Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Data Coordinating Center (U24 - Clinical Trial Required) | RFA AA 24 005

Opportunity Information: Apply for RFA AA 24 005

This funding opportunity (RFA-AA-24-005) is a limited competition Notice of Funding Opportunity from the National Institutes of Health (NIH), specifically tied to the National Institute on Alcohol Abuse and Alcoholism (NIAAA). It uses a cooperative agreement mechanism (U24), meaning the awardee is expected to work closely with NIH staff and the broader research network rather than operating fully independently. The goal is to fund a single Data Coordinating Center (DCC) that will support the next phase of the Alcohol-associated Hepatitis Clinical and Translational Network, referred to as the Alcohol-associated Hepatitis Network (AlcHepNet). AlcHepNet has been supported by NIAAA since 2012 and was renewed in 2018, and this NOFO continues that trajectory by focusing on coordinated, late-phase clinical research intended to improve outcomes for people with advanced alcohol-associated liver disease.

The program is structured around a network model. In the upcoming cycle, AlcHepNet is expected to include up to six Clinical Study Sites plus one centralized DCC. Together, they will carry out an integrated treatment clinical trial that explicitly combines treatment for alcohol use disorder (AUD) with treatment of liver disease. The patient populations highlighted for this integrated trial are those with severe alcohol-associated hepatitis (sAH) and those with decompensated alcohol-associated cirrhosis (deAC). The intent is not just to evaluate liver-focused interventions in isolation, but to test approaches that address ongoing alcohol use and addiction treatment as an essential part of improving liver-related and overall health outcomes, including biomedical measures, psychosocial functioning, and quality of life.

The core purpose of the DCC under this U24 is to provide the technical and operational backbone for the network's common-protocol clinical trial as well as to support ancillary studies conducted by individual sites. In practical terms, the DCC is expected to deliver expertise and infrastructure for data management (such as developing and maintaining databases and data pipelines, ensuring data quality, and supporting standardized data collection across sites), statistical analysis (including trial design support, interim and final analyses, and harmonized analytic methods), biospecimen collection coordination (helping standardize procedures and tracking for biologic samples gathered across the network), and broad logistical support. Because this is a cooperative agreement and a network program, the DCC role is fundamentally collaborative: it enables consistent execution across multiple clinical sites, reduces variability in how data and samples are collected and handled, and supports reliable cross-site analyses that can inform clinical practice for these high-risk patient groups.

Eligibility is broad across many U.S.-based organization types commonly allowed for NIH discretionary health funding (CFDA 93.273), including various levels of government (state, county, city/township, special districts), public and private institutions of higher education, federally recognized Native American tribal governments, tribal organizations, public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (excluding small businesses in one category but also listing small businesses separately), and other eligible entities. The NOFO also calls out specific categories 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, and U.S. territories or possessions. At the same time, it clearly restricts foreign involvement: non-U.S. entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed. In other words, the funded DCC and its activities must be fully domestic.

The opportunity was posted with a creation date of March 6, 2024, and an original application closing date of April 24, 2024. The NOFO does not provide an award ceiling or expected number of awards in the summary data provided, but by design it is oriented toward funding the single DCC function for the network. Overall, the grant is aimed at ensuring AlcHepNet has a centralized, expert hub to run a complex, multi-site clinical trial and related studies focused on integrating AUD treatment with liver disease care for patients facing severe alcohol-associated hepatitis and decompensated alcohol-associated cirrhosis.

• 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 Data Coordinating Center (U24 - 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 2024-03-06.
• 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 24 005

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