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

Posting Date: July 14, 2022
Open Date (Earliest Submission Date): September 27, 2022
Letter of Intent Due: 30 days prior to application due date
Due Date: October 27, 2022 and June 27, 2023

Full Announcement

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers.

The over-arching goal of this ORWH R25 program is to support educational activities that complement and/or enhance the training of a diverse workforce to meet the nation’s biomedical, behavioral and clinical research. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

Courses for Skills Development: For example, advanced undergraduate courses in a specific discipline or research area, courses on clinical procedures or specialized research techniques, or community-based courses on topics of relevance to sex and/or gender and health. Specifically, this FOA aims to support courses that develop skills in multidimensional and intersectional health-related research and healthcare delivery. The format of the courses may involve a traditional in-person approach, online activities, a hybrid of both approaches, or other methods.

Curriculum or Methods Development: For example, undergraduate STEMM curricula focused on sex and gender in medicine, advanced curricula to improve biomedical, social and behavioral or clinical science education, or development of novel methods or instructional approaches such as graphic medicine. Proposed curricula or methods should have high potential to improve biomedical, social and behavioral, or clinical research education. Specifically, this FOA aims to support innovative curricula or methods at the undergraduate level or higher that integrate knowledge of sex and gender influences into health-related training or enhance understanding of sex and gender influences on health.

Letter of Intent Due: June 9, 2023
Due Date: June 30, 2023 5:00 PM EDT
Earliest Start Date: September 1, 2023

The Adolescent Trials Network (ATN) is soliciting applications for up to three Site Consortiums (SCs) to join the current Network to maximize recruitment and enrollment in support of the ATN’s scientific agenda. SCs will participate in the development of ATN studies and provide innovative strategies for successful recruitment and enrollment of participants, clinical facilities, local laboratory capacity, and pharmacy support.

A new iteration of ATN with funding from NICHD, NIMH, and NIDA was launched in 2022 through cooperative agreement awards to a Scientific Leadership Center (SLC) and an Operations and Collaboration Center (OCC). Nine SCs were included in the OCC application and are currently active ATN participants.

The ATN develops and conducts innovative behavioral, community-based, translational, therapeutic, microbicide and vaccine trials in youth ages 13-24 years at risk for HIV and living with HIV, with a focus on the inclusion of minors. It is a multi-component project cooperative agreement with a focus on interventional studies, conducted collaboratively and independently, aimed at the reduction of new HIV infections among at-risk youth and improvements in numbers across the HIV care continuum among adolescents and young adults living with HIV. The target populations are medically underserved, low socio-economic status, racial/ethnic minorities (i.e., African American, American Indian, Alaska Native, Asian, Native Hawaiian, or other Pacific Islander, Hispanic), substance using youth, and/or sexual and gender minority (SGM). SGM populations include, but are not limited to, individuals who identify as lesbian, gay, bisexual, asexual, transgender, Two-Spirit, queer, and/or intersex. Individuals with same-sex or -gender attractions or behaviors and those with a difference in sex development are also included. These populations also encompass those who do not self-identify with one of these terms but whose sexual orientation, gender identity or expression, or reproductive development is characterized by non-binary constructs of sexual orientation, gender, and/or sex. Research projects target highly impacted geographic regions and leverage cross-sector collaborations with community and public health authorities, and Federal agencies.

The ATN research agenda will ensure capacity for rapid response to evolving scientific priorities. Research studies will be conducted through the SCs’ multidisciplinary, cross-sectoral collaborative relationships with various participant recruitment resources in their communities (e.g., academic, clinic, health department, community-based organizations [CBOs], online, social media and other virtual health platforms).

A key component of this initiative is leveraging and collaborating with community partners that provide services to youth at risk for and living with HIV to facilitate the implementation of novel, innovative interventions.

Applicants that demonstrate an ability in their Research Strategy to contribute to the Network’s research agenda by providing the following attributes will be given the highest consideration:

 Able to engage community partners to reach 13-24-year-olds living with HIV or at risk of acquiring HIV (e.g., academic, clinic, health department, community-based organizations, emergency room departments, electronic/virtual health platforms, etc.)
 Local regulations that are permissive to the provision of HIV Pre-Exposure Prophylaxis (PrEP) without parental permission.
 Local regulations that are permissive to the provision of gender-affirming medical care to transgender and gender-diverse minors.
 Demonstrated experience in the conduct of investigational new drug (IND) studies.

AWARD INFORMATION

Award Project Period: The proposed project should not exceed 6 years.

Eligible Individuals (Program Director/Principal Investigator): Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Application and Submission Information 

By June 9, 2023, prospective applicants are asked to submit a Letter of Intent that includes the following information:
 Participating Institution(s) and Consortium Name, if applicable
 Name(s) of the PD(s)/PI(s)
 Title of this Solicitation

The letter of intent should be e-mailed to Joy Curvan (joycurvan@westat.com). Address questions to joycurvan@westat.com.

Page Limitations
Applications must be a maximum of six pages. All text must be in Arial 11 point font and single-spaced with 0.5-inch margins.

Instructions for Application Submission

Applications are required to include the following content:

RESEARCH STRATEGY
Clinical, academic, government, community, & other partnerships
 Describe the clinical, academic, government, community, and other partnerships to achieve the ATN research goals and experience in developing and maintaining successful research collaborations.
 Provide a table listing the entities included in each SC (e.g., clinical sites, CBOs).
 Describe existing/prior relationship with consortium members, summarize outcomes of existing/planned collaborations, and anticipated value to ATN.

Organizational structure
 Provide an organizational chart describing the overall SC structure that: demonstrates a cohesive, synergistic, integrated approach to supporting the ATN for which the SC is proposing to affiliate (include a detailed description of lines of authority); and describes plans for a staffing structure, with roles and responsibilities that capitalize on the specific strengths of the SC PD(s)/PI(s), SC Research Coordinator (RC) and Outreach Coordinator (OC).
 For the SC PI and co-PI, describe experience leading and managing a complex HIV/AIDS clinical research operation. Describe facilities that will support implementation of research studies, including investigational pharmacy and laboratories; and address any innovations unique to the organizational structure or processes to facilitate optimal performance to manage, conduct and evaluate clinical research protocol activities.

Provide detailed justification for the proposed affiliation with the ATN and corresponding Network research priority areas.

Performance and past experience:
Describe performance over the previous 5 to 7 years with participation in IND-level or other complex HIV/AIDS multicenter clinical trials or equivalent experience; strengths in overseeing and managing a complex clinical trials enterprise; and challenges experienced in overseeing and managing a complex clinical trials enterprise, as well as activities undertaken to overcome those challenges.

Not included in the six pages:
Letters of Support: Applicants must include at a minimum, a Letter of Support from each SC PI indicating agreement for collaboration with the ATN OCC PD/PI and other partners within the proposed SC, as well as a letter committing support from institutional officials.

NIH Biosketch: for the proposed PD/PI and other Key Personnel, if any.

BUDGET:
Each SC applicant is requested to create a 6-year budget for submission with the application with the following periods of performance:
 9/1/23-6/30/24 and subsequent years 7/1-6/30, through 6/30/29.

Core funding will be provided for:
 Staff and other direct costs;
 Infrastructure expenditures such as maintaining community partnerships;
 Development and management of standard operating procedures;
 Supporting recruitment and retention efforts;
 Conducting regular Community Advisory Board (CAB) meetings; and
 Hosting external site monitoring visits and attending Network Meetings.

Protocol costs (labor and visit costs) are not included in the core costs, as they will be funded separately.

Core labor level of effort is:
 PD/PI 20%
 RC 30%
 OC 100%
 Regulatory Assistant 10%.

Please complete the SF424 form template and a detailed budget justification. Budget questions should be directed to Jackie Loeb (JacquelineLoeb@westat.com).

Application Submission:
Please submit a PDF of your application via e-mail to Joy Curvan at joycurvan@westat.com. Include a subject line indicating ATN Site Consortium Application for “Site Consortium Name.”

Posting Date: April 7, 2023
Open Date (Earliest Submission Date): June 24, 2023
Letter of Intent Due: June 24, 2023
Due Date: July 24, 2023

Full Announcement

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit research to better understand the mechanisms of persistent oral human papillomavirus (HPV) and human immunodeficiency virus (HIV) co-infection as well as its role in the induction and pathogenesis of HPV-associated oropharyngeal cancers (HPV-OPC).

Previous research has found that People with HIV (PWH) have a two- to four-fold increased risk for HPV-OPC as compared to HIV-negative individuals. Recent systematic reviews and meta-analyses of several large longitudinal studies strongly suggest an epidemiologic, synergistic relationship between HIV and HPV. It is well-known that PWH have an increased risk of opportunistic infections which may lead to other severe non-transmissible comorbidities. Such is the case with HPV. Among people without HIV, most oral HPV infections are asymptomatic and clear spontaneously. Yet, PWH are at higher risk for oral transmission, acquisition, and persistent infection of high-risk HPV (e.g., HPV16), all of which are associated with an increase in HPV-OPC. However, there are gaps in our understanding about the underlying mechanisms of oral HPV transmission, acquisition, and early infection in the context of HIV, and how persistent co-infection and biological synergistic interactions of these two viruses impact the induction and pathogenesis of HPV-OPC.

Research is needed to address broad knowledge gaps related to epidemiologic, biological, clinical, and socio-behavioral factors that impact oral HPV transmission, acquisition, early-stage infection, and persistence in the oral cavity and oropharynx in HIV-seropositive individuals, and to further explore the onco-immunologic and onco-genetic mechanisms and pathogenic processes associated with HPV-OPC induction.

This NOFO encourages biological, clinical and/or socio-behavioral research that seeks to determine immunogenetic, onco-genetic and/or onco-immunologic mechanisms underlying oral HPV transmission, acquisition, early-stage infection, and persistence and HIV co-infection and the role in induction and pathogenesis of HPV-OPC. Research involving humans, animals including non-human primates, or in vitro studies are all encouraged.  

Examples of research areas that fall within the scope of this NOFO include, but are not limited to:

• Studying the epidemiology and biology of oral HPV transmission, acquisition, early infection, persistence, and progression in PWH;
• Characterizing the biologic mechanisms underlying synergistic relationships between HIV and oral HPV infection, including clinical observational studies, in vivo experimental studies in animal models, and/or in vitro studies;
• Elucidating mechanisms related to how and to what extent HIV infection affects oral HPV infection, such as immunologic and dynamic pathogenic changes and/or microbiome driven changes in pathogenesis;
• Evaluating the impact of ART on oral microbial and immune pathogenic changes associated with oral HPV transmission, acquisition, early infection and persistence in PWH;
• Uncovering novel pathogenic mechanisms for the development of HPV-OPC in PWH. This would include studies of the onco-genomics and onco-immunology of HPV-OPC and how oral HPV and HIV co-infection contribute to the induction of this condition. Relevant areas include elucidating: biomarkers, high-risk HPV subtypes, molecular or cellular drivers or key mucosal and systemic immunologic components that contribute to oral HPV and HIV co-infection and/or induction of HPV-OPC. 

Posting Date: April 7, 2023
Open Date (Earliest Submission Date): June 24, 2023
Letter of Intent Due: June 23, 2023
Due Date: July 24, 2023

Full Announcement

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit developmental/exploratory research to better understand the mechanisms of persistent oral human papillomavirus (HPV) and human immunodeficiency virus (HIV) co-infection as well as its role in the induction and pathogenesis of HPV-associated oropharyngeal cancers (HPV-OPC).

Previous research has found that People with HIV (PWH) have a two- to four-fold increased risk for HPV-OPC as compared to HIV-negative individuals. Recent systematic reviews and meta-analyses of several large longitudinal studies strongly suggest an epidemiologic, synergistic relationship between HIV and HPV. It is well-known that PWH have an increased risk of opportunistic infections which may lead to other severe non-transmissible comorbidities. Such is the case with HPV. Among people without HIV, most oral HPV infections are asymptomatic and clear spontaneously. Yet, PWH are at higher risk for oral transmission, acquisition, and persistent infection of high-risk HPV (e.g., HPV16), all of which are associated with an increase in HPV-OPC. However, there are gaps in our understanding about the underlying mechanisms of oral HPV transmission, acquisition, and early infection in the context of HIV, and how persistent co-infection and biological synergistic interactions of these two viruses impact the induction and pathogenesis of HPV-OPC.

Research is needed to address broad knowledge gaps related to epidemiologic, biological, clinical, and socio-behavioral factors that impact oral HPV transmission, acquisition, early-stage infection, and persistence in the oral cavity and oropharynx in HIV-seropositive individuals, and to further explore the onco-immunologic and onco-genetic mechanisms and pathogenic processes associated with HPV-OPC induction.

This NOFO encourages biological, clinical and/or socio-behavioral research that seeks to explore immunogenetic, onco-genetic and/or onco-immunologic mechanisms underlying oral HPV transmission, acquisition, early-stage infection, and persistence and HIV co-infection and the role in induction and pathogenesis of HPV-OPC. Research involving humans, animals including non-human primates, or in vitro studies are all encouraged.  

Examples of research areas that fall within the scope of this NOFO include, but are not limited to:

• Exploring biologic mechanisms underlying synergistic relationships between HIV and oral HPV infection;
• Exploring novel mechanisms and the pathogenesis underlying oral HPV persistent infection in the context of PWH;
• Exploring novel pathogenic mechanisms for the development of HPV-OPC in PWH. This would include studies of the onco-genomics and onco-immunology of HPV-OPC and how oral HPV and HIV co-infection contribute to the induction of this condition. Relevant areas include exploring: biomarkers, high-risk HPV subtypes, molecular or cellular drivers or key mucosal and systemic immunologic components that contribute to oral HPV and HIV co-infection and/or induction of HPV-OPC.