External Funding Announcements

Release Date: July 5, 2022

Full Announcement

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

PA-20-183- NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-184- NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-185: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-194, NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-195- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-196- NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

Early Pregnancy loss (EPL), defined as a pregnancy loss occurring up to 20 weeks gestation, is a very common pregnancy complication, occurring in 12-15% of clinically recognized pregnancies, with increased prevalence associated with increasing maternal age. The use of highly sensitive hCG assays allows the detection of pregnancy earlier in gestation than the time of clinical recognition, and gives an even higher estimated loss of 50-70% of conceptions prior to the second trimester. To achieve a successful pregnancy, a series of strict embryonic and maternal conditions must be met, that include high quality embryos, favorable conditions for embryo implantation, receptive maternal endometrium and optimal uterine environment to sustain the conceptus to term. In addition, maternal immune tolerance and hormonal factors play a critical role. While approximately half of all cases of EPL appear to be due to embryonic aneuploidy, very little is known about the physiologic and pathophysiologic processes that underlie non-aneuploid EPL. As a result, there is also a lack of understanding for the underlying causes of recurrent pregnancy loss (RPL). This NOSI seeks to address these critical knowledge gaps by encouraging basic, translational and clinical studies on biological processes that may uncover potential etiologies of EPL and RPL. This includes research to understand implantation mechanistically and identify a range of key factors, involved in implantation and placentation that are important for early pregnancy establishment, including abnormalities that contribute to sporadic EPL and recurrent pregnancy loss.

The major gaps that this NOSI targets include, but are not limited to the following

Discovering novel contributing factors that disturb embryo implantation, placenta development, endometrial receptivity and decidualization that lead to EPL, as well as the mechanisms that govern these processes
Investigation into maternal- and paternal-derived factors in gametes that may be responsible for EPL
Errors in epigenetic reprogramming in gametes and preimplantation embryo and early pregnancy loss
Studies of immunological disorders (e.g., inflammatory cytokines, NK cell dysfunction) that contribute to EPL
Uncovering male factor contribution and underlying mechanisms that lead to EPL
Development of new model systems that allow mechanistic investigation
Studies of nutrition factor contribution to EPL (e.g., over- or under- nutrition and vitamin/protein factors)
Studies of dynamic communication between endometrium and embryo
Of Special Interest:

Studies that explore immune system interactions between endometrium and placenta or embryo

Model systems that allow mechanistic investigation of multi-component interactions – e.g., organoids and organs on a chip

Studies focused on the following topics will be given low priority unless there is a clear demonstration that they provide special advantages (diagnostics, risk prediction) over current approaches.

Genomic abnormalities, such as aneuploidy, and genetic determinants
Maternal Infections
Uterine structure anomalies, such as adenomyosis, intrauterine adhesions and fibroid

Release Date: January 22, 2025

Estimated Publication Date of Notice of Funding Opportunity: March 3, 2025

First Estimated Application Due Date: May 20, 2025

Earliest Estimated Award Date: December 1, 2025

Earliest Estimated Start Date: December 1, 2025

Estimated Total Funding: $3M total cost in each of FY 2026, 2027, and 2028.

Expected Number of Awards: Up to 2

Estimated Award Ceiling: Application budgets are limited to $1M per year in direct costs.

Full announcement

This notice was issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The purpose of this announcement is to alert the research community of the upcoming publication of a Notice of Funding Opportunity (NOFO) for NICHD Program Project Grants for HIV Research. These Program Project (P01) applications will support integrated, multi-project research programs to address HIV scientific areas relevant to the NICHD mission as a well-defined, central research focus or objective. 

The new NOFO will use the NIH Program Project (P01) to conduct and support laboratory research, clinical trials, and studies that explore health processes in HIV scientific areas. NICHD researchers examine growth and development, biologic and reproductive functions, behavior patterns, and population dynamics to protect and maintain the health of all people; and to examine the impact of disabilities, diseases, and defects on the lives of individuals. With this information, the NICHD hopes to restore, increase, and maximize the capabilities of people affected by disease and injury.

This HIV/AIDS P01 NOFO aims to strengthen existing and foster new collaborations in areas of HIV research that could benefit from enhanced multidisciplinary approaches. The work will include NICHD populations of interest including infants, children, adolescents, and women (including pregnant and lactating).

The topics proposed should be in alignment with the NICHD Strategic Plan and the NIH/OAR HIV/AIDS research priorities.

The areas of interest include topics in the following themes:

1) Research to understand changes in immune status and inflammation in HIV exposure or infection and co-infection in the maternal fetal/dyad, during pregnancy including metabolic, hormonal, gut microbiome and virome changes on brain and organ development. Understanding the role that innate immunity plays in the immune response early in life and in response to vaccines and immune based therapies.

2)The use of new technologies from different fields including advanced statistical modeling, Artificial Intelligence (AI) to better track NICHD priority populations in the HIV epidemic and its evolution and co-occurrence in other epidemics/pandemics is encouraged.

3) Development and validation of methods to predict outcomes and inform intervention strategies for HIV prenatal and pregnancy testing, linkage to care, and treatment (i.e., antiretrovirals, contraceptives and multipurpose-prevention technologies, immune-prophylaxis) to improve reproductive health.

4) Basic, biobehavioral, and translational HIV science research to understand altered immune crosstalk in pregnancy, placenta, and fetus, including interaction with environment, biome, nutrition, co-infections, and co-morbidities on the development of the immune system.

5) Research on the effects of HIV and HIV treatment on fertility, pregnancy and post-partum outcomes, complications, co-morbidities, and co-infections including sexually transmitted infections (STIs).

6) Research on the effects of HIV and HIV treatment on reproductive system pathology, male and female urogenital system conditions, fertility, sexual maturation, nutrition, growth, endocrine, and bone development.

7) The study of adverse outcomes related to antiretroviral medications, HIV and co-infections and co-morbidities. 

8) Research on different approaches to vaccine development and HIV cure may be needed for individuals with evolving immune status. Research on the establishment of HIV reservoirs in different developmental stages, acute vs chronic infection and the type, quality, durability, vulnerability, and preferred cell type (stem cells) of the reservoirs needs further elucidation, especially in understudied populations such as pregnant women and infants.

9) Research on HIV and the many elements including infection, inflammation, cellular, molecular, and paternal factors that influence development of the immune system in utero and during the postnatal period.

P01 Program Project

The P01 application must include:

• An administrative Core
• A minimum of three (3) individual research projects that contribute to the program objective. 

The P01 application can include:

• Cores: Scientific/technical cores are optional for this announcement, but applicants may include one or more cores for the proposed research projects. 
• Clinical trials are optional
• Use of relevant secondary data derived from HIV studies.

Publication Date: December 4, 2024

First Application Due Date: June 17, 2025

Earliest Estimated Start Date: April 1, 2026

Estimated Total Funding: $2M in FY 2026

Expected Number of Awards: 2 to 4

Estimated Award Ceiling: The combined budget for direct costs for the 2-year project period may not exceed $275,000. No more than $200,000 may be requested in a single year.

Full announcement

NIH and other funders have invested billions of dollars in the collection of data to inform our understanding of substance use and disorder etiology, neurodevelopmental risk, epidemiology, prevention, treatment, and services, as well as associated HIV risk behaviors and outcomes. Yet much of these data have not been analyzed to their full potential, and further investigation provides opportunities to answer novel research questions at relatively low cost. Existing data provide unique opportunities to better understand interactions between intrapersonal and environmental factors and substance use and disorder (defined as alcohol, tobacco, prescription, and other substance use and disorder), as well as factors related to disease patterns and progressions, and variations in response to preventive interventions and substance use disorder (SUD) treatment and HIV services utilization. 

Existing Data Sets: The National Institute on Drug Abuse (NIDA) is particularly interested in the utilization of the Adolescent Brain Cognitive DevelopmentSM study (ABCD) data set to inform the development of more powerful computational and analytic approaches that capture the interactions among biological, environmental, behavioral, cultural and familial factors and how they predict risk or resilience to substance use. Applicants using the ABCD data set, and others where appropriate, are required to include a plan to pre-register plans for statistical analyses with a publicly accessible registry or as a registered report at a journal.

This mechanism also may be used to analyze cross-sectional or longitudinal behavioral, health services, neuroimaging, and social science data from other NIDA funded studies or from other sources, including state and local data. Proposed research must bedistinct from previously/currently funded research using these data. Applicants are encouraged to collaborate with investigators holding private data sets, use innovative statistical strategies to link methodologically comparable datasets, or utilize public use and administrative data readily available. 

Specific Areas of Research Interest include but are not limited to the following approaches or topic areas:

• Estimate the magnitude, impact, and risk of substance use and disorder in a population and provide direction for developing strategies to prevent or treat substance use and disorder, plan and evaluate SUD services, and suggest new areas for basic, clinical, and treatment research;
• Identify state-level factors or policies that contribute to or prevent overdose mortality;
• Describe, discriminate, and predict the complex nature and course of substance use and disorder, elucidate factors predicting substance use and disorder trajectories such as the impact of psychiatric comorbidity, environmental or contextual influences, or gene X environment interplay;
• Identify risk factors and consequences of substance use or use disorder associated with health disparate populations, such as those with high prevalence and/or intensity of use or who experience disparate outcomes from use (e.g., race/ethnicity, sex, sexual identity, age, disability, socioeconomic status, geographic location, comorbid mental health or SUD diagnoses, individuals with physical disabilities, veterans/military, and criminal justice populations), analyses on these characteristics or other social determinants of health that affect development and could lead to interventions to ameliorate the impact. 
• Examine gender differences in the nature and extent of substance-using behaviors, in the pathways and determinants of initiation, progression and maintenance of alcohol and other SUD, differential responsivity to preventive interventions, and in the utilization of SUD treatment services. For more information on these topics, see NOT-OD-15-102 "Consideration of Sex as a Biological Variable in NIH-funded Research";
• Characterize through model-based simulations or combinations of multiple data sources, the differential trajectories among groups of individuals who initiate and use drugs, including recovery trajectories (both with and without access to formal treatment and informal supports), and structural, systemic, or individual-level barriers to implementation and utilization of prevention, treatment, and other life-saving services;
• Analyses of the organizational and system contexts that improve the accessibility, utilization, efficiency, effectiveness, and quality of prevention intervention, treatment implementation, and service delivery, including variation in factors such as organizational structure, manpower characteristics, training, policy context, shifting attitudes towards drug use, and drug availability;
• Identify effective clinical shared decision-making factors in the prevention and treatment of SUD and related disorders;
• Examine morbidity (e.g., disability status) and mortality (suicide and other causes of death) outcomes of substance use and disorder behaviors and potential mitigating interventions at the state and local level to improve public health impact;
• Understand how structural interventions, including policies at the federal, state, and local level influence initiation of use, progression to misuse, addiction, and recovery from disordered use of substances such as cannabis, tobacco, prescription drugs, and other substances. Studies may consider unintended consequences of interventions and other health outcomes. Analysis of differential effects of these interventions on various health disparity groups (racial, ethnic, gender minorities) are encouraged;
• Analyses of individual developmental trajectories using brain, cognitive, emotional, academic, and/or other data, including examination of associations among measures of neurocognition, language use, brain structure and function.
• Analyses of developmental trajectories and their variability resulting from exposure to substance use, including in utero, and identification of risk or ameliorating factors that impact those trajectories;
• Identification of reliable biobehavioral signatures and/or cultural and familial factors that predict risk to or protection from SUD, mental illness, and other health outcomes;
• Analyses of neurobiological mechanisms underlying real-world complexities associated with SUD – e.g., polysubstance use, complex morbidity involving SUD and other neuropsychiatric disorders, transdiagnostic risk factors;
• Development and application of whole-brain computational models that integrate multimodal data (e.g., structural imaging, fMRI, PET) towards understanding mechanisms underlying SUD and the impact of behavioral/pharmacological interventions;
• Development of innovative analytical and/or visualization tools for complex datasets (e.g., large-scale longitudinal data; multimodal data including brain, behavior, and genetics) including the use of artificial intelligence approaches (e.g., machine learning, natural language processing, neural networks, deep learning, large language models).

NIDA also intends to commit funds towards research that is in alignment with NIDA’s HIV priority areas, including but not limited to:

• Identify factors to improve the efficiency, effectiveness, quality and utilization of treatment and prevention services for substance use disorder and related disorders (e.g. HIV) both in traditional substance treatment settings and in non-traditional settings such as criminal justice, schools, and primary care settings;
• Identifying factors to further understand substance use and HIV/AIDS pathogenesis and improve prevention services (including pre-exposure prophylaxis for high risk individuals), service delivery, testing and treatment for individuals living with HIV;
• Use data on HIV/AIDS pathogenesis and viral suppression to understand the roles played by substance use in these processes and associated HIV clinical outcomes.
• Research to understand how social determinants of health, stigma, discrimination and racism contribute to and perpetuate disparities in HIV and substance use service use and outcomes.
• Increase the understanding of polysubstance use patterns and their associations with HIV acquisition, participation in HIV prevention and care services, as well as HIV clinical outcomes.
• Use the epidemiological data to generate models to drive targeted response/mitigation strategies to address HIV and viral hepatitis outbreaks in people who use drugs.
• Provide models for conducting emulated clinical trials from observational clinical and population-based cohorts.

Publication Date: December 4, 2024

First Application Due Date: June 17, 2025

Earliest Estimated Start Date: April 1, 2026

Estimated Total Funding: $2M in FY 2026

Expected Number of Awards: 2 to 4

Estimated Award Ceiling: The combined budget for direct costs for the 2-year project period may not exceed $275,000. No more than $200,000 may be requested in a single year.

Full announcement

NIH and other funders have invested billions of dollars in the collection of data to inform our understanding of substance use and disorder etiology, neurodevelopmental risk, epidemiology, prevention, treatment, and services, as well as associated HIV risk behaviors and outcomes. Yet much of these data have not been analyzed to their full potential, and further investigation provides opportunities to answer novel research questions at relatively low cost. Existing data provide unique opportunities to better understand interactions between intrapersonal and environmental factors and substance use and disorder (defined as alcohol, tobacco, prescription, and other substance use and disorder), as well as factors related to disease patterns and progressions, and variations in response to preventive interventions and substance use disorder (SUD) treatment and HIV services utilization. 

Existing Data Sets: The National Institute on Drug Abuse (NIDA) is particularly interested in the utilization of the Adolescent Brain Cognitive DevelopmentSM study (ABCD) data set to inform the development of more powerful computational and analytic approaches that capture the interactions among biological, environmental, behavioral, cultural and familial factors and how they predict risk or resilience to substance use. Applicants using the ABCD data set, and others where appropriate, are required to include a plan to pre-register plans for statistical analyses with a publicly accessible registry or as a registered report at a journal.

This mechanism also may be used to analyze cross-sectional or longitudinal behavioral, health services, neuroimaging, and social science data from other NIDA funded studies or from other sources, including state and local data. Proposed research must bedistinct from previously/currently funded research using these data. Applicants are encouraged to collaborate with investigators holding private data sets, use innovative statistical strategies to link methodologically comparable datasets, or utilize public use and administrative data readily available. 

Specific Areas of Research Interest include but are not limited to the following approaches or topic areas: 

• Estimate the magnitude, impact, and risk of substance use and disorder in a population and provide direction for developing strategies to prevent or treat substance use and disorder, plan and evaluate SUD services, and suggest new areas for basic, clinical, and treatment research;
• Identify state-level factors or policies that contribute to or prevent overdose mortality; 
• Describe, discriminate, and predict the complex nature and course of substance use and disorder, elucidate factors predicting substance use and disorder trajectories such as the impact of psychiatric comorbidity, environmental or contextual influences, or gene X environment interplay;
• Identify risk factors and consequences of substance use or use disorder associated with health disparate populations, such as those with high prevalence and/or intensity of use or who experience disparate outcomes from use (e.g., race/ethnicity, sex, sexual identity, age, disability, socioeconomic status, geographic location, comorbid mental health or SUD diagnoses, individuals with physical disabilities, veterans/military, and criminal justice populations), analyses on these characteristics or other social determinants of health that affect development and could lead to interventions to ameliorate the impact. 
• Examine gender differences in the nature and extent of substance-using behaviors, in the pathways and determinants of initiation, progression and maintenance of alcohol and other SUD, differential responsivity to preventive interventions, and in the utilization of SUD treatment services. For more information on these topics, see NOT-OD-15-102 "Consideration of Sex as a Biological Variable in NIH-funded Research";
• Characterize through model-based simulations or combinations of multiple data sources, the differential trajectories among groups of individuals who initiate and use drugs, including recovery trajectories (both with and without access to formal treatment and informal supports), and structural, systemic, or individual-level barriers to implementation and utilization of prevention, treatment, and other life-saving services;
• Analyses of the organizational and system contexts that improve the accessibility, utilization, efficiency, effectiveness, and quality of prevention intervention, treatment implementation, and service delivery, including variation in factors such as organizational structure, manpower characteristics, training, policy context, shifting attitudes towards drug use, and drug availability; 
• Identify effective clinical shared decision-making factors in the prevention and treatment of SUD and related disorders;
• Examine morbidity (e.g., disability status) and mortality (suicide and other causes of death) outcomes of substance use and disorder behaviors and potential mitigating interventions at the state and local level to improve public health impact;
• Understand how structural interventions, including policies at the federal, state, and local level influence initiation of use, progression to misuse, addiction, and recovery from disordered use of substances such as cannabis, tobacco, prescription drugs, and other substances. Studies may consider unintended consequences of interventions and other health outcomes. Analysis of differential effects of these interventions on various health disparity groups (racial, ethnic, gender minorities) are encouraged;
• Analyses of individual developmental trajectories using brain, cognitive, emotional, academic, and/or other data, including examination of associations among measures of neurocognition, language use, brain structure and function.
• Analyses of developmental trajectories and their variability resulting from exposure to substance use, including in utero, and identification of risk or ameliorating factors that impact those trajectories.
• Identification of reliable biobehavioral signatures and/or cultural and familial factors that predict risk to or protection from SUD, mental illness, and other health outcomes;
• Analyses of neurobiological mechanisms underlying real-world complexities associated with SUD – e.g., polysubstance use, complex morbidity involving SUD and other neuropsychiatric disorders, transdiagnostic risk factors;
• Development and application of whole-brain computational models that integrate multimodal data (e.g., structural imaging, fMRI, PET) towards understanding mechanisms underlying SUD and the impact of behavioral/pharmacological interventions;
• Development of innovative analytical and/or visualization tools for complex datasets (e.g., large-scale longitudinal data; multimodal data including brain, behavior, and genetics) including the use of artificial intelligence approaches (e.g., machine learning, natural language processing, neural networks, deep learning, large language models).

NIDA also intends to commit funds towards research that is in alignment with NIDA’s HIV priority areas, including but not limited to:

• Identify factors to improve the efficiency, effectiveness, quality and utilization of treatment and prevention services for SUD and related disorders (e.g. HIV) both in traditional substance treatment settings and in non-traditional settings such as criminal justice, schools, and primary care settings;
• Identifying factors to further understand substance use and HIV/AIDS pathogenesis and improve prevention services (including pre-exposure prophylaxisfor high risk individuals), service delivery, testing and treatment for individuals living with HIV;
• Use data on HIV/AIDS pathogenesis and viral suppression to understand the roles played by substance use in these processes and associated HIV clinical outcomes.
• Research to understand how social determinants of health, stigma, discrimination and racism contribute to and perpetuate disparities in HIV and substance use service use and outcomes.
• Increase the understanding of polysubstance use patterns and their associations with HIV acquisition, participation in HIV prevention and care services, as well as HIV clinical outcomes.
• Use the epidemiological data to generate models to drive targeted response/mitigation strategies to address HIV and viral hepatitis outbreaks in people who use drugs.
• Provide models for conducting emulated clinical trials from observational clinical and population-based cohorts.

Forecasted Date: December 24, 2024

Estimated Publication Date of Notice of Funding Opportunity: July 1, 2025

Estimated Application Due Date: September 25, 2025

Estimated Award Date: July 1, 2026

Earliest Estimated Start Date: August 1, 2026

Estimated Total Funding: $9M 

Expected Number of Awards: 8

Estimated Award Ceiling: $1M 

Full Announcement

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to promote a new initiative by publishing a Notice of Funding Opportunity (NOFO) to solicit applications for research on the intersection of alcohol and HIV/AIDS.

The new Funding Opportunity Announcement (NOFO) will�use the NIH Program Project (P01) mechanism to support cross-cutting research on alcohol and HIV/AIDS. NIAAA seeks to encourage research that can be translated into interventions in order to reduce infection and transmission of HIV. The goals of the proposed center must be consistent with the priorities as described in the NIH Office of AIDS Research (OAR), NIH Strategic Plan for HIV and HIV-Related Research.

The NOFO will solicit applications for human studies that will advance operations or implementation research in the context of alcohol and HIV/AIDS by facilitating the development of: (1) broader systems approaches for monitoring complex HIV and alcohol-related patient outcomes including frailty, morbidity and mortality, and (2) interventions to reduce the impact of alcohol and alcohol-related comorbidities on HIV disease progression and transmission in the context of aging. Research funded under the NOFO should serve to advance the next generation of intervention studies to address alcohol use from prevention to treatment of HIV. Intervention studies should inform implementation efforts to improve provision of alcohol-related interventions and treatments for people living with HIV (PWH) in healthcare and community settings. This proposed research initiative is aligned with the research priorities set forth in the NIAAA Strategic Plan for Research and the NIH Strategic Plan for HIV and HIV-Related Research. 

These research areas include, but are not limited to, alcohol use and alcohol use disorders as risk factors for HIV and associated noncommunicable diseases. Elucidate pathogenesis of HIV-associated comorbidities, coinfections, and complications:

Study etiology, cofactors, pathogenesis, disease progression, and consequences of coinfections including those that contribute significantly to HIV acquisition, transmission, and viral persistence after therapy such as opportunistic infections, treatment-related, concomitant disease or substance use disorder, and other major causes of comorbidities.

Investigate the pathogenesis of HIV-associated non-communicable diseases (NCDs) across the life-span and in diverse populations, including but not limited to malignancies, cardiovascular disease, diabetes, substance use disorder, and neurocognitive disorders, and their interactions with HIV. Elucidate behavioral and social factors and processes:

Expand the identification and analysis of behavioral, interpersonal, social, and structural factors, processes, dynamics, and contexts that influence and are influenced by HIV. Elucidate causal chains between HIV-associated factors, processes, dynamics, and contexts and their differential outcomes in prevention, treatment, co-occurring conditions, and cure in diverse populations and settings.

Investigate the associations among and impacts of co-occurring behavioral and social factors, such as mental health, substance use, social support, and resilience, with respect to HIV risk, acquisition, transmission, disease progression, care, and cure. Promote community-engaged and community-led HIV research: Enhance models of effective academic and community research partnerships, community-based participatory research, and community-initiated research in diverse settings. Support studies that identify factors that facilitate or impede effective community engagement in HIV research at all stages. Evaluate the impact of community engagement in HIV testing, prevention, treatment, care, and cure-directed concept/studies. Use established guidance, frameworks, and principles to inform meaningful and intentional community-engaged and community-led research.

Develop and evaluate community-led interventions that address communities specific biomedical, behavioral, and social needs and priorities, including those focused on HIV-associated intersectional stigma and discrimination, as well as mental health and substance use.