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Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional)

Description:

Background Over the years, there has been continued improvement of health for Americans with the introduction of medical and scientific advances. Despite notable health improvements for the population as a whole through technological advancement, there continues to be an alarming disproportionate burden of illness among persons from racial and ethnic minority and other population groups who experience health disparities. To meet this challenge, the NIMHD is committed to supporting a wide range of research, aimed at the development of innovative diagnostics, treatments, and prevention strategies that improve the health of racial and ethnic minority populations so as to reduce, and eventually eliminate health disparities. The purpose of this funding opportunity is to engage small business concerns (SBC) in developing technologies and products that engage, empower, and motivate individuals. and communities, including providers and healthcare institutions, in sustainable health promoting activities and interventions that lead to improved health, healthcare delivery, and the elimination of health disparities in one or more NIH-defined population groups who experience health disparities including racial and ethnic minorities (African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders), socioeconomically disadvantaged individuals, individuals residing in underserved rural areas, and sexual/gender minorities. Appropriate considerations relevant to the technology and products should include: Effectiveness in improving the current quality of care for racial/ethnic and health disparity population; Affordability for the population. For example, can the technology or products be used with existing community resources or an organization’s existing infrastructure; and Acceptability. For example, is the technology suitable for the population’s culture, language, literacy level, and content. Regarding Organizations: Does it assist in advancing the mission of the organization? Is it compatible with the organizational culture of the customer? Can the proposal be combined with or embedded within other current services or programs within the organization? Is the technology or product accessible and or deliverable to the desired populations and those who intended to use the technology? Research Objectives While this FOA supports new and innovative technologies or products, nonetheless, proposals must address reducing or eliminating health disparities issues in one or more NIHMD identified populations. Applicants should review refer to the NIMHD Research Framework, https://nimhd.nih.gov/about/overview/research-framework.html for additional insight on NIHMD’s strategic approach. The NIMHD Research Framework identifies diverse factors within socio-ecological domains and levels that individually and synergistically influence the distribution of disparate health outcomes among racial/ethnic populations and other populations who experience health disparities compared to the majority U.S. population. Within the context of the SBIR/STTR programs, SBCs can leverage this framework to inform product conceptualization and design in their proposals. This framework can also help proposals incorporate into design thinking and outcome-driven innovation methods. Applications that do not explicitly address minority health or health disparities will be considered non-responsive. In addition to the factors listed in the Research Framework, technologies and products are needed to assist in overcoming barriers such as the social determinants of health (SDOH) and other barriers, including but not limited to: Physical Barriers – Factors such as proximity to healthcare facilities and transportation may limit access to healthcare Knowledge Barriers - Health literacy and language barriers inhibiting healthcare delivery and attaining patient information for the healthcare provider Infrastructure Barriers - Health providers, such as rural health clinics, federally qualified health centers, and critical access hospitals, may not have the same resources and expertise of large hospitals and health networks Economic Barriers - Lack of public and private insurance coverage or financial resources Cultural Barriers - Beliefs and practices shared among social and religious groups, including racial/ethnic populations, communities, healthcare organizations, institutions, and facilities. Cultural/religious variables can impede access to healthcare and health-promoting activities For racial/ethnic minorities and other NIH-designated populations experiencing health disparities, the proposed technology and product may provide increased and more attractive opportunities for improved and better health, preventing and treating disease, and maintaining a long and healthy lifestyle. Nutrition-related technologies should not duplicate existing information and should use science-based nutrition content from the Dietary Guidelines for Americans, 2015-2020 or from sources of federal nutrition communications for the public, such as http://www.choosemyplate.gov or http://www.fns.usda.gov/tn/team-nutrition. Lastly, empowering technologies and products that are appealing, attractive, accessible, easy to use, adoptable, affordable and sustainable. Effective technology and products providing users with improvements in access, quality, and affordability relative to their current health status and well-being. The technology and product proposal should be reliable, robust, and have reproducible outcomes. Applicants should make explicit how the proposed technology and product will: 1) Lead to improvements in racial/ethnic minority population health and well-being; or 2) Reduce or eliminate one or more disparities by identifying the disparity and the processes or mechanisms involved in realizing reductions and expectations. Specific Areas of Research Interest Technologies and products that might achieve the objectives of this initiative include, but are not limited to: Facilitate or enhance disease self-management, patient-healthcare provider or system communication, and/or care coordination between primary care providers, family care givers, hospital emergency department staff, specialty physicians, dental health professionals, nurse practitioners, providers of mental health and behavioral health services, patient navigators, etc., in medically underserved communities and regions. Culturally attuned behavioral or evidenced-based interventions that empower and promote opportunities for individuals, families, social networks, and communities to engage in health-seeking behaviors and health-promoting activities (diet choice, exercise/physical activity, oral hygiene, medication adherence, child immunizations, etc.) and to avoid risky behaviors (smoking, vaping, alcohol/drug misuse, unsafe sex, etc.). Detecting, measuring, and assessing a broad array of unhealthy social and environmental exposures (discrimination, stress, pollutants, allergens, noise, crime, etc.), and for characterizing cumulative exposures across multiple individuals and communities and linking this information to physiological responses and health indicators at the individual and population levels. These technologies may include efforts to improve and standardize data collection and the integration of social determinants of health (SDOH) and other data across disparate data sources, including clinical patient data, electronic medical records, public health data, census data, housing data, employment data, and crime statistics. Engage, empower, and motivate individuals, families, and communities to enhance the quality of life and to sustain health gains. .Culturally appropriate survey instruments, tools, modules and databases to promote community-based research engaging populations that experience health disparities. Culturally appropriate, evidence-based health empowering promotion and disease prevention educational media, such as software, informational videos, and printed materials. Innovative software, tools and technology for science and health education curriculum materials, interactive teaching aids, serious and applied games, models for classroom instruction for K-12 and undergraduate students, and the general public. Mobile health (mHealth) and telehealth/telemedicine technologies and apps for improving communication among health care providers and between patients, families, and physicians and healthcare providers, medication adherence, diagnosis, monitoring, evaluation, medical management, screening, tracking, and treatment in underserved community settings and rural and remote locations. Promote big data science or enhance data scientist training to address health inequities and/or minority health research, for example software or tools developed to link social determinants of health easily (e.g., years of education, race/ethnicity, etc.) with massive datasets such as electronic medical record (EMR), genomic information, census data, national surveys, and other state or community-level data sources. Such technology will be instrumental in understanding fundamental causes of health disparities and developing meaningful interventions. Linking family medical histories and family ancestries. Technologies for clinical trials and biobanking, such as the rapid identification in human specimens (e.g., blood, buccal swabs, etc.) of genes and/or genomic variants of known importance to minority health. Educating prospective social entrepreneurs, and minority and health disparity communities on how to transition technologies from the bench to the bedside. Promoting precision medicine and other precision-based strategies such as utilizing All of Us Research Program research tools. Leveraging electronic health records and communication technologies to deliver and evaluate interventions that reduce health disparities by removing accessibility and health literacy barriers, facilitating population tailoring and personalization, and decreasing cost. Understanding the causes of health disparities and associated variables such as SDOH for preventing one or more health disparities. Using systems modeling, artificial intelligence, or other techniques to predict relationships between health disparities and health determinants and to assess health disparities interventions outcomes. Creating and testing tailored algorithms that identify interventions tailored, target, and optimized for implementation in specific communities for reducing or eliminating disparities in one or more specific health condition, disease, or health outcome. Leveraging robotic and autonomous systems for improving health, and preventing, reducing, and eliminating health disparities. Preventing and minimizing adverse exposures and health risks (post-traumatic stress) or promoting health, well-being, resilience, and recovery resulting from disasters or the threat of a disaster. Disasters may include public health threats such COVID-19 or a similar pandemic. Examples may include new tools, apps, education, curricula, or other technologies to detect, screen, treat, or prevent or otherwise mitigate adverse health outcomes or leverage community and or population resilience and prevention efforts. Topics of Interest to NCATS: NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline to speed the delivery of new drugs, diagnostics and medical devices to patients. Projects of most interest to NCATS include those that focus on drug discovery and development, biomedical, clinical and health research informatics and clinical, dissemination and implementation research. Applicants are strongly encouraged to contact program staff at NCATS-SBIRSTTR@mail.nih.gov prior to submitting an application. For additional information onNCATS SBIR areas of interest, please refer to https://ncats.nih.gov/smallbusiness/priorities. Please note that the NCATS SBIR program does not accept applications that include clinical trials. Topics of Interest to NHLBI: The NHLBI is interested in funding the development of disease diagnostics and monitoring devices, wearable technologies, mobile applications, and other tools to improve heart, lung, blood, and sleep (HLBS) health in historically underserved, low-resource, and remote communities. Examples of disorders and conditions of interest to NHLBI include, but are not limited to: Hypertension, Congestive Heart Failure, Coronary Artery Disease, Stroke/Cerebrovascular Disease, Asthma, Chronic Obstructive Pulmonary Disease, Pulmonary Fibrosis, Obstructive Sleep Apnea, Sickle Cell Disease, and HLBS-related complications of Acquired Immunodeficiency Syndrome (AIDS). In addition to the above conditions, the NHLBI is also interested in funding the development of tools and technologies that will address barriers to uptake of the implementation and dissemination of evidence-based interventions for HLBS conditions and disorders in minority and low-income communities. A complete list of scientific focus areas in the NHLBI can be found at:https://www.nhlbi.nih.gov/science. Topics of Interest to NIA: The NIA is interested in each of the above topics for this FOA as they pertain to Alzheimer’s Disease and Related Dementias. Topics of Interest to NIBIB: The NIBIB is interested in the above topics for this FOA as they pertain to NIBIB mission. NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding) to determine if their research fits within the NIBIB mission. NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development. Topics of Interest to NIDA: NIDA is interested in the FOA topics as they pertain to prevention, management, monitoring, diagnosis, and treatment of Substance Use Disorders (e.g., Opioid Use Disorder, Stimulant Use Disorder) and are congruent to NIDA’s mission (https://www.drugabuse.gov/about-nida/strategic-plan/nidas-mission). Topics of Interest to NIDDK: The NIDDK is interested in the above topics as they pertain to diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders associated with NIDDK diseases, and obesity; and kidney, urologic, and hematologic diseases. To be assigned to the NIDDK, applications must be directly related to the mission of the NIDDK (https://www.niddk.nih.gov/about-niddk/meet-director/mission-vision). Topics of Interest to NIMH: The NIMH is interested in each of the above topics for this FOA as they pertain to the treatment and prevention of serious mental illness. Applications Not Responsive to the FOA: Applications that do not explicitly address minority health or health disparities will be considered non-responsive and will not be reviewed. Potential applicants are encouraged to discuss responsiveness with the Scientific Contact.
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