NIDDK is issuing this Notice of Special Interest (NOSI) in response to the urgent need for research on how coinfection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent for Coronavirus Disease 2019 (COVID-19), might affect HIV-associated comorbidities, coinfections, and complications (CCCs) within its mission. NIDDK supports biomedical research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases. For this funding opportunity announcement, NIDDK is interested in studies to elucidate if COVID-19 might provoke or exacerbate noncommunicable gastrointestinal, liver, kidney/urological and metabolic/endocrine diseases in people with HIV (PWH) or worsen the consequences of viral hepatitis coinfection. Conversely, it is also important to elucidate whether people with HIV (PWH) with CCCs within the mission of NIDDK have different COVID-19 outcomes. Studies are expected to align with the HIV/AIDS research priorities outlined by the NIH Office of AIDS Research (OAR) in NOT-OD-20-018 UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding.

Background

The current COVID-19 pandemic is having a substantial public health impact in the United States and there are currently no approved coronavirus cures or therapeutics. Although the pathogenic mechanisms associated with COVID-19 infection are poorly understood, there is emerging recognition of severe gastrointestinal manifestations, endocrine/metabolic disorders, and acute kidney injury associated with COVID-19. Likewise, gastrointestinal, endocrine/metabolic, and kidney/urological CCCs result in significant pathology in PWH. Research on whether and how coinfection with SARS-CoV-2 provokes or worsens these CCCs therefore is urgently warranted.

Moreover, many HIV CCCs within NIDDK's mission may put people at risk for worse COVID-19 outcomes. These include obesity, diabetes, metabolic disease, kidney disease, noncommunicable liver disease, and viral hepatitis. Therefore, research on the impact of pre-existing CCCs within the mission of the NIDDK on the severity of COVID-19 disease is also urgently needed.

Research Objectives

NIDDK encourages the submission of applications for Competitive Revisions to active grants to address the following research areas of interest:

• Collection of biosamples that could yield pathophysiologic insights into the impact of COVID-19 on HIV-associated CCCs within the mission of the NIDDK; especially those related to the gastrointestinal, liver, renal/urological, and metabolic/endocrine systems.
• Studies to gather data from health care systems and ongoing cohort studies to elucidate whether PWH with CCCs within the mission of the NIDDK have different COVID-19 outcomes.
• Studies that utilize nonhuman primate or ex vivo human models to characterize the effect of HIV-SARS-CoV-2 coinfection on gastrointestinal, liver, renal/urological, and metabolic/endocrine systems and processes.
• Studies to elucidate how HIV and SARS-CoV-2 coinfection impacts kidney or liver damage severity mediated by antiretroviral drugs.
• Pilot clinical studies designed to understand the natural history of COVID-19 related to either provoking or exacerbating HIV-associated CCCs within the mission of NIDDK, or to evaluate strategies for preventing or treating HIV-associated CCCs within the mission of NIDDK in the context of SARS-CoV-2 coinfection.

Application and Submission Information

Submit applications for this initiative using the following funding opportunity announcement (FOA) or its subsequent reissued equivalent:

• PA-18-935: Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

Revision applications can support a significant expansion of the scope and research protocol approved and funded for the parent award on which the revision application is based. Prospective investigators can consult the Scientific/Research Contacts listed below to ensure that projects will considerably contribute to achieving the goal of this Notice.

The NIDDK will only accept applications in response to this Notice for the following activity codes: R01, RC2, P01, U2C, UH3, U01, P50, U54, R41, R42, R43 and R44

Application budgets are limited to the current year direct cost budget, or $500,000 direct costs (whichever is less), exclusive of consortium F&A costs, and must reflect the actual needs of the proposed project.

The parent award must be active when the supplement/revision application is submitted (e.g. within the originally reviewed and approved project period), regardless of the time remaining on the current project.

All instructions in the SF424 (R&R) Application Guide and and PA-18-935 must be followed, with the following additions:

• For funding consideration, applicants must include NOT-DK-20-020 in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Applications nonresponsive to the terms of this Notice will not be considered for this initiative.
• All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package.
• Competitive revision applications to PA-18-935 must use the application form package with the Competition ID of NOT-DK-20-020-FORMS-E." This FOA will be reissued with a NOT-DK-20-020-FORMS-F package on May 25, 2020. Submissions to the reissued FOA will be accepted on or after May 25, 2020 through the expiration date of this Notice.

Projects with one or more components that are not aligned with the HIV/AIDS research priorities outlined by the NIH Office of AIDS Research (OAR) in NOT-OD-20-018 will not be supported by this FOA.

Applicants are strongly encouraged to discuss any application in response to this NOSI with the scientific program staff listed below.