Limited Competition: Clinical Research Sites for MACS/WIHS Combined Cohort Study, MACS/WIHS-CCS (U01-Clinical Trials Not Allowed) | RFA HL 19 008

Opportunity Information: Apply for RFA HL 19 008

This funding opportunity, RFA-HL-19-008, is a limited-competition NIH cooperative agreement (U01; clinical trials not allowed) aimed at advancing scientific understanding of HIV infection, with a strong emphasis on HIV-related comorbidities. It specifically supports the continuation and coordinated work of existing Clinical Research Sites (CRS) that are part of the combined cohort created from two major long-running U.S. studies: the Multi-Center AIDS Cohort Study (MACS) and the Women's Interagency HIV Study (WIHS). The overall intent is to keep these established sites operating as an integrated network so they can carry out a unified, harmonized research agenda that builds on the unique longitudinal clinical, behavioral, and biological data collected from participants over time.

Under this FOA, each funded CRS is expected to do two core things. First, it must implement the full MACS/WIHS Combined Cohort Study (MACS/WIHS-CCS) unified science agenda, meaning the site will follow common protocols, coordinated procedures, and standardized data and specimen collection approaches that allow findings to be compared and combined across sites. Second, beyond simply participating, each site is also expected to contribute leadership and specialized expertise to a defined component of that unified agenda. The announcement gives examples of what that leadership could look like, such as taking a lead role in protocol development, serving as a reading center for standardized interpretation of clinical tests or imaging, or providing key laboratory capabilities. In other words, the sites are not just enrollment and follow-up locations; they are intended to function as active scientific hubs with defined responsibilities that strengthen the overall cohort infrastructure.

The FOA also allows for targeted recruitment, but only when it is well-justified. This signals that the program prioritizes maintaining and leveraging the existing cohort while permitting strategic enrollment to address specific scientific gaps, improve representation, or support particular analytic goals tied to comorbidities and other priority research questions. Because this is a cooperative agreement, awardees should expect substantial NIH scientific and programmatic involvement in coordinating activities, aligning methods across sites, and ensuring the network delivers on the unified agenda, which is typical for large, multi-site cohort efforts where consistency and shared governance are critical.

A key structural element is that the CRS awards are designed to work alongside a companion cooperative agreement that funds the MACS/WIHS-CCS Data Analysis and Coordination Center (DACC). The DACC functions as the central coordination and analytic backbone for the study, supporting harmonized data management, quality control, and cross-site analyses. The separation of roles (sites doing clinical research operations and scientific leadership pieces, while the DACC coordinates and supports centralized analysis and data functions) reflects a deliberate network model meant to keep data comparable, accelerate multi-site research, and support large-scale investigations into HIV and its associated health conditions.

Eligibility is restricted and intentionally narrow because this is a limited competition focused on current MACS and WIHS Clinical Research Sites. The listed eligible applicants include public and state-controlled institutions of higher education, and the FOA clearly excludes foreign participation: non-U.S. entities are not eligible to apply; non-U.S. components of U.S. organizations are not eligible; and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. This means the work must be carried out within eligible U.S.-based institutional structures without foreign components embedded in the application. The administering agency is the National Institutes of Health, the opportunity falls under the broad health-related assistance framework (with multiple CFDA numbers reflecting NIH institute participation), the FOA was created on 2017-12-22, and the original closing date was 2018-05-02. The award ceiling and expected number of awards are not specified in the provided summary, which is common in some listings when final budgets depend on the scope negotiated with participating sites and the overall network structure.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Limited Competition: Clinical Research Sites for MACS/WIHS Combined Cohort Study, MACS/WIHS-CCS (U01-Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.242, 93.279, 93.307, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.855, 93.856.
• This funding opportunity was created on 2017-12-22.
• Applicants must submit their applications by 2018-05-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education.

Apply for RFA HL 19 008

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