Key Dates

Related Announcements

NOT-AG-20-059 - Notice of NIA Withdrawal from Participation in NOT-MH-20-053

NOT-MD-21-006 - NIMHD Withdraws Participation in NOT-MH-20-053

PA-18-591 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-HL-20-801 - Notice of NHLBI Participation in NOT-OD-20-097

Issued by

National Institute of Mental Health (NIMH)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Nursing Research (NINR)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Sexual and Gender Minority Research Office (SGMRO)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Purpose

This Notice of Special Interest (NOSI) highlights interest in research to strengthen the healthcare response to Coronavirus Disease 2019 (COVID-19) caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and to future public health emergencies, including pandemics. While the direct clinical effects of COVID-19 are supported by other funding opportunities, the purpose of this NOSI is to support research to address secondary health effects of the social, behavioral, and economic changes, particularly among populations who experience health disparities and vulnerable populations through the use of digital health assessments and interventions to yield measurable near-term impact.

Background

Across the life span, the COVID-19 pandemic will result in social, behavioral, and economic changes that impact health. These adverse effects are compounded by disruptions in the provision and access to healthcare including access to allied health providers, such as therapists and visiting nurses.In response, the healthcare landscape in the United States and around the world has shifted dramatically to a rapid uptake of digital health technologies delivered online across a variety of platforms for addressing health and disease management.

Existing digital health interventions [e.g., mobile health (mhealth), telemedicine and telehealth, health information technology (IT), wearable devices, and personalized medicine] provide opportunities to help consumers and clinicians manage and improve health during and following population level healthcare and other critical disruptions. Most importantly, digital health interventions offer the potential to increase access to screening, self-management and prevention services for individuals at risk or who currently need but are unable to access treatment and other services, particularly populations who experience health disparities, to bridge the treatment gap and provide evidence-based interventions.

This notice is not intended to support the development of novel digital health interventions. Interventions may utilize phone delivery, app-based approaches, video delivery, web-based platforms, wearable devices, and/or new technologies.

Research Objectives

In order to significantly improve near term impact of treatment and identification of individuals at risk for, or experiencing worsening health secondary to the COVID-19 pandemic across the full lifespan, supplements will focus particularly on NIH-designated health disparity (racial/ethnic minorities, less privileged socioeconomic status, rural residents and sexual and gender minorities) and other populations with medical or social vulnerabilities. The latter include residents of chronic care facilities, community-dwelling older adults, pregnant women, children, individuals with cognitive impairment or dementia, homeless, and those incarcerated or involved with the criminal justice system, individuals with substance use disorder or severe mental illness, those who are deaf or with visual, hearing, communication, or mobility impairment, and uninsured individuals. Those on the frontlines of healthcare during the COVID-19 pandemic also are vulnerable populations. Research may evaluate the effects of the pandemic on vulnerable frontline health care workers and first responders, including physicians in direct patient care, nurses, dentists, respiratory therapists, mental health therapists, other support staff, home health aides, police officers, fire fighters, emergency medical technicians, and all workers with direct patient contact, as well as family or informal caregivers. Research on frontline vulnerable populations also extends to those working in essential business operations (e.g., grocery, pharmacy, and transit workers, postal and other delivery service workers, sanitation workers) who may be disproportionately impacted by the pandemic and its social, behavioral, and economic impacts on health.

Applications are expected to describe how research outcomes will lead to a tangible difference within 6 months to a year of completing the supplement work, with respect to improving how we identify, treat, or provide services for health conditions secondary to the COVID-19 pandemic for health disparate and vulnerable populations. Submission of applications to address the following areas of scientific interest are encouraged:

• Strategies to increase the reach, access, engagement, efficiency, quality and sustainability of existing evidence-based or validated digital health interventions to address healthcare needs of health disparate and other vulnerable populations including screening, prevention, self-management, wellness behaviors and treatment both during and following the pandemic.
  • Clinical trials that incorporate strategies to address the digital divide (e.g., augmented digitalor alternative interventions with non-digital components) as it relates to vulnerable populations, including elderly and low-income communities, as well as the caregiver community, that cannot easily use or access many digital interventions.
  • Studies that use existing implementation science strategies and methods to identify individual and intervention-level characteristics that are associated with discontinuation vs sustained use across health disparities and vulnerable populations to promote adherence, engagement, and sustained use of digitally-assisted interventions.
  • Strategies to extend the reach and uptake of services of established digital health interventions in medically underserved geographic areas and populations.
  • Approaches for matching individuals to digital health interventions of appropriate intensity, including studies that use existing data to inform algorithms for intervention assignment (e.g., stepped-care approaches, adaptive interventions).
  • The use of digital health strategies to identify healthcare workers at high risk of behavioral or other secondary health symptoms, conduct diagnostic screening, refer to the appropriate level of care, and provide just in time and tailored interventions.
  • Integration and analysis of data from multiple digital health platforms leveraging common data elements to identify population level trends, the long-term health impact and the cost effectiveness of providing digital health care at scale.
  • Studies that investigate the influence of sex and gender on the use of digital health interventions for disease prevention, identification, self-management, and treatment and that ultimately contribute to a more individualized approach to health care.
  • Integration of stigma indicators into digital health interventions.
• Studies to evaluate the near-term impact of replacement (or substitution) of face to face services with digital health as a result of the pandemic to address health disparities and vulnerable population needs.
• • Strategies to understand if changes in service delivery as a result of the pandemic will yield durable and sustainable system level changes in practice that improve or maintain access and quality care.
  • Strategies to identify previously understudied or unknown services and care delivery pathways that emerged as a result of the pandemic and how to capitalize on these novel digital health pathways, such as ways to segment levels of care (e.g., crisis line support that could transfer to higher levels of telehealth psychiatric/ addiction/ urgent medical care for more complex cases when in person treatment is not feasible).
  • The use of existing validated digital health platforms to rapidly identify individuals at high risk of behavioral health symptoms, disorder or crisis (e.g., suicide attempt, overdose, medication withdrawal, acute symptom return), conduct diagnostic screening, refer to the appropriate level of care, and provide just in time and tailored interventions.

Applicants proposing supplements to study the following research areas will not be supported:

• • Research to develop new digital health interventions; examine digital health tools or platforms and or non validated treatments, or adapt established interventions to new platforms are outside the goals of this initiative.
  • Proposed studies that do not include participants with baseline levels of measurable clinically significant symptoms and/or functional impairment.
  • Proposing the use of digital health platforms with insufficient users to conduct rapid, appropriately powered studies to yield actionable changes in identification, treatment, or service delivery for secondary health effects related to the current pandemic among health disparate and vulnerable populations.
  • Applications that propose the translation of existing face-to-face treatments into digital health interventions.
  • Studies that propose additional study assessments and surveys in the absence of a conceptual model and accompanying analyses that address at least one of the above described scientific areas of interest.
  • Applications that propose research that will not result in measurable near-term impact (within 12 months of the completion of the proposed study) at scale on the broader population of interest.

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions:

Investigators who wish to evaluate the effect of a digital health intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods are required for analysis and sample size estimation. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

• Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-18-591 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. The parent award must be active when the supplement application is submitted (e.g. within the originally reviewed and approved project period), regardless of the time remaining on the current project. Only active awards from the Institutes listed in the ISSUED BY section are eligible to submit for this NOSI.

Applicants are reminded that the appropriate consideration of sex and gender as described in NOT-15-102 is NIH policy and a consideration for NIH support.

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide must be followed, with the following additions:

• Applications will be accepted on a rolling basis from June 10, 2020 through December 15, 2020, by 5:00 PM local time of applicant organization.

• Applications submitted before July 15, 2020 will be considered for funding in in Fiscal Year 2020. Applications received after July 16, 2020 may be held for consideration in Fiscal Year 2021 and not be eligible for funding until October 2020.

• The Research Strategy section of the application is limited to 6 pages.

The project period will generally be limited to one year but two years are allowed with strong justification.

Application budgets are limited to no more than $200,000 direct costs and should reflect the actual needs of the proposed project.

Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award

• Consistent with achieving the goals of the program, a Data Sharing Plan is expected to be included and describing how the investigators will:
  • Sharing Data via the NIMH Data Archive: To advance research through widespread data sharing among researchers, investigators funded in response to this NOSI are encouraged to share human subjects data via the NIMH Data Archive (NDA) (See NOT-MH-19-033 Notice of Data Sharing Policy for the National Institute of Mental Health). Established by the NIMH, and supported by other NIH Institutes, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, results, tools, and supporting documentation.
• • Where possible, investigators funded in response to this notice are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://nda.nih.gov/contribute/sharing-regimen.html. A resource sharing plan, formulated in accordance with these NDA Data Sharing Terms and Conditions, should be included in the supplement application. The NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technologies. Investigators funded in response to this notice should use these technologies to submit and share their research data and results at the appropriate times. The NDA Cost Estimation Tool is a customizable Excel worksheet that can be used to calculate an estimate of the resources needed to submit and share data with the NDA. This resource estimate should be submitted as part of the application budget (http://nda.nih.gov/contribute_cost_estimation.html).
  • To minimize the proliferation of one-off survey items, encourage comparisons across samples, and facilitate data integration and collaboration, a trans-NIH working group is making existing COVID-19 survey items and investigator contact information 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 ]. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded, if consensus based measures (e.g.,https://www.phenxtoolkit.org/collections/view/1) are not available.
  • Consistent with achieving the goals of the program, researchers funded in response to this NOSI who develop novel survey items as part of their research plan will be required to share their survey items to make them public for other researchers to consider by submitting their surveys to NIHCOVID19Measures@nih.gov
• All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package.
  • Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains FORMS-F-ADMINSUPP . In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
  • Competitive revision applications to PA-18-935 must use the application form package with the Competition ID that contains FORMS-F-COMP-REV .

IMPORTANT: For funding consideration, applicants must include NOT-MH-20-053 (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.

Investigators planning to submit an application in response to the NOSI are strongly encouraged to contact the program officers listed below to discuss the proposed project in the context of the parent award. All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package:

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to:

Adam Haim, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-3593
Email:?Haima@mail.nih.gov