Limited Competition: Clinical Research Sites (CRS) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trial Not Allowed) | RFA HL 26 009

Opportunity Information: Apply for RFA HL 26 009

This funding opportunity (RFA-HL-26-009) is an NIH cooperative agreement (U01; clinical trial not allowed) aimed at renewing and continuing the MACS/WIHS Combined Cohort Study (MWCCS) for a new six-year project period running from 2026 through 2032. The MWCCS is a long-running U.S. epidemiologic cohort focused on understanding health and aging among middle-aged and older adults living with HIV (PLWH), alongside a comparison group of adults living without HIV (PLWOH). The renewal is intended to preserve continuity in a uniquely valuable national cohort by maintaining longitudinal follow-up and ongoing data and specimen collection for more than 5,600 participants who have been extensively characterized over time.

A central scientific emphasis in this renewal is the use of a "populomics" approach. In practice, this means the cohort will be used to study health determinants across many layers at once, rather than isolating single factors. The NOFO highlights scales of influence that range from molecular and cellular processes to physiology and clinical outcomes, and then outward to lifestyle and behavior, household context, neighborhood and environmental exposures, and broader cultural and sociopolitical influences. The goal is to use multidisciplinary methods to map how these interacting determinants shape health, quality of life, comorbidities, and survival for adults aging with HIV in the United States, and to compare those patterns with adults without HIV.

The awards supported under this NOFO specifically fund the Clinical Research Sites (CRS) that carry out the on-the-ground cohort operations. These sites are the clinical and field infrastructure responsible for participant engagement and retention, standardized study visits, collection of clinical measures and questionnaires, and acquisition and handling of biological specimens, all in alignment with the MWCCS protocol and the cooperative agreement structure where NIH program staff have substantial involvement. NIH anticipates supporting up to 13 CRS awards under this announcement, helping maintain national geographic reach and the ability to continue consistent, high-quality longitudinal follow-up.

This is a limited competition opportunity. Only institutions that were previously funded under RFA-HL-19-008 are eligible to apply, which is meant to ensure continuity of expertise, established participant relationships, and compatibility with existing MWCCS operating procedures and systems. Eligible applicant organization types include public and state-controlled institutions of higher education and private institutions of higher education, but the limitation tied to prior funding under the specified earlier RFA is the key gatekeeping criterion.

The CRS NOFO is designed to operate alongside two companion limited competition U01 announcements that cover the other major pillars of the consortium: one for the Data Analysis and Sharing Center (DASC; RFA-HL-26-010) and one for the Leadership and Coordination Center (LACC; RFA-HL-26-011). Together, these three coordinated awards are structured to support a multi-site consortium model in which clinical sites generate harmonized data and specimens, while centralized leadership, coordination, analysis, and data-sharing functions ensure standardization, governance, and broad scientific use of the cohort resources.

Administrative details included in the source information indicate the agency is the National Institutes of Health, the funding instrument is a cooperative agreement, and the opportunity is categorized as discretionary. The application closing date listed is May 2, 2025, and the award ceiling is $2,400,000 (noting that actual budgets and the number of awards depend on NIH determinations and the final scope of funded sites). The NOFO also makes clear that foreign involvement is not permitted: non-U.S. organizations cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Limited Competition: Clinical Research Sites (CRS) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.173, 93.233, 93.242, 93.273, 93.279, 93.307, 93.313, 93.361, 93.393, 93.837, 93.838, 93.839, 93.840, 93.855, 93.865, 93.866.
• This funding opportunity was created on 2025-01-16.
• Applicants must submit their applications by 2025-05-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $2,400,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education, Private institutions of higher education.

Apply for RFA HL 26 009

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