Limited Competition: Clinical Research Sites (CRS) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trial Not Allowed)

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Description

This opportunity supports the renewal of Clinical Research Sites (CRS) for the MACS/WIHS Combined Cohort Study (MWCCS), a long-standing, deeply phenotyped epidemiological cohort of over 5,700 adults living with and without HIV across the United States. The MWCCS investigates the health, quality of life, and survival of middle-aged and older people living with HIV (PLWH) and comparable people living without HIV (PLWOH), using a "populomics" approach—examining health determinants across molecular, cellular, physiological, behavioral, social, and environmental levels.

The renewal will fund up to 13 CRSs for a 6-year period (2026–2032), enabling continued follow-up, data collection, and scientific investigation into HIV and its comorbidities, aging, and health disparities. The initiative is highly collaborative, with parallel funding opportunities for a Data Analysis and Sharing Center (DASC) and a Leadership and Coordination Center (LACC).

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Due Dates

• Letter of Intent (optional): 30 days prior to application due date
• Application Deadline: May 2, 2025 (by 5:00 PM local time)
• Scientific Merit Review: November 2025
• Advisory Council Review: January 2026
• Earliest Start Date: April 2026

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Funding Amount

• Award Ceiling: $2,400,000 direct costs per year (FY2026–2031)
• Project Period: 6 years (2026–2032)
• Total Anticipated Funding: ~$34.17M across all awards in FY2026
• Number of Awards: Up to 13 CRSs

Budgets should reflect the complexity and scope of proposed activities and the number of participants completing in-person exams.

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Eligibility

• Limited Submission: Only institutions previously funded under RFA-HL-19-008 are eligible.
• Eligible Applicants: Public and state-controlled institutions of higher education; private institutions of higher education.
• Ineligible: Non-U.S. entities, non-U.S. components of U.S. organizations, and foreign components.
• PD/PI Requirements: Multiple PI (mPI) leadership structure is required, with complementary expertise (including clinical knowledge of HIV and/or comorbidities).
• Cost Sharing: Not required.

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Application Process

• Submission: Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
• Required Registrations: SAM, eRA Commons, Grants.gov (may take 6+ weeks).
• Application Components:
  • Specific Aims (1 page: ½ page operational, ½ page investigational)
  • Research Strategy (6 pages operational, 6 pages investigational)
  • Multiple PI Leadership Plan (2 pages)
  • Operational and Scientific Progress Report (4 pages)
  • Biographical sketches for all key personnel
  • Budget and justification (including participant compensation, biospecimen shipping, trainee support, travel)
  • Letters of support (for subcontractors/consultants)
  • Data Management and Sharing Plan
• Review Criteria: Significance, innovation, approach (rigor and feasibility), investigator expertise, environment, and alignment with NIH scientific priorities.

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Additional Information

• Scope: No clinical trials allowed; focus is on observational cohort research.
• Scientific Priorities: Cardiovascular, metabolic, pulmonary, hematologic, sleep, cancer, mental health, aging, substance use, oral health, minority health, women’s health, and more (see full list of NIH priorities).
• Cohort Participants: Must retain all MWCCS participants enrolled 2019–2025; may optionally enroll eligible former STAR cohort participants.
• Data Collection: Annual visits only (no semi-annual visits supported); use of common data elements encouraged.
• Collaboration: Active participation in MWCCS Executive and Steering Committees, scientific and operational workgroups, and community advisory boards is required.
• Companion Opportunities: DASC (RFA-HL-26-010), LACC (RFA-HL-26-011).

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External Links

• NIH Funding Opportunity Announcement (RFA-HL-26-009)
• Grants.gov Opportunity Listing
• NIH How to Apply – Application Guide
• NIH Strategic Plan for HIV and HIV-Related Research
• NIH Data Management and Sharing Policy

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Contact Information

For additional contacts (including financial/grants management), see the full NOFO contact section.

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