The funding opportunity titled "HIV Prevention and Alcohol (R01 Clinical Trials Optional)" is issued by the National Institutes of Health (NIH) through the National Institute on Alcohol Abuse and Alcoholism (NIAAA). This Notice of Funding Opportunity (NOFO), identified by number PAS-25-208, is a reissue of PAS-23-173 and seeks to support laboratory research, clinical trials, and intervention studies focused on alcohol use in the context of HIV prevention. With a focus on diverse alcohol-impacted populations, the NOFO supports integrating evidence-based prevention and treatment interventions that address behavioral and biological risks for HIV acquisition. Applicants are encouraged to align proposals with NIH priorities and use innovative approaches and technologies in research designs.

The primary purpose of this opportunity is to expand the HIV/AIDS prevention toolkit through interventions tailored for populations affected by episodic or long-term alcohol use. Six research areas are of interest: PrEP utilization, treatment as prevention (TasP), integration of preventive strategies, cross-cutting prevention research, syndemic approaches, and implementation and operations research. Research should also address health disparities and prioritize high-risk groups such as MSM, commercial sex workers, and people in low-resourced HIV epicenters. Technological innovation, such as mHealth and real-time alcohol consumption tracking, is encouraged to improve intervention delivery.

The funding will support applications that demonstrate relevance to NIAAA’s mission and NIH’s strategic goals for HIV prevention. Applicants may propose new, resubmission, revision, or renewal applications related to prior RFA-AA-21-016 funding. Research projects may be up to five years in duration and should reflect the actual costs required. A total of $2 million is allocated for FY 2025, with an estimated 2–4 awards to be made, depending on availability of funds.

Eligible applicants include a wide range of institutions and organizations: higher education institutions, local and state governments, tribal entities, nonprofit organizations, small businesses, and foreign organizations. Applications must follow the Research (R) Instructions in the NIH Application Guide and be submitted electronically via ASSIST, Grants.gov Workspace, or institutional systems. Key pre-application steps include registration in SAM.gov, obtaining a UEI, and ensuring compliance with data sharing and human subject research policies.

Applications are due on NIH standard AIDS due dates, including May 7, 2025; September 7, 2025; January 7, 2026; and May 7, 2026. Letters of intent should be submitted 30 days prior to each due date. The earliest start dates range from December 2025 through December 2026, depending on the application cycle. Review criteria include the importance of the research, feasibility, rigor, and expertise and resources of the research team.

Applications must not focus solely on patients already in HIV care without addressing TasP, include vertebrate animals, or fail to translate behavioral/biological findings into intervention activities. NIH policies on clinical trials, data management, and ethical compliance apply. Awardees must also follow HHS standards for health IT, cybersecurity, and mandatory disclosures. Contacts for scientific, peer review, and grants management support are provided in the NOFO.