Opportunity Information: Apply for RFA DA 26 007
This NIH grant opportunity (RFA-DA-26-007) invites R01 research applications focused on the biology that sits at the intersection of sex hormones, HIV infection, and addictive substances. The central goal is to support mechanistic studies that clarify how sex hormones shape the health and biological consequences of co-occurring HIV and substance use, and then use that mechanistic understanding to identify or validate biological pathways that could serve as therapeutic targets for HIV and substance use disorder (SUD) comorbidity. In practical terms, the NOFO is aimed at foundational, molecular-to-systems research that explains "how it works" rather than testing an intervention in people; clinical trials are not allowed under this announcement.
The scientific emphasis is on molecular targets and mechanisms. Applicants are expected to move beyond descriptive associations and instead propose studies that can delineate causal pathways linking sex hormones (and potentially their receptors, downstream signaling, metabolism, and regulatory networks) to HIV-related processes and to the biological effects of addictive substances. The opportunity is tailored to research that explains why and how hormone-related biology may alter HIV pathogenesis, immune responses, viral persistence, inflammation, neurobiology, or other HIV-relevant outcomes in the context of drug exposure, and conversely how addictive substances may modify hormone-linked pathways that matter for HIV outcomes. A strong application would typically connect these threads into a coherent mechanistic model and include a clear plan for how findings could nominate actionable targets (for example, receptor pathways, signaling nodes, epigenetic regulators, metabolic enzymes, or immune mediators) that might eventually be leveraged to reduce harm from the combined burden of HIV and SUD.
A major compliance requirement in this NOFO is the Plan for Enhancing Diverse Perspectives (PEDP). The PEDP is not optional; it is a required component that will be evaluated during scientific and technical peer review. Applications submitted without a PEDP will be deemed incomplete and withdrawn, which means they will not proceed to review. The NOFO explicitly encourages applicants to carefully follow the PEDP instructions and consult the associated guidance materials. In essence, NIH is signaling that teams should thoughtfully address how diverse perspectives will be meaningfully incorporated into the proposed research effort, and that this plan is part of the application quality bar rather than a perfunctory add-on.
From an administrative standpoint, this is a discretionary grant using the R01 mechanism, offered under CFDA 93.279, and administered by the National Institutes of Health. The original application due date is March 13, 2025. The listed award ceiling is $400,000. The opportunity record indicates expected awards but does not specify a number in the provided text, so applicants would need to consult the full announcement for any institute-specific funding expectations and budget guidance.
Eligibility is broad and includes many common applicant types such as public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and a wide range of governmental entities (state, county, city/township, special districts, independent school districts), as well as public housing authorities and Indian housing authorities. Tribal eligibility includes federally recognized Native American tribal governments and Native American tribal organizations (other than federally recognized tribal governments). The NOFO also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities, meaning foreign organizations are allowed to apply.
Overall, the announcement is aimed at accelerating biologically grounded research that can explain hormone-related differences and mechanisms in the intertwined problems of HIV and substance use, with an explicit expectation that these mechanistic insights will point toward future therapeutic strategies. The combination of the "clinical trials not allowed" restriction and the focus on molecular targets signals a priority for rigorous mechanistic work, while the PEDP requirement makes it clear that NIH also expects applicants to demonstrate a credible, well-integrated plan for incorporating diverse perspectives into the research approach and team environment.Apply for RFA DA 26 007
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advancing Research on Molecular Targets and Mechanisms that Influence the Interplay Between Sex Hormones, HIV, and Addictive Substances (R01 Clinical Trials 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 2024-08-15.
- Applicants must submit their applications by 2025-03-13. (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 $400,000.00 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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Frequently Asked Questions (FAQs): NIH R01 RFA-DA-26-007
1) What is the main purpose of this NIH funding opportunity (RFA-DA-26-007)?
This opportunity invites R01 research applications that focus on the biology at the intersection of sex hormones, HIV infection, and addictive substances. The goal is to support mechanistic research that explains how sex hormones shape the health and biological consequences of co-occurring HIV and substance use, and to use that understanding to identify or validate biological pathways that could serve as future therapeutic targets for HIV and substance use disorder (SUD) comorbidity.
2) What kind of research is NIH looking for under this announcement?
NIH is looking for foundational mechanistic studies (molecular-to-systems) that clarify causal pathways. Applications are expected to move beyond descriptive associations and propose research that can delineate how sex hormones (including receptors, downstream signaling, metabolism, and regulatory networks) interact with HIV-related processes and with the biological effects of addictive substances.
3) Are clinical trials allowed under this NOFO?
No. Clinical trials are not allowed under this announcement. The emphasis is on explaining "how it works" biologically rather than testing an intervention in people.
4) What is meant by a "mechanistic" focus in this NOFO?
A mechanistic focus means the proposed work should aim to identify and test causal biological pathways rather than report correlations. The NOFO emphasizes molecular targets and mechanisms, such as hormone receptors, signaling nodes, epigenetic regulators, metabolic enzymes, immune mediators, and other actionable components that help explain HIV and substance-related biology.
5) What scientific topics are explicitly emphasized?
The scientific emphasis includes how hormone-related biology may alter HIV pathogenesis, immune responses, viral persistence, inflammation, neurobiology, or other HIV-relevant outcomes in the context of drug exposure. It also includes the reverse direction: how addictive substances may modify hormone-linked pathways that matter for HIV outcomes.
6) Does the NOFO require studies to connect sex hormones, HIV biology, and addictive substances together?
Yes. A strong application would typically connect these elements into a coherent mechanistic model and explain how the proposed research links sex hormones to HIV-related processes in the context of substance exposure (and/or how substances affect hormone-linked pathways relevant to HIV outcomes).
7) What does NIH mean by identifying or validating "therapeutic targets" in this context?
The NOFO seeks mechanistic insights that can nominate actionable biological pathways that might eventually be leveraged to reduce harm from the combined burden of HIV and SUD. Examples mentioned include receptor pathways, signaling nodes, epigenetic regulators, metabolic enzymes, or immune mediators.
8) Is descriptive or association-based research sufficient for this opportunity?
No. The NOFO indicates applicants are expected to move beyond descriptive associations and propose studies that can delineate causal pathways linking sex hormones to HIV-related processes and the effects of addictive substances.
9) What funding mechanism is being used?
This is offered under the NIH R01 research project grant mechanism.
10) What is the CFDA number listed for this opportunity?
The opportunity is listed under CFDA 93.279.
11) Which agency administers this grant opportunity?
It is administered by the National Institutes of Health (NIH).
12) What is the application due date?
The original application due date is March 13, 2025.
13) What is the award ceiling listed in the provided information?
The listed award ceiling is $400,000.
14) Does the provided information state how many awards NIH expects to make?
No. The record indicates expected awards but does not specify a number in the provided text. Applicants would need to consult the full announcement for any institute-specific funding expectations.
15) What is the Plan for Enhancing Diverse Perspectives (PEDP), and is it required?
The PEDP (Plan for Enhancing Diverse Perspectives) is a required component of the application under this NOFO. It is not optional and will be evaluated during scientific and technical peer review.
16) What happens if an application is submitted without a PEDP?
Applications submitted without a PEDP will be deemed incomplete and withdrawn, meaning they will not proceed to review.
17) How important is the PEDP to peer review?
The PEDP is explicitly evaluated during scientific and technical peer review, and NIH signals that it is part of the application quality bar rather than a perfunctory add-on.
18) What types of organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofits (501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); small businesses; and many governmental entities (state, county, city/township, special districts, independent school districts), as well as public housing authorities and Indian housing authorities.
19) Are tribal organizations eligible?
Yes. Eligibility includes federally recognized Native American tribal governments and Native American tribal organizations (other than federally recognized tribal governments).
20) Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The NOFO highlights eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, and faith-based and community-based organizations.
21) Are federal agencies eligible to apply?
Yes. The NOFO lists eligible federal agencies among eligible applicants.
22) Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are listed as eligible applicants.
23) Are foreign (non-U.S.) organizations allowed to apply?
Yes. The opportunity states that non-domestic (non-U.S.) entities are eligible, meaning foreign organizations are allowed to apply.
24) Does this NOFO prioritize any particular overall outcome or impact?
Yes. It is aimed at accelerating biologically grounded research explaining hormone-related differences and mechanisms in the intertwined problems of HIV and substance use, with the expectation that mechanistic insights will point toward future therapeutic strategies.
25) What is the key practical takeaway about the scope of work?
The scope is rigorous mechanistic biology focused on molecular targets and causal pathways, not human intervention testing. Applications should integrate the HIV, substance use, and sex hormone dimensions into a coherent mechanistic framework and include a compliant, well-integrated PEDP.
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