National Lupus Outreach and Clinical Trial Education Program

The National Lupus Outreach and Clinical Trial Education Program, solicited under MP-CPI-26-001, is a federal grant opportunity administered by the Office of the Assistant Secretary for Health within the Department of Health and Human Services to increase participation of underrepresented populations—particularly racial and ethnic minorities, women of childbearing age, and medically underserved or rural communities—in lupus clinical trials across the entire pathway from awareness to retention. Funded under Section 1707 of the Public Health Service Act, this initiative aims to reduce lupus-related health disparities by supporting community-based, integrated interventions that address systemic barriers such as mistrust, limited access, and low health literacy through approaches like patient navigation, digital tools, site readiness, and public-private partnerships. Applicants must design projects that target at least two stages of the clinical trial participation continuum and ensure cultural and linguistic appropriateness for the intended populations, with a strong emphasis on measurable outcomes including increased recruitment, screening, and enrollment metrics. Applications must be submitted via Grants.gov by July 10, 2026, and require an active SAM.gov registration with a Unique Entity Identifier, along with complete submission of required forms including SF-424, SF-424A, SF-LLL, and a Project Abstract Summary, plus three core files: a 40-page Project Narrative, supporting Appendices including a detailed Work Plan, and a Budget Package with cost-share or matching documentation, all limited to a total of 65 pages and submitted in acceptable formats such as PDF or Word. Proposals will be evaluated on organizational capacity (20 points), goals and outcomes aligned to SMART criteria (15 points), project significance supported by quantitative data (10 points), and dissemination strategies using understandable formats (10 points), with additional pass/fail gates for technical, budgetary, and grants management compliance, financial stability, management system quality, past performance, audit history, and SAM integrity checks. Awards are anticipated to be up to $500,000 each for six recipients, totaling $3 million, with a 36-month performance period beginning September 30, 2026, funded in annual budget periods. Recipients must comply with federal grant regulations including 2 CFR Part 200, 45 CFR Part 46 for human subjects, research integrity standards, and civil rights statutes, maintain internal controls for financial management, submit quarterly and final performance reports via GrantSolutions, and undergo a Single