Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=3&sort=-other_investigators
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-other_investigators", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1424&sort=-other_investigators", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=4&sort=-other_investigators", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=2&sort=-other_investigators" }, "data": [ { "type": "Grant", "id": "15937", "attributes": { "award_id": "3U01AI069911-20S6", "title": "East Africa International Epidemiology Database to evaluate AIDS (IeDEA) Regional Consortium", "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": 44382, "first_name": "JOANAD'ARC C", "last_name": "ROE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-06-01", "end_date": "2026-05-31", "award_amount": 47470, "principal_investigator": { "id": 44383, "first_name": "AGGREY SEMWENDERO", "last_name": "SEMEERE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44384, "first_name": "Kara Kay", "last_name": "Wools-Kaloustian", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 44385, "first_name": "CONSTANTIN THEODORE", "last_name": "YIANNOUTSOS", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 3402, "ror": "", "name": "INDIANA UNIVERSITY INDIANAPOLIS", "address": "", "city": "", "state": "IN", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary/Abstract: Our primary goal continues to be the provision of answers to questions that clinicians, governments, programs and international organizations consider central to the evolution and sustainability of their long term HIV care and treatment strategies for achieving the UNAIDS 2030 targets of 95-95-95 in the midst of the SARS-CoV-2 pandemic and changes in public health funding priorities. Our central hypothesis is that retention in the HIV care cascade and treatment outcomes are influenced by patient-level demographic, clinical, developmental, and behavioral factors, as well as, factors within the ambient health care and broader contextual environment. We will leverage our strengths, including robust working relationships with HIV treatment programs, a substantial harmonized regional database, plus broad experience in sampling-based methodologies and novel analytical approaches. Over the course of this research we will: SA-1: Describe movement through the HIV care cascade with a focus on identifying broader and health care environment contextual factors that influence optimal retention in care and viral suppression, in the face of global disruption due to the COVID-19 pandemic and changes in donor funding priorities. The Post COVID-19 Double-Sampling Cohort (Post COVID) will address the impact of broader contextual factors (COVID-19) while the Telehealth and Structural Adaptations project will address the impact of health care structure. SA-2: Examine the impact of developmental stage and behavioral factors on retention in the cascade and subsequent outcomes. The multiregional Adolescent and Young Adult Network of IeDEA (AYANI) and regional Measuring Adverse Pregnancy and Newborn Congenital Outcomes (MANGO) cohorts will assess the impact of developmental stage on the cascade, while the Syndemics cohort will address the impact of mental health on the cascade.SA- 3: Examine the immediate and long-term outcomes of people diagnosed with Tuberculosis (TB) with a focus on identifying and addressing factors associated with patient outcomes. The multiregional TB Sentinel Research Network (TB-SRN) will focus on understanding TB outcomes and long-term pulmonary complications including associated factors. SA-4: Explore the use of new technologies, including eHealth and machine (deep) learning to diagnose and manage HIV-associated cancers with a focus on Kaposi’s Sarcoma (KS) and Cervical Cancer. The KS Project will assess implementation of a Dermatology Telehealth Program and the Cervical Cancer Project will assess the implementation of cervical image capture with machine learning for cancer diagnoses and management. SA-5: Examine the epidemiology of NCD comorbidities and ART complications with a focus on the oldest and youngest-age groups affected by HIV. The multi-regional Sentinel Research Network (SRN) will address non-communicable diseases in people living with HIV (PLHIV) > 40 years and the regional MANGO Cohort will address complications of ART/HIV exposure on HIV-Exposed Infants.", "keywords": [ "2019-nCoV", "AIDS related cancer", "Achievement", "Acquired Immunodeficiency Syndrome", "Address", "Adolescent and Young Adult", "Affect", "Africa", "Behavioral", "COVID-19", "COVID-19 pandemic", "Caring", "Cervical", "Clinic", "Clinical", "Collaborations", "Communities", "Country", "Data", "Data Sources", "Databases", "Dermatology", "Development", "Diagnosis", "Disease", "Environment", "Epidemiology", "Evolution", "Funding", "Gender", "Genetic", "Geography", "Goals", "Government", "Grant", "HIV", "HIV/AIDS", "Health", "Health Care", "Home", "Image", "Infant", "International", "Joints", "Kaposi Sarcoma", "Kenya", "Knowledge", "Learning", "Liver diseases", "Longevity", "Machine Learning", "Malignant Neoplasms", "Malignant neoplasm of cervix uteri", "Measures", "Mental Depression", "Mental Health", "Methodology", "Methods", "Movement", "Newborn Infant", "Operations Research", "Outcome", "Patient-Focused Outcomes", "Patients", "Persons", "Policies", "Pregnancy", "Public Health", "Research", "Resource-limited setting", "Risk Factors", "Sampling", "Sentinel", "Statistical Methods", "Structure", "Tanzania", "Technology", "Telemedicine", "Treatment outcome", "Tuberculosis", "Tuberculosis diagnosis", "Uganda", "United Nations", "Viral", "age group", "antiretroviral therapy", "cancer diagnosis", "cardiovascular risk factor", "care outcomes", "co-infection", "cohort", "comorbidity", "contextual factors", "eHealth", "experience", "implementation evaluation", "implementation research", "insight", "new technology", "novel", "post-COVID-19", "programs", "pulmonary", "scale up", "substance use", "syndemic", "telehealth", "tool", "treatment guidelines", "treatment program", "treatment strategy" ], "approved": true } }, { "type": "Grant", "id": "15939", "attributes": { "award_id": "3U01AI069911-20S2", "title": "East Africa International Epidemiology Database to evaluate AIDS (IeDEA) Regional Consortium", "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": 44382, "first_name": "JOANAD'ARC C", "last_name": "ROE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-06-01", "end_date": "2026-05-31", "award_amount": 121192, "principal_investigator": { "id": 44383, "first_name": "AGGREY SEMWENDERO", "last_name": "SEMEERE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44384, "first_name": "Kara Kay", "last_name": "Wools-Kaloustian", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 44385, "first_name": "CONSTANTIN THEODORE", "last_name": "YIANNOUTSOS", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 3402, "ror": "", "name": "INDIANA UNIVERSITY INDIANAPOLIS", "address": "", "city": "", "state": "IN", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary/Abstract: Our primary goal continues to be the provision of answers to questions that clinicians, governments, programs and international organizations consider central to the evolution and sustainability of their long term HIV care and treatment strategies for achieving the UNAIDS 2030 targets of 95-95-95 in the midst of the SARS-CoV-2 pandemic and changes in public health funding priorities. Our central hypothesis is that retention in the HIV care cascade and treatment outcomes are influenced by patient-level demographic, clinical, developmental, and behavioral factors, as well as, factors within the ambient health care and broader contextual environment. We will leverage our strengths, including robust working relationships with HIV treatment programs, a substantial harmonized regional database, plus broad experience in sampling-based methodologies and novel analytical approaches. Over the course of this research we will: SA-1: Describe movement through the HIV care cascade with a focus on identifying broader and health care environment contextual factors that influence optimal retention in care and viral suppression, in the face of global disruption due to the COVID-19 pandemic and changes in donor funding priorities. The Post COVID-19 Double-Sampling Cohort (Post COVID) will address the impact of broader contextual factors (COVID-19) while the Telehealth and Structural Adaptations project will address the impact of health care structure. SA-2: Examine the impact of developmental stage and behavioral factors on retention in the cascade and subsequent outcomes. The multiregional Adolescent and Young Adult Network of IeDEA (AYANI) and regional Measuring Adverse Pregnancy and Newborn Congenital Outcomes (MANGO) cohorts will assess the impact of developmental stage on the cascade, while the Syndemics cohort will address the impact of mental health on the cascade.SA- 3: Examine the immediate and long-term outcomes of people diagnosed with Tuberculosis (TB) with a focus on identifying and addressing factors associated with patient outcomes. The multiregional TB Sentinel Research Network (TB-SRN) will focus on understanding TB outcomes and long-term pulmonary complications including associated factors. SA-4: Explore the use of new technologies, including eHealth and machine (deep) learning to diagnose and manage HIV-associated cancers with a focus on Kaposi’s Sarcoma (KS) and Cervical Cancer. The KS Project will assess implementation of a Dermatology Telehealth Program and the Cervical Cancer Project will assess the implementation of cervical image capture with machine learning for cancer diagnoses and management. SA-5: Examine the epidemiology of NCD comorbidities and ART complications with a focus on the oldest and youngest-age groups affected by HIV. The multi-regional Sentinel Research Network (SRN) will address non-communicable diseases in people living with HIV (PLHIV) > 40 years and the regional MANGO Cohort will address complications of ART/HIV exposure on HIV-Exposed Infants.", "keywords": [ "2019-nCoV", "AIDS related cancer", "Achievement", "Acquired Immunodeficiency Syndrome", "Address", "Adolescent and Young Adult", "Affect", "Africa", "Behavioral", "COVID-19", "COVID-19 pandemic", "Caring", "Cervical", "Clinic", "Clinical", "Collaborations", "Communities", "Country", "Data", "Data Sources", "Databases", "Dermatology", "Development", "Diagnosis", "Disease", "Environment", "Epidemiology", "Evolution", "Funding", "Gender", "Genetic", "Geography", "Goals", "Government", "Grant", "HIV", "HIV/AIDS", "Health", "Health Care", "Home", "Image", "Infant", "International", "Joints", "Kaposi Sarcoma", "Kenya", "Knowledge", "Learning", "Liver diseases", "Longevity", "Machine Learning", "Malignant Neoplasms", "Malignant neoplasm of cervix uteri", "Measures", "Mental Depression", "Mental Health", "Methodology", "Methods", "Movement", "Newborn Infant", "Operations Research", "Outcome", "Patient-Focused Outcomes", "Patients", "Persons", "Policies", "Pregnancy", "Public Health", "Research", "Resource-limited setting", "Risk Factors", "Sampling", "Sentinel", "Statistical Methods", "Structure", "Tanzania", "Technology", "Telemedicine", "Treatment outcome", "Tuberculosis", "Tuberculosis diagnosis", "Uganda", "United Nations", "Viral", "age group", "antiretroviral therapy", "cancer diagnosis", "cardiovascular risk factor", "care outcomes", "co-infection", "cohort", "comorbidity", "contextual factors", "eHealth", "experience", "implementation evaluation", "implementation research", "insight", "new technology", "novel", "post-COVID-19", "programs", "pulmonary", "scale up", "substance use", "syndemic", "telehealth", "tool", "treatment guidelines", "treatment program", "treatment strategy" ], "approved": true } }, { "type": "Grant", "id": "15930", "attributes": { "award_id": "1R24AI192250-01", "title": "Repository of Monoclonal Antibodies (RoMA) against Hamster and Guinea Pig Proteins", "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": 32843, "first_name": "JOSEPH J", "last_name": "BREEN", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-07-24", "end_date": "2030-06-30", "award_amount": 835137, "principal_investigator": { "id": 44375, "first_name": "JAMES A", "last_name": "DUTY", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44376, "first_name": "Domenico", "last_name": "Tortorella", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 3386, "ror": "", "name": "ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Small animal models are ideal to study diverse infectious and inflammatory diseases with mice being a widely used model system due to the well-characterized immune response and availability of reagents. Yet, the drawbacks of the mouse animal model are that it does not mimic many diseases due to the lack of clinical symptoms, differences in immune activation, and non-susceptible to infection of many pathogens. In fact, ferrets, Guinea pigs, and hamsters are a more suited animal model for numerous infectious pathogens including bat coronaviruses (SARS-CoV and SARS-CoV-2), influenza virus, and respiratory syncytial virus, respectively; yet, the lack of reagents that define the immune and inflammatory responses in ferrets, Guinea pigs, and hamsters prevent their utilization to comprehensively understand disease pathology and effectiveness of therapeutics and vaccines. Thus, there is a severe reagent gap for monoclonal antibodies against immune and inflammatory markers of ferrets, Guinea pigs, and hamsters to use these animal models in infectious disease studies. The main objective of the R24 application is to create a Repository of Monoclonal Antibodies (RoMA) for use in small animal models for evaluating infectious and inflammatory disorders fulfilling a major reagent gap in the scientific community. We hypothesize that reagents that monitor the immune response in hamster and Guinea pig model systems will be widely used in infectious disease model systems to predict disease progression and effectiveness of vaccines and therapeutics in human disease. A panel of monoclonal antibodies will be generated upon completion of the following aims: Aim 1: Develop antibodies targeting hamster and guinea pig surface markers on the respective immune cells. The hamster has become an excellent model for respiratory pathogens including SARS-corona viruses, Rift Valley fever, and Clostridium difficile; while the Guinea pig animal model provides insight into numerous infection and transmission models such as influenza virus and herpesviruses. Aim 2: Identify and generate monoclonal antibodies to hamster and guinea pig immune cell activation markers. We plan to identify and generate monoclonal antibodies to activated immune cell immune markers of hamster and Guinea pigs. These activated biomarkers will consist of previously characterized human and mouse orthologs that likely function in immune regulation. We expect to generate a total of 50 monoclonal antibodies (25 anti-hamster and 25 anti-Guinea pig proteins) over the 5-year grant period that will be available to the scientific community. These antibodies will be essential for evaluating the immune and inflammatory responses in the hamster and Guinea pig animal models.", "keywords": [ "2019-nCoV", "Animal Model", "Animals", "Antibodies", "B-Lymphocytes", "Bacterial Infections", "Biological Markers", "Biological Models", "Blood", "Cavia", "Cell surface", "Cells", "Chiroptera", "Clinical", "Clinical Pathology", "Clostridium difficile", "Communicable Diseases", "Communities", "Coronavirus", "Dendritic Cells", "Disease", "Disease Progression", "Evaluation", "Ferrets", "Grant", "Hamsters", "Herpesviridae", "Human", "Immune", "Immune System Diseases", "Immune response", "Immunologic Factors", "Immunologic Markers", "Immunologic Monitoring", "Immunologic Stimulation", "Infection", "Infectious Agent", "Inflammatory", "Inflammatory Response", "Laboratories", "Lymphoid", "Lymphoid Cell", "Macrophage", "Modeling", "Monoclonal Antibodies", "Mouse Protein", "Mus", "Myelogenous", "Myeloid Cells", "Natural Killer Cells", "Orthologous Gene", "Oryctolagus cuniculus", "Pathology", "Phenotype", "Physiology", "Prevention", "Proteins", "R24", "Rattus", "Reagent", "Research", "Respiratory syncytial virus", "Rift Valley Fever", "SARS coronavirus", "Scientific Advances and Accomplishments", "Spleen", "Surface", "Symptoms", "T-Lymphocyte", "Therapeutic", "Transgenic Animals", "Treatment Efficacy", "United States National Institutes of Health", "Vaccines", "Virus Diseases", "Zebrafish", "animal model selection", "cost", "cross reactivity", "design", "diagnostic tool", "guinea pig model", "human disease", "immune activation", "immunological status", "immunoregulation", "infectious disease model", "inflammatory marker", "influenzavirus", "insight", "monocyte", "neutrophil", "next generation sequencing", "nonhuman primate", "pathogen", "preclinical study", "prevent", "programs", "repository", "respiratory pathogen", "response", "therapeutic effectiveness", "transmission process", "vaccine effectiveness", "vaccine efficacy" ], "approved": true } }, { "type": "Grant", "id": "15927", "attributes": { "award_id": "1U01DA063078-01", "title": "A binational cohort of the intersection between substance use, HIV, and associated comorbidities among people who inject drugs in San Diego, CA", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Drug Abuse (NIDA)" ], "program_reference_codes": [], "program_officials": [ { "id": 44370, "first_name": "SHEBA KING", "last_name": "DUNSTON", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-07-15", "end_date": "2030-05-31", "award_amount": 2437310, "principal_investigator": { "id": 23320, "first_name": "STEFFANIE A.", "last_name": "STRATHDEE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 760, "ror": "https://ror.org/0168r3w48", "name": "University of California, San Diego", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 44371, "first_name": "Britt", "last_name": "Skaathun", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2637, "ror": "", "name": "UNIVERSITY OF CALIFORNIA, SAN DIEGO", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "We will prospectively study the intersection between substance use, HIV and related co-morbidities in a cohort of people who use drugs (PWUD) in San Diego County (SD). For >25 years, Strathdee has studied the epidemiology of HIV and related co-infections among PWUD across North America, with N=500-1000 and annual retention ≥90%. Since 2020, our La Frontera I cohort situated on the U.S.-Mexico border has documented the highest HIV and HCV incidence among people who inject drugs in North America. Currently, HIV prevalence among former injectors in SD is 16% compared to 10% among current injectors. Consistent with other U.S. cities, we observed a dramatic shift from injection to non-injection of opiates in recent years, leading us to propose cohort expansion to non-injectors. Due to our location on a major drug trafficking corridor, we observe a wide range of substances (e.g., heroin, fentanyl, methamphetamine, xylazine, benzodiazepines). We previously leveraged La Frontera I to evaluate initiatives to improve uptake of PrEP, COVID-19 testing and vaccination. We propose: 1) To characterize trends and predictors of use of established and emerging drugs, drug use transitions (e.g., shifts from IDU to non-IDU & vice versa) and their impact on HIV incidence and utilization of HIV prevention and treatment. 2) To study prevalence and incidence of the following co-morbidities and their relationship to HIV incidence and utilization of HIV prevention and treatment: i) HCV; ii) STIs (i.e., syphilis, gonorrhea, Chlamydia, MPox), iii) neurobehavioral disturbances. 3) To evaluate the influence of structural interventions on HIV-related risk behaviors and utilization of HIV prevention and treatment including: i) new homelessness policies; ii) drug checking services; iii) vending machines. 4) To contribute to a shared database and biorepositories that serve as a platform for collaborations with end users and community partners. To meet these aims, we will continue to follow PWUD from La Frontera I who are actively using illicit substances, replenishing to arrive at 500 PWID and 500 PWUD (non-injectors) for a total sample of 1000. This will include subgroups vulnerable to HIV in SD (e.g., sex workers, people experiencing homelessness) among whom we expect 52 HIV seroconversions after 5 years of follow-up. Our cohort will include at least 50 PWUD living with HIV who will provide samples for viral load, sequencing and biobanking. All participants will undergo semi-annual interviews and specimen collection. SD is designated as a high priority jurisdiction for the Ending the HIV Epidemic Initiative (EHE) and a high intensity drug trafficking area by the DEA. La Frontera II leverages NIH-funded T32s, the California NeuroHIV Tissue Network, Last Gift Study brain/tissue repositories and the PREPARE Institute which tracks emerging and re-emerging infectious disease threats. Our work is aligned with priorities identified by RFA-DA-25-003, the NIH Office of AIDS Research and the EHE.", "keywords": [ "AIDS prevention", "Area", "Benzodiazepines", "Biological", "Border Crossings", "Brain", "COVID-19", "COVID-19 testing", "COVID-19 vaccination", "California", "Chlamydia", "Cities", "Collaborations", "County", "Coupled", "Drug usage", "Drug user", "Emerging Communicable Diseases", "Environmental Exposure", "Epidemic", "Epidemiology", "Fentanyl", "Functional disorder", "Funding", "Gifts", "Goals", "Gonorrhea", "HIV", "HIV Seropositivity", "HIV risk", "HIV/HCV", "Harm Reduction", "Health", "Hepatitis C Incidence", "Hepatitis C virus", "Heroin", "Homelessness", "Incidence", "Infectious disease threat", "Injecting drug user", "Injections", "Intervention", "Interview", "Lived experience", "Location", "Meta-Analysis", "Methamphetamine", "Mexico", "Modeling", "Molecular Epidemiology", "Monkeypox", "Mood Disorders", "NIH Office of AIDS Research", "National Institute of Drug Abuse", "Needle Sharing", "Neurocognitive", "North America", "Opioid", "Participant", "Pattern", "Persons", "Pharmaceutical Preparations", "Policies", "Positioning Attribute", "Postdoctoral Fellow", "Prevalence", "Prevalence Study", "Prospective Studies", "Prospective cohort", "Prospective cohort study", "Research", "Research Priority", "Risk Behaviors", "Sample Size", "Sampling", "Services", "Statutes and Laws", "Subgroup", "Syphilis", "Testing", "Tissue Banks", "Tissues", "Travel", "United States National Institutes of Health", "Viral Load result", "Visit", "Work", "Xylazine", "biobank", "co-infection", "cohort", "community partners", "comorbidity", "data sharing", "end of life", "epidemiology study", "experience", "fentanyl use", "follow-up", "housing instability", "improved", "member", "neuroAIDS", "neurobehavioral", "novel", "pre-doctoral", "pre-exposure prophylaxis", "prevention service", "recruit", "repository", "response", "retention rate", "sample collection", "seroconversion", "severe mental illness", "sex", "shared database", "sociodemographics", "substance use", "syndemic", "synthetic drug", "systematic review", "trafficking", "transmission process", "treatment services", "trend", "uptake" ], "approved": true } }, { "type": "Grant", "id": "15920", "attributes": { "award_id": "1R01HD114790-01A1", "title": "Health Outcomes of Youth Who Experience Caregiver Death", "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": 44281, "first_name": "VALERIE", "last_name": "MAHOLMES", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-07-24", "end_date": "2030-03-31", "award_amount": 569563, "principal_investigator": { "id": 44365, "first_name": "Dylan B.", "last_name": "Jackson", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44366, "first_name": "Terrinieka Williams", "last_name": "Powell", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2615, "ror": "", "name": "JOHNS HOPKINS UNIVERSITY", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "Each year, over two million US youth experience the death of a caregiver before the age of 18 (hereafter referred to as caregiver death). Given the syndemic of COVID-19, the opioid crisis, and gun violence, rates of caregiver death among US children are likely to remain elevated or increase in the next decade. US non-Hispanic Black children are three times more likely to experience parent death than White children. Bereaved youth (i.e., who experienced a caregiver death) are vulnerable to adverse emotional and behavioral health (EBH) outcomes, such as higher risks of depression, anxiety, substance use, and suicidality. The goal of this research is to identify opportunities for improving EBH outcomes among bereaved youth. Three knowledge gaps must be filled to achieve this goal. First, we need to evaluate caregiver death in the context of other co-occurring adverse experiences. Second, we need to understand how the caregiving context mediates the relationship between caregiver death and EBH outcomes. Third, we need to learn from the lived experiences of bereaved young people. In addition to our multidisciplinary investigative team with relevant content and methodological expertise, an Advisory Board of bereaved young adults and grief professionals will be developed to inform this research. Guided by a Life Course Framework and Multidimensional Grief Theory, we will use a convergent mixed-method design to achieve three aims and fill the identified knowledge gaps: 1) Assess associations between caregiver death and EBH outcomes in the context of adverse childhood expereinces among young adults from the Future of Families and Child Wellbeing Study (N = ~2900); 2) Determine the extent to which the caregiving context (i.e., material hardship and parental monitoring) mediates the relationship between caregiver death and EBH outcomes; 3) Identify diverse strategies to support bereaved youth using longitudinal survey data and lived experiences (i.e., life history interviews with 80 young adults and consensus building with our Advisory Board). Achieving these aims will improve our ability develop tailored, family-centered interventions, practices and policies that support bereaved youth across sociodemographic groups. Ultimately, study findings will inform theory-driven and data-informed recommendations for future research, practice, and policies to improve EBH outcomes for the growing number of bereaved young people.", "keywords": [ "Adverse effects", "Adverse event", "Affect", "Age", "Anxiety", "Bereavement", "Black race", "COVID-19", "Caregivers", "Cessation of life", "Characteristics", "Child", "Child Health", "Child Welfare", "Childhood", "Consensus", "Data", "Development", "Dimensions", "Emotional", "Ethnic Origin", "Exhibits", "Family", "Family member", "Future", "Gender", "Goals", "Grief reaction", "Health", "Intervention", "Interview", "Joints", "Knowledge", "Learning", "Life Cycle Stages", "Lived experience", "Longitudinal Surveys", "Mediating", "Mental Depression", "Mental disorders", "Methodology", "Methods", "Not Hispanic or Latino", "Outcome", "Parents", "Persons", "Policies", "Policy Maker", "Public Health", "Reaction", "Recommendation", "Research", "Research Personnel", "Schools", "Shapes", "Symptoms", "Translating", "Voice", "Youth", "behavioral health", "caregiving", "comparison group", "data centers", "design", "experience", "gun violence", "high risk", "improved", "life history", "multidisciplinary", "opioid epidemic", "parental monitoring", "post-traumatic stress", "prevent", "racial difference", "sociodemographic group", "substance use", "suicidal", "syndemic", "theories", "transition to adulthood", "young adult" ], "approved": true } }, { "type": "Grant", "id": "15913", "attributes": { "award_id": "1R21AI194204-01", "title": "Notch regulation of airway epithelial-immune cell cross-talk in SARS-CoV-2 infection", "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": 32599, "first_name": "MICHELLE MARIE", "last_name": "ARNOLD", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-07-09", "end_date": "2027-06-30", "award_amount": 448688, "principal_investigator": { "id": 44356, "first_name": "Susan", "last_name": "Kovats", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44357, "first_name": "Matthew Stuart", "last_name": "Walters", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 3399, "ror": "", "name": "OKLAHOMA MEDICAL RESEARCH FOUNDATION", "address": "", "city": "", "state": "OK", "zip": "", "country": "United States", "approved": true }, "abstract": "Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the causative agent of COVID-19. Infection with SARS-CoV-2 begins in epithelial cells of the upper airways, which triggers multiple antiviral responses that activate myeloid immune cells, coordinate the early innate immune response, and limit viral spread. Notably, our understanding of the cell signaling mechanisms that regulate early epithelial-immune cell interactions and induction of tissue pathology during SARS-CoV-2 infection of the human airway remains limited. To investigate these processes, we have developed a novel in vitro all human 3D model of the upper airways (HUA) composed of layers of primary differentiated airway epithelial cells expressing ACE2, lung fibroblasts in a collagen matrix, and pulmonary endothelial cells, with myeloid cells present in each layer. SARS-CoV-2 infection of the HUA model results in virus replication and induction of an immune response reminiscent of in vivo infection, and the presence of myeloid cells limits viral replication. Therefore, we will use the HUA model to perform kinetic studies of the mechanisms by which human airway cells interact to regulate virus-host interactions, inflammation, and tissue pathology associated with SARS-CoV-2. We will focus on the Notch pathway, which acts via direct cell- to-cell signaling to regulate airway epithelial cell fate decisions as well as myeloid cell maintenance, Toll-like receptor signaling, pro-inflammatory polarization, and antiviral functions. However, the mechanisms by which Notch signaling regulates airway epithelial-myeloid cell interactions during SARS-CoV-2 infection remain unknown. Our preliminary analyses showed that airway epithelial cells and myeloid cells express multiple Notch ligands and receptors in uninfected HUA models, suggesting that the Notch pathway will mediate bidirectional crosstalk during the airway response to infection. We will test the central hypothesis that Notch receptor signaling in myeloid cells regulates their pro-inflammatory phenotype, thereby promoting the host innate antiviral immune response and contributing to airway epithelial cell damage and remodeling during SARS-CoV-2 infection. Using lentivirus vectors and inducible expression systems, we will attenuate expression of individual Notch ligands and receptors in a cell-type specific and temporal manner. Following SARS-CoV-2 infection, we will quantify the impact of reducing Notch signaling activity on virus replication, myeloid cell phenotypes, the host immune response, and airway epithelial remodeling. The data collected in this study will advance our understanding of the mechanisms that regulate airway epithelial-immune cell interactions during SARS-CoV-2 infection and may identify candidate therapeutic targets in the Notch pathway to enhance antiviral immunity and reduce epithelial injury and remodeling in the upper airway.", "keywords": [ "2019-nCoV", "ACE2", "Address", "Anti-viral Response", "Anti-viral Therapy", "Attenuated", "COVID-19", "COVID-19 treatment", "Cell Communication", "Cell Differentiation process", "Cell Maintenance", "Cell Separation", "Cells", "Cessation of life", "Collagen", "Data", "Dendritic Cells", "Endothelial Cells", "Environment", "Epithelial Cells", "Epithelium", "Fibroblasts", "Gene Modified", "Human", "Immune", "Immune response", "In Vitro", "Individual", "Infection", "Inflammation", "Inflammatory", "Innate Immune Response", "Kinetics", "Lentivirus Vector", "Ligands", "Lung", "Macrophage", "Maintenance", "Mediating", "Membrane", "Modeling", "Myelogenous", "Myeloid Cells", "NOTCH1 gene", "Notch Signaling Pathway", "Pathology", "Pathway interactions", "Phenotype", "Play", "Process", "Receptor Signaling", "Regulation", "Role", "SARS-CoV-2 infection", "Shapes", "Signal Transduction", "Structure of parenchyma of lung", "System", "Testing", "Tissue Model", "Tissues", "Toll-like receptors", "Viral", "Viral Physiology", "Virus", "Virus Activation", "Virus Replication", "airway epithelium", "antiviral immunity", "candidate identification", "cell injury", "cell type", "epithelial injury", "human disease", "in vivo", "inducible gene expression", "lung injury", "lung microvascular endothelial cells", "lung repair", "monocyte", "notch protein", "novel", "pandemic disease", "post SARS-CoV-2 infection", "pulmonary", "receptor", "respiratory infection virus", "respiratory virus", "response", "single-cell RNA sequencing", "therapeutic target", "three-dimensional modeling", "virus host interaction" ], "approved": true } }, { "type": "Grant", "id": "15910", "attributes": { "award_id": "1R21AI188227-01", "title": "Novel point-of-care liquid biopsy for early detection of sepsis-associated organ damage", "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": 44351, "first_name": "MICHAEL", "last_name": "MINNICOZZI", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-07-25", "end_date": "2027-06-30", "award_amount": 473937, "principal_investigator": { "id": 44352, "first_name": "ROBY PAUL", "last_name": "BHATTACHARYYA", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44353, "first_name": "Nezihi Murat", "last_name": "Karabacak", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2623, "ror": "", "name": "MASSACHUSETTS GENERAL HOSPITAL", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "Sepsis, defined as a dysregulated immune response to infection leading to end-organ damage, is a critical problem that imposes considerable burdens on health care systems globally. However, despite its importance, sepsis is notoriously challenging to diagnose with precision, since neither infection nor organ dysfunction may be evident upon initial clinical assessment. Our overall objective in this application is to develop a novel circulating cellular biomarker for the early detection and assessment of sepsis-induced organ damage. Our team pioneered the “liquid biopsy” approach to cancer detection and monitoring, and we have recently extended this approach to systemic infection, detecting circulating lung epithelial cells in severe COVID-19, and cardiomyocytes in children with cardiac manifestations of multisystem inflammatory syndrome (MIS-C), providing proof of concept for extending our approach to infectious diseases. Our central hypothesis is that the detection of tissue-derived circulating rare cells (tCRCs, e.g. cells originating from the lungs, kidney, etc.) in the peripheral blood of sepsis patients will serve as a measurement of early organ/tissue damage to enable early diagnosis and monitoring of patients. The ability to noninvasively sample tissues affected by sepsis, COVID-19 and hyperinflammatory sequelae such as MIS-C, and ultimately other systemic infectious or inflammatory syndromes may both (1) clarify diagnosis of these syndromes that often lack specific diagnostic criteria or tests and (2) provide important insights into disease mechanisms, tropisms, and treatment response. To minimize one source of heterogeneity (anatomical source of infection) in this pilot study of a notoriously heterogeneous clinical syndrome, we will limit enrollment to sepsis of suspected pulmonary source. We propose two specific aims: In Aim 1, we propose to optimize a microfluidic enrichment and droplet- based digital PCR (ddPCR) assay to detect tCRCs first in spike-in samples, then in a series of 60 patients with pneumonia at risk for sepsis (n = 30 adjudicated to have sepsis, and 30 without). In Aim 2, we will identify tCRC transcriptional signatures for early detection of sepsis-induced organ damage via bulk (n = 60) and single-cell (n = 15) RNA-Seq. We will use patient enrollment criteria that we have successfully used in prior studies of sepsis. The proposed research is innovative because our approach has the potential to fill the significant gaps in (1) diagnosis and monitoring of disease progression and treatment response via non-invasive methods (i.e., liquid biopsy) with high sensitivity and specificity, and (2) early, non-invasive pathophysiological characterization of sepsis and potentially other inflammatory conditions. The project is significant because it has the potential to provide a blood-based cellular biomarker for a common and critical illness, via an approach that can potentially extend to other systemic diseases. Ultimately, building upon this pilot proposal, we anticipate in the longer term that this novel approach can offer a novel diagnostic tool to non-invasively sample end-organs affected by systemic infection, just as circulating tumor cell detection has revolutionized the detection of cancer metastasis.", "keywords": [ "Address", "Affect", "Anatomy", "Antibiotics", "Biological Assay", "Biological Markers", "Blood", "Blood specimen", "Body System", "COVID-19", "Cancer Detection", "Cancer Diagnostics", "Cardiac", "Cardiac Myocytes", "Cardiovascular Diseases", "Cells", "Child", "Circulation", "Clinical", "Clinical Management", "Clinical Research", "Clinical assessments", "Communicable Diseases", "Critical Illness", "Data", "Detection", "Diagnosis", "Diagnostic", "Diagnostic tests", "Disease", "Disease Progression", "Disseminated Malignant Neoplasm", "Early Diagnosis", "Early treatment", "Endothelial Cells", "Enrollment", "Epithelial Cells", "Follow-Up Studies", "Functional disorder", "Gene Expression", "Gene Expression Profile", "Goals", "Health", "Health Care Systems", "Heterogeneity", "Immune response", "Infection", "Inflammatory", "Inpatients", "Kidney", "Laboratories", "Longitudinal Studies", "Lung", "Malignant neoplasm of lung", "Measurement", "Measures", "Messenger RNA", "Methods", "Microfluidics", "Molecular", "Monitor", "Multisystem Inflammatory Syndrome in Children", "Neoplasm Circulating Cells", "Neoplasm Metastasis", "Non-Invasive Detection", "Organ", "Pathway interactions", "Patient Monitoring", "Patients", "Performance", "Peripheral", "Physiological", "Physiology", "Pilot Projects", "Pneumonia", "Research", "Risk", "Sampling", "Selection for Treatments", "Sensitivity and Specificity", "Sepsis", "Series", "Severities", "Societies", "Source", "Syndrome", "System", "Systemic disease", "Systemic infection", "Technology", "Testing", "Therapeutic Studies", "Tissue Sample", "Tissues", "Trauma", "Tropism", "Whole Blood", "adjudication", "cell type", "diagnostic algorithm", "diagnostic criteria", "diagnostic tool", "differential expression", "disease diagnostic", "droplet digital PCR", "early detection biomarkers", "follow-up", "hemodynamics", "innovation", "innovative technologies", "insight", "kidney cell", "liquid biopsy", "molecular diagnostics", "multidisciplinary", "novel", "novel diagnostics", "novel strategies", "organ injury", "participant enrollment", "peripheral blood", "point of care", "point-of-care diagnostics", "programs", "pulmonary", "risk stratification", "sepsis diagnosis", "sepsis treatment", "septic patients", "severe COVID-19", "single-cell RNA sequencing", "specific biomarkers", "transcriptome", "transcriptome sequencing", "transcriptomics", "treatment r" ], "approved": true } }, { "type": "Grant", "id": "15908", "attributes": { "award_id": "1R25CA298919-01", "title": "Dissemination of the Education in Palliative and End-of-life Care–Pediatrics (EPEC-Pediatrics) Train-the-Trainer Curriculum: Phase 2", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [ { "id": 44346, "first_name": "MARIAM", "last_name": "ELJANNE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-07-10", "end_date": "2030-06-30", "award_amount": 322439, "principal_investigator": { "id": 44347, "first_name": "Stefan J", "last_name": "Friedrichsdorf", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44348, "first_name": "Andrea", "last_name": "Postier", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2635, "ror": "", "name": "UNIVERSITY OF CALIFORNIA, SAN FRANCISCO", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Most children living with advanced cancer experience highly distressing symptoms, and many do not have access to subspecialist pediatric palliative care (PPC) services or clinicians trained in primary palliative care. Despite the call from national organizations for the integration of palliative care for patients with cancer, a lack of high-quality PPC education persists as a barrier to PPC implementation. From 2012-2017 the investigators of the current proposal developed and disseminated the most comprehensive PPC curriculum worldwide to date: Education in Palliative and End-of-Life Care (EPEC)-Pediatrics (NIH/NCI grant #R25 CA151000-01). The 24-module curriculum is designed to teach clinicians how to teach and advance PPC concepts. The primary target audience was pediatric oncology prescribing clinicians. The curriculum is delivered through combined online learning and face-to-face conferences. When the COVID-19 pandemic emerged, an online training platform was created, enabling remote worldwide participation. Forty conferences have been held to date, training 1,992 clinicians from 122 countries. Most participants have reported improvement in PPC knowledge, attitudes, and skills, and advancements in patient care for children with cancer and serious illnesses. Further dissemination has been achieved through five publications and dozens of academic presentations. The primary goal of this project is to improve EPEC-Pediatrics accessibility and inclusivity by targeting participants from US pediatric oncology programs outside of large tertiary centers, including non-prescribing interprofessional clinicians (e.g. social workers). The project will also address disparities in PPC education by adding faculty from underrepresented communities, such as infants. Further, the curriculum will be updated to ensure content is current and inclusive, reflecting the needs of all children with cancer and families, including those with special needs. Specific aims are to: 1) Disseminate the EPEC-Pediatrics curriculum through five annual EPEC-Pediatrics Train-the-Trainer conferences in previously geographically underrepresented areas of the US (e.g., Southern region). 2) Update and expand the existing EPEC-Pediatrics curriculum and dissemination project by: a) Seeking guidance from an interprofessional group of clinical experts (e.g., bereaved parents) to improve curriculum content and ensure it includes equitable and inclusive content; b) Strengthening the psychosocial-spiritual curriculum content through emphasis of care for special populations (e.g., infants with cancer); and c) Designing a learning pathway for non-prescribing clinicians. Successful adaptation and dissemination of a more holistic EPEC-Pediatrics curriculum will promote transfer of PPC best practices to underserved communities, ultimately changing clinician behavior and improving care for children with cancer and their families.", "keywords": [ "Address", "Adolescent", "Adult", "Advanced Malignant Neoplasm", "Area", "Attitude", "COVID-19 pandemic", "Cancer Education Grant Program", "Caring", "Catchment Area", "Child", "Child Care", "Childhood", "Clinical", "Communities", "Country", "Development", "Disparity", "Distress", "E-learning", "Education", "Education and Outreach", "Educational Curriculum", "Educational process of instructing", "Emotional", "Ensure", "Equity", "Faculty", "Family", "Fees", "Fright", "Geography", "Goals", "Grant", "Hospitals", "Impairment", "Infant", "Infrastructure", "Insurance Coverage", "Knowledge", "Language", "Learning", "Life Experience", "Malignant Childhood Neoplasm", "Malignant Neoplasms", "Modification", "Neurologic", "Oncology", "Opiate Addiction", "Palliative Care", "Parents", "Participant", "Pathway interactions", "Patient Care", "Patients", "Pediatric Hospitals", "Pediatric Oncology", "Pediatric Oncology Group", "Personal Satisfaction", "Phase", "Population", "Poverty", "Publications", "Quality of life", "Reporting", "Request for Applications", "Research Personnel", "Resources", "Rural Population", "Services", "Social Workers", "Special Population", "Special needs", "Spirituality", "Symptoms", "Time", "Trainers Training", "Training", "Travel", "United States", "United States National Institutes of Health", "Update", "advanced disease", "barrier to care", "care systems", "child health care", "curriculum enhancement", "design", "end of life", "end of life care", "experience", "improved", "marginalized population", "neonate", "new pandemic", "oncology program", "outreach program", "palliative", "prescription opioid", "program dissemination", "programs", "provider behavior", "psychosocial", "public health insurance", "response", "rural area", "skills", "success", "symposium", "underserved community" ], "approved": true } }, { "type": "Grant", "id": "15900", "attributes": { "award_id": "1UG3DA063344-01", "title": "Telehealth-Delivered tDCS for Cannabis Addiction Recovery: The C.A.R.E.S. (Cannabis Addiction Recovery Enhancement Stimulation) Initiative", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Drug Abuse (NIDA)" ], "program_reference_codes": [], "program_officials": [ { "id": 44337, "first_name": "JIA BEI", "last_name": "WANG", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-07-15", "end_date": "2027-06-30", "award_amount": 684694, "principal_investigator": { "id": 22511, "first_name": "Leigh", "last_name": "Charvet", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 832, "ror": "", "name": "NEW YORK UNIVERSITY SCHOOL OF MEDICINE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 27548, "first_name": "Giuseppina", "last_name": "Pilloni", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 44338, "first_name": "Abhishek", "last_name": "Datta", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 832, "ror": "", "name": "NEW YORK UNIVERSITY SCHOOL OF MEDICINE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Cannabis use in the U.S. has surged, driven by widespread legalization and accelerated by the COVID-19 pandemic. Over 55 million U.S. adults are current users, and approximately 30% will develop cannabis use disorder (CUD). Despite the urgent need for effective treatments, no FDA-approved options exist, and current interventions have proven insufficient, underscoring the necessity for innovative and accessible solutions. We propose a novel, home-based intervention combining transcranial direct current stimulation (tDCS) with mindfulness meditation, targeting the dorsolateral prefrontal cortex—a key region in the neural circuitry underlying the addiction cycle. Delivered via the ElectraRx telehealth portal, this approach is both cost-effective and widely accessible. Our extensive preliminary data, involving over 600 patients and 17,000 home-based tDCS sessions, along with our pilot study of this intervention in CUD, demonstrate its feasibility and potential. However, further development and testing are required to advance it to clinical use. The initial UG3 phase (Years 1-2) will involve developing a tDCS home-based administration system by Soterix Medical Inc. (SMI), tailored specifically for the intended population and environment (\"ElectraRx-CARES\"). We will then refine and validate the tDCS-mindfulness intervention through a double-blind, sham-controlled feasibility trial with n = 46 adults with CUD. If at least 50% of participants complete 70% of the sessions, we will advance to the UH3 phase, where a large-scale RCT enrolling n = 192 participants with CUD to assess the intervention's efficacy in reducing cannabis use and withdrawal symptoms. Follow-up assessments at three months will evaluate the persistence of these effects. FDA guidance on device development and data collection will be obtained throughout. Finally, we will optimize intervention delivery, iterate the device, and advance the regulatory process, including pursuing Breakthrough Device Designation. This scalable intervention addresses a critical public health need and represents a promising step forward in treating the rapidly growing problem of CUD.", "keywords": [ "Acceleration", "Address", "Adult", "Affect", "Anodes", "Back", "Behavior Therapy", "Breakthrough device", "COVID-19 pandemic", "Cannabis", "Clinical", "Clinical Trials", "Data", "Data Collection", "Data Reporting", "Development", "Device or Instrument Development", "Devices", "Double-Blind Method", "Drug Screening", "Enrollment", "Ensure", "Environment", "Equipment and supply inventories", "FDA approved", "Feedback", "Frequencies", "Goals", "Health", "Health Services Accessibility", "Home", "Individual", "Intervention", "Intervention Studies", "Left", "Legal", "Marijuana", "Marijuana Dependence", "Measures", "Medical", "Medical Device", "Monitor", "Outcome", "Outcome Measure", "Participant", "Patient Self-Report", "Patients", "Pharmacotherapy", "Phase", "Pilot Projects", "Population", "Prefrontal Cortex", "Prevalence", "Process", "Public Health", "Randomized", "Recovery", "Risk", "Rural Community", "Safety", "Self Administration", "System", "Systems Development", "Testing", "Time", "Treatment Efficacy", "Urine", "Withdrawal Symptom", "addiction", "arm", "attentional bias", "barrier to care", "cannabis withdrawal", "cost effective", "effective therapy", "efficacy evaluation", "evidence base", "feasibility trial", "follow up assessment", "follow-up", "innovation", "intervention delivery", "marijuana use", "marijuana use disorder", "meetings", "mindfulness", "mindfulness intervention", "mindfulness meditation", "minority communities", "neural circuit", "neuroregulation", "novel", "portability", "predictive marker", "predictive test", "response", "response biomarker", "telehealth", "therapy design", "timeline", "transcranial direct current stimulation", "underserved community" ], "approved": true } }, { "type": "Grant", "id": "15887", "attributes": { "award_id": "1R44AI186871-01A1", "title": "AT191: An inhaled & precision RNA therapeutic with pan-variant SARS-CoV-2 efficacy", "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": 32536, "first_name": "DIPANWITA", "last_name": "BASU", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-10", "end_date": "2028-08-31", "award_amount": 1004473, "principal_investigator": { "id": 44323, "first_name": "Timothy", "last_name": "Notton", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44324, "first_name": "Ariel", "last_name": "Weinberger", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 3392, "ror": "", "name": "AUTONOMOUS THERAPEUTICS, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "This Phase II SBIR will de-risk a new class of antivirals that can be developed to target any RNA virus from SARS-CoV-2 to influenza. The effort will specifically translate a lead, platform-derived SARS-CoV-2 candidate (AT191) designed to be self-administered and to prevent hospitalizations or deaths by any SARS-CoV-2 variant. Despite vaccines and 2 blockbuster antivirals marketed to prevent hospitalizations, 900,000 Americans were hospitalized due to SARS-CoV-2 in 2023. Beyond vaccine hesitancy and durability concerns, existing antivirals only reduce hospitalizations and deaths by 40–50%. SARS-CoV-2 antivirals are further limited by contraindications (e.g. Paxlovid) and safety concerns (e.g. molnupiravir). Moreover, there is a risk that SARS- CoV-2 acquires resistance to all existing classes of antivirals—as occurred with all SARS-COV-2 monoclonal antibodies prior to 2024. There is a clear unmet need for new classes of antivirals, especially antivirals that can: (i) be used at-home to prevent hospitalizations, and (ii) maintain (variant-proof) efficacy as novel variants emerge. Encrypted RNA (encRNA) is a new class of RNA developed by Autonomous Therapeutics. The plug-and-play platform technology can develop antivirals against any RNA virus and can encode any therapeutic protein. Unlike state-of-the-art mRNA, each platform-derived encRNA only activates its (broad-spectrum) antiviral payload in targeted virus-infected cells. More specifically, encRNA only translate encoded proteins when bound, transcribed, and amplified by targeted viral RNA polymerase (RdRp) complexes conserved across a viral species. Thus, encRNA remain translationally inactive and safe in uninfected cells (e.g. as prophylactics). AT191 is our lead, first-in-class encRNA therapeutic candidate developed to confer inhaled and variant-proof efficacy against all variants of SARS-CoV-2 (and SARS-CoV-1). AT191 confers precision and pan-sarbecovirus efficacy—because AT191’s antiviral payload (IFN-β) is only activated and translated by sarbecovirus RdRp. In Phase I-equivalent studies, we developed: (i) the encRNA platform technology, (ii) the AT191 lead candidate, and (iii) an inhalable lipid nanoparticle (LNP) for encRNA self-administration using marketed nebulizers. We further demonstrated the (iv) variant-proof efficacy of AT191 against every tested SARS-CoV-2 variant in vitro, and the (v) preliminary in vivo safety and efficacy of AT191 in both mice and hamsters. Here we propose to develop AT191 into a GLP-ready candidate ready for IND-enabling studies. We propose to test the pan-sarbecovirus efficacy (SARS-CoV-1 & 2) of AT191 in vivo and to perform critical CMC, inhalation, dose-timing, and dose-finding studies in hamsters. We will also test safety/efficacy in non-human primates. The effort will culminate in a pre-IND. If successful in follow-on clinical studies, AT191 could be used at-home as a prophylactic or therapeutic: e.g. for immediate use after exposure to an infected child or family member. 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