Cooperative Agreement U01FD007876

THE EXPERIENCES OF ETHNIC MINORITIES, AND THOSE WITH LIVER DISEASE, DURING COVID-19, AND THE IMPACT ON RELATED HEALTH AND PREVENTION BEHAVIORS - THE EXPERIENCES OF ETHNIC MINORITIES, AND THOSE WITH LIVER DISEASE, DURING COVID-19, AND THE IMPACT ON RELATED HEALTH AND PREVENTION BEHAVIORS CHRONIC HEPATITIS B (CHB) INFECTION AFFECTS UP TO 2.4 MILLION PEOPLE LIVING IN THE U.S., AND DISPROPORTIONATELY IMPACTS PEOPLE OF ASIAN AND AFRICAN ORIGIN AND PACIFIC ISLANDERS, WHO ALSO FACE MANY CHALLENGES TO HEALTHCARE ACCESS. PEOPLE LIVING WITH HEPATITIS B (PLHB) WHO REPRESENT ETHNIC MINORITIES ALSO LACK ACCESS TO CLINICAL TRIALS; DELAYING THEIR EQUITABLE ACCESS TO INNOVATIVE MEDICINAL PRODUCTS, BLURRING THE TRUE PICTURE ABOUT THE SAFETY AND EFFECTIVENESS OF SUCH PRODUCTS WHEN USED BY THESE COMMUNITIES, AND HINDERING THE ACCEPTABILITY AND UPTAKE OF SUCH PRODUCTS BY MEMBERS OF ETHNIC MINORITIES. ULTIMATELY, THIS LEADS TO MAJOR DISPARITIES AND WORSE HEALTH OUTCOMES. PLHB AND ETHNIC MINORITIES WERE UNDERREPRESENTED IN CLINICAL TRIALS FOR THE VACCINE AGAINST SARS-COV-2 (COVID-19). THIS HAS LED PLHB TO BE CONCERNED ABOUT HOW THE VACCINE WOULD AFFECT THEIR LIVER OR HEALTH CONDITION AND HAS EXPOSED AN EXISTING GAP OF LACK OF DIALOGUE BETWEEN DRUG DEVELOPERS AND COMMUNITY ORGANIZATIONS REPRESENTING PLHB AND ETHNIC MINORITIES. THE PROPOSED STUDY WILL HELP BETTER UNDERSTAND THE CHALLENGES AND RESULTING HEALTH BEHAVIORS (INCLUDING COVID-19 VACCINE UPTAKE) AMONG INDIVIDUALS FROM MINORITY POPULATIONS, INCLUDING PLHB, INCLUDING AN ASSESSMENT OF THEIR ACCESS TO CREDIBLE AND PATIENT-CENTERED INFORMATION ON THE SAFETY OF COVID-19 VACCINES. THE STUDY PROPOSES A MIXED-METHODS APPROACH, COLLECTING AND ANALYZING DATA FROM PLHB AND ETHNIC MINORITIES, AND THEIR HEALTHCARE PROVIDERS, THROUGH ONE-ON-ONE INTERVIEWS AND AN ONLINE SURVEY. THE STUDY ALSO PROPOSES ESTABLISHING AN INFORMED COMMUNITY ADVISORY BOARD (CAB) COMPOSED OF PLHB WHO REPRESENT ETHNIC POPULATIONS MOST IMPACTED BY CHB. CAB MEMBERS WILL BE TRAINED ON TOPICS RELATED TO COVID-19, PUBLIC HEALTH EMERGENCIES, AND CLINICAL TRIAL PARTICIPATION. CAB MEMBERS WILL CULTIVATE A SUSTAINABLE DIALOGUE WITH THE DRUG DEVELOPMENT COMMUNITY, SUCH AS REGULATORY AUTHORITIES AND DRUG DEVELOPERS, ESPECIALLY DURING TIMES OF PUBLIC HEALTH EMERGENCIES. THIS STUDY WILL BROADEN OUR UNDERSTANDING OF HOW ETHNIC MINORITIES PERCEIVE NEWLY APPROVED MEDICINAL PRODUCTS, AND IDEAS FOR IMPROVING FUTURE COMMUNICATION ABOUT THESE PRODUCTS. STUDY RESULTS CAN BE USED TO PROMOTE DIVERSITY AND INCLUSION IN CLINICAL TRIALS FOR COVID-19 VACCINES AND THERAPEUTICS AND NEWLY DEVELOPED PRODUCTS IN OTHER DISEASE AREAS, AND ENSURE THAT THE BENEFITS OF SUCH TRIALS REACH THE COMMUNITIES MOST IN NEED, IN THE U.S. AND GLOBALLY.