Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Clinical Centers (U01-Clinical Trial required) | RFA AA 24 004

Opportunity Information: Apply for RFA AA 24 004

This funding opportunity, RFA-AA-24-004, is a limited-competition NIH cooperative agreement (U01; clinical trial required) run through the National Institute on Alcohol Abuse and Alcoholism (NIAAA). It is designed to build directly on the existing Alcohol-associated Hepatitis Clinical and Translational Network (AlcHepNet), a program NIAAA has supported since 2012 and renewed in 2018. The main idea is continuity: instead of starting from scratch, NIAAA wants to leverage the clinical infrastructure, trial-ready sites, and operational experience already developed under the prior late-phase clinical trials and observational studies program focused on alcohol-associated hepatitis.

In the next program cycle, the network structure is planned to include up to six Clinical Study Sites (the clinical centers funded under this announcement) plus a separate Data Coordinating Center (referenced in the description as part of the overall network). The core scientific deliverable is an integrated treatment clinical trial that intentionally combines active treatment for Alcohol Use Disorder (AUD) with medical treatment for alcohol-associated liver disease (ALD). In other words, the program is not treating liver disease in isolation; it is explicitly pairing liver-directed care with evidence-based addiction care, reflecting the reality that sustained outcomes in alcohol-associated liver disease are tightly linked to addressing alcohol use itself.

The patient populations targeted are those with high severity and high clinical need: severe alcohol-associated hepatitis (sAH) and decompensated alcohol-associated cirrhosis (deAC). These groups are often medically fragile, frequently hospitalized, and at elevated risk of mortality and complications, which makes standardized, network-based clinical research especially important. By focusing on sAH and deAC, the NOFO is aiming at stages of alcohol-associated liver disease where effective combined interventions could have major impacts on survival, relapse prevention, rehospitalization, and longer-term liver outcomes.

Applicants are expected to propose an investigator-initiated, common-protocol clinical trial conducted across the network, meaning the trial is intended to be harmonized rather than fragmented into separate, unrelated studies at each site. At the same time, the NOFO allows and encourages site-specific ancillary studies. Those ancillary studies are meant to complement the main trial (for example, mechanistic substudies, biomarkers, implementation questions, or other scientifically justified add-ons) while still operating within the broader network framework and leveraging shared infrastructure and patient enrollment.

Because this is a U01 cooperative agreement, awardees should anticipate substantial NIH program involvement compared with a typical investigator-initiated R01. In practice, that usually means the NIH and the funded sites collaborate closely on trial oversight, milestone-driven progress, protocol alignment across sites, and network governance. The emphasis on a common protocol and a coordinated network is consistent with that cooperative model, especially for late-phase or pragmatic clinical trials where consistent implementation across multiple sites is essential.

Each Clinical Center application must be built around a multidisciplinary team, with a hepatologist and an addiction medicine specialist explicitly required. That requirement signals the integrated-care expectation: funded sites need genuine clinical and research capacity on both the liver disease side and the AUD treatment side. The NOFO also stresses that the clinical center should include a primary site and, when needed, subsites, but in either case the group must demonstrate a track record of successful enrollment in prior clinical trials. That enrollment history requirement matters because the target populations (sAH and deAC) can be difficult to recruit and retain, and the network is expected to execute a complex, integrated trial rather than a small pilot study.

Eligibility is broad across typical NIH domestic applicant categories, including state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, the NOFO is clear about geographic restrictions: non-U.S. (foreign) organizations are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are not allowed. In effect, the network and its funded clinical centers must be fully domestic in their operational footprint.

Administratively, the opportunity is categorized as discretionary funding using the cooperative agreement instrument, with activity in the health domain and CFDA number 93.273. The original application closing date listed is April 24, 2024, and the posting creation date is March 7, 2024. The award ceiling and expected number of awards are not specified in the provided source text, but the program description indicates the network is expected to include up to six clinical sites plus a data coordinating center, which gives a practical sense of the intended scale.

Overall, this NOFO is essentially about sustaining and evolving an established NIAAA-sponsored clinical trials network so it can run a coordinated, multi-site clinical trial that treats alcohol-associated liver disease and alcohol use disorder together, in the same protocol, for patients with severe and decompensated disease. The emphasis on multidisciplinary teams, proven enrollment capacity, and an integrated ALD-AUD intervention approach reflects a push toward research that is both clinically realistic and more likely to translate into measurable improvements in outcomes.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Clinical Centers (U01-Clinical Trial required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273.
• This funding opportunity was created on 2024-03-07.
• Applicants must submit their applications by 2024-04-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AA 24 004

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