High Priority HIV and Substance Use Research (R01 Clinical Trial Optional)

The National Institute on Drug Abuse (NIDA) has issued the High Priority HIV and Substance Use Research (R01) funding opportunity to encourage research addressing the critical intersection of HIV and substance use. This Notice of Funding Opportunity (NOFO) aims to advance understanding and develop strategies for HIV prevention, treatment, and possible cure among individuals affected by substance use and substance use disorders (SUDs). The initiative seeks innovative research in basic science, epidemiology, clinical studies, and implementation science to open new avenues in HIV and substance use research. Applicants must propose studies aligned with NIH’s HIV/AIDS research priorities, specifically targeting areas like HIV transmission prevention, disease pathogenesis, and improved health outcomes in populations using addictive substances.

Research applications are expected to include preliminary data and a well-defined connection to substance use. NIDA encourages diverse research approaches, including innovative intervention methods, models predicting HIV hotspots related to substance use, and studies on HIV-related comorbidities, especially in aging and at-risk populations. Special areas of interest include interventions for reducing stigma, increasing PrEP uptake among methamphetamine users, integrating HIV care with overdose prevention, and testing non-opioid pain management for aging individuals with HIV. Research on strategies for ART-free remission, the interaction of HIV in the central nervous system (CNS), and the influence of substances on HIV replication are also prioritized.

This funding opportunity mandates a Plan for Enhancing Diverse Perspectives (PEDP), underscoring NIH’s commitment to inclusivity in scientific research. This plan must outline strategies to include diverse perspectives throughout the project’s development and execution, and it will be evaluated during peer review. Applications that omit a PEDP will be deemed incomplete and disqualified from review.

The grant allows for a maximum project period of five years, with NIDA committing approximately $3 million annually from 2025 to 2027, expecting to fund between three and five projects each year. Award budgets are not predetermined but must reflect the actual needs of the proposed research.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and governmental bodies, including federally recognized tribal governments. International entities are also eligible. All applicants must ensure they are registered in the System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE), eRA Commons, and Grants.gov well ahead of the application deadline, as late applications will not be accepted. Specific deadlines for submissions are February 11 and August 13 each year through 2027.

Applications will undergo peer review, focusing on the scientific merit of the proposal, the rigor and feasibility of the approach, and the qualifications of the research team. Reviews will also consider factors such as human and animal subject protections and the PEDP. The final funding decisions will be based on scientific merit, alignment with NIDA’s priorities, and availability of funds. Selected projects will be required to provide annual updates on PEDP implementation.

For assistance, NIDA provides contact information for submission inquiries, peer review questions, and scientific or administrative guidance. This NOFO aligns with NIH policies for scientific rigor, transparency, and diversity, reinforcing NIH’s commitment to advancing research that addresses HIV and substance use in diverse and impacted populations.