HIV Prevention and Alcohol (R34 Clinical Trials Optional)

The U.S. Department of Health and Human Services, through the National Institutes of Health and its component, the National Institute on Alcohol Abuse and Alcoholism (NIAAA), has announced the reissue of the funding opportunity titled HIV Prevention and Alcohol (R34 Clinical Trials Optional). This opportunity is listed under Funding Opportunity Number PAS-25-161 and is paired with a companion opportunity, PAS-25-208, which is an R01 Research Project. The program supports pilot clinical trials that address HIV prevention within populations impacted by alcohol use. It is aligned with the NIH’s overall strategic priorities for reducing HIV incidence and supporting public health interventions. The purpose of this Notice of Funding Opportunity (NOFO) is to support planning studies that are both necessary and sufficient to inform the design and execution of subsequent larger clinical trials under the companion R01 announcement. Applications should demonstrate that the proposed R34 activities are critical for the development of a future Phase II, III, or IV clinical trial intended to test efficacy, safety, or implementation of interventions for HIV prevention. Studies may be pragmatic and should be structured to provide results that directly inform trial readiness without requiring further preliminary research. The scope of eligible research includes behavioral, biomedical, and social science interventions focused on high-risk populations where alcohol use plays a significant role in HIV acquisition or transmission. Specific groups of interest include men who have sex with men, sex workers, HIV-serodiscordant couples, women with high-risk partners, pregnant women living with HIV, and individuals newly released from incarceration. Research approaches may include examining pre-exposure prophylaxis (PrEP) adherence, treatment as prevention (TasP), alcohol screening and intervention, community and place-based prevention models, and syndemic approaches that address alcohol-related comorbidities such as trauma and violence. Applicants are encouraged to incorporate innovative methodologies such as mHealth, virtual reality, and real-time monitoring of alcohol use behaviors. Funding availability for this NOFO includes an estimated total of $1,500,000 for fiscal year 2025, supporting approximately 2 to 4 awards. The budget for individual projects may not exceed $450,000 in direct costs across the three-year project period, with no more than $225,000 allowed in any single year. Awards will be administered according to NIH Grants Policy and may last up to three years. Applications that do not focus on intervention design for HIV prevention or that propose animal studies or basic research without translational intent will be deemed non-responsive. Eligibility for this grant is broad and includes U.S. and foreign entities, with categories spanning higher education institutions, nonprofit and for-profit organizations, tribal entities, local and state governments, federal agencies, and community-based organizations. Independent school districts and public housing authorities are also eligible. Applicants must have appropriate registrations completed in SAM.gov, Grants.gov, and eRA Commons prior to submission, and principal investigators must have active eRA Commons accounts. No cost-sharing or matching is required. Applications from non-U.S. organizations or those with foreign components are permitted. The application process requires electronic submission through Grants.gov, with forms accessed via NIH ASSIST, Grants.gov Workspace, or institutional system-to-system solutions. Letters of Intent, while optional, are strongly encouraged and must be submitted 30 days prior to the application due date. For this NOFO, AIDS-related applications are due on May 7, 2025; September 7, 2025; January 7, 2026; and May 7, 2026. All applications are due by 5:00 PM local time of the applicant organization. The expiration date for this opportunity is May 8, 2026. Peer review will follow NIH standards, including evaluation of significance, innovation, rigor, feasibility, investigator expertise, and institutional environment. For assistance, applicants can contact the NIAAA Office of Extramural Activities at [email protected] for letters of intent. Specific scientific and research contacts include Kendall Bryant, Ph.D. (301-402-0332, [email protected]), Robert Freeman, Ph.D. (301-443-8820, [email protected]), Deidra Roach, M.D. (301-443-5820, [email protected]), Joe Wang, Ph.D. (301-451-0747, [email protected]), and John Matochik, Ph.D. (301-451-7319, [email protected]). Financial and grants management inquiries should be directed to Judy Fox (301-443-4704, [email protected]). This funding opportunity provides a critical resource for advancing integrated HIV and alcohol research aimed at reducing incidence, improving treatment outcomes, and addressing health disparities.