Weaving Community Connections: Community-to-Clinical Trial Navigation Project - Looms for Lupus proposes Weaving Community Connections: Community-to-Clinical Trial Navigation Project, a 36-month community-based initiative to increase equitable participation in lupus clinical trials among populations historically underrepresented in research. The project will serve lupus patients, caregivers/carepartners, and community members across Georgia, South Carolina, and North Carolina, with intentional outreach to Black/African American women, Hispanic/Latina women, women of color, rural and low-income communities, Spanish-speaking communities, and individuals experiencing barriers related to transportation, language access, health literacy, specialty care access, trust, and clinical trial awareness. The project will address gaps across the lupus clinical trial participation continuum, including awareness, referral, screening, enrollment, and retention support. Looms for Lupus will implement a culturally and linguistically responsive navigation model that combines plain-language lupus clinical trial education, trusted messengers and promotoras/community health workers, patient navigation, barrier reduction, clinical and research referral pathways, and closed-loop tracking with continuous quality improvement. Looms for Lupus will build on established lupus community relationships and clinical/research connections, including its relationship with Dr. Niti Goel and Duke lupus research resources, while formalizing additional qualified referral pathways during the first quarter. Clinical trial sites and research partners will retain responsibility for eligibility determination, informed consent, screening, enrollment, and protocol-specific requirements. Over 36 months, Looms for Lupus will reach at least 4,000 individuals, provide direct education to 2,000 participants, train 175 trusted messengers and provider/community partners, establish 10–12 active partnerships, generate 350 referrals or warm handoffs, support 175 trial-site screenings or eligibility reviews, achieve 20 partner-verified lupus clinical trial enrollments, document 20 additional lupus research connections, and provide retention/navigation follow-up for 80% of eligible pathway participants where consent and site protocols allow. An independent evaluator will assess implementation and outcomes, including reach, knowledge change, partner capacity, referral pathways, screenings, clinical trial enrollment, research connections, retention support, barriers, and sustainability. Findings and tools will be shared through community reports, partner resources, dissemination products, and a replication guide to support broader adoption of community-to-clinical-trial navigation approaches.
