NOT-TW-19-003: Notice of Availability of Administrative Supplements for NIH Grants to Promote Implementation Research for Brain and Nervous System Disorders in Low- and Middle-Income Countries

Notice of Availability of Administrative Supplements for NIH Grants to Promote Implementation Research for Brain and Nervous System Disorders in Low- and Middle-Income Countries

Notice Number: NOT-TW-19-003

Key Dates
Release Date: April 03, 2019

Issued by
Fogarty International Center (FIC)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to solicit administrative supplement applications for implementation research/ research training to existing awards on brain and nervous system related topics in low- and middle-income countries (LMICs). One-year supplements to active NIH neuro-related grants under eligible mechanisms, may be requested. Eligible parent grants must be focused on neuro-health which is used here to denote prevention, diagnosis, treatment, and rehabilitation of neurological, neuropsychiatric, developmental, addiction and behavioral disorders and enhancing or improving, cognitive, motor and other neurological function.

The supplement request for support of pilot research or research training projects and activities related to implementation science in global neuro-health must be based on and within the scope of an existing grant with the primary performance site in an eligible LMIC. The goal of these projects and/or activities is to help accelerate the translation of evidence into policy and practice for effective interventions for brain and nervous system disorders within community and population-level programs, services, and strategies at scale, within LMICs. The supplement FOA Notice supports proposals for activities including but not limited to: 1) extension of neuro-health research results through applications for development of targeted implementation research and research capacity building in LMICs and 2) integration of neuro-health related implementation research into existing and/or planned health practice, programming or policy.

Proposals must:

Be within the scope of the active parent award and be for research and research-related activities at the parent grant LMIC site.
Not be currently focused primarily on implementation research but add implementation research, research training or planning activities, or expand current implementation science activities, as a primary focus of the supplement, within the scope of the program.
Propose to address one or more implementation research/ research capacity building objectives
Be likely to stimulate additional activity leading to progress on neuro-health related implementation research
Address a priority for the IC that issued the parent award

Background:

For the purposes of this supplement request we define implementation research as application of implementation science strategies in research to develop, test, adopt and integrate evidence-based health interventions into the context of clinical and community settings. The gap between the promise of scientifically-proven health interventions for brain and neurological disorders and their successful implementation as standard care in the real world persists. Implementation research has the potential to address this challenge and is critical for determining how to develop and scale up effective implementation of evidence-based strategies that address today’s key global health problems.

Implementation research studies should not assume that empirically-supported interventions can be integrated into any service setting or applied to any patient group or population without attention to local context, nor that a unidirectional flow of information (e.g., publishing a recommendation, trial, or guideline) is sufficient to achieve practice or policy change. Relevant intervention studies should develop a knowledge base about "how" interventions are integrated within real-world practice settings and patient populations, which will likely require more than the distribution of information about the interventions. Research on models, theories and conceptual frameworks of the implementation process are encouraged that move away from an exclusively "top-down" approach to a greater emphasis on the resources of local care settings and the needs of multiple stakeholders.

The main purpose of these supplements is to develop pilot implementation research projects or activities extending the global neuro-health research results of the parent grant. The goal of these pilot projects and/or activities is to help further develop and accelerate the application and translation of effective interventions for brain and neurological disorders into medical/clinical, community and population-level programs and services in LMICs. Proposed activities under the supplement should use and/or contribute to the development of the knowledge base for effective scale up of evidence-based interventions developed, adapted and tested in the local context.

Implementation Science Objectives:

Proposed research and research training should be host-country driven and address questions about implementation of scientifically-proven interventions for neuro-health. Where possible, within the goal of building on the parent grant, this includes research training and related activities that strengthen implementation research capacity.

Implementation research goals to address may include:

- Communication and collaboration between researchers and research end users (program implementers, health practitioners, and policy-makers);

- Cost-effective, novel, innovative research methods that demonstrate how effective interventions can be implemented and brought to scale;

- Innovative methods for the study of implementation and scale-up of proven interventions to achieve improved health outcomes;

- Dissemination of research findings, implementation and scale-up of proven health interventions for neuro-health.

- Using, testing and evaluation of strategies to implement interventions related to health promotion, prevention, screening, early detection, diagnosis, effective treatments and proven clinical procedures or guidelines integrated into existing care systems for neuro-health.

Research/ research training is also encouraged that focuses on the adoption, implementation and sustainability of evidence-based practices in clinical and community settings through studies on:

- implementation of multiple evidence-based practices to meet the complex needs of patients and diverse systems of care;

- systematic identification of intervention components that must be modified for most effective local adaptation of evidence-based practices;

- how to influence organizational structure, climate, culture, and processes to enable dissemination and implementation of information and the implementation of effective interventions.

Approaches to implementation research/ research training may include team science, community-based participatory research, action research and related frameworks that engage stakeholders and end users throughout the research process.

The in-country LMIC partners must be clearly involved in the supplement application. Proposed research/ research training and related research activities should address synergies with country public health plans and/or national health research priorities, where appropriate. Plans to facilitate this synergy should be included as part of the supplement application. This strategy may include, for example, a letter from the Ministry of Health stating that the neuro-health implementation research/ research training in being developed would be valuable to develop the evidence base for the country’s policies or programming.

Specific Research Interests of the FOA Sponsors:

Participating NIH Institutes and Centers (ICs) provided specific statements of interest for this FOA below. Applicants can obtain more information on research interests for each of the NIH participants in this FOA at their web sites and through their Scientific/Research contact listed in this announcement.

The Fogarty International Center (FIC) is interested in supplement applications to eligible neuro-health related R01 or D43 FIC grants relevant to the neuro-health implementation science research focus of this Notice and the FIC mission (subject to funds available). Parent grants in their first year of funding or on extension are not eligible for FIC supplement funding under this Notice. The FIC Strategic plan (http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx) includes the following relevant goals: 1) Stimulate innovation in the development and implementation of technologies and other locally-relevant solutions to address global health problems; 2) Support research and research training in implementation science;

The National Institute of Mental Health(NIMH) is interested in implementation questions facing LMICs in their efforts to expand access to evidence-based mental health care, improve the quality of mental health care, and/or foster evidence-based policy and program development in mental health. Supplement applications considered relevant to NIMH priorities under this FOA include, but are not limited to, those that propose to:

Develop and/or validate implementation measures for use in mental health care across low-resource settings

Identify and test mechanisms of system- or provider-level change that are causally associated with quality of care and/or therapeutic endpoints

Use existing data to model and test causal relations among interventions, intervention targets, and proximal and distal (clinical) outcomes

Optimize the uptake, effectiveness, or quality of mental health screening, assessment, and intervention in varied settings (e.g., medical and non-medical)

Estimate the costs of integrating mental health care into alternative delivery settings (e.g., schools, chronic disease care, social services, justice settings)

Evaluate dissemination strategies (e.g., social marketing, technology-based, social media, peer network) to increase awareness and increase demand for mental health screening, assessment, and intervention services

Assess the implementation needs (e.g., knowledge, skills, training, practice) of health care providers in HIV care and treatment settings with respect to screening, assessment, and care for mental disorders

Identify key tasks related to mental health care that are amenable to management by HIV care and treatment teams, which can be used to guide the development of implementation strategies for integrating mental health care into HIV care

Develop and test innovative implementation strategies for training, supporting, and supervising HIV care providers in the effective delivery of a basic package of mental health services

Build research capacity in implementation science theory and methods within LMICs and/or foster evidence-based policy and program development in mental health

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting mechanistic, epidemiological, prevention, translational and clinical research across the spectrum of neurological, neuromuscular, neuroinfectious and neurovascular diseases and disorders in all ages. In addition to prevalent neurological disorders and stroke, NINDS is also interested in supporting research and capacity building in areas of rare and neglected neurological diseases that are relevant to the collaborating LMICs (NINDS Disorder Indexhttp://www.ninds.nih.gov/disorders/disorder_index.htm). NINDS would like to encourage the development of networks in neuro-related topical disease-related areas (e.g., stroke, epilepsy or other high burden neurological disorders in LMICs) or linked to existing programs or resources in LMICs (e.g., MEPI, H3Africa, or other NIH-funded projects) to share capacity building activities and conduct collaborative research. Under this FOA, the NINDS is interested in implementation research-related applications that lay the groundwork for future clinical trials, such as conducting surveys of available patient populations, developing clinical trial protocols and training materials, and establishing trial infrastructure for recruiting and treating subjects and collecting, receiving, storing and distributing study drugs, and processing data and laboratory specimens. Applicants interested in clinical trials for neurological disorders within the NINDS mission are also referred to NINDS clinical trial-specific funding announcements (PAR-17-202 and PAR-17-122, PAR-17-314 ).

National Institute on Drug Abuse: The mission of the National Institute on Drug Abuse (NIDA) is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. The NIDA International Program fosters international cooperative research and the exchange of information by substance use disorder researchers around the globe. Although some international researchers receive NIDA support through a direct foreign grant, most international research is supported through a domestic grant with a foreign component, where a principal investigator from a U.S. institution works with a researcher from another country.

For this FOA, eligible NIDA projects must be conducting research in a low and/or middle-income country (LMIC) that focuses on neuro-health specific to substance use disorders. NIDA research projects seeking these supplemental funds must have a sufficiently developed program, practice or intervention to warrant incorporation of pilot and feasibility research on implementation that will lead to a full-scale implementation study (e.g., clinical trial), and ultimately to lead to the adoption and delivery of interventions and/or services in LMICs. Projects must include involvement of in-country LMIC partners, as outlined above in the FOA. The implementation research should demonstrate relevance to the US.

Research in LMICs focused on implementation science of interest to NIDA include, but are not limited to, the following examples:

-Early stage implementation research on capacity to identify or address organizational factors to facilitate delivery of evidence-based programs, practices and interventions in LMIC systems and settings

-Feasibility research to determine approaches for delivering substance use prevention and treatment interventions in rural and/or other hard to reach community settings, developed through collaborative partnerships

-Pilot and feasibility research to optimize interventions for delivery in LMIC systems and settings

-Pilot research to support the use of hybrid effectiveness-implementation designs in LMICs

-Feasibility research to develop models for multi-level interventions (e.g., that target patients and organizations) for the adoption, implementation and utilization of evidence-based substance use prevention and treatment interventions

-Research to develop cross-system collaborations (e.g., health and education) to support delivery of evidence-based prevention and treatment interventions

Investigators should submit applications as responses to the parent active administrative supplement PA, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) : https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html

Supplements to existing clinical trials are allowed, but addition of a new clinical trial that was not a part of the parent award is not allowed.

Before submitting a supplement request, principal investigators are strongly encouraged to contact their program officer, or the program contact at the Institute, Center or Office supporting the parent award to discuss whether the proposed supplement is within the scope of the project and the priorities of the IC supporting the parent award or with any questions.

Award Project Period

To be eligible, the parent award must receive funds in FY19 (Oct. 1, 2018-Sept. 30, 2019) and may not be in an extension period. The request is for one year of funding.

Budget

Supplement budget requests for the one-year supplement cannot exceed $100,000 in direct costs exclusive of Facilities and Administrative costs on sub-contracts, or 50% of the direct costs of the current parent award, whichever is less. Requests must reflect the actual needs of the proposed project. Modular and categorical budgets are permitted.

Eligible Individuals (Program Director/Principal Investigator)

Individual(s) submitting as PD/PIs must hold an active grant or cooperative agreement on an eligible neuro-health topic in an eligible LMIC. For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.

Submitting an Application

For additional information, see the parent program announcement to Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) PA-18-591.

As part of the application investigators should submit a no more than one-page abstract of the proposed research that shows the relevance to the existing grant and implementation research/ research training goals and articulates the component(s) and any IC-specific priorities that the supplement is addressing. Applicants should begin the supplement application abstract by stating: This application is being submitted to PA-18-591 in accordance with NOT-TW-19-003."

Page Limits: NIH will consider supplements with a Research Strategy of no more than 6 pages, in addition to the abstract.

Supplements should be submitted electronically if allowed by parent mechanism. In addition, applicants are strongly encouraged to notify the program contact at the institute that is supporting the parent award (see list below) that an application has been submitted in response to this FOA to facilitate efficient processing of the request.

Requests must be received by 5:00 PM Pacific Daylight Time (P.D.T.) on May 22, 2019.

Institute, Center (IC) and Office-specific Instructions

Review process

Each IC will conduct administrative reviews of applications submitted to their IC separately.

Criteria:
1. Are the parent grant and proposed supplement related to neuro-health (under the definition in the Notice) and is the work proposed within the scope of the active award?
2. Is the proposed implementation research-related work relevant to the parent grant? How well does it enhance the goals of the parent grant?
3. Does the work proposed address one or more of the components listed under the implementation research objectives?
4. Does the work proposed have scientific merit and/or increase implementation research capacity in neuro-health?
5. Is the work likely to stimulate additional activity leading to progress on implementation research?
6. Does the work address a priority for the IC that issued the parent award (if applicable-see IC interests )?

Inquiries

Please direct all inquiries to:

Kathleen Michels, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-435-6031
Email: michelsk@ficod.fic.nih.gov

Beverly Pringle, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3725
Email: bpringle@mail.nih.gov

Belinda Sims, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: bsims@nida.nih.gov

Dallas Anderson, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: andersda@nia.nih.gov

Claudia Moy, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: MoyC@ninds.nih.gov