Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=4&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=5&sort=-other_investigators", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=3&sort=-other_investigators" }, "data": [ { "type": "Grant", "id": "15885", "attributes": { "award_id": "1U48DP006966-01", "title": "BREATHE WELL: Development and Implementation of a Training Program to Increase Vaccination in Early Childcare and Education Centers", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Center for Immunization and Respiratory Diseases (NCIRD)" ], "program_reference_codes": [], "program_officials": [ { "id": 44318, "first_name": "NATALIE", "last_name": "DARLING", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-30", "end_date": "2029-09-29", "award_amount": 499950, "principal_investigator": { "id": 44319, "first_name": "Roshanak", "last_name": "Mehdipanah", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 25237, "first_name": "Marc A", "last_name": "Zimmerman", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 770, "ror": "", "name": "UNIVERSITY OF MICHIGAN AT ANN ARBOR", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true } ] }, { "id": 44320, "first_name": "Abram Luther", "last_name": "Wagner", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 770, "ror": "", "name": "UNIVERSITY OF MICHIGAN AT ANN ARBOR", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "/ ABSTRACT Early childcare and education (ECE) centers are trusted institutions that engage with parents regularly, positioning them as key messengers for childhood immunization and respiratory health promotion. While ECE centers ensure compliance with mandated vaccines, their potential to support uptake of non-mandated immunizations—such as influenza vaccine, COVID-19 vaccine, maternal RSV vaccine, and nirsevimab antibody—remains underutilized. The BREATHE Well (Building Readiness, Engagement, and Trust for Healthy Environments) Toolkit is an evidence-based intervention designed to enhance ECE-originating vaccine communication, training ECE staff to effectively engage parents on immunization topics. This study will evaluate the feasibility, acceptability, and effectiveness of the BREATHE Well toolkit using a cluster- randomized controlled trial (RCT). The project will be guided by three specific aims: (1) Develop and refine the BREATHE Well toolkit through formative research, incorporating input from ECE staff, parents, and public health officials; (2) Assess the acceptability and feasibility of the toolkit through focus groups and surveys with ECE staff and parents in demonstration sites within Michigan; and (3) Evaluate the effectiveness of the toolkit in a cluster-randomized trial of ECE centers, measuring changes in parental vaccine confidence, intent to vaccinate, and staff capacity to serve as trusted messengers. The BREATHE Well toolkit will be designed as a scalable approach usable in different types of ECEs. Findings from this study will inform best practices for integrating vaccine-related education into ECE settings, with the goal of increasing parental vaccine confidence and improving uptake of recommended immunizations.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15880", "attributes": { "award_id": "1R21HL175534-01A1", "title": "A novel shift-level approach to optimizing ICU interprofessional team composition for mechanically ventilated adults", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 44231, "first_name": "INGRID CECILIA", "last_name": "ESPINOZA GRANDON", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-01", "end_date": "2027-08-31", "award_amount": 272226, "principal_investigator": { "id": 44312, "first_name": "Deena Kelly", "last_name": "Costa", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44313, "first_name": "Amy Witkoski", "last_name": "Stimpfel", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 3390, "ror": "", "name": "NEW YORK UNIVERSITY", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "At the core of critical care delivery is the interprofessional team, comprised of nurses, physicians, and respiratory therapists, who provide around-the-clock care to the most critically ill patients. The COVID-19 pandemic underscored the need for a robust critical care workforce and exposed existing structural inequities in the healthcare system. Research has shown disparities in mechanical ventilation (MV) care and outcomes based on patient characteristics, such as age and ethnicity. One evidence-based practice associated with improved outcomes for MV patients—spontaneous awakening and spontaneous breathing trials (SATs and SBTs)—requires effective coordination and collaboration among the entire team. For decades, researchers have sought to optimize the organization of critical care teams to enhance patient outcomes. While studies within individual professions, such as nurses or physicians, have examined the impact of clinician characteristics (e.g., experience) and scheduling characteristics (e.g., overtime) on outcomes, there remains a dearth of research investigating how variations in clinician and scheduling characteristics across the entire team influences patient outcomes. To address this knowledge gap, this application aims to determine how clinician and scheduling characteristics impact patient outcomes, and explore the moderating effect that clusters of patient characteristics have on the relationship between clinician and scheduling characteristics on patient outcomes. We propose a novel secondary analysis utilizing a unique dataset that links electronic health record data from nearly 17,000 critically ill patients to human resource clinician characteristics of 8,000 clinicians across 5 intensive care units from 2018-2021. Our specific aims are: 1) Test the hypothesis that patients cared for by teams with better clinician characteristics and scheduling characteristics will be more likely to receive SATs and SBTs each shift (when eligible), more likely to be extubated each shift, and less likely to die each shift. Among (n=8,952) MV patients, we will use a patient-level design and a longitudinal, repeat-measures analysis, where patients serve as their own control. 2) Evaluate the moderating effect of patient characteristics on the relationship between clinician and scheduling characteristics and patient outcomes. Among all ICU patients (N=16,940), we will use multiple interactions to identify what clusters of patient characteristics (e.g., age, sex, race, ethnicity) may be most vulnerable, i.e., experience negative outcomes, to variation in clinician and scheduling characteristics of the assigned team. If supported by our findings and replicated in a larger national study, then a patient-centered approach to ICU team assignments could be a cost-effective intervention that does not require additional staffing. This proposal has the potential to significantly transform the way interprofessional teams are assigned to ICU patients.", "keywords": [ "Address", "Admission activity", "Adult", "Age", "American", "Analgesics", "Attention", "Breathing", "COVID-19 pandemic", "Caring", "Characteristics", "Chest", "Collaborations", "Complex", "Coordination and Collaboration", "Critical Care", "Critical Illness", "Data", "Data Analyses", "Data Set", "Disparity", "Education", "Electronic Health Record", "Eligibility Determination", "Ensure", "Equity", "Ethnic Origin", "Evidence based practice", "Goals", "Health Care Systems", "Health Professional", "Hospitals", "Human Resources", "Individual", "Inequity", "Intensive Care Units", "Interruption", "Knowledge", "Life", "Link", "Measures", "Mechanical ventilation", "Morbidity - disease rate", "National Heart Lung and Blood Institute", "Nurse Practitioners", "Nurses", "Nursing Societies", "Outcome", "Patient Care", "Patient Care Team", "Patient-Focused Outcomes", "Patients", "Pattern", "Physician Assistants", "Physicians", "Positioning Attribute", "Provider", "Race", "Readiness", "Research", "Research Personnel", "Research Project Grants", "Schedule", "Sedation procedure", "Students", "Survival Rate", "System", "Team Nursing", "Testing", "Variant", "Work", "care delivery", "clinical practice", "cost", "cost effective intervention", "design", "disparity reduction", "evidence base", "experience", "health inequalities", "implementation barriers", "improved", "improved outcome", "innovation", "meetings", "member", "mortality", "novel", "patient oriented", "respiratory", "secondary analysis", "sex" ], "approved": true } }, { "type": "Grant", "id": "15878", "attributes": { "award_id": "1R01AI189484-01", "title": "Role of norovirus capsid dynamics in adaptive immune evasion", "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": 44307, "first_name": "RODOLFO M", "last_name": "ALARCON", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-01", "end_date": "2029-08-31", "award_amount": 2920356, "principal_investigator": { "id": 44308, "first_name": "THOMAS JAMES.", "last_name": "SMITH", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44309, "first_name": "Christiane", "last_name": "Wobus", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 851, "ror": "", "name": "UNIVERSITY OF TEXAS MED BR GALVESTON", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "Human noroviruses are responsible for almost a fifth of all cases of gastroenteritis worldwide. Containment of disease is difficult since as few as ten virions are sufficient to infect a normal adult. Noroviruses evolve continuously with new strains arising every 2-4 years that cause worldwide epidemics. Emergence of new strains can increase the number of cases by 50%. In the US alone, there are more than 2 million outpatient clinic visits, ~100,000 hospitalizations, and ~900 deaths (mostly among adults 65 and older) annually. Globally, there are ~200 million cases among children less than 5 years old, leading to ~50,000 deaths every year. However, no vaccines or antivirals are approved to limit infections. Efforts to develop an effective vaccine have been hindered by a lack of detailed structural information about antibody binding and the mechanisms of antibody escape. Understanding these processes has been difficult with human noroviruses because of the lack of a tissue culture system that supports the generation of a cell culture-derived virus stock and small animal model. To this end, we will be using the highly tractable mouse norovirus system where we have a highly efficient cell culture system, infectious clone, and natural mouse model. We have recently shown, for the first-time, that a virus (i.e., mouse norovirus, MNV) can use host metabolites to switch between two ‘faces’: one recognized by antibodies from recovered animals (apo) and one activated for infection. In conditions found in systemic circulation, the protruding domain (P domain) of the apo form floats above the shell by ~16Å and the loops at the tip are splayed apart. It is this conformation to which the antibody response is made. Once the virus enters the alimentary canal, low pH, bile salts, and metal ions individually and synergistically activate the virus whereby the P domain rotates and contracts onto the shell, and the antibody binding epitope at the tip of the P domain closes. This blocks antibody recognition while enhancing receptor binding. Essentially, each time MNV infects the host, the antibody response is naïve for that conformation. Importantly, we propose that this could explain why the antibody response to norovirus infection in both mice and humans appears to be notoriously short-lived. The goal of this proposal is to test our immune evasion model by creating mutant forms of MNV locked into either the apo or activated states and observing how those changes affect the pathogenesis and immune response in the host. These studies will detail the activation process at the molecular level, elucidate the reason why caliciviruses evolved such mobile P domains, and greatly impact the development of norovirus vaccines and therapeutics. Finally, subsequent to our publications, similar host metabolite immune evasion was observed with COVID-19. Therefore, our results will increase awareness of possible similar features in other virus families and may become paradigms in the future.", "keywords": [ "2019-nCoV", "5 year old", "Acute", "Adult", "Affect", "Affinity", "Ambulatory Care Facilities", "Animal Model", "Animals", "Annual Reports", "Anti-viral Agents", "Antibodies", "Antibody Affinity", "Antibody Response", "Awareness", "Bile Acids", "Binding", "Biology", "Blocking Antibodies", "C-terminal", "COVID-19", "Calicivirus", "Capsid", "Capsid Proteins", "Case Study", "Cell Culture System", "Cell Culture Techniques", "Cessation of life", "Characteristics", "Child", "Circulation", "Clinic Visits", "Containment", "Contracts", "Cryoelectron Microscopy", "Crystallography", "Development", "Dimerization", "Disease", "Distal", "Dose", "Environment", "Epidemic", "Epitopes", "Exhibits", "Face", "Failure", "Family", "Future", "Gastroenteritis", "Gastrointestinal tract structure", "Generations", "Genetic Variation", "Genome", "Goals", "Hospitalization", "Human", "Immune", "Immune Evasion", "Immune response", "Immunity", "Immunologic Memory", "Immunologics", "In Vitro", "Individual", "Infection", "Ingestion", "Innate Immune Response", "Intestines", "Invaded", "Ions", "Libraries", "Ligands", "Lymphatic System", "Mediating", "Metals", "Modeling", "Molecular", "Molecular Conformation", "Mus", "Mutagenesis", "Norovirus", "Pathogenesis", "Pathogenicity", "Persons", "Population", "Process", "Property", "Publications", "Retinal blind spot", "Role", "Rotation", "Series", "Site", "Spleen", "Structure", "Support System", "Surface", "Symptoms", "System", "Tertiary Protein Structure", "Testing", "Therapeutic", "Time", "Tissues", "Vaccines", "Viral Pathogenesis", "Virion", "Virus", "Viviparous-1 protein", "Work", "acute infection", "adaptive immune response", "adaptive immunity", "bile salts", "biophysical techniques", "design", "gastrointestinal epithelium", "human old age (65+)", "improved", "in vivo", "in vivo evaluation", "mouse model", "mutant", "oral infection", "receptor", "receptor binding", "recombinant virus", "reverse genetics", "structural biology", "tissue culture", "tool", "vaccine development", "viral RNA", "volunteer" ], "approved": true } }, { "type": "Grant", "id": "15870", "attributes": { "award_id": "1R01CA303579-01", "title": "Advancing next-generation CAR-NK therapies targeting CD5 positive T cell malignancies to the clinic", "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": 44297, "first_name": "LORI A", "last_name": "HENDERSON", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-19", "end_date": "2029-08-31", "award_amount": 1847485, "principal_investigator": { "id": 44298, "first_name": "Rafet", "last_name": "Basar", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 23208, "first_name": "Katy", "last_name": "Rezvani", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1420, "ror": "", "name": "UNIVERSITY OF TX MD ANDERSON CAN CTR", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true } ] }, { "id": 44299, "first_name": "May", "last_name": "Daher", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1420, "ror": "", "name": "UNIVERSITY OF TX MD ANDERSON CAN CTR", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "Summary: Patients with relapsed/refractory (R/R) T cell malignancies have poor outcomes and novel therapies are urgently needed. While CAR-T cells have shown remarkable efficacy in patients with B-cell malignancies and multiple myeloma, targeting T-cell malignancies presents unique challenges. One of the major issues is fratricide due to the shared expression of target antigens on both malignant and normal T cells, leading to self-targeting. Additionally, there is a risk of product contamination with malignant T cells during the manufacturing process, and the prolonged life-span of CAR-T cells poses the risk of long-term T-cell aplasia. In contrast, CAR- engineered natural killer (NK) cells offer several advantages. Unlike T-cells, NK cells do not express T cell target antigens such as CD5, eliminating the risk of fratricide. CAR-NK cells also avoid the issue of product contamination with malignant cells, as they can be derived from healthy donors rather than the patient’s own cells. Their shorter life-span reduces the likelihood of prolonged T-cell aplasia. Moreover, CAR-NK cells retain their innate cytotoxicity while also providing tumor specificity against the target antigen through engineering, without the concerns of graft-versus-host disease in the allogeneic setting, cytokine release syndrome or neurotoxicity. Building on our successful first-in-human trial of cord blood (CB) derived CAR19/IL-15 NK cells in patients with relapsed/refractory B-cell malignancies (published in NEJM 2020; Nature Medicine 2024), we now propose a clinical trial targeting CD5 in T cell malignancies. Our engineered CAR-NK cells express an scFv against CD5, IL-15 to enhance persistence, and an inducible caspase-9 (iC9) safety switch (collectively termed iC9/CAR5-28ζ/IL-15 NK cells). A key innovation in this proposal is our novel ex vivo expansion protocol for CAR- NK cells, incorporating IL-12, IL-18, TGF-β and Rapamycin to enhance the metabolic fitness of the cells. Preclinically, iC9/CAR5-28ζ/IL-15 NK cells generated using this novel expansion strategy demonstrated potent activity against T-cell lymphoma models. The clinical protocol has received IRB and FDA (protocol #2021-0526, IND 30087) and is currently enrolling patients. In parallel, we will conduct state-of-the-art correlative studies to comprehensively characterize the infused CAR-NK cells, tracking their persistence, trafficking, and immune modulation in patients. Additionally, we have developed a robust genome-wide CRISPR screening platform to identify novel regulators of CAR-NK cell function and mechanisms of resistance in T cell malignancies. Insights from these studies will inform the development of next-generation CAR-NK cells, optimized to overcome immune evasion strategies and improve patient outcomes. In Aim 1 we will conduct a Phase I/II clinical trial to test the safety and efficacy of iC9/CAR5-28ζ/IL-15 NK cells in patients with CD5+ T cell malignancies. In Aim 2 we will apply comprehensive correlative studies. In Aim 3, we will perform genome-wide CRISPR screens in both our iC9/CAR5-28ζ/IL-15 NK cells and T cell malignancy cell lines to uncover novel mechanisms of resistance and inform the design of next-generation CAR-NK cell therapies.", "keywords": [ "Adoptive Transfer", "Allogenic", "Antigen Targeting", "Antigens", "Autologous", "B lymphoid malignancy", "Biology", "Blood", "Blood donor", "Bone Marrow", "CAR T cell therapy", "CASP9 gene", "CRISPR screen", "Cell Line", "Cell Physiology", "Cell Therapy", "Cells", "Clinic", "Clinical", "Clinical Protocols", "Clinical Trials", "Clustered Regularly Interspaced Short Palindromic Repeats", "Collection", "Correlative Study", "Cryopreservation", "Data", "Development", "Disease", "Donor Selection", "Dose", "Engineering", "Event", "Future", "Home", "Hour", "IL18 gene", "Immune Evasion", "Immune response", "Institutional Review Boards", "Interleukin-12", "Interleukin-15", "Life", "Malignant - descriptor", "Malignant Neoplasms", "Medicine", "Modeling", "Multiple Myeloma", "NK cell therapy", "Natural Killer Cells", "Natural Killer T cell", "Nature", "Outcome", "Pathway interactions", "Patient-Focused Outcomes", "Patients", "Phase I/II Clinical Trial", "Phase I/II Trial", "Prognosis", "Progression-Free Survivals", "Proliferating", "Protocols documentation", "Publishing", "Recruitment Activity", "Refractory", "Relapse", "Resistance", "Risk", "Role", "Safety", "Sampling", "Selection Criteria", "Sirolimus", "Site", "Source", "Survival Rate", "T-Cell Lymphoma", "T-Lymphocyte", "Therapeutic", "Therapeutic Uses", "Time", "Toxic effect", "Transforming Growth Factor beta", "Treatment outcome", "Tumor Cell Line", "Umbilical Cord Blood", "biobank", "cancer cell", "cellular transduction", "chimeric antigen receptor", "chimeric antigen receptor T cells", "chimeric antigen receptor natural killer cells", "cost", "cytokine release syndrome", "cytotoxicity", "design", "engineered NK cell", "exhaustion", "extend lifespan", "first-in-human", "follow-up", "genome-wide", "graft vs host disease", "immunodeficiency", "immunoregulation", "improved", "improved outcome", "in vivo", "innovation", "insight", "leukemia/lymphoma", "life span", "lymph node biopsy", "manufacturing process", "metabolic fitness", "multiple omics", "neurotoxicity", "next generation", "novel", "novel therapeutic intervention", "novel therapeutics", "participant enrollment", "peripheral blood", "pharmacologic", "pre-clinical", "preclinical study", "resistance mechanism", "response", "safety testing", "spatial transcriptomics", "success", "targeted treatment", "tool", "trafficking", "tumor", "tumor specificity" ], "approved": true } }, { "type": "Grant", "id": "15864", "attributes": { "award_id": "1R21AI191193-01A1", "title": "Mobilizing Innovative Strategies to Improve TB Diagnosis and Retention in the TB Care Cascade for Migrant Communities in New York City", "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": 32562, "first_name": "KAREN A", "last_name": "LACOURCIERE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-09", "end_date": "2027-08-31", "award_amount": 253497, "principal_investigator": { "id": 44290, "first_name": "Yael R", "last_name": "Hirsch-Moverman", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44291, "first_name": "Max", "last_name": "O'Donnell", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 781, "ror": "", "name": "COLUMBIA UNIVERSITY HEALTH SCIENCES", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Since 2021, TB incidence in New York City (NYC) has surged partly due to decreased attenƟon during the COVID-19 pandemic and in part due to increased migraƟon across the southern US border. Approximately 205,000 migrants from TB-endemic regions arrived in NYC since April 2022. In 2023, TB incidence in NYC rose by 28%, the highest rates in over a decade, with 89% of cases among individuals born outside the US. Our proposal aims to evaluate innovaƟve methods to improve TB detecƟon, prevenƟon, and treatment among migrants in NYC. IniƟal work by our team in NYC migrant shelters has demonstrated high numbers of persons with of latent TB infecƟon (LTBI) and acƟve TB. Current clinic-based approaches to TB surveillance are ineffecƟve since few high-risk persons complete TB screening and fewer are retained in the TB cascade of care. The proposed intervenƟon, SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB), evaluates the use of mobile diagnosƟc teams integraƟng ultraportable digital chest radiography paired with arƟficial intelligence-assisted interpretaƟon, upfront tesƟng for TB (interferon gamma release assay) and HIV, and community engagement to improve iniƟaƟon and retenƟon in the TB cascade of care compared to convenƟonal, clinic- based approaches to TB surveillance. Aim 1 is to idenƟfy acƟve and latent TB in migrant communiƟes using this mobile detecƟon platiorm, hypothesizing that it will increase the proporƟon of migrants compleƟng diagnosƟc evaluaƟon compared to convenƟonal approaches. Aim 2 is to determine the feasibility and acceptability of the SPOT-TB strategy using mixed methods, hypothesizing that it will be highly feasible and acceptable to both care workers and parƟcipants. Aim 3 is to evaluate structural and behavioral barriers to TB care in NYC migrant communiƟes, hypothesizing that unstable housing will be a fundamental barrier and that perceived TB sƟgma will predict subsequent loss to retenƟon in the care cascade. This project employs mixed methods to evaluate the intervenƟon’s feasibility, acceptability, and effecƟveness, uƟlizing advanced staƟsƟcal techniques to understand complex relaƟonships. The scalable SPOT-TB model aims to provide a robust framework for improving TB care in urban settings, with data supporƟng future NIH R01 submissions for larger trials. By enhancing TB detecƟon and care retenƟon, the project seeks to reduce TB transmission and improve health outcomes for NYC's migrant populaƟon.", "keywords": [ "Address", "Advocacy", "Artificial Intelligence enhanced", "Behavioral", "Biological Assay", "COVID-19 pandemic", "Caring", "Cessation of life", "Chest", "Clinic", "Clinical Sciences", "Communities", "Complex", "Country", "Data", "Detection", "Diagnosis", "Emergency Situation", "Epidemiology", "Evaluation", "Fostering", "Future", "HIV", "HIV/TB", "Health", "Hospitals", "Image", "Improve Access", "Incidence", "Individual", "Infrastructure", "Intelligence", "Interferon Type II", "Intervention", "Interview", "Knowledge", "Mental Health", "Methods", "Migrant", "Modeling", "New York City", "Outcome", "Participant", "Persons", "Prevention", "Public Health", "Resources", "Risk", "Risk Assessment", "Roentgen Rays", "Science", "Services", "Shelter facility", "Site", "Social Sciences", "Symptoms", "System", "Techniques", "Thoracic Radiography", "Tuberculosis", "Tuberculosis diagnosis", "Uganda", "United States", "United States National Institutes of Health", "Universities", "Work", "acceptability and feasibility", "barrier to care", "case finding", "community collaboration", "community engagement", "community setting", "digital", "follow-up", "future implementation", "high risk population", "housing instability", "image guided", "improved", "innovation", "insight", "low and middle-income countries", "novel", "portability", "programs", "screening", "social stigma", "transmission process", "tuberculosis diagnostics", "urban setting" ], "approved": true } }, { "type": "Grant", "id": "15858", "attributes": { "award_id": "1SB1AI191871-01A1", "title": "Development of highly potent human monoclonal for RSV immunoprophylaxis", "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": 21312, "first_name": "SONNIE", "last_name": "KIM", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-24", "end_date": "2028-08-31", "award_amount": 993353, "principal_investigator": { "id": 44282, "first_name": "Ellen", "last_name": "Monson", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44283, "first_name": "Larry", "last_name": "Zeitlin", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 3382, "ror": "", "name": "MAPP BIOPHARMACEUTICAL, INC.", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Globally, respiratory syncytial virus (RSV) causes over 3 million hospitalizations of neonates/infants. While there are licensed vaccines in the U.S. for use in elderly populations, they are neither approved nor appropriate for use in neonates/infants who have immature immune systems. Palivizumab, a prophylactic monoclonal antibody (mAb) marketed by AstraZeneca and Sobi as Synagis™, has been available since 1998, but due to high cost and modest efficacy, its use has been restricted to high-risk infants. The recently approved single dose, long-acting mAb, nirsevimab (previously known as MEDI8897 and marketed as Beyfortus™ by Sanofi), has improved efficacy compared to palivizumab and was approved for use in all children up to 24 months of age. However, severe shortages and cost barriers have limited its availability in countries where it is currently approved (EU, US, Japan, Australia, Canada and China). In October 2023 the CDC issued Health Alert Network CDCHAN-00499 that recommended limiting the use of nirsevimab to higher risk children in the 2023- 2024 season due to the shortages, resulting in many eligible infants not receiving prophylaxis. In addition, nirsevimab is not currently available in any low- or middle-income countries (LMICs) and is unavailable in 8/10 of the most populous countries in the world. Mapp Biopharmaceutical, Inc. is developing a fully human mAb product, MBP002, that like nirsevimab, can be administered in a single dose per RSV season. Mapp’s objective is to dramatically lower the price and increase the global availability of RSV immunoprophylaxis. Further, unlike nirsevimab and Merck’s Phase 3 candidate, MK-1654, Mapp’s product is a two mAb cocktail, reducing the risk not only of clinical development of resistance, but also of a naturally occurring strain evading a single mAb. Indeed, this method of product failure occurred during a recent Phase 3 trial with Regeneron’s RSV mAb candidate and is the reason several mAb candidates lost their emergency use authorization for use against COVID-19. While nirsevimab resistant mutations were rare in a survey of 5675 RSV strains between 2015 and 2021, several mutations in the nirsevimab binding site have increased since 2020, including the resistant RSV-B variant K68N present in the U.S. and Australia. The impact of widespread use of nirsevimab on the frequency of resistant variants is under close post-marketing surveillance due to the potential for selection of escape mutants. Mapp has screened 70+ RSV clinical strains and found neutralization resistant strains to palivizumab, nirsevimab (MEDI8897) and Regeneron’s candidate, but no resistant strains to one of the MBP002 mAbs. In addition, the MBP002 mAbs are dramatically more potent in vitro and in vivo than palivizumab and have comparable neutralization and in vivo activity to nirsevimab. The requested SBIR support, together with significant in-kind contributions by Mapp, will allow for the advancement of MBP002 to IND submission (Investigational New Drug Application) and initiation of a Phase 1 clinical trial.", "keywords": [ "2 year old", "Adult", "Age Months", "Age Years", "Antibodies", "Asthma", "Australia", "Binding Sites", "Biological Assay", "Biological Products", "COVID-19", "Canada", "Child", "Childhood", "China", "Chronic lung disease", "Clinical", "Congestive Heart Failure", "Country", "Development", "Development Plans", "Dose", "Drug Kinetics", "Elderly", "Eligibility Determination", "Escape Mutant", "Experimental Designs", "FDA Emergency Use Authorization", "Failure", "Frequencies", "Health", "Hospitalization", "Hospitals", "Immune system", "In Vitro", "Income", "Infant", "Influenza A virus", "Investigational New Drug Application", "Japan", "Licensing", "Ligand Binding", "Lower respiratory tract structure", "Marketing", "Methods", "Monoclonal Antibodies", "Mutation", "Nursing Homes", "Palivizumab", "Pharmaceutical Preparations", "Phase", "Phase I Clinical Trials", "Population", "Price", "Prophylactic treatment", "Recommendation", "Rehabilitation therapy", "Resistance", "Resistance development", "Respiratory Tract Diseases", "Respiratory syncytial virus", "Risk Reduction", "Seasons", "Small Business Innovation Research Grant", "Surveys", "Testing", "Toxicology", "Vaccines", "Validation", "Variant", "Virus Diseases", "Wheezing", "burden of illness", "clinical development", "comparative efficacy", "cost", "high risk", "high risk infant", "human monoclonal antibodies", "human old age (65+)", "immunoprophylaxis", "improved", "in vivo", "low and middle-income countries", "manufacture", "method development", "neonate", "phase III trial", "post-market", "prevent", "prophylactic", "resistance mutation", "resistant strain" ], "approved": true } }, { "type": "Grant", "id": "15856", "attributes": { "award_id": "1R43AG094486-01", "title": "Characterizing neurocognitive deficits in post-acute sequelae of COVID-19", "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": 44278, "first_name": "DAVID WITT", "last_name": "FRANKOWSKI", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-16", "end_date": "2027-05-31", "award_amount": 325672, "principal_investigator": { "id": 44279, "first_name": "Jennifer", "last_name": "Graves", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44280, "first_name": "Amir Hossein", "last_name": "Meghdadi", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 3381, "ror": "", "name": "ADVANCED BRAIN MONITORING, INC.", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Post-acute sequelae of COVID-19 (PASC), or Long COVID, is an emerging global health crisis with an urgent need for objective assessment tools to quantify neurocognitive deficits. This proposal aims to validate and leverage a novel mobile electroencephalography (EEG) platform to provide accessible, cost-effective cognitive assessments for individuals suffering from neurological manifestations of PASC (nPASC). Our preliminary data suggests that EEG/event-related potential (ERP) biosignatures, including delayed neural responses during auditory and memory tasks, are sensitive to cognitive impairments in nPASC. However, the trajectory and specificity of these deficits remain unclear. This study will validate these preliminary findings in a larger cohort (n=52) and longitudinally monitor changes over one year to map recovery or detect early signs of persistent cognitive decline. The innovative approach integrates resting-state EEG with multiple task-based ERP protocols, enabling comprehensive profiling of neural dysfunction associated with nPASC. Leveraging Advanced Brain Monitoring's FDA-cleared mobile EEG platform and validated analysis pipelines will provide a scalable solution for widespread clinical use and remote assessments. If successful, this study will deliver a quantitative EEG/ERP biomarker profile specific to neuro-PASC, enabling objective evaluation of cognitive deficits. Longitudinal monitoring will elucidate the natural trajectory, identify potential risk factors for persistent impairment, and provide outcome measures for future therapeutic interventions. This innovative diagnostic tool will empower patients and clinicians by providing objective evidence of nPASC severity and treatment efficacy.", "keywords": [ "2019-nCoV", "Acute", "Address", "Age", "Algorithms", "Alzheimer's Disease", "Anxiety", "Assessment tool", "Attention", "Auditory", "Brain", "COVID-19", "COVID-19 patient", "COVID-19 severity", "COVID-19 treatment", "Central Nervous System", "Clinical", "Cognition", "Cognitive", "Cognitive deficits", "Control Groups", "Data", "Diagnosis", "Early Diagnosis", "Electroencephalography", "Empirical Research", "Evaluation", "Event-Related Potentials", "Exhibits", "Fatigue", "Future", "Health Professional", "Heterogeneity", "High Prevalence", "Impaired cognition", "Impairment", "Individual", "Infection", "Long COVID", "Maps", "Memory", "Mental Depression", "Methods", "Modality", "Monitor", "Nature", "Neurocognitive Deficit", "Neurologic", "Neurologic Symptoms", "Neuronal Dysfunction", "Outcome", "Outcome Measure", "Participant", "Pathway interactions", "Patient Self-Report", "Patients", "Phase", "Pilot Projects", "Post-Acute Sequelae of SARS-CoV-2 Infection", "Process", "Protocols documentation", "Public Health", "Quality of life", "Random Allocation", "Recovery", "Reporting", "Reproducibility", "Research", "Rest", "Risk", "Risk Factors", "Sample Size", "Self Assessment", "Severities", "Specificity", "Statistical Models", "Symptoms", "Techniques", "Technology", "Therapeutic Intervention", "Time", "Treatment Efficacy", "Validation", "Visit", "analysis pipeline", "auditory processing", "biomarker identification", "biosignature", "case control", "cognitive task", "cognitive testing", "cohort", "cost effective", "cost efficient", "data acquisition", "design", "diagnostic tool", "effective intervention", "empowerment", "epidemiology study", "executive function", "experience", "follow-up", "global health", "innovation", "machine learning model", "mild cognitive impairment", "neural", "neural correlate", "neurologic sequelae of COVID-19", "neuropathology", "neurophysiology", "neuropsychiatry", "novel", "post-COVID-19", "potential biomarker", "primary endpoint", "remote assessment", "response", "specific biomarkers", "symptomatology", "therapy development", "trend", "visual memory" ], "approved": true } }, { "type": "Grant", "id": "15847", "attributes": { "award_id": "3U01AR071128-08S3", "title": "MoTrPAC DXA Quality Control", "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": 44264, "first_name": "EMILY FORAN", "last_name": "CARIFI", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-15", "end_date": "2026-08-31", "award_amount": 116380, "principal_investigator": { "id": 44265, "first_name": "Joseph A", "last_name": "Houmard", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44266, "first_name": "WILLIAM E", "last_name": "KRAUS", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2652, "ror": "", "name": "DUKE UNIVERSITY", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "MoTrPAC DXA Supplement - Project Summary The Molecular Transducers of Physical Activity Consortium (MoTrPAC) is designed to discover and characterize the range of molecular transducers underlying the effects of exercise in humans. MoTrPAC was launched in 2016 with six adult clinical centers and a pediatric center that have collaborated to generate extensive Manual of Operations to guide research protocols involving all aspects of the clinical operations (Phase I). Phase II began in the fall of 2019 with all human clinical centers showing excellent progress towards initial recruitment goals and implementation of the protocol. The initial goal set forth by NIH was to recruit 270 children (10-17 years of age) and 1980 sedentary adults (age 18 years or greater) randomized to endurance training (170 youth, 840 adults), resistance training (840 adults), or non-exercise controls (50 youth, 300 adults). An additional group of highly active endurance (50 youth, 150 adults) and resistance (150 adults) trained individuals serve as comparators, not participating in the MoTrPAC exercise training programs. The recruitment and enrollment approach are sex-balanced, with participants across a wide range of ages (10-17, 18-39, 40-59 and >60-year age groups) and of different races. Due to the COVID-19 pandemic, beginning in March 2020, MoTrPAC activities were suspended for over a year with continued constraints through 2022. Despite the numerous challenges encountered as a result of the pandemic, the human clinical centers have successfully enrolled and completed the adult and pediatric highly active cohorts, the pediatric cross-sectional cohort, and the previously sedentary adult and low-active pediatric randomized control trial portion of the study as of May 2025. As data quality control is underway, discrepancies in dual-energy X-ray absorptiometry (DXA) data have been detected across different machines. This led NIAMS to provide MoTrPAC with funding to conduct additional DXA scans among previously enrolled MoTrPAC participants to develop a correction equation accounting for differences in DXA machines, allowing all MoTrPAC DXA data to be included in the final dataset. Altogether, this will allow MoTrPAC to complete the intended goals as originally envisioned, will provide a more complete public database of the health benefits of exercise, and will provide insight into how physical activity mitigates disease risk.", "keywords": [ "17 year old", "18 year old", "Accounting", "Acute", "Address", "Adult", "Age", "Age Years", "Animals", "Award", "Bioinformatics core", "Biological Process", "Body Composition", "COVID-19 pandemic", "Calibration", "Charge", "Chemicals", "Child", "Childhood", "Chronic", "Clinical", "Clinical Research", "Collaborations", "Communities", "Data", "Data Set", "Development", "Disease Outcome", "Dual-Energy X-Ray Absorptiometry", "Enrollment", "Ensure", "Equation", "Exercise", "Fatty acid glycerol esters", "Funding", "Goals", "Health", "Health Benefit", "Human", "Individual", "Manuals", "Manufacturer", "Maps", "Measurement", "Methodology", "Minerals", "Molecular", "Multi-site clinical study", "National Health and Nutrition Examination Survey", "National Institute of Arthritis and Musculoskeletal and Skin Diseases", "Observational Study", "Participant", "Pathway interactions", "Phase", "Physical activity", "Physiological", "Procedures", "Process", "Protocols documentation", "Public Health", "Quality Control", "Race", "Randomized", "Randomized Controlled Trials", "Reporting", "Research", "Resistance", "Resources", "Scanning", "Site", "Standardization", "System", "Thinness", "Time", "Tissues", "Training", "Training Programs", "Transducers", "United States National Institutes of Health", "Weight", "Youth", "age group", "bone", "clinical center", "clinical research site", "cohort", "data quality", "design", "disorder risk", "endurance exercise", "exercise training", "falls", "improved", "insight", "instrument", "multiple omics", "operation", "pandemic disease", "phenotypic data", "pre-clinical", "public database", "recruit", "resistance exercise", "response", "sedentary", "sex" ], "approved": true } }, { "type": "Grant", "id": "15848", "attributes": { "award_id": "3U01AR071128-08S2", "title": "Molecular Transducers of Physical Activity and Health: NC Consortium Clinical Site", "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": 44264, "first_name": "EMILY FORAN", "last_name": "CARIFI", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-01", "end_date": "2026-08-31", "award_amount": 345063, "principal_investigator": { "id": 44265, "first_name": "Joseph A", "last_name": "Houmard", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44266, "first_name": "WILLIAM E", "last_name": "KRAUS", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2652, "ror": "", "name": "DUKE UNIVERSITY", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "MoTrPAC Project Summary The Molecular Transducers of Physical Activity Consortium (MoTrPAC) is designed to discover and characterize the range of molecular transducers underlying the effects of exercise in humans. MoTrPAC was launched in 2016 with six adult clinical centers and a pediatric center that have collaborated to generate extensive Manual of Operations to guide research protocols involving all aspects of the clinical operations (Phase I). Phase II began in the fall of 2019 with all human clinical centers showing excellent progress towards initial recruitment goals and implementation of the protocol. The initial goal set forth by NIH was to recruit 270 children (10-17 years of age) and 1980 sedentary adults (age 18 years or greater) randomized to endurance training (170 youth, 840 adults), resistance training (840 adults), or non-exercise controls (50 youth, 300 adults). An additional group of highly active endurance (50 youth, 150 adults) and resistance (150 adults) trained individuals serve as comparators, not participating in the MoTrPAC exercise training programs. The recruitment and enrollment approach are sex-balanced, with participants across a wide range of ages (10-17, 18-39, 40-59 and >60-year age groups) and of different races. Due to the COVID-19 pandemic, beginning in March 2020, MoTrPAC activities were suspended for over a year with continued constraints through 2022. Despite the numerous challenges encountered as a result of the pandemic, the human clinical centers have successfully enrolled ~80% (adult) and 95% (pediatric) of the highly active cohort, ~93% of cross-sectional (pediatric), and ~60% (adult) and ~50% (pediatric) of the current target enrollment numbers in the randomized control trial portion of the study. This will enrich the participant cohorts that are critical to the understanding of exercise adaptations and heterogeneity across age, gender, and minority groups. Altogether, this supplement will allow MoTrPAC to complete the intended goals as originally envisioned, will provide a more complete public database of the health benefits of exercise, and will provide insight into how physical activity mitigates disease risk. The purpose of the supplement, which was previously discussed with Program Officer ,will be to assemble, curate andwill be to assemble, curate and harmonize the cardiopulmonary exercise testing (CPET) database.", "keywords": [ "17 year old", "18 year old", "Acute", "Adipose tissue", "Adult", "Age", "Age Years", "Ancillary Study", "Animals", "Attention", "Award", "Bioinformatics core", "Biological Process", "Blood", "COVID-19", "COVID-19 pandemic", "California", "Cardiopulmonary", "Categories", "Charge", "Chemicals", "Child", "Childhood", "Chronic", "Clinical", "Clinical Protocols", "Clinical Research", "Clinical Trials Data Monitoring Committees", "Collaborations", "Collection", "Communication", "Communities", "Data", "Databases", "Development", "Disease Outcome", "Enrollment", "Ensure", "Exercise", "Exercise Test", "Frequencies", "Funding", "Gender", "Goals", "Health", "Health Benefit", "Heterogeneity", "Human", "Individual", "Institutional Review Boards", "Intervention", "Manuals", "Manuscripts", "Maps", "Measurement", "Minority Groups", "Molecular", "Multi-site clinical study", "Muscle", "Observational Study", "Participant", "Pathway interactions", "Pediatric cohort", "Phase", "Phenotype", "Physical activity", "Physiological", "Procedures", "Protocols documentation", "Public Health", "Race", "Randomized", "Randomized Controlled Trials", "Recruitment Activity", "Research", "Research Personnel", "Resistance", "Resources", "Rest", "Site", "Suspensions", "Testing", "Time", "Tissues", "Training", "Training Programs", "Transducers", "United States National Institutes of Health", "Universities", "Visit", "Woman", "Youth", "age group", "clinical center", "clinical research site", "cohort", "design", "disorder risk", "endurance exercise", "ethnic minority", "exercise intervention", "exercise training", "falls", "improved", "innovation", "insight", "men", "multiple omics", "novel", "operation", "pandemic disease", "phenotypic data", "physical conditioning", "pre-clinical", "programs", "public database", "quality assurance", "racial minority", "recruit", "resistance exercise", "response", "sedentary", "sex", "working group" ], "approved": true } }, { "type": "Grant", "id": "15845", "attributes": { "award_id": "1R61DA063659-01", "title": "PeRsOnlized MethadOne TrEatment (PROMOTE) by implementing shared decision making", "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": 44216, "first_name": "JULIA BETH", "last_name": "ZUR", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-09-30", "end_date": "2027-08-31", "award_amount": 488334, "principal_investigator": { "id": 44260, "first_name": "Paul J", "last_name": "Joudrey", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 44261, "first_name": "Cristina", "last_name": "Murray-Krezan", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 848, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "In the US, methadone treatment for opioid use disorder (OUD) occurs within opioid treatment programs (OTPs). Methadone treatment decreases OUD-related mortality by 50%, but engagement and retention remain suboptimal. Strict restrictions, including on initial dose and take-home medication amounts, limit clinicians’ ability to partner with patients and address individual preferences. This contributes to reduced patient satisfaction, quality of life, suboptimal treatment retention, and clinician burnout. Additionally, daily methadone dose and take-home medication amounts vary by patient demographics suggesting suboptimal clinical decision making. Following COVID-19, the Substance Abuse and Mental Health Services Administration recommended “patient-provider shared decision making”, and made OTP regulations more flexible to facilitate shared decision making (SDM). The overarching goal of our research is to improve methadone treatment by establishing and sustaining greater person centered care within OTPs. The objective of the Personalized Methadone Treatment (PROMOTE) study is to adapt and test the impact of Implementation Facilitation (IF), a bundle of preparation, implementation, and sustainment strategies, on supporting systematic SDM implementation within OTPs. Our rationale for evaluating SDM implementation in a hybrid type 3 implementation-effectiveness trial is that it is indicated in the setting of incomplete effectiveness data when consensus guidelines, patient advocacy groups, and health system administrators all call for implementation. The primary objective will involve three specific aims: 1) adapt IF to support SDM implementation in OTPs; 2) determine the feasibility of executing and evaluating IF for SDM implementation in OTPs; and 3) evaluate the impact of IF on SDM implementation in OTPs. For Aim 1, we will use implementation mapping involving iterative rounds of focus groups at two OTPs, research team development, and advisory board review guided by the updated Consolidated Framework for Implementation Research. For Aim 2, we will conduct a 7-month pilot study of the preparation and implementation stages of the IF intervention at a single OTP, and concurrently collect 25 patient and 10 clinician semi-structured interviews and quantitative data necessary for Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) outcomes ascertainment. For Aim 3, we will conduct a pragmatic hybrid type 3 implementation-effectiveness stepped wedge cluster randomized trial in 10 OTPs in AZ, NY, and OH (i.e., strict versus less strict state regulation) using a mixed-methods evaluation of outcomes according to the RE-AIM framework, which includes assessment of sustainability. We will explore if reach of SDM, daily methadone dose, and take-home medication amounts vary by demographics. This study is innovative in that it implements SDM in a novel setting in a community engaged manner. 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