Building Marylands First Statewide Public Health Infrastructure for Representative Lupus Clinical Trial Participation - The Healthy Maryland Lupus Clinical Trial Consortium will establish sustainable statewide public health infrastructure linking routine community care with Maryland's lupus clinical research ecosystem. Although Maryland has a strong concentration of lupus research, it lacks a coordinated pathway connecting community clinicians, community health workers, patients, and trial sites. The Consortium will close this systems-level gap by embedding lupus trial awareness, education, navigation, and retention support into trusted care and community settings through standardized, technology-enabled workflows that reduce clinician burden and support all participating Maryland lupus trial sites, rather than any single sponsor or study. The Consortium will focus on Maryland communities with high lupus burden and limited research access, beginning in Baltimore City, Prince George's County, and Montgomery County and expanding to rural Western Maryland, Southern Maryland, and the Eastern Shore. Consistent with lupus epidemiology, outreach will prioritize populations disproportionately affected or underserved, including Black/African American, Hispanic/Latino, and Asian American communities, women, particularly those of childbearing age, and medically underserved rural residents. Implementation will be anchored by Catalyst Connect™, an NIH SBIR–funded platform, and delivered through a clinician-anchored, Community Health Worker–extended Three-Touchpoint education and navigation model. Trusted clinicians will introduce lupus trial awareness and reinforce lupus recognition during routine care. Community Health Workers will provide culturally and linguistically appropriate education and navigation consistent with National CLAS Standards and address non-clinical barriers such as transportation, childcare, health literacy, and trust. Interested patients will be connected to nearby participating lupus trial sites and supported through follow-up education and retention touchpoints. Participating sites conduct all protocol-specific activities under their own IRB oversight, and the Coordinating Center will not collect protected health information. The Consortium brings together the Center for a Healthy Maryland and MedChi for governance, fiscal oversight, and physician leadership; ACHIEVE Clinical Expertise, Inc. as Coordinating Center for implementation, clinician and CHW activation, CME/CE-accredited training, workflows, and performance monitoring; S-3 Research for NexCT™/Catalyst Connect™ technology; MACHC for FQHC and community health center reach; Monument Health for physician engagement in high-lupus-burden Black communities; NHHRI and OCA–Asian Pacific American Advocates for culturally and linguistically appropriate clinician and CHW activation serving Hispanic/Latino and Asian American communities; MWK TrustMakers for community pharmacist recruitment and CHW engagement in underserved communities; the Maryland Commission for Women for women's outreach; BHCC for community pharmacist activation; and participating Maryland lupus trial sites. Independent evaluation will be led by Claudia R. Baquet, MD, MPH, reporting directly to the Consortium Governance Board. Over 36 months, the Consortium will activate approximately 330 clinicians and CHWs, deliver approximately 7,500 education and navigation touchpoints to 1,500 individuals, generate 400–600 patient connections to participating sites, and produce 150–300 documented referrals. Quarterly monitoring will assess increases from verified site baselines in referrals, screening, enrollment, and retention. The beneficiaries are Maryland residents living with or being evaluated for lupus, the trial sites serving them, and the broader field seeking a replicable model for representative clinical trial participation.
