Latinx, and patients from rural communities. We will implement the following aims:1)Specific Aim 1-Phase I. Design Health 360x Clinical Research Platform (Health 360x)2) Specific Aim 2-Phase II. Test the feasibility of implementing Health 360x SOP in theworkflow of three practices, serving under-represented patients.3)Specific Aim 3-Phase II. Evaluate the adoption, implementation, effectiveness, andmaintenance of Health 360x in practices serving under-represented patientsPrimary outcome: Adoption and implementation progress of Health 360x withperformance indicators based on the CVIS Registry protocol; IRB/informed consent;PhenX surveys for social determinants; Recruitment and Retention rates; Cost analysis.This Fast-Track SBIR project will directly address NCATS priority on research efficiencyby implementing a commercially viable clinical research platform that adapts tocommunity practice settings, and is scalable, to recruit, track and retain patients who areunder represented in biomedical research.

Public Health Relevance Statement:
Project Narrative This project addresses the under representation of African Americans, Latinx and rural populations in clinical research by implementing and evaluating processes for the point of care adoption of Health 360xClinical Research Platform

Project Terms:
Academy ; Adoption ; Affect ; Americas ; Biomedical Research ; Cardiovascular system ; Cardiovascular ; Cardiovascular Body System ; Cardiovascular Organ System ; Heart Vascular ; circulatory system ; Clinical Research ; Clinical Study ; Clinical Trials ; Communication ; Communities ; Cost Analysis ; Cost Analyses ; assess cost ; cost assessment ; Cues ; Data Collection ; Focus Groups ; Goals ; Health ; Industry ; Informed Consent ; Institutes ; Interview ; Maintenance ; Medicine ; Methods ; mortality ; United States National Institutes of Health ; NIH ; National Institutes of Health ; Patients ; Physicians ; Public Health ; Registries ; Research ; research and development ; Development and Research ; R & D ; R&D ; Research Design ; Study Type ; study design ; Rural Population ; sound ; Surveys ; Survey Instrument ; Time ; Work ; Reminder Systems ; African American ; Afro American ; Afroamerican ; Black Populations ; black American ; Rural Community ; base ; Procedures ; Phase ; caucasian American ; white American ; Policies ; Measurement ; Knowledge ; Protocol ; Protocols documentation ; Services ; Needs Assessment ; American ; experience ; Performance ; Participant ; Categories ; Modeling ; Provider ; disparity in health ; health disparity ; Effectiveness ; Address ; Consent ; Data ; Community Practice ; Enrollment ; enroll ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Process ; point of care ; informant ; pandemic disease ; pandemic ; data integration ; design ; designing ; Population ; Quasi-experiment ; Quasi-experimental analysis ; Quasi-experimental approach ; Quasi-experimental design ; Quasi-experimental methods ; Quasi-experimental research ; Quasi-experimental study ; Quasi-experimental technique ; ethnic minority population ; ethnic minority ; primary outcome ; Institutional Review Boards ; IRB ; IRBs ; vaccine trial ; vaccination study ; vaccination trial ; vaccine study ; retention rate ; retention strategy ; student retention ; Data Analytics ; rural dwellers ; rural resident ; rural patients ; recruit ; practice setting ; COVID-19 ; COVID19 ; CV-19 ; CV19 ; corona virus disease 2019 ; coronavirus disease 2019 ; social determinants ; sociodeterminant ; budget impact ; implementation study ; PhenX Toolkit ; Phenx ; feasibility testing ; Latinx ;