Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

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

NOT-OD-20-128 - Notice of Requirement for Electronic Submission of all Administrative Supplements

NOT-OD-20-118 - Guide Notice of Information Highlighting Harmonization and Data Sharing Expectations for Supplement and Revision Projects Addressing Social, Behavioral, Economic and Health Impacts of the COVID-19 Public Health Emergency

NOT-OD-20-018 - UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding

Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is issuing this Notice of Special Interest (NOSI) in response to the need for research on how infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent for Coronavirus Disease 2019 (COVID-19), may affect individuals with HIV and associated comorbidities, coinfections, and complications (CCCs). NICHD supports biomedical research to understand the effects of infection with HIV and SARS-CoV-2 among populations central to the NICHD mission, including pregnant, postpartum, and lactating women, infants, children, adolescents and young adults, people with intellectual and developmental disabilities, and individuals with physical disabilities or mobility impairments. This funding opportunity announcement encourages studies to examine the effect of the COVID -19 pandemic and infection with SARS-CoV-2 on social, behavioral and health outcomes in people with HIV (PLWH). 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 continues to have a profound public health consequence in the United States (US) and globally. SARS-CoV-2 and HIV are considered syndemic since they occur together and disproportionally affect similar vulnerable populations. HIV co-morbidities and/or co-infections are considered risk factors for severe COVID-19 disease and the disruption in services for care and treatment of people living with HIV (PLWH) may have implications on susceptibility to COVID-19 and subsequent transmission of SARS-CoV-2 variants by PLWH with unsuppressed viral loads. Further, among at-risk communities, the social, medical and community structures that underpin control of HIV transmission remain hindered by the COVID pandemic, especially in the US among concentrated hot spots and generally across low and middle income countries (LMIC). In addition to horizontal transmission, the risk of mother-to-child transmission (MTCT) of HIV among those affected by SARS-CoV-2, whether by maternal co-infection or by pandemic effect on HIV services, remains poorly understood.

Because service disruptions have far reaching effects on health outcomes, including MTCT, of PLWH and those at risk, studies to expand our understanding of the consequences of COVID-19 disease in these populations are needed. Studies that explore the social and behavioral health determinants of PLWH and those at risk, before and during the pandemic and after SARS-CoV-2 vaccine implementation, including attitudes concerning COVID 19 and vaccination should be considered. In addition, the pathogenic mechanisms associated with SARS-CoV-2 transmission, and infection, including risk factors for severe COVID-19 and the long-term consequences such as post-acute sequalae (PASC) in vulnerable populations of infants, children, adolescents and young adults, and pregnant women at risk for and those living with HIV need further study. Finally, the biologic interactions of HIV, its associated comorbidities, coinfections, and complications, including TB, CMV, obesity, Type I, II and gestational diabetes and SARS-CoV-2 infection need to be explored. This NOSI is intended to cover both COVID-related and COVID-affected HIV research.

Research Objectives:

NICHD encourages the submission of applications for Competitive revisions and Administrative Supplements to active HIV grants to address the following research areas of interest within the HIV mission of NICHD:

• Studies that explain SARS-CoV-2 transmission and COVID-19 disease on HIV and other health outcomes, such as menstrual health and acquisition and disease progression, in infants, children, adolescents/young adults, and, pregnant and lactating women at risk for and living with HIV.
• Studies among PLWH that address their social and behavioral health responses to COVID-19 disease and vaccination related to HIV risk acquisition, health disparities and social determinants of health.
• Studies on the incidence of post-acute sequelae of COVID-19 (PASC) among PLWH and those at risk including infants, children, adolescents/young adults, and pregnant and lactating women.
• Studies exploring the biological interactions between SARS-CoV-2 and HIV using biospecimens and data from ongoing HIV studies and/ or secondary data relevant to COVID-19 disease, vaccination, HIV-and other associated infectious diseases and comorbidities.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalents:

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
• PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement -Clinical Trial Optional)
• The funding instrument, or activity code, will be the same as the parent award.

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide, PA-20-272, and PA-18-935 must be followed, with the following additions:

• The Research Strategy section of the application is limited to 6 pages and should include the following information:
  • A discussion of the scientific rationale and relevance of the COVID-19 pandemic to the HIV epidemic and PLWH.
  • For studies that involve sites:
    • Discuss how sites will coordinate, harmonize, and submit
    • Discuss which sites will participate
  • Common data elements (CDEs) proposed, description of instruments, and description of any other measures proposed for data collection (applicants are encouraged to use the NICHD and NIH resources listed in the Data Harmonization section below)
  • Proposed milestones and timeline

Data Harmonization

Researchers addressing COVID-19 questions, whether population-based or for clinical research, are advised to consider the COVID-19 specific survey item repositories and select existing survey items or protocol modules. Existing COVID-19 survey items are publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/] and the PhenX Toolkit [https://www.phenxtoolkit.org/index.php]. Investigators are encouraged to use these data resources.

• Data Harmonization for SDoH, COVID-19, mental health, and other relevant measures via the PhenX Toolkit: Investigators involved in human-subject studies are encouraged to employ a common set of tools and resources that will promote the collection of comparable data on SDoH and mental health across studies. In particular, human-subject studies should incorporate SDoH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (https://www.phenxtoolkit.org/collections/view/6) and the Psychosocial and Mental Health toolkit (https://www.phenxtoolkit.org/sub-collections/view/34)

• NICHD Promoting Data Harmonization to Accelerate COVID-19 Pregnancy Research, which encompasses a collective contribution of NIH extramural and intramural investigators from the relevant research community

Review Process

NICHD staff will conduct administrative reviews of applications that will then be prioritized. Applications for competitive revisions will be evaluated for scientific and technical merit by an appropriate review panel convened by CSR.

Criteria:

• Is the work proposed within the scope of the active parent award (for administrative supplements)?
• Is the parent award progressing satisfactorily/according to planned timeline and milestones?
• Is the proposed project technically feasible within the budget and funding period?
• Is the overall strategy, methodology, and analyses proposed in the application well-reasoned and appropriate to accomplish the activities in the proposed project period?

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• AIDS Application Due Date(s) – September 7, 2021, January 7, 2022, May 7, 2022, by 5:00 PM local time of applicant organization. Applications received after the designated receipt dates will not be considered.
• For funding consideration, applicants must include “NOT-HD-21-037” (without quotation marks) 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.
• All applications must be submitted electronically using a single-project application form package.
• Application budgets are limited to the $150,000/year , direct cost, 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.
• Investigators planning to apply in response to the NOSI are advised to contact the program officers of the parent award to discuss the proposed project in the context of the parent award.
• Applications nonresponsive to the terms of this Notice will not be considered for this initiative.
• 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.
• Requests may be for one year of support only.

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

Inquiries

Please direct all inquiries to:

Denise Russo, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-640-6328
E-mail: [email protected]