Opportunity Information: Apply for RFA DA 25 024

The National Institutes of Health (NIH) is soliciting applications for the High Priority HIV and Substance Use Research program (R01 Clinical Trial Optional), Funding Opportunity Number RFA-DA-25-024. This discretionary grant opportunity is designed to fund high-impact research that sits squarely at the intersection of HIV and substance use, with a clear emphasis on work that can push the field forward in meaningful ways. The central goal is to support innovative projects that either open up new directions in HIV/AIDS research or generate practical new avenues for HIV prevention, treatment, and potentially cure, specifically for people who use drugs (PWUD). The announcement makes it clear that the substance use connection cannot be incidental; applicants must explicitly describe and justify the nexus between HIV and substance use in their proposed work.

The scope is intentionally broad, covering the full research pipeline from basic and mechanistic science through clinical studies and implementation research. In other words, NIH is not limiting this to one type of methodology or setting. Projects might focus on biological mechanisms that link substance use to HIV acquisition, persistence, or comorbidities; clinical approaches that improve HIV outcomes among PWUD; or real-world service delivery and implementation strategies that increase uptake, adherence, retention, or equity in HIV prevention and care for substance-using populations. Clinical trials are allowed but not required, which gives applicants flexibility to propose either trial-based interventions or non-trial research designs, as long as the scientific rationale and public health importance are compelling.

Applications are expected to be mature and well-developed. NIH requires a detailed research plan and preliminary data, signaling that this FOA is looking for proposals that are ready to execute and have evidence supporting feasibility and scientific premise. A strong application will also align clearly with the NIH HIV/AIDS Research Priorities described in NOT-OD-20-018 (Update: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding). That alignment is not a formality; the FOA states that all studies must focus on these NIH HIV/AIDS priorities, so applicants need to map their aims and outcomes to those guidelines in a direct and readable way.

Eligibility is expansive and includes both individual investigators and collaborative research teams, reflecting NIH interest in both single-lab innovation and multi-disciplinary efforts. Eligible applicant organizations include a wide range of domestic entities such as state, county, and municipal governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicants 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 (AANAPISISs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations. This broad eligibility signals an interest in reaching diverse communities and enabling research capacity across many institutional types and geographies, including settings where HIV and substance use burdens may be concentrated.

From an administrative standpoint, this is an NIH grant using the R01 mechanism, categorized under Education and Health, with CFDA number 93.279. The opportunity was created on 2024-08-02, and the original closing date listed is 2027-02-11. While the award ceiling and expected number of awards are not specified in the provided source information, applicants should plan around typical NIH R01 expectations: a rigorous scientific premise, clear and measurable aims, strong methodological detail, appropriate protections for human subjects when applicable, and a realistic approach to recruitment and retention if working with PWUD populations. Overall, this FOA is best read as a call for well-substantiated, high-priority HIV research that takes substance use seriously as a driver of risk, outcomes, and disparities, and that can produce actionable knowledge for prevention, treatment, care delivery, and long-term progress toward ending the HIV epidemic among people who use drugs.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "High Priority HIV and Substance Use Research (R01 Clinical Trial Optional)" 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 2024-08-02.
  • Applicants must submit their applications by 2027-02-11.
  • 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 25 024

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Frequently Asked Questions (FAQs)

What is the name of this funding opportunity?

This opportunity is the National Institutes of Health (NIH) High Priority HIV and Substance Use Research program (R01 Clinical Trial Optional).

What is the Funding Opportunity Number (FOA)?

The Funding Opportunity Number is RFA-DA-25-024.

Which agency is offering this grant?

The grant is offered by the National Institutes of Health (NIH).

What type of grant mechanism is being used?

This opportunity uses the NIH R01 research project grant mechanism.

Are clinical trials required?

No. Clinical trials are allowed but not required. The FOA is labeled "Clinical Trial Optional," so applicants may propose either clinical trial or non-trial research designs, as long as the scientific rationale and public health importance are strong.

What is the main purpose of this program?

The central purpose is to fund high-impact research at the intersection of HIV and substance use, with a focus on projects that can meaningfully advance the field and generate actionable knowledge for HIV prevention, treatment, and potentially cure, specifically for people who use drugs (PWUD).

Does the application need to focus on both HIV and substance use?

Yes. The FOA emphasizes that the substance use connection cannot be incidental. Applicants must explicitly describe and justify the nexus between HIV and substance use in the proposed work.

What populations is this program especially concerned with?

The program highlights people who use drugs (PWUD) as a key focus, particularly in relation to HIV prevention, treatment, care, and outcomes.

What kinds of research are within scope?

The scope is intentionally broad and spans the full research pipeline, including basic and mechanistic science, clinical studies, and implementation research focused on real-world service delivery and uptake.

Can projects focus on biological mechanisms linking substance use and HIV?

Yes. The FOA explicitly includes research on biological mechanisms that link substance use to HIV acquisition, HIV persistence, or HIV-related comorbidities.

Can projects focus on improving HIV outcomes among people who use drugs?

Yes. Clinical approaches intended to improve HIV outcomes among PWUD are within the described scope.

Can implementation and service delivery research be proposed?

Yes. The FOA includes implementation strategies aimed at increasing uptake, adherence, retention, or equity in HIV prevention and care for substance-using populations.

How developed does the project need to be at the time of application?

Applications are expected to be mature and well-developed. NIH requires a detailed research plan and preliminary data, which signals an emphasis on feasibility and a strong scientific premise.

Is preliminary data expected?

Yes. The FOA indicates that preliminary data are required, supporting feasibility and the scientific premise of the proposed research.

Are applicants required to align with NIH HIV/AIDS Research Priorities?

Yes. The FOA states that all studies must focus on the NIH HIV/AIDS Research Priorities described in NOT-OD-20-018 (Update: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding). Applicants should map aims and outcomes clearly to those guidelines.

What is NOT-OD-20-018 and why does it matter here?

NOT-OD-20-018 is the NIH notice describing HIV/AIDS Research Priorities and guidelines used to determine HIV/AIDS funding. This FOA requires that proposed studies focus on these priorities, so proposals should explicitly show how the project aligns with them.

Who is eligible to apply?

Eligibility is broad and includes individual investigators and collaborative research teams, with eligible applicant organizations spanning many domestic entity types and also including non-U.S. (foreign) organizations.

What types of U.S. organizations are eligible to apply?

Eligible U.S. applicants include (as listed in the provided information): state, county, and municipal governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.

Are minority-serving institutions specifically encouraged or included as eligible applicants?

Yes. The FOA explicitly highlights eligibility for institutions 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 (AANAPISISs).

Are faith-based and community-based organizations eligible?

Yes. The provided opportunity information explicitly includes faith-based or community-based organizations among eligible applicants.

Are U.S. territories or possessions eligible?

Yes. The FOA includes U.S. territories or possessions among eligible applicants.

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

Yes. Non-U.S. (foreign) organizations are explicitly listed as eligible applicants in the provided information.

Are federal agencies eligible to apply?

Yes. The opportunity information includes eligible federal agencies among eligible applicants.

Is this opportunity limited to one discipline or methodology?

No. NIH is not limiting this FOA to one methodology or setting. The FOA supports diverse approaches, from mechanistic studies to clinical and implementation research, provided the work clearly sits at the HIV and substance use intersection.

What category is this opportunity listed under?

The opportunity is categorized under Education and Health.

What is the CFDA number associated with this opportunity?

The CFDA number provided is 93.279.

When was this opportunity created?

The opportunity was created on 2024-08-02.

What is the closing date for this funding opportunity?

The original closing date listed is 2027-02-11.

Is the award ceiling specified?

No. The provided information does not specify an award ceiling.

Is the expected number of awards specified?

No. The provided information does not specify the expected number of awards.

What does NIH seem to be emphasizing for a strong application?

Based on the provided description, NIH is emphasizing well-substantiated, high-priority work with a detailed research plan, preliminary data, a clear and justified HIV-substance use nexus, and direct alignment with NIH HIV/AIDS Research Priorities (NOT-OD-20-018).

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