A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials

Racial and ethnic minorities represent the fastest growing segment of the United Statesadult population, yet they remain significantly underrepresented in cancer clinicaltrials (CCTs). Low trust in clinical research and recruitment approaches that fail toaddress multilevel barriers to CCT participation are key reasons for minority populationunderrepresentation. Community health educators (CHEs) improve trust in research amongunderrepresented populations, yet relying on exclusively on CHE availability can limitintervention reach. Virtual CHEs (vCHEs) improve scalability by extending CHEcapabilities and capitalizing on remote recruitment techniques. The purpose of thecurrent project is to increase referral of diverse participants to NCI‐supported clinicaltrials via a culturally responsive, multi‐level intervention that utilizes vCHEs to reachdiverse populations. The investigators will consolidate existing referral channels withinthe ALEX Research Portal. ALEX offers a custom experience for clinicians, CHEs, andpatients to facilitate CCT referrals. Clinicians can utilize the portal to refer to CCTs;CHEs can use the portal to create an avatar that can provide introductory information topatients and schedule video‐conference follow‐ups; patients, families, and communitymembers can use the portal to easily navigate to key information and make self‐andother‐referrals. The ability to streamline information to patients and CCT referrals tostudy coordinators is expected to improve the overall referral to CCTs. The ALEX ResearchPortal utilizes the adaptive virtual human technology developed at the University ofFlorida that provides users with culturally and linguistically tailored CCT information.The ALEX Research Portal will be developed and launched across three distinct geographicareas of Florida (Gainesville, Jacksonville, and Miami). This unique collaborativeopportunity will provide access to participants representative of the racial and ethnicdiversity of the state as well as cancer centers conducting CCTs associated with nationalnetworks [Experimental Therapeutics Clinical Trials Network (ETCTN), National ClinicalTrials Network (NCTN)]. Guided by the Interactive Systems Framework for dissemination andimplementation, our goal is to increase referrals to CCTs by optimizing the ALEX ResearchPortal for broad use. The outcome will be an evidence‐based intervention that can bewidely disseminated to quickly increase the referral of diverse patients to CCTs. Thisproject will be conducted in three phases: (Phase I) establish a baseline of referralsand accrual of diverse participants to CCTs across multiple Florida Center Centers,(Phase 2) adapt and pilot the ALEX Research Portal using a randomized controlled clinicaltrial, and (Phase 3) scale the intervention by dissemination via the OneFlorida network.The proposed study will result in an empirically‐tested vCHE Research Portal forincreasing trust in CCTs among diverse populations that can easily be adapted anddisseminated across the state to overcome challenges associated with recruiting diverseparticipants to CCTs.