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.
Apply for RFA DA 25 073

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Frequently Asked Questions (FAQs)

What is the funding opportunity number and sponsor?

The opportunity is RFA-DA-25-073 and it is sponsored by the National Institutes of Health (NIH).

What type of grant mechanism is used?

This opportunity uses the NIH R01 grant mechanism, which is generally intended for substantial, multi-aim research projects.

Are clinical trials allowed under this RFA?

No. The opportunity is explicitly designated as "Clinical Trial Not Allowed." Projects should be planned so they do not meet NIH's definition of a clinical trial (for example, assigning human participants to interventions to evaluate health-related outcomes).

What is the main scientific focus of this program?

The program supports exploratory research aimed at uncovering biological and mechanistic links between substance use disorders (SUDs) and key aspects of HIV disease biology.

What kinds of research questions are encouraged?

The emphasis is on mechanistic questions, such as how substance use or SUD-related factors influence HIV infection, viral replication, viral persistence and latency, and HIV-related pathogenesis.

Does the scope include neurological or cognitive outcomes in HIV?

Yes. The scope explicitly includes HIV-associated neurocognitive disorders (HAND), recognizing neurological and cognitive outcomes as an important dimension of HIV disease biology, particularly in populations affected by substance use.

What does "mechanistic" mean in the context of this opportunity?

In this context, "mechanistic" research aims to explain underlying biological pathways and processes (the "how" and "why"), rather than focusing on service delivery, implementation, or testing clinical interventions.

What types of study approaches are consistent with the "Clinical Trial Not Allowed" designation?

Approaches that may fit include observational human studies, laboratory-based investigations, animal models, and other methods appropriate for answering causal or mechanistic questions, as long as they do not cross into prohibited clinical trial territory.

What are examples of biological systems or processes mentioned as relevant?

The opportunity highlights areas such as immune function, viral dynamics, tissue reservoirs, neuroinflammation, and blood-brain barrier integrity, among other biological systems that shape HIV outcomes.

Is this opportunity focused on implementation, service delivery, or clinical intervention testing?

No. The scientific aim is framed around mechanistic biology rather than implementation research, service delivery programs, or clinical intervention testing.

Who is eligible to apply?

Eligibility is broad and includes a wide range of domestic and international organizations, including governments, higher education institutions, nonprofit organizations, for-profit organizations (other than small businesses), and small businesses.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. Non-domestic (non-U.S.) entities are explicitly included among potential applicants.

What types of U.S. government entities are eligible?

Eligible applicants include state, county, city, or township governments; special district governments; and eligible federal agencies.

Are tribal entities eligible?

Yes. Eligible applicants include Native American tribal governments (federally recognized) and Native American tribal organizations that are not federally recognized tribal governments.

Are colleges and universities eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education as well as private institutions of higher education.

Are minority-serving institutions specifically highlighted?

Yes. The announcement highlights expanded eligibility for organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are specifically highlighted among eligible organization types.

Are U.S. territories or possessions included?

Yes. U.S. territories or possessions are included among eligible applicants.

What is the activity category and CFDA number listed?

The opportunity is listed in the Education and Health activity category, with CFDA number 93.279.

What is the maximum (ceiling) award amount?

The award ceiling is listed as $700,000, indicating the upper bound of funding expected per award under the opportunity terms.

When was the announcement created?

The announcement was created on 2024-09-09.

What is the application closing date?

The original closing date for applications is 2025-08-14.

How many awards will be made?

The expected number of awards is not specified in the provided information.

What makes an application likely to be competitive for this RFA based on the description?

Applications are likely to be strongest when they clearly define a mechanistic problem at the HIV-SUD interface, justify why the proposed models and methods can answer that mechanistic question, and explain how the findings would advance the field beyond descriptive associations.

How does the opportunity connect to HIV persistence, latency, and cure-related research?

The description notes that the work can inform prevention, treatment, and cure-related strategies, including efforts aimed at understanding and disrupting HIV latency and persistent reservoirs, as long as the proposed work remains mechanistic and non-clinical-trial in nature.

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