HIV Prevention and Alcohol (R01 Clinical Trials Optional)

The HIV Prevention and Alcohol (R01 Clinical Trials Optional) funding opportunity, issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a component of the National Institutes of Health (NIH), aims to address critical intersections between alcohol use and HIV/AIDS prevention. This funding mechanism is a reissue of PAS-23-173 and continues NIH's commitment to integrating biomedical and behavioral approaches to public health challenges. This initiative is supported by other NIH offices such as the Division of Program Coordination, Planning and Strategic Initiatives and the Office of Disease Prevention, and may be co-funded depending on relevance to broader NIH priorities. The funding opportunity supports research that expands the HIV/AIDS prevention toolkit among populations impacted by alcohol. Research efforts can focus on developing, testing, or implementing new or existing prevention and treatment interventions. The priority is on understanding how alcohol use—both episodic and chronic—and associated behavioral and biological factors elevate HIV acquisition risks. Six major research areas are highlighted: Pre-exposure Prophylaxis (PrEP) Utilization, Treatment as Prevention (TasP), Integration of Preventive Intervention Strategies, Cross-cutting Prevention Research, Syndemic Approaches, and Implementation and Operations Research. These areas encompass diverse populations and settings, particularly those with co-occurring mental health and substance use conditions. The scope of the award includes funding for laboratory studies, clinical trials, and epidemiological interventions that investigate how alcohol consumption affects HIV prevention and treatment outcomes. Applications are encouraged to address high-risk populations such as MSM (especially young MSM of color), sex workers, people inconsistently using HIV prophylaxis, trauma victims, individuals recently released from incarceration, and residents of underserved “hot spots” such as the Southern U.S. Proposals are also expected to incorporate innovative technologies, such as passive alcohol sensors, virtual reality tools, mobile health interventions, and advanced analytic methods like agent-based modeling to enhance precision and outreach. Applications must adhere to NIH’s stringent submission guidelines via systems such as ASSIST, institutional system-to-system solutions, or Grants.gov Workspace. The earliest submission date is April 7, 2025, with recurring deadlines specific to AIDS-related applications: May 7, 2025; September 7, 2025; January 7, 2026; and May 7, 2026, all due by 5:00 PM local time. Clinical trials are optional under this opportunity, and foreign organizations or components are eligible to apply. The award mechanism is a research project grant (R01), and while there is no budget ceiling, budgets must be commensurate with project needs. The project period may not exceed five years. Applications must comply with NIH’s data sharing and data management policies. If human subjects are involved, detailed study records must be included. NIH expects adherence to updated requirements related to genomic data sharing and responsible conduct of research. Pre-application requirements such as LOIs are not mandatory unless specified by individual Institutes. Evaluation criteria focus on the importance and innovation of the research, rigor and feasibility of the approach, and the expertise and environment of the investigators. Awards will be made based on scientific merit, relevance to program priorities, and availability of funds. Applicants may contact several scientific leads within NIAAA for questions, including Dr. Kendall Bryant ([email protected]), Dr. Robert Freeman ([email protected]), and others. The funding opportunity will remain open until May 8, 2026. The program anticipates funding 2 to 4 awards in fiscal year 2025 with an estimated total funding pool of $2,000,000. Matching funds are not required. NIH emphasizes the inclusion of underserved populations and health disparity groups in research design and implementation.