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

The High Priority HIV and Substance Use Research (R01 Clinical Trial Optional) grant is offered through the National Institutes of Health (NIH), under the National Institute on Drug Abuse (NIDA). This funding opportunity, identified as RFA-DA-25-024, is a reissue of RFA-DA-22-040 and reflects updates aligning with current agency priorities. The primary objective of this funding opportunity is to support research that investigates the intersection of HIV and substance use, with a focus on projects that may unlock new pathways for HIV/AIDS research or lead to innovative strategies for prevention, treatment, or cure among populations that use addictive substances. NIDA has allocated funding for a wide scope of research approaches—ranging from basic science and epidemiology to clinical interventions and implementation studies—so long as these projects demonstrate a strong connection to substance use or substance use disorders. Successful applications must include a detailed research plan supported by preliminary data. Projects should align with the NIH’s HIV/AIDS Research Priorities, as outlined in NOT-OD-20-018, and may include novel biomedical, behavioral, or integrated strategies for prevention and treatment. Applicants are encouraged to consider unique risk profiles, co-morbidities, and treatment barriers affecting populations who use substances. The scope of allowable research is extensive and includes efforts to reduce stigma, address social determinants of health, expand access to evidence-based treatments like PrEP, and enhance HIV services in overdose prevention settings. Modeling studies to predict HIV hotspots, data aggregation techniques, and longitudinal cohort analyses are also encouraged. Proposals may also include innovative approaches to drug resistance, viral latency, immune responses, neurocognitive disorders, or substance-induced modulation of HIV infection and persistence. Strategies that prioritize populations such as women of color or aging adults with HIV are explicitly welcomed. Applicants may propose clinical trials, but doing so is optional. Foreign and domestic entities are eligible, including higher education institutions, nonprofit organizations, for-profit businesses, tribal governments, and faith-based or community-based organizations. Both new and renewal applications are permitted, as well as revisions and resubmissions. Application budgets are not capped but should correspond to the actual needs of the proposed work. The maximum project period is five years. Applications must be submitted through Grants.gov using NIH’s ASSIST system, institutional system-to-system solutions, or Grants.gov Workspace. Letters of Intent are due 30 days prior to the final application deadline. For AIDS-related applications, the next available deadlines are February 11 and August 13 for each of the years 2025 through 2027. The earliest submission date is January 11, 2025. Applications must be submitted by 5:00 PM local time of the applicant organization and late submissions will not be accepted. Scientific merit reviews will be followed by advisory council reviews and funding decisions, with start dates as early as December of the same year. The funding instrument is a grant, with $3 million expected to be distributed annually from FY2025 through FY2027, supporting 3 to 5 awards each year. Evaluation criteria include the significance, innovation, and feasibility of the research, as well as the investigators' expertise and resources. NIDA provides several key contacts for scientific inquiries, peer review, and financial questions, ensuring that applicants have guidance at every stage of the process.

Ensure strong nexus with substance use and HIV; align with NIH HIV/AIDS research priorities; follow NIH rigor and reproducibility expectations.