Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1392&sort=-abstract
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-abstract", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1424&sort=-abstract", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1393&sort=-abstract", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1391&sort=-abstract" }, "data": [ { "type": "Grant", "id": "6525", "attributes": { "award_id": "3R01HL133793-04S1", "title": "CV Wizard: Does a Prioritized, Point-of-Care Clinical Decision Support Tool Improve Guideline-Based CVD Risk Factor Control in Safety Net Clinics?", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [ { "id": 21864, "first_name": "Larry", "last_name": "Fine", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-09-09", "end_date": "2023-02-28", "award_amount": 312242, "principal_investigator": { "id": 21865, "first_name": "RACHEL", "last_name": "GOLD", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 769, "ror": "", "name": "KAISER FOUNDATION RESEARCH INSTITUTE", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 769, "ror": "", "name": "KAISER FOUNDATION RESEARCH INSTITUTE", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "/ ABSTRACT: Substantial progress in reducing cardiovascular disease (CVD) morbidity and mortality would be achieved if evidence-based guidelines for CVD risk factor control were implemented consistently in primary care settings. Electronic health record (EHR)-based clinical decision support (CDS) systems that identify uncontrolled CVD risk factors and provide individualized care recommendations improved rates of guideline-concordant CVD care in large, integrated healthcare settings, but little is known about how effective such CDS may be in safety net community health centers (CHCs). CHCs' socioeconomically vulnerable patients have far worse CVD risk factor control and higher rates of major CVD events than the general population. Implementing CDS that leads to improved CVD risk factor control in CHCs could reduce national disparities in CVD outcomes, but CHCs rarely have the resources to develop sophisticated CDS, and very few currently have such systems for CVD care. The proposed study is designed to address this. We will randomize 60 CHCs with a shared EHR to immediate vs. delayed implementation of a sophisticated CDS system that provides point-of-care CVD care recommendations to the primary care provider and the patient, and has been proven highly successful in large, integrated care settings. Before implementing the CDS, we will ask CHC patients and providers about the particular patient needs and perspectives and clinic workflows likely to influence adoption and impact of the CDS in CHCs. This input will inform development of CHC care team training strategies, and adaptation of the patient-facing aspects of the CDS system. We will measure adoption of the CDS, and impact of its use over time on CVD risk scores and risk factor control (blood pressure, HbA1c, lipid levels; aspirin use; smoking; body mass index) in high-CVD risk CHC patients. We will also conduct a mixed methods process evaluation, to identify facilitators and barriers to use of the CDS, and to iteratively develop and test strategies for supporting its adoption and ongoing use in CHC workflows. We anticipate that this intervention could (a) improve CVD care among low-income CHC patients, (b) reduce CVD care disparities between CHC populations and national rates, and (c) facilitate greater CHC patient engagement in CVD treatment decision-making and prioritization. The proposed work directly responds to PAR 15-279 goals: it addresses gaps in guideline- based care in high-risk populations with targeted, innovative, multi-level strategies; considers setting-specific needs; and supports patient engagement. Our team's research experience and established partnerships with key healthcare system stakeholders increase the likelihood of project success. Results will yield EHR- agnostic CDS tools for use by any CHC with an implementation guide, build knowledge about how to minimize disparities in CVD care and outcomes using scalable CDS strategies, and help translate investments in informatics into clinical benefit for millions of high-risk, low-income Americans.", "keywords": [ "Address", "Adoption", "Affect", "American", "Appointment", "Aspirin", "Blood Pressure", "Body mass index", "COVID-19", "COVID-19 pandemic", "Cardiovascular Diseases", "Cardiovascular system", "Caring", "Centers for Population Health", "Clinic", "Clinic Visits", "Clinical", "Clinical Decision Support Systems", "Community Developments", "Data", "Decision Making", "Disease Outcome", "Documentation", "Electronic Health Record", "Evaluation", "Event", "Face", "Funding Mechanisms", "Future", "General Population", "Glycosylated hemoglobin A", "Goals", "Guidelines", "Health", "Health Policy", "Healthcare Systems", "Infection", "Informatics", "Intervention", "Interview", "Investments", "Knowledge", "Learning", "Lipids", "Low income", "Measures", "Methods", "Morbidity - disease rate", "Neighborhood Health Center", "Outcome", "Parents", "Patients", "Period Analysis", "Persons", "Population", "Preventive care", "Primary Health Care", "Process", "Provider", "Qualitative Methods", "Quality of Care", "Randomized", "Recommendation", "Regression Analysis", "Relapse", "Research", "Resources", "Risk Factors", "Risk Management", "Role", "Smoking", "Targeted Research", "Technology", "Telephone", "Testing", "Time", "TimeLine", "Training", "Translating", "Update", "Visit", "Wait Time", "Work", "arm", "base", "blood pressure regulation", "cardioprotection", "cardiovascular disorder risk", "care outcomes", "care providers", "clinical decision support", "clinical encounter", "coronavirus disease", "cost", "design", "digital", "disparity reduction", "evidence based guidelines", "experience", "follow-up", "health care settings", "health disparity", "health practice", "high risk", "high risk population", "improved", "indexing", "innovation", "mortality", "pandemic disease", "parent grant", "patient engagement", "patient oriented", "personalized care", "point of care", "primary care setting", "primary outcome", "response", "safety net", "shared decision making", "socioeconomics", "success", "support tools", "tool", "uptake", "virtual" ], "approved": true } }, { "type": "Grant", "id": "15950", "attributes": { "award_id": "1K08AI196255-01", "title": "Neutralizing antibody pressure on the evolution of SARS-CoV-2 variants.\"", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 32891, "first_name": "MARY KATHERINE BRADFORD", "last_name": "PLIMACK", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2026-04-02", "end_date": "2031-03-31", "award_amount": 194160, "principal_investigator": { "id": 44394, "first_name": "Ian Alexander", "last_name": "Mellis", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 3409, "ror": "", "name": "COLUMBIA UNIVERSITY HEALTH SCIENCES", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "/ ABSTRACT: Rationale: SARS-CoV-2 evolution has led to the emergence of viral variants that evade existing immunity in the human population, which continue to pose a threat to global public health. It has proven challenging to predict which mutations will arise in future dominant viral variants, and, as a result, it is difficult to design vaccines that provide adequate protection against viruses that will circulate in future waves of infections. Our preliminary data show that viral variant evolution is most closely correlated with evasion of serum neutralizing antibodies, and that serum neutralizing antibody responses are shaped by immune imprinting to the ancestral D614G strain. This mentored career project aims to leverage these observations to develop an in vitro model for predicting where mutations will appear in the virus and to use that information to design updated vaccines. Candidate: As a Transfusion Medicine fellow with a PhD in Genomics and Computational Biology and two years of experience in virology and immunology research, I bring a unique complement of perspectives and skills to the analysis of viral and antigenic evolution and to vaccine design strategies. Further training in advanced BSL-2-compatible pseudovirus culture, mouse immunization, and computational structural biology will be central to the completion of the proposed project and to my development as an independent physician-scientist aiming to improve our understanding and mitigation of pathogen evolution. My primary mentor, Dr. David Ho, an international leader in virology, and my complementary multidisciplinary advisory team, will ensure my research and career development progress. Environment: The Ho laboratory at the Columbia University Irving Medical Center (CUIMC) is a world leader in the study of pandemic viruses, including SARS-CoV-2, with expertise in the characterization of viral variants and serum antibody analysis. The Ho lab has access to abundant resources and many collaborators, including leaders in pseudovirus construction, structural biology, and vaccine design. CUIMC also has a long track record of supporting junior physician-scientists on their paths to successful independent careers in academic medicine. Approach: We will test the central hypothesis that widespread early exposure to ancestral SARS-CoV-2 shapes the evolutionary trajectory of the virus and that such a trajectory can be modeled in vitro. In Aim 1 we will assess the impact of mouse serum neutralizing antibodies elicited by different immunization histories on mutational profiles in cultured BSL-2-rated pseudoviruses and correlate mutations with historical public health databases. In Aim 2, we will identify whether particular epitopes on the spike protein are particularly susceptible to the emergence of mutations under serum antibody selective pressure. In Aim 3, we will design and test novel COVID-19 vaccine candidates in mice based on observed mutations that arise in pseudoviruses. This project will enhance our understanding of SARS-CoV-2, provide a framework for in vitro modeling of antigenically variable pathogens, and contribute to vaccine design strategies.", "keywords": [ "2019-nCoV", "Advisory Committees", "Antibodies", "Antibody Response", "Antigenic Variation", "Antigens", "Biological Assay", "COVID-19", "COVID-19 booster", "COVID-19 vaccine", "Cessation of life", "Complement", "Computational Biology", "Data", "Databases", "Dengue", "Development", "Doctor of Philosophy", "Ensure", "Environment", "Epitopes", "Escape Mutant", "Evolution", "Exposure to", "Formulation", "Frequencies", "Future", "Genomics", "Growth", "Human", "Immune", "Immune response", "Immunity", "Immunization", "Immunize", "Immunology", "Impairment", "In Vitro", "Individual", "Infection", "Influenza", "International", "Junior Physician", "Laboratories", "Machine Learning", "Maps", "Measures", "Medical center", "Medicine", "Mentors", "Modeling", "Monoclonal Antibodies", "Mus", "Mutation", "Physicians", "Population", "Predisposition", "Proteins", "Public Health", "RNA vaccine", "Recording of previous events", "Research", "Resolution", "Resources", "SARS-CoV-2 spike protein", "SARS-CoV-2 variant", "Scientist", "Serum", "Shapes", "Structural Models", "System", "Testing", "Training", "Universities", "Update", "Vaccination", "Vaccine Design", "Vaccines", "Variant", "Vesicular stomatitis Indiana virus", "Viral", "Viral Genome", "Virus", "Work", "booster vaccine", "candidate identification", "career", "career development", "cohort", "design", "emerging virus", "experience", "exposure mixture", "genome sequencing", "imprint", "improved", "in vitro Model", "innovation", "multidisciplinary", "mutant", "mutation screening", "neutralizing antibody", "novel", "novel vaccines", "pandemic disease", "pandemic virus", "pathogen", "predictive modeling", "pressure", "public health intervention", "recurrent infection", "research and development", "skills", "structural biology", "therapy development", "transfusion medicine", "vaccine candidate", "vaccine development", "variants of concern", "virology" ], "approved": true } }, { "type": "Grant", "id": "15231", "attributes": { "award_id": "1K08AI180347-01", "title": "Elucidating the impact of immune imprinting on SARS-CoV-2 variant vaccination strategies using a humanized mouse model", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 26918, "first_name": "Michelle Marie", "last_name": "Arnold", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-15", "end_date": "2029-07-31", "award_amount": 193644, "principal_investigator": { "id": 31815, "first_name": "Anthony", "last_name": "Bowen", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 781, "ror": "", "name": "COLUMBIA UNIVERSITY HEALTH SCIENCES", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "/ ABSTRACT: Rationale: Continued evolution of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has led to immune-evasive variants that pose a persistent threat to global public health. Updated vaccines are needed to provide improved immune responses against emerging variants, but current approaches targeting the Omicron BA.4/5 variant may have limited effectiveness due to immune imprinting caused by prior immune system exposure to ancestral D614G variant antigens. Our preliminary data suggests that bivalent boosters targeting BA.4/5 do not provide superior neutralizing antibody (NAb) responses to SARS-CoV-2 variants compared to the original monovalent vaccine. This mentored career project aims to elucidate the impact and molecular basis of immune imprinting following primary D614G vaccination on subsequent humoral responses to variant antigens. Candidate: As an Infectious Diseases physician with a PhD in Microbiology and Immunology, I am uniquely positioned to bridge the gap between biomedical research and patient care to advance our knowledge of humoral immune responses to SARS-CoV-2. Further training in virology, structural biology, bioinformatics, and monoclonal antibody characterization will be crucial for completion of the proposed research and my development as an independent physician-scientist specializing in humoral immunity to pathogens of global importance. I have a globally recognized mentor in Dr. David Ho and benefit from an outstanding multidisciplinary team of experts to guide my training and research progress. Environment: The Ho laboratory at the Columbia University Irving Medical Center (CUIMC) is a leading group in the study of SARS-CoV-2, with expertise in the characterization of viral variants and monoclonal antibodies. This enriching environment provides access to a large network of collaborators including experts in cryo-electron microscopy, single cell sequencing, and antibody repertoire analysis. CUIMC also has a strong track record of enabling junior physician-scientists to develop independent and successful careers in academic medicine. Approach: Our central hypothesis is that primary vaccination targeting the SARS-CoV-2 D614G strain induces immunological imprinting that restricts antibody responses to subsequently encountered viral variant antigens. In Aim 1, we will test the impact of imprinting on NAb responses following BA.4/5 boosting strategies in a humanized mouse model. In Aim 2, we will characterize the antibody repertoires of immunized mice to identify imprinting effects using single B cell sequencing and bioinformatic approaches. In Aim 3, we will use high- throughput techniques to produce monoclonal antibodies, determine their neutralizing activity, and identify epitopes associated with imprinting responses though structural and binding assays. Through these aims, we will expand understanding of the immunologic and structural basis underlying imprinting in SARS-CoV-2. Our results should inform novel strategies for structure-based vaccine design to circumvent imprinting responses and produce broader immunity to SARS-CoV-2 variants and possibly other antigenically variable pathogens.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "9124", "attributes": { "award_id": "3R41EB029284-01S1", "title": "A PORTABLE MULTI-MODAL OPTICO-IMPEDANCE SYTEM FOR EARLY WARNING OF PROGRESSION IN STABLE COVID-19 PATIENTS", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Biomedical Imaging and Bioengineering (NIBIB)" ], "program_reference_codes": [], "program_officials": [ { "id": 6433, "first_name": "Tiffani Bailey", "last_name": "Lash", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-07-01", "end_date": "2022-01-31", "award_amount": 155282, "principal_investigator": { "id": 24907, "first_name": "Ryan Joseph", "last_name": "Halter", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1798, "ror": "", "name": "MULTIVARIATE SYSTEMS, INC.", "address": "", "city": "", "state": "NH", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1798, "ror": "", "name": "MULTIVARIATE SYSTEMS, INC.", "address": "", "city": "", "state": "NH", "zip": "", "country": "United States", "approved": true }, "abstract": "/ Abstract: COVID-19, the clinical presentation associated with SARS-CoV-2 infection, has already profoundly impacted healthcare systems globally. Of particular note, communities such as long-term care facilities, assisted living communities, and prisons, are being devastated because of their high density of vulnerable individuals. Nursing home residents, which represent only 0.5% of the US population, account for 25% of COVID-19 deaths. Early detection of COVID-19 progression in these patients is critical to improving outcomes of patients who are in an early stable condition but at risk of deteriorating, but must be balanced with efficient use of primary care resources and adequate protection of healthcare workers. An early alert to progression with a high sensitivity and an acceptable rate of false-negatives would save patient lives, reduce exposure of healthcare workers, and would also facilitate resource-shifting in the face of a surge. The time, money and effort saved by allowing medical resources to be applied more accurately is the essence of precision medicine. During our current STTR efforts, we have developed and evaluated an opto-impedance system capable of integrating and classifying optical, electrical impedance spectroscopy and tomography data to detect change from baseline signatures of early ongoing hemorrhage with high accuracy. This proposal will (1) scale up our hardware inventory, (2) deploy on COVID-positive patients to collect continuous multiplex data and (3) retrain our algorithms using the data to detect associated deterioration due to progression of COVID symptoms. This multivariate approach that has already been demonstrated in other pre-shock models, has the potential to provide critical diagnostic and prognostic feedback in high-risk individuals.", "keywords": [ "Accident and Emergency department", "Address", "Algorithms", "Animals", "Assisted Living Facilities", "Blood Volume", "COVID-19", "COVID-19 detection", "COVID-19 diagnosis", "COVID-19 early detection", "COVID-19 mortality", "COVID-19 patient", "Cardiac Output", "Cardiovascular system", "Chest", "Clinic", "Clinical", "Clinical Trials", "Communities", "Complex", "Computer software", "Data", "Data Discovery", "Data Set", "Detection", "Deterioration", "Development", "Device or Instrument Development", "Devices", "Diagnosis", "Diagnostic", "Diagnostic tests", "Disease", "Drops", "Equipment and supply inventories", "Evaluation", "Extravascular Lung Water", "Family suidae", "Feedback", "Fluid Balance", "Funding", "Goals", "Health", "Health Personnel", "Health care facility", "Healthcare", "Healthcare Systems", "Hemorrhage", "Hospitalization", "Hospitals", "Individual", "Instruction", "Learning", "Legal patent", "Long-Term Care", "Lower Body Negative Pressure", "Lung", "Measurement", "Medical", "Modeling", "Monitor", "Morbidity - disease rate", "Nursing Homes", "Optics", "Outpatients", "Oxygen", "Parents", "Patient Monitoring", "Patient-Focused Outcomes", "Patients", "Peripheral", "Phase", "Population", "Preparation", "Primary Health Care", "Prisons", "Pulse Oximetry", "Resources", "Respiratory System", "Risk", "SARS-CoV-2 infection", "Shock", "Small Business Technology Transfer Research", "Spectrum Analysis", "Symptoms", "System", "Systemic disease", "Technology", "Time", "Water", "acute care", "algorithm development", "cohort", "college", "commercialization", "community living", "coronavirus disease", "cost", "density", "electric impedance", "electrical impedance tomography", "high risk", "human study", "human subject", "improved outcome", "light weight", "lung volume", "mortality", "multimodality", "non-invasive monitor", "pandemic disease", "portability", "precision medicine", "prognostic", "programs", "prototype", "response", "scale up", "sensor", "tissue oxygenation", "tomography", "transmission process" ], "approved": true } }, { "type": "Grant", "id": "11892", "attributes": { "award_id": "1R25GM150142-01", "title": "Eradicating Misconceptions about Viruses using Multimodal Trace Data in an Intelligent Game-based Environment across Educational Contexts", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 9054, "first_name": "LAWRENCE A.", "last_name": "BECK", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-07-03", "end_date": "2028-05-31", "award_amount": 263413, "principal_investigator": { "id": 27792, "first_name": "BARRIE D", "last_name": "ROBISON", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 984, "ror": "https://ror.org/03hbp5t65", "name": "University of Idaho", "address": "", "city": "", "state": "ID", "zip": "", "country": "United States", "approved": true }, "abstract": "/ Abstract. Scientific misconceptions are becoming increasingly pervasive and damaging to the national interest. The ongoing SARS-CoV-2 pandemic has highlighted how misconceptions related to infectious disease can pose serious medical, economic, and social challenges by increasing non-compliance with public health recommendations and undermining trust in scientific institutions. Unfortunately, once scientific misconceptions are adopted by an individual, they are notoriously difficult to remediate by merely presenting the “correct” information. We need educational programs and tools that integrate evidence-based information with broader societal factors, representation of individual risk, and multiple representations of information to improve our ability to correct misconceptions. Our goal is to create an innovative, sustainable, and reproducible educational program that: (1) Creates and deploys an innovative game-based simulation to educate users about infectious diseases, (2) Inspires young people from diverse backgrounds to consider careers in biomedical research, (3) Provides teachers with engaging and easily adopted digital tools that build students’ systems thinking and data science literacy skills, and (4) Conducts innovative STEM education research about the remediation of misconceptions using systems thinking and Advanced Learning Technologies.", "keywords": [ "Adopted", "Award", "Awareness", "Belief", "Biology", "Biomedical Research", "COVID-19 pandemic", "Child", "Cognitive", "Collaborations", "Communicable Diseases", "Complex", "Computer software", "Country", "County", "Data", "Data Science", "Development", "Disease", "Disease Outbreaks", "Economically Deprived Population", "Economics", "Ecosystem", "Education", "Educational Materials", "Environment", "Evaluation", "Feedback", "Florida", "Game Based Learning", "Goals", "Health", "Heterogeneity", "Hispanic", "Idaho", "Incidence", "Income", "Individual", "Institution", "Intelligence", "Learning", "Medical", "Misinformation", "Modeling", "Molecular", "Nonlinear Dynamics", "Participant", "Pathway interactions", "Pattern", "Pediatric Hospitals", "Persons", "Predisposition", "Process", "Property", "Psyche structure", "Psychological reinforcement", "Public Health", "Recommendation", "Reproducibility", "Risk", "Rural", "Schools", "Science", "Science Technology Engineering and Mathematics Education", "Social Processes", "Societal Factors", "Students", "System", "Technology", "Testing", "Thinking", "Trust", "Universities", "Vaccination", "Virus", "Visualization", "career", "combat", "computer science", "data literacy", "design", "digital", "economic disparity", "education research", "educational atmosphere", "evidence base", "experience", "formal learning", "game development", "improved", "infectious disease model", "informal learning", "innovation", "instrument", "interest", "iterative design", "literacy", "multimodality", "non-compliance", "programs", "remediation", "science museum", "science technology engineering mathematics and medicine", "simulation", "skills", "social", "teacher", "tool" ], "approved": true } }, { "type": "Grant", "id": "11904", "attributes": { "award_id": "1R21AI174606-01A1", "title": "Synthetic biology toolkit for precise tuning of T cell activity", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 6717, "first_name": "Conrad M.", "last_name": "Mallia", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-07-10", "end_date": "2025-06-30", "award_amount": 227575, "principal_investigator": { "id": 27805, "first_name": "Guolin", "last_name": "Ma", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 27806, "first_name": "Yubin", "last_name": "Zhou", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1643, "ror": "", "name": "TEXAS A&M UNIVERSITY HEALTH SCIENCE CTR", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "/ Abstract. Chimeric antigen receptor (CAR) T cell-based immunotherapy has shown curative potential in patients with haematological malignancies. However, it faces significant safety issues (e.g., cytokine release syndrome and neurotoxicity) and efficacy loss arising from tonic signaling and T cell exhaustion. These undesireable features are more or less decoded in the distal end of lymphocyte activation pathway, the two-component Calcium Release-Activated Calcium (CRAC) channel composed of stromal interaction molecule (STIM) and ORAI to form a major Ca2+ entry route in T cells and control T cell activation. Upon T-cell receptor (TCR) engagement, Ca2+ depletion in the endoplasmic reticulum (ER) is sensed by stromal interaction molecule 1 (STIM1) to initiate a series of conformational changes, culminating in the activation of the pore-forming subunit of the CRAC channel, ORAI1. Ca2+ influx induces a series of processes in T cells, including the secretion of cytolytic granules and the activation of Ca2+-dependent enzymes, including calcineurin, CaMKII and Erk1/2, as well as master transcription factors, such as NF-κB and nuclear factor of activated-T cells (NFAT), that are essential for adaptive immunity. Most importantly, nuclear translocated NFAT differentially engages its binding partners to promote the activation, differentiation, anergy/exhaustion, and effector functions of various T cell subsets. Notably, tonic signaling and exhaustion observed in CAR-T cell therapy are associated with hyperactive Ca2+/NFAT signaling. Till now, no FDA-approved CRAC channel blockers are in hand to modulate the CRAC channel for therapeutic applications. There remains, therefore, a critical need to exploit novel interventional approaches by targeting the distal CRAC channels in T cells. Unlike most existing studies centered on CAR per se or the proximal signaling components in modulating CAR-T cell activation pathway, this project focuses on engineering the distal end of lymphocyte activation pathway without any modifications to the chimeric antigen receptor or proximal TCR signaling. The m-PIs propose to to develop a suite of genetically-encoded CRAC channel Blockers (CRAB) that can be precisely controlled by light or drugs (LiCRAB for Aim 1, and DiCRAB for Aim 2, respectively), thereby conferring tight control of T cell activity to fine-tune T cell efficacy and mitigate CAR-T cell tonic signaling and/or exhaustion. The successful execution of this project will explore innovative immunoengineering approaches to accelerate the design of intelligent cell-based therapies for human disease. Mechanistically, the tools can be utilized to probe the kinetic requirement of Ca2+/NFAT signaling during CAR-T cell activation. From a translational perspective, we will generate broadly-applicable genetically-encoded tools for therapeutic T cell functional tuning, which hold great promise to overcome tonic signaling / exhaustion, and curtail cytokine storm associated with existing FDA-approved CAR T-cell therapies.", "keywords": [ "Acceleration", "Antigens", "Binding", "Biomedical Research", "C-terminal", "CAR T cell therapy", "CD19 gene", "Caffeine", "Calcineurin", "Calcium", "Calcium Channel", "Calcium Channel Blockers", "Cell Therapy", "Cell membrane", "Cell physiology", "Cellular immunotherapy", "Chemicals", "Coupled", "Cytoplasmic Granules", "Cytosol", "Data", "Dimerization", "Disease", "Distal", "Endoplasmic Reticulum", "Engineering", "Enzymes", "Event", "Exhibits", "FDA approved", "Face", "Functional disorder", "Genetic", "Genetic Transcription", "Goals", "Hand", "Hematologic Neoplasms", "Hyperactivity", "Immunotherapy", "In Vitro", "Inflammatory", "Intelligence", "Intervention", "Ion Channel", "Kinetics", "Light", "Lymphocyte Activation", "Malignant Neoplasms", "Modeling", "Modification", "Molecular", "Molecular Conformation", "Names", "Nuclear Translocation", "Pathway interactions", "Patients", "Peptides", "Pharmaceutical Preparations", "Physiological Processes", "Pilot Projects", "Process", "Production", "Protein Dephosphorylation", "Proteins", "Publications", "Receptor Signaling", "Route", "STIM1 gene", "Safety", "Scheme", "Series", "Signal Transduction", "System", "T cell therapy", "T-Cell Activation", "T-Cell Activation Pathway", "T-Cell Receptor", "T-Lymphocyte", "T-Lymphocyte Subsets", "Tail", "Testing", "Therapeutic", "Time", "Toxic effect", "adaptive immunity", "anergy", "calmodulin-dependent protein kinase II", "cell mediated immune response", "chimeric antigen receptor", "chimeric antigen receptor T cells", "cytokine", "cytokine release syndrome", "design", "exhaustion", "human disease", "immunoengineering", "improved", "in vivo", "innovation", "neurotoxicity", "novel", "nuclear factors of activated T-cells", "optogenetics", "public health relevance", "recruit", "side effect", "small molecule inhibitor", "synthetic biology", "tool", "transcription factor", "translational potential" ], "approved": true } }, { "type": "Grant", "id": "15025", "attributes": { "award_id": "5R21AI174606-02", "title": "Synthetic biology toolkit for precise tuning of T cell activity", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 6717, "first_name": "Conrad M.", "last_name": "Mallia", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-07-10", "end_date": "2025-06-30", "award_amount": 189781, "principal_investigator": { "id": 27806, "first_name": "Yubin", "last_name": "Zhou", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1643, "ror": "", "name": "TEXAS A&M UNIVERSITY HEALTH SCIENCE CTR", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "/ Abstract. Chimeric antigen receptor (CAR) T cell-based immunotherapy has shown curative potential in patients with haematological malignancies. However, it faces significant safety issues (e.g., cytokine release syndrome and neurotoxicity) and efficacy loss arising from tonic signaling and T cell exhaustion. These undesireable features are more or less decoded in the distal end of lymphocyte activation pathway, the two-component Calcium Release-Activated Calcium (CRAC) channel composed of stromal interaction molecule (STIM) and ORAI to form a major Ca2+ entry route in T cells and control T cell activation. Upon T-cell receptor (TCR) engagement, Ca2+ depletion in the endoplasmic reticulum (ER) is sensed by stromal interaction molecule 1 (STIM1) to initiate a series of conformational changes, culminating in the activation of the pore-forming subunit of the CRAC channel, ORAI1. Ca2+ influx induces a series of processes in T cells, including the secretion of cytolytic granules and the activation of Ca2+-dependent enzymes, including calcineurin, CaMKII and Erk1/2, as well as master transcription factors, such as NF-κB and nuclear factor of activated-T cells (NFAT), that are essential for adaptive immunity. Most importantly, nuclear translocated NFAT differentially engages its binding partners to promote the activation, differentiation, anergy/exhaustion, and effector functions of various T cell subsets. Notably, tonic signaling and exhaustion observed in CAR-T cell therapy are associated with hyperactive Ca2+/NFAT signaling. Till now, no FDA-approved CRAC channel blockers are in hand to modulate the CRAC channel for therapeutic applications. There remains, therefore, a critical need to exploit novel interventional approaches by targeting the distal CRAC channels in T cells. Unlike most existing studies centered on CAR per se or the proximal signaling components in modulating CAR-T cell activation pathway, this project focuses on engineering the distal end of lymphocyte activation pathway without any modifications to the chimeric antigen receptor or proximal TCR signaling. The m-PIs propose to to develop a suite of genetically-encoded CRAC channel Blockers (CRAB) that can be precisely controlled by light or drugs (LiCRAB for Aim 1, and DiCRAB for Aim 2, respectively), thereby conferring tight control of T cell activity to fine-tune T cell efficacy and mitigate CAR-T cell tonic signaling and/or exhaustion. The successful execution of this project will explore innovative immunoengineering approaches to accelerate the design of intelligent cell-based therapies for human disease. Mechanistically, the tools can be utilized to probe the kinetic requirement of Ca2+/NFAT signaling during CAR-T cell activation. From a translational perspective, we will generate broadly-applicable genetically-encoded tools for therapeutic T cell functional tuning, which hold great promise to overcome tonic signaling / exhaustion, and curtail cytokine storm associated with existing FDA-approved CAR T-cell therapies.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "11221", "attributes": { "award_id": "1R03AI171469-01A1", "title": "An innovative and straightforward approach to construct and manipulate viral infectious clones", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 26420, "first_name": "MARY KATHERINE", "last_name": "Bradford", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-03-28", "end_date": "2025-02-28", "award_amount": 75478, "principal_investigator": { "id": 24303, "first_name": "James D", "last_name": "Weger", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 839, "ror": "", "name": "VIRGINIA POLYTECHNIC INST AND ST UNIV", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 839, "ror": "", "name": "VIRGINIA POLYTECHNIC INST AND ST UNIV", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true }, "abstract": "/ Abstract. RNA viruses like SARS-CoV-2 (family Coronaviridae) and dengue virus (DENV; family Flaviviridae) cause significant disease globally. The rise of SARS-CoV-2 variants of concern has highlighted the need to understand the viral genetic determinants underlying disease severity, transmission potential, and ability to evade immunity, which requires molecular tools to make viral mutants. However, current approaches to constructing and manipulating viral infectious clones rely on a living host (bacteria or yeast), which can lead to unwanted mutations and deletions in the viral genome, especially for larger viruses like coronaviruses and flaviviruses. Due to these issues, few labs can successfully perform this work. Since the host causes these unwanted mutations, a strategy that removes the need for a living host represents the best way forward. Our long-term goal is to create simple-to-use tools that facilitate fundamental virology research aimed at reducing disease burden, in line with NIH’s mission. This project aims to develop and optimize a paradigm- shifting but straightforward host-free approach for constructing and manipulating viral infectious clones, facilitating studies seeking to identify viral genetic determinants of disease, transmission, and other phenotypes. This approach can also be used to construct recombinant vaccine viruses and diagnostic tools like reporter viruses. We will use an exciting technique—replication cycle reaction (RCR)—which reconstitutes the E. coli DNA replication machinery in a tube. RCR can efficiently amplify a single DNA molecule of up to 1 Mb with high fidelity in a simple-to-use format. Here, we propose developing this RCR-based system to construct new infectious clones (Aim 1) and manipulate existing ones (Aim 2). Aim 1 will use chemically synthesized DNA to create infectious clones for the rapidly spreading SARS-CoV-2 Omicron variant and DENV strain Puo-218, a component of the approved DENV vaccine, Dengvaxia. The impact of this aim will be an innovative system to generate new infectious clones. Aim 2 will use the RCR-based system to make mutations and deletions in the SARS-CoV-2 Omicron variant in an existing infectious clone; we will then study the impact these mutations have on viral replication in primary human cells. The impact of this aim will be a straightforward method to generate viral mutants, facilitating mechanistic studies to understand the viral genetic determinants of pathogenesis, transmission, and immune evasion. These studies will also identify mutations outside Spike that impact viral replication. We expect these studies will have a sustained impact on molecular virology by empowering more labs to construct and manipulate infectious clones. We anticipate the techniques generated here to be broadly applicable to other positive-sense RNA viruses and negative-sense RNA and DNA viruses as well. Finally, we will share all the methods and tools generated here openly and without restriction.", "keywords": [ "2019-nCoV", "Applied Research", "Attenuated Vaccines", "Bacteria", "Basic Science", "Biology", "Biomedical Research", "Bypass", "Cells", "Circular DNA", "Clonality", "Cloning", "Communities", "Complementary DNA", "Coronavirus", "DNA", "DNA Viruses", "DNA biosynthesis", "DNA chemical synthesis", "Data", "Databases", "Dengue Vaccine", "Dengue Virus", "Dengvaxia", "Disease", "Epithelial Cells", "Escherichia coli", "Family", "Flaviviridae", "Flavivirus", "Future", "Genetic", "Genetic Determinism", "Genome", "Genotype", "Goals", "Growth", "Human", "Immune Evasion", "Immunity", "In Vitro", "Kinetics", "Link", "Measures", "Mediating", "Methods", "Mission", "Molecular", "Molecular Virology", "Mutation", "Nose", "Pathogenesis", "Phenotype", "Plasmid Cloning Vector", "Plasmids", "Point Mutation", "Polymerase", "Protocols documentation", "Public Health", "RNA Viruses", "Reaction", "Recombinants", "Reporter", "Research", "Resource Sharing", "Resources", "SARS-CoV-2 variant", "Scientist", "Serotyping", "Severity of illness", "System", "Techniques", "Toxic effect", "Tube", "United States National Institutes of Health", "Vaccines", "Variant", "Viral", "Viral Genome", "Virus", "Virus Assembly", "Virus Replication", "Work", "Yeasts", "airway epithelium", "burden of illness", "deep sequencing", "diagnostic tool", "empowerment", "fighting", "fundamental research", "innovation", "mutant", "novel", "novel strategies", "pathogen", "promoter", "recombinant virus vaccine", "reconstitution", "reverse genetics", "tool", "transmission process", "vaccine candidate", "variants of concern", "virology", "virus genetics" ], "approved": true } }, { "type": "Grant", "id": "9658", "attributes": { "award_id": "3R61HD105613-02S1", "title": "Identifying biomarker signatures of prognostic value for Multisystem Inflammatory Syndrome in Children (MIS-C)", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 6155, "first_name": "Sai Prasanna", "last_name": "Majji", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-01-01", "end_date": "2022-11-30", "award_amount": 195200, "principal_investigator": { "id": 23935, "first_name": "MICHAEL A", "last_name": "LYNES", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1664, "ror": "https://ror.org/01a1jjn24", "name": "Connecticut Children's Medical Center", "address": "", "city": "", "state": "CT", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 23936, "first_name": "David A", "last_name": "Lawrence", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 23937, "first_name": "Juan C", "last_name": "Salazar", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1664, "ror": "https://ror.org/01a1jjn24", "name": "Connecticut Children's Medical Center", "address": "", "city": "", "state": "CT", "zip": "", "country": "United States", "approved": true }, "abstract": "/ ABSTRACT – No Changes From the Original Application In adults, SARS-CoV-2 infection exhibits a wide range of clinical outcomes, from asymptomatic and mild disease to severe viral pneumonia, respiratory distress, acute kidney injury, thrombotic disorders, and serious cardiac, cerebrovascular and vascular complications. Severe infection can also occur both in children and young adults (< 21), and a significant proportion of children admitted with Covid-19 require ICU support, frequently including mechanical ventilation. In addition, children and adolescents with initially asymptomatic SARS-CoV-2 infection have presented with a rare, but very severe multisystem inflammatory syndrome (MIS-C). Epidemiologic, clinical and laboratory predictors of progression towards severe forms of acute infection with SARS-CoV-2 and MIS-C are thus urgently needed in the fight against Covid-19 in this population. As defined in the NIH Rapid Acceleration of Diagnostics (RADx) program, biomarker discovery can enable risk stratification and guide interventional studies to target Covid-19 patients at enhanced risk of developing complications and/or severe disease. To target this discovery initiative, herein we will use a battery of biological, immunological and molecular tests, including Grating-Coupled Fluorescence Plasmonic (GCFP) and advanced flow cytometry, to study children and young adults (<21 years) with mild, moderate or severe SARS-CoV-2 infection. GCFP allows the use of disposable biosensor chips that can be mass-produced at low cost and spotted in microarray format to greatly increase multiplexing capabilities. In addition, we will use a similar biomarker approach for rapid differentiation of patients with MIS-C versus other pediatric infectious or inflammatory conditions where the clinical presentation resembles MIS-C, most importantly Kawasaki disease. A child's biologic and immunologic response to SARS-CoV-2 exposure is likely influenced by a variety of factors, including genetics, epigenetics and products of the mucosa/gut-brain axis, adipose tissue and neuroendocrine immune network, and further modulated by environmental exposures. With these factors in mind, we hypothesize that a child's biomarker profile in response to SARS-CoV-2 infection enables a timely and accurate prediction of severity of Covid-19 and diagnosis of MIS-C, and will help guide treatment strategies, and predict patient outcomes. To test this hypothesis, we will use a non-traditional diagnostic and comprehensive biomarker discovery to characterize the clinical and laboratory spectrum of children and adolescents with mild, moderate and severe SARS-CoV-2 infection, as well as MIS-C. We will then validate our newly developed diagnostic and prognostic algorithm to distinguish MIS-C from other inflammatory disorders with overlapping clinical manifestations, including Kawasaki disease, and predict the longitudinal risk of complications.", "keywords": [ "2019-nCoV", "Acute", "Acute Renal Failure with Renal Papillary Necrosis", "Acute Respiratory Distress Syndrome", "Adipose tissue", "Adolescent", "Adult", "Antibodies", "Antibody Affinity", "Antibody Repertoire", "Antibody Response", "Asthma", "Attention", "Biological", "Biological Assay", "Biological Markers", "Biological Products", "Biosensor", "Blood Vessels", "COVID-19", "COVID-19 diagnosis", "COVID-19 patient", "COVID-19 severity", "Cardiac", "Child", "Childhood", "Clinical", "Collaborations", "Colombia", "Coupled", "Development", "Diagnostic", "Disease", "Elderly", "Enrollment", "Environmental Exposure", "Epidemiology", "Epigenetic Process", "Epitopes", "Exhibits", "Flow Cytometry", "Fluorescence", "Generations", "Genetic", "Grant", "Growth", "Gut Mucosa", "Humoral Immunities", "Immune", "Immune response", "Immunoglobulin G", "Immunologics", "Infection", "Inflammatory", "Inflammatory Bowel Diseases", "Intervention Studies", "Kinetics", "Laboratories", "Libraries", "Measures", "Mechanical ventilation", "Mind", "Molecular", "Molecular Conformation", "Mucocutaneous Lymph Node Syndrome", "Multisystem Inflammatory Syndrome in Children", "Neurosecretory Systems", "Nucleocapsid", "Obesity", "Oral", "Outcome", "Parents", "Patient-Focused Outcomes", "Patients", "Phage Display", "Pharmaceutical Preparations", "Population", "Proteins", "RADx", "RNA vaccination", "RNA vaccine", "Respiratory distress", "Risk", "SARS-CoV-2 antibody", "SARS-CoV-2 exposure", "SARS-CoV-2 genome", "SARS-CoV-2 infection", "SARS-CoV-2 spike protein", "SARS-CoV-2 variant", "Surface Plasmon Resonance", "Symptoms", "Syndrome", "Technology", "Testing", "Thrombosis", "Time", "United States", "United States National Institutes of Health", "Vaccinated", "Vaccination", "Vaccines", "Variant", "Viral Pneumonia", "Virus", "accurate diagnosis", "acute infection", "biomarker discovery", "biomarker signature", "care outcomes", "cerebrovascular", "cohort", "cost", "cross reactivity", "diagnostic algorithm", "fight against", "gut microbiome", "gut-brain axis", "improved", "minority children", "mortality", "neutralizing antibody", "novel coronavirus", "plasmonics", "prognostic", "prognostic algorithm", "prognostic value", "prognostication", "programs", "response", "risk stratification", "severe COVID-19", "treatment strategy", "young adult" ], "approved": true } }, { "type": "Grant", "id": "7418", "attributes": { "award_id": "3R44DA048712-01S1", "title": "RCT of Woebot for Substance Use Disorders", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Alcohol Abuse and Alcoholism (NIAAA)" ], "program_reference_codes": [], "program_officials": [ { "id": 12311, "first_name": "LEONARDO MARIA", "last_name": "Angelone", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2019-09-01", "end_date": "2020-08-31", "award_amount": 139951, "principal_investigator": { "id": 23213, "first_name": "Athena", "last_name": "Robinson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1577, "ror": "", "name": "WOEBOT LABS, INC.", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1577, "ror": "", "name": "WOEBOT LABS, INC.", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "/ ABSTRACT Woebot for Substance Use Disorders (W-SUDs) is a two-phase NIDA-funded SBIR. Presently, W-SUDs, a novel digital therapeutic, is being evaluated in the Phase I pilot. Phase II will investigate W-SUDs’s efficacy compared to an active control condition. Since the initial award, and across mere months, Covid-19 became a global pandemic, and users worldwide came to Woebot to discuss it and seek help. The company responded by building and deploying Covid- 19 specific programming (W-C19) in March 2020. W-C19 elements have been integrated into W-SUDs; we felt it was timely and appropriate to address users' concerns about the pandemic and demonstrate that Woebot was ‘intelligent’ to the crisis. Experts expect Covid-19’s direct and indirect impact upon individuals with SUDs to be particularly heavy. These individuals often have physical vulnerabilities, which increase the relative risk of death from Covid-19, and face limited health care access -- fundamentally challenging given often comorbid mental illness. Moreover, high rates of housing insecurity hinders compliance with shelter-in- place and social distancing recommendations, thereby increasing contagion risk. This proposal, with the timely addition of a randomized controlled trial comparing W-SUDs to a waitlist control (WL), expands understanding of W-SUDs’ efficacy whilst investigating Covid-19’s impact upon the SUD population. Secular trends of increased substance use are anticipated given Covid-19 stressors (e.g., shelter-in- place, disease concerns, economic strife, under-/unemployment). Hence, the WL condition is essential for testing W-SUDs’ efficacy in mitigating these Covid-19 related downstream effects. This proposal extends the parent grant by: (i) adding a randomized controlled evaluation of W-SUDs compared to WL and (ii) investigating potential between group differences on (a) substance use, (b) Covid-19 related components (e.g., social distancing; employment and parental factors), and (c) other SUD treatment engagement. While 20.2 million (8.4%) American adults had a SUD within the past year, only 20% received treatment, given significant treatment access barriers [1]. W-SUDs: (i) is poised to reduce or eliminate common yet significant barriers to traditional SUD treatment; (ii) offers virtual access, optimal for socially distancing and shelter-in-place adherence; (iii) has unconstrained and immediate scale potential; and (iv) delivers content text-based conversation, optimal for engagement. This study offers immediate access to a digital therapeutic in a resource constrained, socially distanced healthcare ecosystem for an already vulnerable and underserved population, likely faced with readily growing psychological challenges.", "keywords": [ "Address", "Adherence", "Adult", "Alcohol or Other Drugs use", "American", "Anxiety", "Area", "Award", "COVID-19", "Child", "Control Groups", "Data", "Disease", "Economics", "Ecosystem", "Elements", "Emotional", "Employment", "Evaluation", "Face", "Feedback", "Funding", "Grief reaction", "Health Services Accessibility", "Healthcare", "Home environment", "Housing", "Human", "Individual", "Intelligence", "Intervention", "Investigation", "Loneliness", "Mental Depression", "Mental disorders", "Moods", "National Institute of Drug Abuse", "Outcome", "Participant", "Phase", "Population", "Randomized", "Randomized Controlled Trials", "Recommendation", "Relative Risks", "Reporting", "Resources", "Risk", "S Phase", "Shelter facility", "Small Business Innovation Research Grant", "Social Distance", "Substance Use Disorder", "Testing", "Text", "Therapeutic", "Time", "Treatment outcome", "Underserved Population", "Unemployment", "Vulnerable Populations", "Waiting Lists", "Work", "active control", "base", "comorbidity", "comparative efficacy", "contagion", "craving", "design", "digital", "evidence base", "health care availability", "help-seeking behavior", "mortality risk", "novel", "pandemic disease", "parent grant", "psychologic", "stressor", "trend", "trial comparing", "virtual" ], "approved": true } } ], "meta": { "pagination": { "page": 1392, "pages": 1424, "count": 14236 } } }