NIDA Avant-Garde Program for HIV and Substance Use Disorder Research (DP1 Clinical Trial Optional)

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Description

This opportunity, offered by the National Institute on Drug Abuse (NIDA) at NIH, funds individual scientists of exceptional creativity to pursue innovative, high-risk/high-reward research that opens new areas in HIV/AIDS science relevant to substance use or substance use disorders (SUD). The program seeks proposals that are substantially different from the applicant’s or others’ current research, with the potential for transformative impact on HIV prevention, treatment, or cure among people who use drugs.

Projects may be basic, clinical, translational, or implementation research, and may include (but are not limited to):

• Novel strategies to prevent HIV transmission in high-risk substance-using populations
• Approaches to improve outcomes of HIV and HIV-related comorbidities in people with SUD
• Research to achieve functional or sterilizing cure of HIV in the context of substance use
• Studies using populations, samples, in vitro systems, or animal models relevant to substance use and HIV

Applicants must clearly articulate the nexus between substance use and the proposed HIV research, and demonstrate how the work is distinct from ongoing projects.

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Due Dates

• Letter of Intent: July 1, 2025 (30 days prior to application deadline; not required but strongly encouraged)
• Application Deadline: August 15, 2025 (by 5:00 PM local time of applicant organization)
• Reference Letters Deadline: August 15, 2025 (three required, no more than three; must be received by deadline)
• Earliest Start Date: April 2026

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Funding Amount

• Direct Costs: Up to $700,000 per year
• Project Period: Up to 5 years (maximum $3.5 million direct costs)
• Facilities & Administrative (F&A) costs: Determined at time of award; do not include in budget request
• Number of Awards: Contingent on NIH appropriations and program priorities

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Eligibility

Eligible Organizations

• 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

Eligible Individuals

• Any individual with the skills, knowledge, and resources to carry out the proposed research
• Only one PD/PI per application (no multiple PD/PI applications)
• NIH intramural investigators are not eligible
• Must commit at least 35% research effort (4.2 person months/year) to the project if awarded

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Application Process

• Letter of Intent: Email to NIDALetterofIntent@mail.nih.gov with project title, PD/PI name and contact, key personnel, institutions, and funding opportunity number.

• Application Submission: Use NIH ASSIST, Grants.gov Workspace, or institutional S2S system.

• Required Registrations: SAM, eRA Commons, Grants.gov (can take 6+ weeks; start early).

• Application Components:

  • Research Strategy: Upload as an essay (no detailed scientific plan; focus on vision, innovation, and how the work differs from current research).
  • Biographical Sketch: For PD/PI only (omit personal statement and research support sections).
  • Current and Pending Support: For PD/PI.
  • Letters of Support: From significant collaborators.
  • Reference Letters: Three required, submitted directly by referees via NIH Reference Letter system by the application deadline.
  • No budget forms required: Enter only the five-year total ($3.5M) in the application.
  • No Specific Aims page or additional key personnel biosketches.
  • Data Management and Sharing Plan: Required for all applications.

• Clinical Trials: Applications may propose or not propose clinical trials.

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Additional Information

• Review Criteria: Emphasis on the significance and potential impact of the research, innovation, and the applicant’s creativity and potential for transformative science.
• Distinct Research Direction: The proposed project must be a new research direction, not an extension of ongoing funded work.
• Reference Letters: Applications missing reference letters or with late letters will not be reviewed.
• Effort Commitment: Awardees must devote at least 35% of their research effort to the project.
• Foreign Applicants: Non-U.S. organizations and foreign components are eligible.
• Data Sharing: All applications must include a Data Management and Sharing Plan in accordance with NIH policy.

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External Links

• NIH Funder Home Page
• Full Funding Opportunity Announcement (PAR-25-261)
• Grants.gov Opportunity Listing
• NIH HIV/AIDS Research Priorities (NOT-OD-20-018)
• NIH Application Guide
• Reference Letter Submission Portal

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Contact Information

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