HIV Prevention and Alcohol (R34 Clinical Trials Optional) | PAS 25 161

Opportunity Information: Apply for PAS 25 161

The HIV Prevention and Alcohol (R34 Clinical Trials Optional) funding opportunity (PAS 25-161) is a National Institutes of Health grant led by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) that focuses on strengthening HIV prevention efforts for people and communities affected by alcohol use. The central idea is that alcohol use, whether episodic (for example, binge drinking) or long-term, can increase HIV acquisition risk through behavioral pathways (such as higher likelihood of condomless sex or reduced adherence to prevention behaviors) and biological pathways (such as alcohol-related changes that may affect susceptibility). This NOFO aims to expand the HIV prevention toolkit for these alcohol-impacted populations by encouraging research that integrates effective HIV prevention and relevant treatment approaches, while also generating practical, cross-cutting knowledge that can help reduce new infections.

This announcement uses the R34 mechanism, which is intended for clinical trial planning and pilot work rather than running a full-scale efficacy or implementation trial. The purpose is to support studies that are both necessary and sufficient to plan a subsequent clinical trial that would fit under the companion R01 announcement, HIV Prevention and Alcohol (R01 Clinical Trials Optional). In practical terms, applicants are expected to clearly describe the clinical trial they ultimately want to run (typically a Phase II, III, or IV trial) and then justify why the proposed R34 activities are essential to design that trial properly. The NIAAA is signaling that the R34 work should directly answer key scientific or operational questions needed for the future trial, and that the results should be sufficient to move forward without needing additional preliminary studies. These pilot or planning studies may be pragmatic in nature, meaning they can focus on real-world constraints and feasibility issues that commonly determine whether a larger trial can succeed.

The future, planned trial must be primarily aimed at HIV prevention and should test intervention efficacy, safety, clinical management strategies, or implementation approaches. The interventions can include prevention and treatment elements, as long as the main endpoint and intent remain HIV prevention. Overall, the R34 is positioned as a bridge between an idea for an HIV prevention intervention in alcohol-impacted populations and a well-designed larger clinical trial, by funding targeted work that reduces uncertainty and improves trial readiness.

Key administrative details include an award ceiling of $450,000 and an original application closing date of May 7, 2026. The opportunity is categorized as discretionary funding, uses the grant funding instrument, and falls under the health activity category (CFDA 93.273). Eligibility is broad and includes many types of U.S. and non-U.S. organizations: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities. The NOFO also explicitly highlights additional eligible applicant categories such as Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities. The opportunity was created on November 25, 2024, and is administered through NIH/NIAAA.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "HIV Prevention and Alcohol (R34 Clinical Trials Optional)" 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 2024-11-25.
• Applicants must submit their applications by 2026-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $450,000.00 in funding.
• 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 PAS 25 161

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