Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement 2 (TIMELY 2) - Despite recent advancements made towards increasing clinical trial awareness, substantial disparities exist in clinical trial participation. These disparities are particularly a problem in conditions such as lupus that disproportionately affect racial/ethnic minority populations. Pertinent to those who suffer with lupus, African American/Black and Hispanic/Latino patients are underrepresented in lupus clinical trials, despite being over-represented in the patient population of people with lupus. To address this disparity, the American College of Rheumatology (ACR) proposes leveraging advancements made over the past six years, with the support of the Office of Minority Health. The ACR proposes working in conjunction with two lupus clinical trial sites (University of North Carolina Chapel Hill and University of Rochester Medical Center) as well as two community health worker organizations (Curamericas Global and Community Health Workers Association of Rochester) to implement this project. The project will further collaborate with researchers, advancing practicing professionals and practicing providers (rheumatologists, nephrologists, advanced practicing professionals and dermatologists) serving African American/Black and Hispanic/Latino patients. The ACR proposes to implement the Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement 2 (TIMELY 2) project in Raleigh, NC and Rochester, NY. The proposed TIMELY 2 project plan is informed by lessons learned in prior OMH supported projects with adjustments made based upon feedback from participants in those programs, recommendations from researchers, and insights shared by persons living with lupus. Key lessons learned that will impact the implementation of TIMELY 2 include: 1) strengthening the connection between clinical trial sites, coordinators and principal investigators directly with community health workers (CHWs) to establish a clearer understanding of the local clinical trial enrollment and screening process, 2) providing additional education and awareness on lupus among CHWs who work primarily in other disease areas, 3) adjusting the time requirements for provider engagement, 4) revising the IRB and enrollment process for the project to address the complex preexisting IRB requirements for recruitment and referrals. This revised strategy will improve the proposed outcomes and objectives of the project. Across the proposed programmatic period, ACR will take advantage of the teams and infrastructure to Further utilize existing evidence-based, theoretically grounded clinical trial and lupus educational materials to implement a multi-stage, interactive training program for providers and CHWs; Collaborate with clinical trial sites to enhance clinical trial health literacy among providers, CHWs, and underrepresented patients; Engage state, local, and community organizations to build partnerships and host clinical trial roundtables aimed at reducing hesitancy in referring to clinical trials and referral pathways; Support trained CHWs in informing and educating underrepresented patients about lupus clinical trials; Leverage ACR's connections with CHW networks and clinical trial sites to engage and enroll individuals living with lupus in a clinical trial referral database and implement a robust evaluation and sustainability plan. TIMELY 2 will ultimately lead to increased recruitment, screening, and enrollment of underrepresented patients in lupus clinical trials. At the conclusion of the proposed project, we will have: (1) an intervention to increase lupus clinical trial referrals for underrepresented patients; (2) public-private and community partnerships to increase clinical trial literacy and adopt promising clinical trial diversity practices; (3) dissemination of the TIMELY 2 model lessons learned and results to academic and community audiences; and (4) a project dissemination and sustainability plan.
