Navigation Network for Clinical Trial Equity and Trust Initiative, Health Ministry AME Zion Church, Inc. - Health Ministry A.M.E. Zion Church, Inc. (HMAZI), in partnership with the University of Rochester Medical Center (URMC), proposes the Community Navigation Network for Clinical Trial Equity and Trust (CONNECT) to increase equitable participation in lupus clinical trials among historically underrepresented populations throughout the Rochester metropolitan area and Western New York. Although lupus disproportionately affects African American women and other medically underserved populations, these groups remain significantly underrepresented in clinical research, limiting equitable access to emerging therapies and reducing the generalizability of research findings. CONNECT will implement a comprehensive, community-to-clinical research model that addresses multiple stages of the clinical trial participation continuum, including awareness, referral, screening, enrollment, and retention. The project will focus primarily on African American women of childbearing age, Hispanic populations, and other medically underserved communities experiencing persistent barriers to healthcare access and clinical research participation. The intervention integrates culturally responsive community outreach and education, faith-based engagement, Community Research Navigators, provider referral coordination, participant navigation, and continuous quality improvement to address well-documented barriers, including limited awareness, historical mistrust of medical research, fragmented referral pathways, transportation challenges, and health literacy limitations. Community Research Navigators will provide individualized education, referral coordination, participant support, and follow-up throughout the clinical trial participation process to improve access, strengthen trust, and reduce barriers to participation. CONNECT is built upon strong public-private and community partnerships among HMAZI, URMC, healthcare providers, community-based organizations, faith communities, patient advocates, and a multidisciplinary Community Advisory Board. These partnerships will strengthen community engagement, improve referral pathways, support participant recruitment and retention, and establish a sustainable infrastructure for expanding equitable participation in future clinical research. Project outcomes will be evaluated using a mixed-methods, implementation science framework. Measurable outcomes include a 30 percentage-point increase in community awareness of lupus clinical trials above the Project Initiation Baseline, at least 100 community referrals annually, enrollment of at least 5 participants into lupus clinical trials, and participant retention of at least 90 percent. Through this evidence-based, community-centered implementation model, CONNECT will strengthen equitable participation in lupus clinical trials, advance health equity, and establish a scalable model for improving participation among historically underrepresented populations By connecting trusted communities with clinical research opportunities, CONNECT transforms fragmented recruitment efforts into an integrated community-to-clinical research system that expands equitable participation, strengthens scientific discovery, and improves health outcomes for populations disproportionately affected by lupus.
