HIV Prevention and Alcohol (R01 Clinical Trials Optional)

The U.S. Department of Health and Human Services, through the National Institutes of Health and its National Institute on Alcohol Abuse and Alcoholism (NIAAA), has issued the reissued funding opportunity PAS-25-208 titled HIV Prevention and Alcohol (R01 Clinical Trials Optional). This program supports research efforts that expand the HIV/AIDS prevention toolkit specifically among populations impacted by alcohol use. The announcement underscores the connection between alcohol use, particularly alcohol use disorder, and barriers to successful HIV prevention, treatment, and overall health outcomes. This initiative builds on the NIH Strategic Plan for HIV and HIV-Related Research, and applications are encouraged to align with NIAAA’s mission to support research on growth, development, health behaviors, and population outcomes in alcohol-using populations affected by HIV. The funding opportunity is designed to support projects that integrate preventive and treatment interventions, expand existing effective strategies, and develop new methods to reduce HIV incidence in alcohol-impacted populations. Six primary areas of research interest are highlighted: pre-exposure prophylaxis (PrEP) utilization, treatment as prevention (TasP), integration of preventive intervention strategies, prevention-related cross-cutting research, syndemic approaches, and implementation and operations research. These areas reflect an emphasis on both biomedical and behavioral approaches, innovative prevention designs, and real-world implementation that can improve outcomes for vulnerable populations. Research that addresses disparities and engages minority and underserved communities is strongly encouraged. Applicants may propose projects in domestic or international contexts. High-risk groups identified include men who have sex with men, particularly younger men of color, commercial sex workers, HIV-serodiscordant couples, pregnant women living with HIV and their infants, individuals who inconsistently use HIV prophylaxis, victims of trauma or violence, individuals released from incarceration, and populations in HIV epicenters such as the U.S. South. The funding announcement further encourages innovative strategies for recruitment and retention of participants, the use of new technologies such as mobile health (mHealth) interventions and real-time data collection tools, and adaptive clinical trial designs. Eligibility is broad. Higher education institutions, both public and private, nonprofit organizations, for-profit organizations including small businesses, state and local governments, tribal governments, school districts, housing authorities, and foreign organizations may apply. Independent school districts, faith-based organizations, and regional organizations are also eligible. Applicants must complete required registrations including SAM.gov, Grants.gov, eRA Commons, and obtain a Unique Entity Identifier. Both domestic and international applicants are eligible to apply, and foreign components of U.S. institutions may also participate. The anticipated budget allows for an estimated two to four awards in fiscal year 2025, with total program funding projected at $2,000,000. Application budgets are not capped but must reflect the actual needs of the project. The maximum project period is five years. Applications requesting $500,000 or more in direct costs in any given year must contact a program officer six weeks in advance. Matching funds are not required. Clinical trials are optional, meaning that applications proposing or not proposing trials will be accepted. Applications follow NIH standard deadlines for AIDS-related research, with the next due date on May 7, 2025, followed by September 7, 2025, January 7, 2026, and May 7, 2026. Letters of intent are due 30 days prior to the application deadlines, although they are not required. Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or institutional system-to-system solutions, with tracking through eRA Commons. The funding opportunity expires on May 8, 2026. Reviews are conducted by NIH scientific review groups, followed by Advisory Council review, with awards issued no earlier than December 2025. Contacts for this opportunity include scientific and research program officers within NIAAA: Dr. Kendall Bryant (301-402-0332, kbryant@mail.nih.gov), Dr. Robert Freeman (301-443-8820, rfreeman@mail.nih.gov), Dr. Deidra Roach (301-443-5820, droach@mail.nih.gov), Dr. Joe Wang (301-451-0747, wangh4@mail.nih.gov), Dr. John Matochik (301-451-7319, John.Matochik@nih.gov), and Dr. Denise Stredrick (301-594-7553, stredrid@mail.nih.gov). Grants management contact is Judy Fox (301-443-4704, jfox@mail.nih.gov). Applicants are reminded that incomplete, noncompliant, or nonresponsive applications will not be reviewed and that timely submission is essential.