Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=2&sort=-end_date
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-end_date", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1405&sort=-end_date", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=3&sort=-end_date", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-end_date" }, "data": [ { "type": "Grant", "id": "15756", "attributes": { "award_id": "1R01AI190195-01", "title": "The Impact of Systemic Immunosuppression on RSV Antibody Generation and Effector Functions After Vaccination", "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": "2025-08-01", "end_date": "2030-07-31", "award_amount": 775187, "principal_investigator": { "id": 32819, "first_name": "Andrew Hoover", "last_name": "Karaba", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2615, "ror": "", "name": "JOHNS HOPKINS UNIVERSITY", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "Immunosuppressed persons (ISPs) have a nearly 40% risk of hospitalization if infected with respiratory syncytial virus (RSV). Recently, novel RSV vaccines based on the prefusion F protein of the virus were found to be effective at reducing RSV disease, but these were not tested in high-risk ISPs. Owing to immunosuppression, ISPs often develop attenuated antibody responses to vaccines and require either additional doses or different formulations to achieve protective levels of antibodies. Antibodies against prefusion F are associated with protection from RSV disease and thought to be central to the protection afforded by RSV vaccines. Our preliminary data indicate that, among ISPs, the antibody response to RSV vaccines is heterogeneous, with many ISPs demonstrating minimal or no response. However, the nature of this decreased response (i.e. unrecognized antibody epitopes and impact on neutralizing and non-neutralizing functions) remains unknown. Furthermore, the influence of specific immunosuppressive medications and the type of vaccine received (adjuvanted vs. unadjuvanted) is undetermined. To protect this high-risk group from this common and often devastating infection, a comprehensive understanding of the antibody response to these vaccines by ISPs is necessary and will improve vaccine recommendations, design, and medication management. The proposed research will address these uncertainties by systematically studying the antibody response to novel RSV vaccines in a national observational cohort of ISPs, comparing the responses to those of healthy participants (HPs). This national cohort of highly engaged ISPs was critical in our previous successful efforts to define the effects of immunosuppression on SARS-CoV-2 vaccination, and we will leverage this opportunity to discern the impact of immunosuppression on antibody responses to RSV vaccines. We will accomplish this by quantifying the prefusion F and neutralizing antibody response longitudinally in these groups and determining the impact of vaccine type (adjuvanted vs. unadjuvanted), type of immunosuppressive medication, and demographic factors (Aim 1). Additionally, we will study the entire viral antibody epitope landscape before and after vaccination using innovative DNA barcoded-protein technology to identify key gaps in epitope recognition, measure the impact of pre-existing immunity on vaccine responses, and correlate specific epitope responses with antibody function (Aim 2). Finally, the researchers will measure the effect of immunosuppression and vaccine adjuvant on antibody subtype, subclass, and non-neutralizing functions using a systems serology approach (Aim 3). The investigators’ established productive collaborative relationships, extensive experience studying antibody responses in high-risk and/or immunosuppressed populations, and this cohort of ISPs provide the ideal circumstances to provide critical knowledge that promises to be directly applicable to improving RSV vaccine responses in this high-risk group and inform future vaccine design for immunosuppressed persons.", "keywords": [ "Adjuvant", "Antibodies", "Antibody Formation", "Antibody Response", "Attenuated", "Autoimmune Diseases", "Bar Codes", "COVID-19 vaccination", "COVID-19 vaccine", "Cells", "Clinical", "Clinical Trials", "Complement Activation", "Complex", "DNA", "Data", "Demographic Factors", "Disease", "Dose", "Enzyme-Linked Immunosorbent Assay", "Epitopes", "Formulation", "Future", "Generations", "Goals", "Hospitalization", "Immune response", "Immune signaling", "Immunity", "Immunocompromised Host", "Immunoglobulin A", "Immunoglobulin G", "Immunoglobulin M", "Immunologics", "Immunosuppression", "Individual", "Infection", "Innate Immune System", "Knowledge", "Measures", "Medication Management", "Modeling", "Molecular", "Nature", "Older Population", "Participant", "Peptides", "Persons", "Pharmaceutical Preparations", "Play", "Population", "Process", "Productivity", "Proteins", "Recommendation", "Regimen", "Research", "Research Personnel", "Respiratory Syncytial Virus Infections", "Respiratory Syncytial Virus Vaccines", "Respiratory syncytial virus", "Risk", "Role", "Serology", "Solid", "System", "Technology", "Testing", "Toxic effect", "Uncertainty", "Vaccination", "Vaccine Adjuvant", "Vaccine Design", "Vaccines", "Viral", "Viral Antibodies", "Viral Proteins", "Virus", "Virus Diseases", "antibody-dependent cell cytotoxicity", "attenuation", "cohort", "design", "disorder prevention", "experience", "high risk", "high risk population", "immune activation", "immunogenicity", "immunosuppressed", "improved", "in vitro Model", "indexing", "innovation", "machine learning model", "neutralizing antibody", "novel", "organ transplant recipient", "pathogen", "pharmacologic", "response", "self assembly", "vaccine access", "vaccine immunogenicity", "vaccine response" ], "approved": true } }, { "type": "Grant", "id": "15778", "attributes": { "award_id": "1R50CA305057-01", "title": "A System to Support Development and Success of NCI-Sponsored Trials for Rare Diseases", "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": 32853, "first_name": "SONYA", "last_name": "ROBERSON", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-11", "end_date": "2030-07-31", "award_amount": 122610, "principal_investigator": { "id": 32854, "first_name": "Kim A", "last_name": "Reiss Binder", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2627, "ror": "", "name": "UNIVERSITY OF PENNSYLVANIA", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "R50 Abstract – Reiss Gastrointestinal maligancies remain lethal and difficult-to-treat, with poor outcomes for many patients. In spite of this, we are in a moment of a scientific and clinical revolution with the development of biomarker-driven therapies for selected patients. With these advances come multiple new questions for the field, many of which the NCTN infrastructure is optimally suited to address. To date, I have demonstrated a strong commitment to clinical and translational research for populations of patients with rare subsets or biomarkers, including via the development and implementation of NCI-trials at my own institution: I am the international study chair and lead accruer for EA2192 as well as the study champion and lead national accruer for SWOG-2001. On the larger scale, I hold leadership roles within the Abramson Cancer Center (ACC) at the University of Pennsylvania and at the NCTN. I serve as the co-chair of the ECOG- ACRIN GI Committee, I am the co-leader of the ACC Cancer Therapeutics Program and I am the co-leader of the ACC Pancreatic Clinical Trial Program. These leadership positions are optimal platforms upon which to spearhead programs that (1) formally and longitudinally assist junior and mid-career oncology faculty in their quests to develop investigator-initiated studies and (2) develop a program at the NCTN that focuses on developing realistic trials for rare populations and then on accruing them successfully. To date, I have demonstrated a persistent and strong commitment to the NCI research enterprise. I have been involved with NCI-related research since my early career, initially attending meetings and later developing my own protocol, EA2192. Based on my steady engagement and input, I was appointed as the co-chair of the GI Committee in 2022 alongside Jordan Berlin (see LOS). Together, we have made a commitment to improving the process of clinical trial development, a mission that will be critical in order for the NCTN to remain competitive in an ever-changing landscape. Over the past three years, we have employed multiple initiatives including boosting the education of our investigators about the NCTN process, leaning on the excellent Working groups chairs to fine-tune concepts prior to Committee Presentation and providing substantial assistance during the submission process. With the support of the R50 Research Specialist award, I will build further on this approach in two ways: At the ACC, I will develop a sustainable program for early and mid-career investigators to provide longitudinal support in the development of investigator-initiated trials, with a particular focus on rare disease studies that can be best executed via the ECOG-ACRIN system. Within the NCTN, I will employ a novel program assisting investigators in the development and successful enrollment of trials for rare disease populations, a subset of studies that have lost ground since the COVID pandemic. Specifically, I will create a living resource for NCTN investigators that focuses on methods to design practical, feasible studies and will provide longitudinal support to those across the NCTN who are developing studies in this space. My ultimate goal is to develop and implement pragmatic clinical trials that address key questions in the field of gastrointestinal malignancies, particularly for patients with rare subsets of disease.", "keywords": [ "Abramson Cancer Center at the University of Pennsylvania", "Address", "American College of Radiology Imaging Network", "Award", "Berlin", "Biological Markers", "COVID-19 pandemic", "Cancer Biology", "Cancer Center", "Clinical", "Clinical Research", "Clinical Trials", "Development", "Disease", "Eastern Cooperative Oncology Group", "Education", "Faculty", "Feasibility Studies", "Genomics", "Goals", "Infrastructure", "Institution", "International", "Jordan", "Knowledge", "Lead", "Leadership", "Malignant Neoplasms", "Malignant neoplasm of gastrointestinal tract", "Methods", "Mission", "Oncology", "Outcome", "Pancreas", "Patient Selection", "Patients", "Persons", "Population", "Positioning Attribute", "Pragmatic clinical trial", "Process", "Program Sustainability", "Protocols documentation", "Rare Diseases", "Research", "Research Personnel", "Resources", "Role", "Selection for Treatments", "Southwest Oncology Group", "Specialist", "System", "Therapeutic", "Thinness", "Translational Research", "biomarker development", "biomarker driven", "cancer subtypes", "career", "design", "gastrointestinal", "improved outcome", "investigator-initiated trial", "meetings", "novel", "patient population", "process improvement", "programs", "success", "trial enrollment", "working group" ], "approved": true } }, { "type": "Grant", "id": "15741", "attributes": { "award_id": "1R35GM160071-01", "title": "Viral Biosensors of Host Post-Translational Modifications", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 22244, "first_name": "MICHAEL", "last_name": "SAKALIAN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-01", "end_date": "2030-07-31", "award_amount": 420984, "principal_investigator": { "id": 26190, "first_name": "Mehdi", "last_name": "Bouhaddou", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2612, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Viruses and their hosts are engaged in a constant, dynamic struggle as part of an ongoing evolutionary arms race. It is well established that viruses continually evolve new offensive strategies, like the production of proteins that disrupt host defenses, while hosts develop countermeasures to detect and neutralize viruses. However, a key question that remains is: how do viruses perceive and respond to host cues in real-time? This ability to sense and adapt to the intracellular environment, akin to real-time \"decision-making,\" which helps them decide when to replicate, assemble, or escape, plays a crucial role in their fitness and ability to spread. To understand how viruses sense and respond to their environment, we will study host-derived post-translational modifications (PTMs) of viral proteins. The overarching hypothesis of this proposal is that viral proteins have evolved as substrates for host enzyme-derived PTMs to equip them with molecular sensors to coordinate viral life cycle transitions. Furthermore, we will study how PTMs enable multifunctionality in viral proteins by creating distinct proteoforms. By understanding the molecular mechanisms of viral biosensors, we expect to pinpoint critical viral dependencies, revealing promising targets for antiviral intervention. PTMs, imposed by the host cell, can dramatically alter the functions of viral proteins, influencing their behavior and ultimately the fate of the virus. Our preliminary mass spectrometry phosphoproteomics analysis of alphavirus infection revealed phosphorylation sites at the capsid-glycoprotein interface, likely regulated by plasma membrane-localized kinases, suggesting a functional switch in glycoproteins at the membrane. We similarly identified phosphorylation sites on herpesvirus latency proteins, which we believe may play a role in allowing the viral genome to replicate alongside the host genome during latency. Lastly, we discovered phosphorylation of a SARS-CoV-2 accessory protein by innate immune kinases, suggesting a feedback mechanism that may modify viral protein function in response to immune activation. Our data have led us to three specific areas of inquiry, each forming a distinct research project being conducted by PhD students, a project scientist, and undergraduate trainees: (1) How do viruses navigate through distinct host subcellular locations during their life cycle? (2) How do viruses coordinate their life cycle with the host cell cycle? (3) How do viruses sense, respond to, and exploit the host innate immune system? The projects and questions outlined in this proposal will serve as the foundation for the primary research in my laboratory over the next five years. Our questions seek to establish a new research area centered on the biochemical mechanisms through which viruses act as biosensors of the host signaling environment, how these biosensors adjust their functionality in response to PTMs, and how targeting these sensors may result in innovative antiviral therapies.", "keywords": [ "2019-nCoV", "Alphavirus Infections", "Anti-viral Therapy", "Area", "Behavior", "Biochemical", "Biosensor", "Capsid", "Cell Cycle", "Cell membrane", "Cells", "Cues", "Data", "Decision Making", "Dependence", "Development", "Disease", "Environment", "Enzymes", "Feedback", "Foundations", "Genome", "Glycoproteins", "Herpesviridae", "Host Defense", "Immune", "Innate Immune System", "Intervention", "Knowledge", "Laboratories", "Life Cycle Stages", "Location", "Mass Spectrum Analysis", "Membrane", "Mission", "Molecular", "Phosphorylation", "Phosphorylation Site", "Phosphotransferases", "Play", "Post-Translational Protein Processing", "Production", "Proteins", "Public Health", "Research", "Research Project Grants", "Role", "Scientist", "Signal Transduction", "Time", "United States National Institutes of Health", "Viral", "Viral Genome", "Viral Physiology", "Viral Proteins", "Virus", "Virus Diseases", "arms race", "doctoral student", "fitness", "immune activation", "innovation", "insight", "novel therapeutic intervention", "phosphoproteomics", "protein function", "response", "sensor", "undergraduate student" ], "approved": true } }, { "type": "Grant", "id": "15776", "attributes": { "award_id": "1R35GM160065-01", "title": "Statistical Approaches to Unlock Protein Function from Deep Mutational Scans", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 32565, "first_name": "GUOQIN", "last_name": "YU", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-01", "end_date": "2030-07-31", "award_amount": 420984, "principal_investigator": { "id": 32849, "first_name": "Harold", "last_name": "Pimentel", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 818, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Understanding how genetic variants impact protein function is essential for unraveling the mechanisms underlying both basic biology and disease, particularly for rare genetic variants. Of the 4.6 million missense variants found in large population studies, only about 2% have clinical interpretations. Due to their rarity, these variants are exceptionally challenging to study through observational methods. However, Deep Mutational Scanning (DMS) offers a high-throughput method for testing thousands of protein variants by generating a mutant library and obtaining a phenotypic readout for each mutation in one sequencing assay. Initially focused on fitness-based readouts, DMS has expanded to include fluorescence-based methods for protein profiling, binding assays, and more. It has been crucial for studying proteins like SARS-CoV-2, BRCA1, and drug-metabolism transporters like OCT1. With over 1,000 protein datasets publicly available, a recent study highlights technical advances by independently assaying over 500 additional proteins in one study. Unfortunately, the development of statistical methods to interpret and analyze these technologies has not kept pace. For example, DMS with fluorescence-activated cell sorting (DMS-FACS), which has been used for nearly a decade to measure protein abundance and other functional phenotypes, still lacks dedicated analysis methods. As a result, analyses are often ad hoc, and small sample sizes (typically three replicates) make standard statistical methods unsuitable. Our recent work demonstrates that naive approaches miss many real effects and lead to many false discoveries. We propose three statistical areas to improve DMS analysis and interpretation through accurate sample comparisons, epistasis analysis, and causal inference. First, we will develop methods to analyze DMS-FACS for assessing how genetic variants affect molecular phenotype targeted by FACS, and enabling precise comparisons between experimental conditions. Second, we will develop methods to improve genetic interaction (epistasis) analysis and interpretation within proteins, and thus ask which protein regions are acting in concert. Third, we open a new area of research for DMS, aiming to identify the causal impact of variants through measured pathways, including complex traits. In summary, we will solve the analysis gap for DMS-FACS, epistasis DMS, and causally link DMS data through structural causal models by leveraging our expertise in DMS data and small sample statistics. Leveraging our expertise in DMS data and small sample statistics, we will create reliable, robust tools for common workflows while also enabling new types of analyses that improve the interpretation of DMS, epistasis, and phenotypic relationships. With strong collaborations with assay developers and DMS experts, along with a proven track record in developing tools for high-throughput sequencing in small sample contexts, we are well-positioned to lead this effort.", "keywords": [ "2019-nCoV", "Affect", "Area", "BRCA1 gene", "Binding", "Biological Assay", "Biology", "Clinical", "Collaborations", "Complex", "Data", "Data Analyses", "Data Set", "Dedications", "Development", "Disease", "Fluorescence", "Fluorescence-Activated Cell Sorting", "Genetic", "Genetic Epistasis", "High-Throughput Nucleotide Sequencing", "Lead", "Libraries", "Link", "Measures", "Methods", "Missense Mutation", "Molecular", "Mutation", "Pathway interactions", "Phenotype", "Population Study", "Positioning Attribute", "Protein Region", "Proteins", "Research", "Sample Size", "Sampling", "Statistical Methods", "Statistical Models", "Technology", "Testing", "Variant", "Work", "causal model", "drug metabolism", "fitness", "genetic variant", "improved", "molecular phenotype", "mutant", "mutation screening", "protein function", "protein profiling", "statistics", "tool", "trait" ], "approved": true } }, { "type": "Grant", "id": "15754", "attributes": { "award_id": "1U01AI186939-01", "title": "Mitigation of multi-organ delayed effects of acute radiation exposure (DEARE) with ACE2 agonist diminazene aceturate.", "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": 32816, "first_name": "CARMEN I", "last_name": "RIOS", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-11", "end_date": "2030-07-31", "award_amount": 546000, "principal_investigator": { "id": 32817, "first_name": "Heather A", "last_name": "Himburg", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2624, "ror": "", "name": "MEDICAL COLLEGE OF WISCONSIN", "address": "", "city": "", "state": "WI", "zip": "", "country": "United States", "approved": true }, "abstract": "With the advent of hematopoietic growth factors for mitigation of acute radiation syndrome (ARS), victims of nuclear or radiological events will be more likely to survive ARS but also at greater risk for the development of a range of late multi-organ toxicities collectively referred to as the delayed effects of acute radiation exposure (DEARE). To date, there are no FDA-approved medical countermeasures (MCMs) for the treatment of DEARE. This application to RFA-AI-23-059 (Development of Candidate Radiation/Nuclear MCMs) proposes to address this unmet need and will focus on the unmet need for MCMs against two life-threatening subsyndromes of DEARE: radiation pneumonitis and nephropathy. Here, we propose to screen three candidate MCMs which target the non-canonical, alternative renin angiotensin system (RAS). As a counterbalance to the canonical RAS, the alternative RAS has broad tissue-protective function by promoting vasodilation, reducing inflammation, and reducing fibrosis. For these reasons, several recent and ongoing clinical trials are evaluating alternative RAS activators for the treatment of severe COVID-19. Data from our lab and others also supports the potential for alternative RAS activation in the treatment of radiation toxicities. Our laboratory has shown diminazene aceturate (DIZE) a small molecule agonist of the alternative RAS pathway promotes survival in rat models of ARS and DEARE. Important to this application, DIZE treatment also mitigated injury to the lung and kidney as evidenced by improved survival during the sub-syndromes of lung and kidney DEARE. Based on these data, we hypothesize the alternative RAS pathway can be targeted pharmacologically to mitigate radiation-induced multi-organ DEARE. Here, we propose a stepwise approach to targeting three key players in the alternative RAS pathway: angiotensin converting enzyme 2 (ACE2), Ang(1-7), and the Mas receptor (MasR). Each Aim of this application will target one of these players using the following lead candidate therapies: DIZE (ACE2 activator), TXA127 (synthetic Ang(1-7)), and BIO101 (MasR activator). We will evaluate the efficacy of the candidate MCMs in an established rat DEARE model which recapitulates the anticipated human sequelae of acute and delayed toxicities. For each candidate MCM, the primary outcome measure will be mitigation of all-cause mortality, which is the clinically relevant endpoint for FDA approval under the Animal Rule.", "keywords": [ "ACE2", "Acceleration", "Acute", "Acute Respiratory Distress Syndrome", "Address", "Adult", "Agonist", "Anti-Inflammatory Agents", "Antiinflammatory Effect", "Antioxidants", "Binding", "Body System", "Bone Marrow", "COVID-19", "Clinical Research", "Clinical Trials", "Data", "Development", "Dose", "Exposure to", "FDA approved", "Fibrosis", "G-Protein-Coupled Receptors", "Generations", "Goals", "Hematopoietic", "Hematopoietic Cell Growth Factors", "Homeostasis", "Human", "Hypoxia", "In Vitro", "Inflammation", "Injury", "Investigation", "Ischemic Stroke", "Kidney", "Kidney Diseases", "Laboratories", "Life", "Lung", "Modeling", "Nuclear", "Nuclear Accidents", "Oral Administration", "Organ", "Outcome Measure", "Pathway interactions", "Peptide Signal Sequences", "Phase I/II Clinical Trial", "Play", "Population", "Radiation", "Radiation Accidents", "Radiation Injuries", "Radiation Pneumonitis", "Radiation Toxicity", "Radiation exposure", "Rattus", "Recovery", "Renin-Angiotensin System", "Reproducibility", "Respiratory Failure", "Risk", "Rodent Model", "Signal Transduction", "Testing", "Therapeutic Uses", "Time", "Tissues", "Toxic effect", "Vasodilation", "Vasodilator Agents", "Work", "animal rule", "clinical investigation", "clinically relevant", "efficacy evaluation", "experience", "improved", "in vivo Model", "irradiation", "lead candidate", "mass casualty", "medical countermeasure", "mortality", "multiorgan injury", "nuclear countermeasure", "pharmacologic", "pre-clinical", "preclinical study", "primary outcome", "programs", "protective effect", "radiation mitigation", "radiation mitigator", "receptor", "response", "severe COVID-19", "small molecule", "stroke patient", "subcutaneous", "therapeutic target" ], "approved": true } }, { "type": "Grant", "id": "15769", "attributes": { "award_id": "1K23HL181397-01", "title": "Optimal Ventilator Management in Patients with ARDS on ECMO", "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": 32586, "first_name": "ROYA", "last_name": "KALANTARI", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-01", "end_date": "2030-07-31", "award_amount": 178846, "principal_investigator": { "id": 32840, "first_name": "Mazen Faris", "last_name": "Odish", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2637, "ror": "", "name": "UNIVERSITY OF CALIFORNIA, SAN DIEGO", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Research Plan: Acute respiratory distress syndrome (ARDS) is a severe and common condition that affects 10% of patients in the intensive care unit (ICU), and was a major cause of morbidity and mortality during the COVID-19 pandemic. While mechanical ventilation is often necessary for ARDS, it can also induce additional lung injury known as ventilator induced lung injury (VILI). VILI may be minimized by using low tidal volumes/driving pressure and with positive end expiratory pressure (PEEP). Some patients with severe and refractory ARDS require veno-venous extracorporeal membrane oxygenation (V-V ECMO), the highest level of life support which provides oxygen and removes carbon dioxide from the blood using an external device. A major benefit of ECMO is thought to be the ability to minimize VILI; however, the optimal ventilator settings for patients with ARDS on ECMO are not known. Current guidelines use a one-size-fits-all approach. Our central hypothesis is that personalized PEEP adjusted by measuring intrathoracic pressures via esophageal manometry (Pes) will decease VILI as assessed by biomarkers of inflammation (main outcomes IL-6 and sRAGE). To carry out these aims, we plan to prospectively randomize 62 patients with ARDS on V-V ECMO and neuromuscular blockade and perform serial biomarker measurements with PEEP of 10 cmH2O (ECMO guidelines) vs. PEEP guided by esophageal manometry. In addition to biomarkers of VILI, we will assess differences in other physiological outcomes including pulmonary mechanics and gas exchange. Although this proposal focuses on patients on ECMO, we believe the knowledge gained will have relevance for all patients with ARDS. Career Development Plan: The goal of the PI, Dr. Mazen Odish, is to personalize ARDS and ventilator strategies for those on ECMO based on physiology and biomarkers. The PI has an interest in applied physiology and critical care, this award will help him refine these skills and develop new skills in clinical trials, statistics, and patient-oriented research, to test rigorously methods to care for critically ill patients with ARDS with or without ECMO. To obtain these new skills Dr. Odish and his excellent and multi-disciplinary mentoring/advisory team (led by Drs. Owens and Malhotra, plus outstanding statistical and methodologic support) has three main training goals. 1) Pulmonary mechanics and biomarkers during ARDS, 2) control of breathing and measurement of work of breathing during ARDS/mechanical ventilation, and 3) clinical trial design and statistical training. These training activities are tailored for the PI to achieve his goals and maximize career development towards becoming an independent physician scientist. Furthermore, his structured course work will lead to a Masters of Advanced Studies in Clinical Research. Dr. Odish is at the right place and time in his career to align his clinical expertise in ECMO and ARDS with his research goals to understand optimal ventilator settings and therapies. Eventually his work and new skill set may improve the lives of all people suffering from respiratory illness.", "keywords": [ "Acute Respiratory Distress Syndrome", "Advisory Committees", "Affect", "Arteries", "Atelectasis", "Automobile Driving", "Award", "Biological Markers", "Blood", "Body Weight", "Breathing", "COVID-19 pandemic", "Carbon Dioxide", "Clinical", "Clinical Research", "Clinical Trials", "Clinical Trials Design", "Critical Care", "Critical Illness", "Development Plans", "Devices", "Esophagus", "Extracorporeal Membrane Oxygenation", "Functional disorder", "Gases", "Goals", "Guidelines", "Heart and Lung machine", "Heterogeneity", "Hour", "Hypoxemia", "Induction of neuromuscular blockade", "Inflammation", "Injury", "Intensive Care Units", "Interleukin-6", "Knowledge", "Life", "Lung", "Lung Compliance", "Manometry", "Measurement", "Measures", "Mechanical ventilation", "Mechanics", "Mediator", "Mentors", "Meta-Analysis", "Methodology", "Methods", "Morbidity - disease rate", "Multiple Organ Failure", "Organ", "Outcome", "Oxygen", "Patient Care", "Patients", "Persons", "Physicians", "Physiological", "Physiology", "Positive-Pressure Respiration", "Process", "Prone Position", "Pulmonary Gas Exchange", "Randomized", "Recommendation", "Recording of previous events", "Refractory", "Research", "Research Design", "Resolution", "Respiratory Failure", "Respiratory System", "Respiratory physiology", "Rest", "Risk", "Scientist", "Stress", "Structure", "Testing", "Tidal Volume", "Time", "Training", "Training Activity", "Venous", "Ventilator", "Ventilator-induced lung injury", "Vision", "Work", "Work of Breathing", "career", "career development", "esophagus pressure", "healing", "improved", "improved outcome", "individual patient", "interest", "lung injury", "mortality", "multidisciplinary", "patient oriented research", "personalized approach", "pressure", "prevent", "primary outcome", "prospective", "pulmonary", "radiological imaging", "respiratory", "skills", "soluble RAGE", "statistics", "theories", "ventilation" ], "approved": true } }, { "type": "Grant", "id": "15775", "attributes": { "award_id": "1R01AI193318-01", "title": "Assessing the mechanisms underlying female sex-predominance in Long COVID", "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": 32597, "first_name": "BROOKE ALLISON", "last_name": "BOZICK", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-22", "end_date": "2030-07-31", "award_amount": 913012, "principal_investigator": { "id": 31372, "first_name": "Michael Joseph", "last_name": "Peluso", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32848, "first_name": "Nadia R", "last_name": "Roan", "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": "Long COVID, or post-acute sequelae of COVID-19 (PASC), is estimated to occur after ~10% of COVID-19 cases and affects tens of millions of people worldwide. The mechanisms underlying Long COVID remain poorly understood, which hinders the ability to establish effective evidence-based treatments for the condition. One of the most striking observations in the epidemiology of Long COVID is its female sex predominance: women, particularly pre-menopausal women, are much more likely than men to have the condition. In this proposal, we leverage the Long-term Impact of Infection with Novel Coronavirus (LIINC) cohort (NCT04362150) – which since April 2020 has recruited >1,000 participants with and without Long COVID – to interrogate the mechanistic basis underlying the increased prevalence of Long COVID in women. Our central hypothesis is that in women with Long COVID, there is an elevated and sustained immune type I IFN (T1IFN) response to SARS-CoV-2 (SCV2) gene products, which in turn diminishes the quality of adaptive immune responses against chronic herpesviruses (EBV, CMV) and SCV2 itself, increases the risk of pathogenic autoantibody responses, and results in overall systemic inflammation and immune dysregulation that is characteristic of Long COVID. We further postulate that both incomplete X chromosome inactivation and sex hormones drive the elevated T1IFN responses in women with Long COVID. In Aim 1, we will subject banked longitudinal blood specimens from women and men from LIINC (including both those with and without Long COVID) to assays that will measure the extent of persistent SCV2, T1IFN responses, the features of adaptive immune responses to persistent viruses associated with Long COVID (SCV2, EBV, CMV), autoantibody responses, and the overall state of inflammation. In Aim 2, we will leverage the LIINC Tissue Biopsy program to obtain paired endometrial and gut biopsies from women with Long COVID, to test the hypothesis that the endometrium is a key site of SCV2 persistence and immune dysregulation during Long COVID. This analysis will be compared to a parallel set of studies using gut specimens from matched men with Long COVID. Finally, Aim 3 will analyze specimens from two clinical trials designed to eliminate SCV2 gene products as treatment for Long COVID. The first of these, performed by Resolve Therapeutics, found that administration of RSLV-132, a catalytically active RNase1 intended to degrade SCV2 RNA, improved Long COVID symptoms in women but not men (NCT04944121). The second, occurring within LIINC, is ongoing (enrollment is complete) and testing the effects of AER002, a monoclonal antibody that directly targets and clears SCV2 protein (NCT05877508). Using specimens from both trials, we will test the notion that SCV2 gene products drive sustained T1IFN responses in women that contribute to Long COVID symptoms. Collectively, our aims will improve our understanding of the mechanisms underlying the female-predominance of Long COVID and improve our overall understanding of the disease. This will be a key step in the identification of evidence-based treatments for both women and men who continue to develop and live with this disabling condition.", "keywords": [ "2019-nCoV", "Acute", "Affect", "Age", "Antibodies", "Antibody Response", "Antigens", "Autoantibodies", "Autoimmunity", "Biological", "Biological Assay", "Biology", "Biopsy", "Biopsy Specimen", "Blood", "Blood specimen", "Body System", "COVID-19", "COVID-19 impact", "COVID-19 prevalence", "Characteristics", "Chronic", "Clinical Trials", "Clinical Trials Design", "Cytomegalovirus", "Data", "Disabling condition", "Disease", "Disproportionately impacts women", "Endometrial", "Endometrium", "Enrollment", "Epidemiology", "Estradiol", "Evidence based treatment", "Exhibits", "Fatigue", "Female", "Functional impairment", "Genes", "Genitourinary system", "Gonadal Steroid Hormones", "Health", "Herpesviridae", "High Prevalence", "Human Herpesvirus 4", "Immune", "Immune System Diseases", "Immune response", "Immunity", "Individual", "Infection", "Inflammation", "Inflammatory", "Inflammatory Response", "Interferons", "Intervention", "Intervention Trial", "Link", "Long COVID", "Longitudinal Studies", "Measurement", "Measures", "Monoclonal Antibodies", "Nature", "Observational epidemiology", "Organ", "Outpatients", "Paper", "Participant", "Pathway interactions", "Persons", "Phenotype", "Post-Acute Sequelae of SARS-CoV-2 Infection", "Premenopause", "Prevalence", "Progesterone", "Proteins", "Publishing", "RNA", "Research Infrastructure", "Risk", "SARS-CoV-2 infection", "SARS-CoV-2 inhibitor", "Sex Differences", "Signal Transduction", "Site", "Specimen", "Symptoms", "T cell response", "TLR7 gene", "Testing", "Testosterone", "Therapeutic", "Tissues", "Vaccination", "Viral", "Virus", "Virus Diseases", "Woman", "Women's prevalence", "X Inactivation", "acute COVID-19", "adaptive immune response", "brain fog", "cohort", "common symptom", "design", "experience", "female reproductive tract", "gene product", "improved", "interest", "longitudinal analysis", "men", "mucosal site", "novel coronavirus", "pathogenic autoantibodies", "programs", "prospective", "randomized trial", "recruit", "repository", "response", "sex", "single-cell RNA sequencing", "systemic inflammatory response", "therapy design", "transcriptome", "women's outcomes" ], "approved": true } }, { "type": "Grant", "id": "12388", "attributes": { "award_id": "1UM1TR004399-01A1", "title": "Colorado Clinical and Translational Sciences Institute (CCTSI)", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Center for Advancing Translational Sciences (NCATS)" ], "program_reference_codes": [], "program_officials": [ { "id": 21790, "first_name": "Pablo", "last_name": "Cure", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-15", "end_date": "2030-07-31", "award_amount": 7722705, "principal_investigator": { "id": 28329, "first_name": "JANINE A", "last_name": "HIGGINS", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 28330, "first_name": "RONALD J.", "last_name": "SOKOL", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 784, "ror": "https://ror.org/02hh7en24", "name": "University of Colorado Denver", "address": "", "city": "", "state": "CO", "zip": "", "country": "United States", "approved": true }, "abstract": "Funded by NIH in 2008, 2013 and 2018, the Colorado Clinical and Translational Sciences Institute (CCTSI) at the University of Colorado Denver (CU Denver) has transformed the clinical and translational research and training enterprise in the Colorado region with the vision of accelerating the translation of discoveries into improved, equitable patient care and public health for all. The CCTSI, headquartered at the CU Anschutz Medical Campus, is a partnership of CU Denver, CU Boulder, Colorado State University (CSU), 5 hospital systems and 20 community organizations, which has advanced translational science by educating a diverse workforce, creating a collaborative environment that supports local and multi-site research, engaging communities through its unique community engagement program, creating methodologies that support research in special populations, and greatly enhancing our informatics and data science capabilities. The CCTSI infrastructure played a critical role in the Colorado response to the COVID pandemic and led to new innovations in research processes and implementation, while recognizing the health inequities and disparities exposed by the pandemic in rural, minority and underserved populations in Colorado. Despite the successes, there remain many challenges to overcoming inefficiencies and roadblocks in clinical translational science (CTS) processes locally and nationally and in reducing health disparities and inequities. This application maps our collaborative path forward to meet these challenges. In the next grant cycle, we will enhance our efforts to improve efficiency and coordination with Partners and across the CTSA Consortium, reinforce our extensive community partnerships, develop innovative informatics and technology solutions to advance CTS, and develop a diverse highly-skilled translational workforce for the future. This UM1 will be tightly coordinated with our other 6 CTSA grant applications, to accomplish the following 6 Overall Strategic Goals: Goal 1: Advance CTS by developing, demonstrating, and disseminating innovative programs to improve the efficiency and impact of translation across the entire T0.5 to T4 spectrum. Goal 2: Promote collaboration, team and data science, and partnerships to accelerate CTS locally, regionally and nationally. Goal 3: Partner locally, regionally and nationally with institutions, stakeholders and communities to develop innovative research programs that will address health inequities and disparities. Goal 4: Further develop operational efficiencies to enhance the quality, safety, efficiency, effectiveness and informativeness of clinical research. Goal 5: Promote a nimble research environment that can rapidly respond to urgent public health needs. Goal 6: Develop and disseminate CTS training programs that educate and sustain a resilient, diverse team of clinical research professionals and investigators. Special efforts will be made to enhance diversity in our workforce. Progress will be monitored and improved by our Evaluation Core and CQI program and we will make mid-course corrections as needed to achieve these goals and ultimately improve the health of our state and the nation.", "keywords": [ "Abbreviations", "Acceleration", "Address", "Adult", "Advisory Committees", "Applications Grants", "Authorization documentation", "Biomedical Research", "Biometry", "COVID-19 pandemic", "Center for Translational Science Activities", "Child", "Clinical", "Clinical Research", "Clinical Sciences", "Clinical Trials", "Collaborations", "Colorado", "Communities", "Contracts", "Data Science", "Discipline of Nursing", "Diverse Workforce", "Education", "Effectiveness", "Electronic Health Record", "Environment", "Epidemiology", "Equity", "Evaluation", "Exposure disparity", "Faculty", "Funding", "Funding Opportunities", "Future", "Goals", "Grant", "Health", "Health Alliance", "Health system", "Healthcare", "Hospitals", "Ice", "Informatics", "Infrastructure", "Innovation Corps", "Institution", "Institutional Review Boards", "Jews", "Lead", "Maps", "Maternal and Child Health", "Medical", "Medical center", "Mentored Clinical Scientist Development Program", "Mentors", "Methodology", "Minority Groups", "Monitor", "Outcomes Research", "Patient Care", "Pediatric Hospitals", "Performance", "Pharmacologic Substance", "Pharmacy Schools", "Play", "Process", "Program Development", "Public Health", "Public Health Informatics", "Public Health Schools", "Reduce health disparities", "Research", "Research Design", "Research Personnel", "Research Support", "Research Training", "Review Committee", "Role", "Rural Community", "Rural Population", "Safety", "School Dentistry", "Science", "Site", "Special Population", "System", "TNFSF15 gene", "Technology", "Time", "Training", "Training Programs", "Translating", "Translational Research", "Translations", "Underserved Population", "United States Department of Veterans Affairs", "United States National Institutes of Health", "Universities", "Vision", "Workforce Development", "authority", "career development", "clinical translation", "collaborative environment", "college", "community based participatory research", "community center", "community engagement", "community organizations", "community partnership", "data sharing", "design", "electronic data", "health data", "health disparity", "health inequalities", "improved", "innovation", "medical schools", "minority communities", "next generation", "pandemic disease", "pre-doctoral", "process improvement", "programs", "public health emergency", "resilience", "response", "skills", "success" ], "approved": true } }, { "type": "Grant", "id": "15762", "attributes": { "award_id": "1K08AI193077-01", "title": "Impact of Spatial and Social Determinants on Invasive Fungal Infection Risk", "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": 32829, "first_name": "DONA", "last_name": "LOVE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-01", "end_date": "2030-07-31", "award_amount": 197640, "principal_investigator": { "id": 32830, "first_name": "Lucy", "last_name": "Li", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2615, "ror": "", "name": "JOHNS HOPKINS UNIVERSITY", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": ": Invasive fungal infections (IFIs) are a growing public health challenge, leading to over 1.5 million deaths each year worldwide. Contextual factors are believed to be critical components of IFI risk as evidenced by historical fungal outbreaks associated with specific geographic distributions and ecological disruptions. Certain communities are thought to be particularly vulnerable with greater exposure to high-risk contextual factors, leading to higher rates of and worse outcomes from IFIs. In addition, socioeconomic status may impact IFI outcomes, due to delays in diagnosis, access to care, and quality of care. However, prior studies of IFI epidemiology have focused primarily on host factors without adequately considering the uneven distribution of hazards and their spatiotemporal trends related to socioeconomic factors. The objective of this proposal is to assess the impact of social determinants on IFI risk by leveraging a national data source, the National COVID Cohort Collaborative, and a more granular hospital system electronic-health medical records data source. In Aim 1, we will determine neighborhood-level contextual and socioeconomic predictors of IFIs. In Aim 2, we will examine the association between individual socioeconomic status factors and clinical outcomes of IFIs. This work will advance our understanding of the spatial and social determinants of IFI risk and outcomes as well as provide a robust training platform for the award recipient, Dr. Lucy Li. Through both research and career development training, Dr. Li will acquire essential skills in large data analysis, including advanced methods in spatial science and social factors research, time series analyses, and risk prediction modeling. Dr. Li will then be well positioned to be an independent clinical investigator focused on IFIs in at-risk populations with an expertise in integrating spatial and social factors data into population health analyses.", "keywords": [ "Address", "Affect", "Air", "Allergic", "American", "Area", "Asthma", "Award", "COVID-19", "Caring", "Censuses", "Cessation of life", "Clinical", "Clinical Investigator", "Clinical Research", "Communities", "Community Surveys", "Computerized Medical Record", "Data", "Data Analyses", "Data Commons", "Data Sources", "Databases", "Diagnosis", "Dimensions", "Disease", "Disease Outbreaks", "Education", "Electronic Health Record", "Employment Status", "Epidemiology", "Equation", "Ethnic Origin", "Exposure to", "Geographic Distribution", "Geographic Locations", "Health Services Accessibility", "Health system", "Hospitalization", "Hospitals", "Housing", "Immunocompetent", "Immunocompromised Host", "Incidence", "Income", "Individual", "Infection", "Insurance Coverage", "Integration Host Factors", "International Classification of Disease Codes", "Intervention", "Length of Stay", "Logistic Regressions", "Longitudinal trends", "Measures", "Mentors", "Methods", "Molds", "Mycoses", "Neighborhoods", "Organ", "Outcome", "Outcome Assessment", "Patients", "Pattern", "Persons", "Play", "Population", "Populations at Risk", "Positioning Attribute", "Public Health", "Quality of Care", "Race", "Research", "Resolution", "Risk", "Risk Factors", "Science", "Seasons", "Shapes", "Site", "Socioeconomic Factors", "Socioeconomic Status", "Source", "System", "Time Series Analysis", "Training", "United States", "Weather", "Work", "Yeasts", "adjudication", "career", "career development", "clinical care", "clinical risk", "cohort", "contextual factors", "design", "electronic medical record system", "fungus", "hazard", "high risk", "improved", "indexing", "infection risk", "low socioeconomic status", "mortality", "multilevel analysis", "patient screening", "population health", "primary outcome", "research and development", "risk prediction", "risk prediction model", "secondary outcome", "skills", "social determinants", "social factors", "social vulnerability", "socioeconomics", "spatial epidemiology", "spatial integration", "spatial relationship", "spatiotemporal", "statistics", "time use", "trend" ], "approved": true } }, { "type": "Grant", "id": "15781", "attributes": { "award_id": "1R01AI183979-01A1", "title": "Expanding access and impact of tuberculosis preventive therapy: Community-friendly delivery and monitoring of TPT to improve uptake and reduce TB transmission", "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": "2025-08-19", "end_date": "2030-07-31", "award_amount": 690538, "principal_investigator": { "id": 28321, "first_name": "ADRIENNE E", "last_name": "SHAPIRO", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2645, "ror": "", "name": "UNIVERSITY OF WASHINGTON", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true }, "abstract": "Enter the text here that is the new abstract information for your application. International and Kenyan guidelines recommend TB preventive therapy (TPT) for people with HIV (PWH) and other people at high risk for TB, including close contacts of people with TB. Despite the evidence for reduced morbidity and mortality for people with HIV (PWH) who receive TPT, and guidelines recommending use, there remains a substantial gap between people recommended to receive and people who actually receive and complete a course of TPT. The 2022 WHO Global TB Report highlighted the growing gap in access and provision of TPT, which has been aggravated by the COVID-19 pandemic. Bridging this gap is a Kenyan and global priority. With the recent availability and evidence for newer, shorter regimens of TPT, a transformation of HIV care delivery models (in part forced by the COVID-19 pandemic) and evolving national guidelines for TPT, it is increasingly urgent to explore new person-friendly models of TPT delivery to inform programmatic guidance that results in greater uptake, adherence, and completion of TPT. HIV care transformed to adopt “differentiated service delivery” (DSD) models, which encourage community-delivered care, infrequent clinic/facility visits, multi- month dispensing, limited laboratory monitoring, and task-shifted treatment models to deliver comprehensive HIV care to stable adults in community settings. These successful models for differentiated HIV care delivery may be able to be adapted to include TPT. The availability of safe, effective, short-course TPT (i.e. 3HP, 3HR) with limited monitoring requirements suggests that similar community-based and multi-month dispensing models may be adapted to scale essential TPT to populations who most need it, including PWH, young child contacts, and all household contacts of people with TB. We will explore two approaches of adapting HIV differentiated services to TB prevention. We hypothesize that people who receive differentiated TPT delivery have higher rates of completion of a course of TPT than people who receive standard-of-care clinic-based TPT. We will 1) conduct a randomized controlled trial of DSD care (multi-month dispensing) vs. clinic standard-of-care TPT delivery in two priority populations for TPT in Kenya: household contacts of people with TB and PWH, 2) investigate the impact of DSD TPT on household and community TB transmission with follow-up testing and mathematical modeling, and 3) examine preferences, barriers and facilitators of TPT completion and TPT implementation using qualitative research. Together, this research will establish the foundation for implementation studies of optimized patient and community-friendly, differentiated TPT delivery approaches to increase TPT uptake and completion in Kenya and ultimately decrease morbidity, transmission, and mortality from TB.", "keywords": [ "Adherence", "Adopted", "Adult", "Adverse effects", "Biological Assay", "COVID-19 pandemic", "Caring", "Cessation of life", "Child", "Client", "Clinic", "Clinical", "Communicable Diseases", "Communities", "Dose", "Drug resistance in tuberculosis", "Eligibility Determination", "Focus Groups", "Foundations", "Friends", "Goals", "Guidelines", "HIV", "HIV/TB", "Health system", "Home", "Household", "Incidence", "Individual", "Interferon Type II", "International", "Interview", "Kenya", "Laboratories", "Measures", "Methodology", "Methods", "Modeling", "Monitor", "Morbidity - disease rate", "Patients", "Persons", "Pharmaceutical Preparations", "Population", "Prevention", "Preventive therapy", "Qualitative Research", "Randomized", "Randomized Controlled Trials", "Recommendation", "Regimen", "Reporting", "Research", "Schedule", "Service delivery model", "Services", "Testing", "Text", "Time", "Toxic effect", "Travel", "Treatment Protocols", "Tuberculosis", "Tuberculosis diagnosis", "Visit", "World Health Organization", "care delivery", "community setting", "cost", "experience", "follow-up", "gaps in access", "health care delivery", "high risk", "immunoreactivity", "implementation strategy", "implementation study", "improved", "informant", "innovation", "isoniazid", "mathematical model", "mortality", "person centered", "pill", "preference", "prevent", "preventable death", "rifapentine", "scale up", "screening", "service delivery", "standard of care", "supply chain", "transmission process", "treatment as usual", "trial comparing", "uptake" ], "approved": true } } ], "meta": { "pagination": { "page": 2, "pages": 1405, "count": 14046 } } }