Exploratory Studies to Investigate Mechanisms of HIV infection, Replication, Latency, and/or Pathogenesis in the Context of Substance Use Disorders (R01 Clinical Trial Not Allowed) | RFA DA 25 073

Opportunity Information: Apply for RFA DA 25 073

This funding opportunity, RFA-DA-25-073, is a National Institutes of Health (NIH) discretionary grant that uses the R01 mechanism and is specifically designated as "Clinical Trial Not Allowed." The program supports exploratory research focused on uncovering biological and mechanistic links between substance use disorders (SUDs) and key aspects of HIV disease. The central emphasis is on studies that investigate how substance use and SUD-related factors influence HIV infection, viral replication, viral persistence and latency, and HIV-related pathogenesis. The scope also explicitly includes work on HIV-associated neurocognitive disorders (HAND), recognizing that neurological and cognitive outcomes are an important dimension of HIV disease biology, particularly in populations affected by substance use.

The scientific aim is broadly framed around mechanistic questions rather than service delivery, implementation, or clinical intervention testing. In practice, this means the opportunity is looking for research that can explain underlying pathways and processes, such as how specific substances or patterns of use may alter immune function, viral dynamics, tissue reservoirs, neuroinflammation, blood-brain barrier integrity, or other biological systems that shape HIV outcomes. Because the R01 clinical trial option is not allowed here, applicants should plan projects that do not involve assigning human participants to interventions to evaluate health-related outcomes in a way that meets NIH's definition of a clinical trial. Instead, the opportunity is geared toward foundational and translational mechanistic work that can include observational human studies, laboratory-based investigations, animal models, or other approaches appropriate for answering causal or mechanistic questions, as long as they do not cross into prohibited clinical trial territory.

Eligibility is intentionally broad and includes a wide range of domestic and international organizations. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); public housing authorities/Indian housing authorities; and Native American tribal organizations that are not federally recognized tribal governments. The opportunity is also open to nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education where relevant), for-profit organizations other than small businesses, and small businesses. In addition, the announcement highlights expanded eligibility for organizations such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; U.S. territories or possessions; and non-domestic (non-U.S.) entities, meaning foreign organizations are explicitly included among potential applicants.

Key administrative details indicate this is a grant opportunity in the Education and Health activity category with CFDA number 93.279. The award ceiling is listed as $700,000, which signals the upper bound of funding expected per award under the terms of the opportunity. The announcement was created on 2024-09-09, and the original closing date for applications is 2025-08-14. While the expected number of awards is not specified in the provided source data, applicants should interpret the ceiling and the R01 format as pointing toward substantial, multi-aim research projects, provided they remain within the non-clinical-trial constraints and maintain a strong mechanistic focus.

Overall, the opportunity is designed for investigators who want to explain how substance use disorders intersect with HIV biology in ways that could ultimately inform prevention, treatment, and cure-related strategies, including efforts aimed at understanding and disrupting latency and persistent reservoirs. Competitive applications will likely be those that clearly define a mechanistic problem at the HIV-SUD interface, justify why the chosen models and methods can answer that mechanistic question, and articulate how the findings could meaningfully advance the field beyond descriptive associations.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Exploratory Studies to Investigate Mechanisms of HIV infection, Replication, Latency, and/or Pathogenesis in the Context of Substance Use Disorders (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2024-09-09.
• Applicants must submit their applications by 2025-08-14. (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 $700,000.00 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.

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