Opportunity Information: Apply for RFA DA 25 021
The National Institutes of Health (NIH) funding opportunity titled "Effect of HIV and Substance Use Comorbidity on the Placenta and Maternal Outcomes (R01 Clinical Trial Optional)" (Funding Opportunity Number RFA-DA-25-021) supports research projects aimed at understanding how HIV infection and exposure to antiretroviral therapy (ART) affect the placenta and, in turn, maternal and pregnancy outcomes, especially when substance use or misuse is also present. The public health backdrop for this program is substantial: HIV remains common among people of reproductive age, and UNAIDS estimated that about 1.3 million people living with HIV become pregnant each year (2019). While ART has dramatically improved prevention of mother-to-child (vertical) transmission, accumulating evidence shows that some ART regimens are linked with increased risks such as preterm birth, stillbirth, and early infant death. This opportunity is built around the idea that the placenta is a central driver of pregnancy health, and that disruptions to placental development and function can have downstream effects on both the pregnant individual and the fetus.
A major motivation for the announcement is the current lack of detailed data on placental changes associated with HIV and ART exposure. Even less is known when HIV/ART exposure occurs alongside substance use, which is a common real-world comorbidity and may introduce additional biological stressors, including inflammation, vascular dysfunction, altered immune responses, and other pathways that could plausibly affect placental structure and performance. The intent is to encourage rigorous investigation into these overlapping exposures so researchers can better explain why adverse outcomes may be more frequent in certain HIV-treated pregnancies and how substance use might intensify or modify those risks. In practical terms, projects funded under this opportunity would be expected to connect HIV status, ART exposure patterns, and substance use characteristics with measurable placental outcomes and clinically meaningful maternal or birth outcomes, helping to fill a clear knowledge gap that affects pregnancy care and perinatal health.
This is an R01 grant mechanism, meaning it is designed for substantial, hypothesis-driven research programs with a clear plan, appropriate expertise, and the ability to generate impactful findings. The announcement notes that clinical trials are optional, which typically signals that NIH will consider applications that are purely observational or mechanistic, as well as projects that may include an intervention or a clinical trial component if scientifically justified. The activity category is listed under education and health, and the CFDA number associated with the program is 93.279. The opportunity is categorized as discretionary funding and uses the grant funding instrument.
Eligibility is broad and includes many types of organizations that commonly conduct biomedical and public health research. Eligible applicants include state, county, city, township, and 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 that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses); small businesses; and other entities. The announcement also explicitly highlights additional eligible applicant groups 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). It further includes faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) organizations, reflecting an interest in encouraging applications that can address HIV in pregnancy across diverse settings and populations.
Key logistical details provided include an original closing date of November 15, 2024, and a creation date of October 30, 2023. An award ceiling is not specified in the provided source, and the expected number of awards is also not listed. Overall, the opportunity is aimed at advancing scientific understanding of how HIV, ART, and substance use together influence placental biology and maternal outcomes, with the longer-term goal of informing safer clinical management of HIV in pregnancy and improving birth outcomes in populations facing overlapping infectious disease and substance use burdens.Apply for RFA DA 25 021
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Effect of HIV and Substance Use Comorbidity on the Placenta and Maternal Outcomes (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 2023-10-30.
- Applicants must submit their applications by 2024-11-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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)
What is the title and funding opportunity number for this NIH grant?
The opportunity is titled "Effect of HIV and Substance Use Comorbidity on the Placenta and Maternal Outcomes (R01 Clinical Trial Optional)." The Funding Opportunity Number is RFA-DA-25-021.
What is the main purpose of this funding opportunity?
This program supports research projects that examine how HIV infection and exposure to antiretroviral therapy (ART) affect the placenta, and how those placental effects relate to maternal and pregnancy outcomes. A major emphasis is understanding these relationships when substance use or misuse is also present.
What public health need is this opportunity responding to?
The opportunity responds to the continuing prevalence of HIV among people of reproductive age and the reality that many people living with HIV become pregnant each year (UNAIDS estimated about 1.3 million in 2019). Although ART has greatly improved prevention of vertical transmission, some ART regimens have been linked with adverse outcomes such as preterm birth, stillbirth, and early infant death. The program is designed to address gaps in understanding why these outcomes may occur.
Why is the placenta a focus of the research supported by this RFA?
The program is built on the idea that the placenta is central to pregnancy health. Disruptions to placental development and function can affect both the pregnant individual and the fetus. NIH is seeking studies that clarify how HIV, ART exposure, and substance use may disrupt placental structure and performance and contribute to clinical outcomes.
What specific knowledge gap is NIH trying to fill with this opportunity?
The announcement highlights a lack of detailed data on placental changes associated with HIV and ART exposure. It also notes that even less is known about placental effects and related maternal or pregnancy outcomes when HIV/ART exposure occurs alongside substance use, which is a common comorbidity.
How does substance use fit into the goals of this funding opportunity?
Substance use or misuse is described as a real-world comorbidity that may add biological stressors that plausibly affect the placenta, including inflammation, vascular dysfunction, altered immune responses, and other pathways. The goal is to encourage rigorous investigation into how substance use might intensify or modify risks in HIV-treated pregnancies.
What types of research approaches are expected under this R01?
Projects are expected to connect HIV status, ART exposure patterns, and substance use characteristics to measurable placental outcomes and clinically meaningful maternal or birth outcomes. The opportunity is framed as supporting substantial, hypothesis-driven research with appropriate expertise and a clear plan.
Are clinical trials required for this opportunity?
No. Clinical trials are optional. This means NIH will consider applications that are observational or mechanistic, as well as studies that include an intervention or clinical trial component if it is scientifically justified.
What is the grant mechanism and funding instrument?
The mechanism is an R01, and the opportunity uses the grant funding instrument. R01s are typically used for substantial, hypothesis-driven research programs intended to generate impactful findings.
What is the activity category listed for this opportunity?
The activity category is listed under education and health.
What is the CFDA number associated with this program?
The CFDA number provided is 93.279.
What type of funding is this categorized as?
The opportunity is categorized as discretionary funding.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including government entities, higher education institutions, tribal governments and organizations, nonprofits, for-profits (other than small businesses), small businesses, and other entities. The announcement also indicates eligibility for faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) organizations.
Are state and local governments eligible applicants?
Yes. Eligible applicants include state, county, city, township, and special district governments, as well as independent school districts.
Are colleges and universities eligible to apply?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicants.
Are tribal entities eligible?
Yes. Federally recognized Native American tribal governments are eligible, and tribal organizations that are not federally recognized are also listed as eligible.
Are nonprofits eligible, including those without 501(c)(3) status?
Yes. Nonprofits with 501(c)(3) status (excluding institutions of higher education under that nonprofit category) and nonprofits without 501(c)(3) status (also excluding institutions of higher education under that nonprofit category) are included in the eligibility list.
Are for-profit organizations and small businesses eligible?
Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also eligible.
Does the opportunity encourage applications from specific institution types?
Yes. The announcement explicitly highlights additional eligible applicant groups 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 non-U.S. (foreign) organizations eligible to apply?
Yes. The eligibility list includes non-U.S. (foreign) organizations.
What is the original closing date for this opportunity?
The original closing date provided is November 15, 2024.
What is the creation date of the funding opportunity?
The creation date provided is October 30, 2023.
Is there an award ceiling listed?
No award ceiling is specified in the information provided.
Is the expected number of awards provided?
No. The expected number of awards is not listed in the information provided.
What kinds of outcomes is this opportunity ultimately trying to improve?
The longer-term aim is to improve understanding of how HIV, ART, and substance use together influence placental biology and maternal outcomes, which can inform safer clinical management of HIV in pregnancy and help improve birth outcomes in populations facing overlapping HIV and substance use burdens.
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