HIV Prevention and Alcohol (R01 Clinical Trials Optional)

---

Description

This opportunity from the National Institutes of Health (NIH), led by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), seeks to expand the HIV/AIDS prevention toolkit for populations impacted by alcohol use. The focus is on research that addresses the behavioral and biological risks for HIV acquisition associated with episodic and long-term alcohol use, including mental health and substance use comorbidities.

The program supports the development, testing, and implementation of new or expanded interventions, as well as integration of effective prevention and treatment strategies in diverse settings and populations. Six primary research areas are emphasized:

• PrEP Utilization
• Treatment as Prevention (TasP)
• Integration of Preventive Intervention Strategies
• Prevention-related Cross-cutting Research
• Syndemic Approaches
• Implementation and Operations Research

Projects may include laboratory, clinical, epidemiological, and intervention studies, and may propose clinical trials (optional). Research should address high-risk groups (e.g., MSM, sex workers, serodiscordant couples, women with high-risk partners, individuals in HIV “hot spots,” etc.) and may incorporate innovative technologies, measurement, and analytic approaches.

---

Due Dates

• September 7, 2025 (AIDS - New/Renewal/Resubmission/Revision)
• January 7, 2026 (AIDS - New/Renewal/Resubmission/Revision)
• May 7, 2026 (AIDS - New/Renewal/Resubmission/Revision)

All applications are due by 5:00 PM local time of the applicant organization. Letters of intent are requested 30 days before the application due date.

---

Funding Amount

• NIH expects to fund 2–4 awards in FY2025, with a total of $2,000,000 available.
• Application budgets are not limited but must reflect actual project needs.
• Maximum project period: 5 years.
• No cost-sharing requirement.
• For direct costs of $500,000 or more in any year, applicants must contact a Scientific/Research Contact at least 6 weeks before submission.

---

Eligibility

Eligible applicants include:

• Public/State and Private Institutions of Higher Education
• Nonprofits (with or without 501(c)(3) status)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Public housing authorities/Indian housing authorities
• Native American tribal governments and organizations (federally recognized and other)
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Non-domestic (non-U.S.) entities (foreign organizations) and foreign components of U.S. organizations

There are no citizenship requirements for the PI, but all applicant organizations must complete required federal registrations (SAM, eRA Commons, Grants.gov).

---

Application Process

• Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the funding announcement.
• Letters of intent (optional but encouraged) should be sent to niaaaoea@mail.nih.gov.
• All required registrations (SAM, eRA Commons, Grants.gov) must be completed prior to submission.
• Applications must include a Data Management and Sharing Plan.
• Clinical trials are optional; applicants must indicate if their project includes a clinical trial.

---

Additional Information

• Applications focusing only on patients in HIV care (not on TasP), those using vertebrate animals, or basic studies not informing intervention translation are not responsive.
• Projects should address health disparities and may use community-based participatory research.
• Data sharing and submission of human subjects data to the NIAAA-sponsored repository are expected.
• Review criteria include significance, innovation, approach, investigator(s), and environment.
• Foreign organizations must use the R&R Budget Form (not modular).

---

External Links

• NIH Funding Opportunity Announcement (PAS-25-208)
• NIH Grants & Funding Main Page
• NIAAA
• NIH Application Guide (Forms-H)
• Apply via Grants.gov

---

Contact Information

For additional contacts, see Section VII. Agency Contacts in the full announcement.