Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=2&sort=award_amount
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=award_amount", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1405&sort=award_amount", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=3&sort=award_amount", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=award_amount" }, "data": [ { "type": "Grant", "id": "6924", "attributes": { "award_id": "1I01BX005616-01", "title": "Vaccine targeting HIV sites of vulnerability", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2021-10-01", "end_date": "2025-09-30", "award_amount": null, "principal_investigator": { "id": 22765, "first_name": "Catarina E", "last_name": "Hioe", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1533, "ror": "", "name": "JAMES J PETERS VA MEDICAL CENTER", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1533, "ror": "", "name": "JAMES J PETERS VA MEDICAL CENTER", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Effective HIV vaccines are not yet available. Of the phase 2b/3 vaccine trials, only the Thai RV144 trial showed efficacy (31%, p=0.04), and high levels of antibodies (Abs) against the V1V2 domain of HIV envelope (Env) were found to be the only primary immune correlate of reduced virus acquisition. Studies of vaccines in SIV or SHIV-challenged monkeys have since recapitulated these findings. To improve upon the RV144 vaccine, we have designed V1V2-targeted vaccine candidates and identified the most immunogenic: V1V2/A244-2J9C, a protein with V1V2 of CRF_01.AE strain A244 spliced into a bacterial trimeric protein scaffold, 2J9C. With our unique vaccine strategy centered on targeting V1V2 using novel recombinant subunit immunogens, we have demonstrated the capacity to induce an Ab response in plasma and vaginal secretion that was focused on V1V2 and diverted from other more immunodominant sites on Env. The elicited Abs displayed cross-reactivity with strains from multiple clades, durability of 1-2 years after the last boost, and antiviral functions including Ab- dependent cellular phagocytosis (ADCP), Ab-dependent cellular cytotoxicity (ADCC), and complement activation—activities that are not readily achieved by immunization with intact gp120. V1V2/A244-2J9C DNA has also been shown as an effective prime, focusing the Ab response on the specific V2 region that accounted for reduced infection in RV144. Altogether these data provide evidence supporting the validation of our lead vaccine candidate and vaccination approach. A US patent has been issued for our V1V2-scaffold designs, with the VA as one of the assignees. This application proposes to produce the lead immunogen V1V2/A244-2J9C under cGMP (current Good Manufacturing Practice) as both DNA plasmid and protein, and test its optimized delivery in order to pave the way toward a human phase I clinical trial. To accomplish this goal, four specific aims are proposed. Aim 1 is to generate a master bank of E. coli transformed with the V1V2/A244-2J9C-expressing DNA plasmid. In Aim 2 we will test the cGMP-grade V1V2/A244-2J9C-encoding DNA for protein production in transiently transfected 293T cells and for immunogenicity in rabbits. In vitro protein analysis will include expression efficiency, mass, oligomerization, glycosylation, stability, and reactivity with a panel of monoclonals Abs (mAbs). Aim 3 is to produce a master bank of HEK293T GnTi-/- cells and a pilot batch of V1V2/A244-2J9C protein using the plasmid from Aim 1. Finally, Aim 4 will test purification methods and conduct in vitro analysis for V1V2/A244-2J9C protein from Aim 3 and then perform in vivo rabbit immunogenicity testing with V1V2/A244-2J9C DNA and protein. The cGMP production will be done by Waisman BioManufacturing, associated with the University of Wisconsin-Madison, under the supervision of Drs. Carl A. Ross and Brian M. Dattilo. In vitro immunogen analysis, protein purification, rabbit vaccination, and immune assessment will be performed in the laboratory of Dr. Catarina Hioe (PI, James J. Peters VA Medical Center, JJP VAMC) in collaboration with Dr. Susan Zolla-Pazner (Mount Sinai School of Medicine, MSSM). The V1V2/A244-2J9C DNA and protein immunogens will be the first of their kind to move toward clinical trials. An effective vaccine to prevent HIV infection and/or disease is an essential portion of the Strategic National Vaccine Plan of the Departments of Health and Human Services and Veterans Affairs. An HIV vaccine is invaluable to protect Veterans who are at risk at home and abroad. This vaccine could as well serve as a prototype for vaccines against other diseases, like COVID19, where a focused Ab response to specific epitopes is requisite for protection.", "keywords": [ "2019-nCoV", "AIDS prevention", "Adherence", "Anti-Retroviral Agents", "Antibodies", "Antibody Formation", "Antibody Response", "Antigens", "Antiviral Agents", "Biomanufacturing", "COVID-19", "Caring", "Cells", "Clinical Trials", "Collaborations", "Complement Activation", "Cyclic GMP", "DNA", "Data", "Development", "Disease", "Epitopes", "Escherichia coli", "Future", "Glycoproteins", "Goals", "HIV", "HIV Envelope Protein gp120", "HIV Infections", "HIV vaccine", "Healthcare Systems", "Home", "Human", "Immune", "Immune response", "Immunization", "Immunize", "Immunodominant Epitopes", "Immunoglobulin G", "In Vitro", "Individual", "Infection", "Laboratories", "Lead", "Legal patent", "Life", "Macaca mulatta", "Mediating", "Medical center", "Methods", "Monkeys", "Monoclonal Antibodies", "Oryctolagus cuniculus", "Outcome", "Pathway interactions", "Phase", "Phase I Clinical Trials", "Plasma", "Plasmids", "Production", "Protein Analysis", "Proteins", "Provider", "Publishing", "RNA Splicing", "Recombinants", "Regimen", "Research", "Risk", "SIV", "Scaffolding Protein", "Site", "Supervision", "Testing", "Transfection", "United States Department of Veterans Affairs", "United States Dept. of Health and Human Services", "Universities", "Vaccination", "Vaccine Clinical Trial", "Vaccines", "Vagina", "Validation", "Veterans", "Veterans Health Administration", "Virion", "Virus", "Virus Diseases", "Wisconsin", "antibody-dependent cell cytotoxicity", "antibody-dependent cellular phagocytosis", "cGMP production", "cross reactivity", "design", "economic impact", "efficacy clinical trial", "env Gene Products", "glycosylation", "immunogenic", "immunogenicity", "improved", "in vivo", "medical schools", "monomer", "nonhuman primate", "novel", "novel vaccines", "pandemic disease", "pathogen", "plasmid DNA", "prevent", "protein purification", "prototype", "scaffold", "simian human immunodeficiency virus", "standard of care", "vaccine candidate", "vaccine efficacy", "vaccine strategy", "vaccine trial", "vaccine-induced antibodies", "virus envelope" ], "approved": true } }, { "type": "Grant", "id": "7937", "attributes": { "award_id": "1IK6BX005962-01", "title": "BLR&D Research Career Scientist Application", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-04-01", "end_date": "2027-03-31", "award_amount": null, "principal_investigator": { "id": 23807, "first_name": "Todd A", "last_name": "Wyatt", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1645, "ror": "", "name": "OMAHA VA MEDICAL CENTER", "address": "", "city": "", "state": "NE", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1645, "ror": "", "name": "OMAHA VA MEDICAL CENTER", "address": "", "city": "", "state": "NE", "zip": "", "country": "United States", "approved": true }, "abstract": "My primary research interests address chronic inflammatory lung disease, and the impact that behavioral and environmental exposures play in the compromise of lung innate defense against pathologic lung infections and injury. Utilizing pre-clinical mouse models and state-of-the-art molecular, biochemical, and cellular approaches, I collaborate closely with pulmonologists who practice at the VA to conduct relevant pre-clinical research that can be used to address current clinical concerns. I translate my findings to Veterans’ health using a well- characterized human lung cell and tissue biobank obtained from our lung transplant program. We have an existing cohort of Veterans with rural/agricultural occupational exposures to conduct relevant studies to our service region. There are 3 major research projects currently underway that impact veterans’ health: Malondialdehyde-acetaldehyde adducts and lung injury. Alcohol abuse causing increased susceptibility to pneumonia has been known for over 200 years. Because the majority (>90%) individuals misusing alcohol smoke cigarettes, we study the combination lung injury effects of both cigarettes and alcohol. We identified that the lungs represent a unique environment for the formation of stable malondialdehyde-acetaldehyde protein adducts (MAA adducts), but only under conditions of combined cigarette smoke and alcohol exposure. These MAA adducts cause airway epithelial cell cilia slowing and impair the innate pathogen clearance from the lung. Surfactant protein D (SPD) is a major lung protein that gets adducted when lung aldehyde concentrations are elevated during combined smoke and alcohol exposure and SPD-MAA adducts are detected in the lung only in drinkers who also smoke, leading to alterations in innate lung defense. (Funded by BX003635). Veterans- centric COVID-19 research. The pathogenesis of the SARS-CoV-2 virus and clinical outcomes from COVID 19 are far worse in individuals with certain pre-existing conditions and those of advanced age. It is essential to the health of Veterans to fully define which at-risk conditions particularly impact them and their unique needs to empower clinical preventive care during this and future viral pandemics. Old age and alcohol misuse are associated with cilia dysfunction. SPD has been documented to specifically bind to and neutralize the Spike protein of coronavirus. We hypothesize that altered innate lung defense at the level of mucociliary clearance, anti-microbial surfactants, and viral receptor function will negatively impact susceptibility and pathogenesis of SARS-CoV-2, placing Veterans particularly in harm’s way. We are currently identifying differences in SARS- CoV-2 infection responses between normal airway epithelium and lung macrophages and those cells collected from individuals with COPD, with alcohol use disorder, or of old age. Defining the modalities of risk will empower clinicians to make informed clinical preventive care decisions for Veterans (Funded by BX005413). Agricultural organic dust-mediated lung injury. VISN 23 encompasses a region responsible for the largest agricultural output in the nation. In collaboration with Omaha VA physician scientists, we have built a cohort of Veterans with agricultural exposures to explore the impact of organic dusts on chronic lung inflammatory injury. Using established mouse models, we have identified the therapeutic impact of IL-10 on lung repair from dust- mediated injury. We are currently defining the mechanisms of action through an active NIOSH R01 study and the Central States Center for Agricultural safety and Health (Funded by OH010162). With these innovative research programs, I have been able to provide training and mentoring to many undergraduates, graduate students, fellows, junior scientists and physicians at the Omaha VAMC and affiliated University of Nebraska Medical Center (UNMC). Our efforts to investigate the underlying mechanisms and identify targets for pulmonary disease have brought together physician scientists and basic scientists at the Omaha VA medical center and UNMC, which has led to the development of a VA-funded live-animal microCT Core facility, which I supervise and is the only such instrument in Omaha.", "keywords": [ "2019-nCoV", "Acetaldehyde", "Address", "Admission activity", "Age", "Agriculture", "Alcohol abuse", "Alcohol consumption", "Alcohols", "Aldehydes", "Animal Model", "Animals", "Area", "Award", "Bacterial Infections", "Behavioral", "Binding", "Biochemical", "Biological Markers", "COVID-19", "Caring", "Cells", "Chronic", "Chronic Obstructive Pulmonary Disease", "Chronic lung disease", "Cigarette", "Cilia", "Clinical", "Collaborations", "Core Facility", "Coronavirus spike protein", "Cyclic AMP-Dependent Protein Kinases", "Development", "Dust", "Elderly", "Environment", "Environmental Exposure", "Epithelial Cells", "Exposure to", "Extramural Activities", "Functional disorder", "Funding", "Future", "Grant", "Health", "Health Care Costs", "Healthcare", "Healthcare Systems", "Heavy Drinking", "Hospitals", "Human", "Impairment", "Individual", "Inflammation", "Inflammatory", "Injury", "Interleukin-10", "Laboratories", "Life", "Lung", "Lung Transplantation", "Lung diseases", "Lung infections", "Malondialdehyde", "Manuscripts", "Mediating", "Medical center", "Mentors", "Methodology", "Military Personnel", "Modality", "Molecular", "Morbidity - disease rate", "Mucociliary Clearance", "Natural Immunity", "Nebraska", "Occupational Exposure", "Outcome", "Output", "Pathogenesis", "Pathologic", "Peer Review", "Physicians", "Play", "Pneumonia", "Predisposition", "Preventive care", "Proteins", "Pulmonary Surfactant-Associated Protein D", "Recording of previous events", "Regulation", "Research", "Research Project Grants", "Respiratory Syncytial Virus Infections", "Risk", "Role", "Rural", "SARS-CoV-2 infection", "SARS-CoV-2 pathogenesis", "Safety", "Sampling", "Savings", "Science", "Scientist", "Seminal", "Services", "Smoke", "Smoker", "Smoking", "Source", "Substance abuse problem", "Supervision", "System", "TNF-alpha converting enzyme", "Therapeutic", "Time", "Tissues", "Training", "Translating", "Universities", "Veterans", "Viral", "Virus", "Virus Diseases", "Virus Receptors", "Work", "adduct", "agricultural center", "airway epithelium", "airway inflammation", "alcohol exposure", "alcohol misuse", "alcohol response", "alcohol use disorder", "antimicrobial", "biobank", "career", "cell motility", "chronic inflammatory lung disease", "cigarette smoke", "cohort", "cost", "desensitization", "digital", "disorder risk", "experience", "exposure to cigarette smoke", "former smoker", "graduate student", "human old age (65+)", "improved" ], "approved": true } }, { "type": "Grant", "id": "6925", "attributes": { "award_id": "1I01BX005794-01", "title": "COVID-19: Significance of Fc properties and functions in antibody responses against SARS-CoV-2", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-01-01", "end_date": "2025-12-31", "award_amount": null, "principal_investigator": { "id": 22765, "first_name": "Catarina E", "last_name": "Hioe", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1533, "ror": "", "name": "JAMES J PETERS VA MEDICAL CENTER", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1533, "ror": "", "name": "JAMES J PETERS VA MEDICAL CENTER", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "The COVID-19 pandemic, which is caused by SARS-CoV-2, a novel coronavirus first detected in November-December 2019, has inflicted millions of deaths worldwide. In the US, the outbreak is affecting millions of lives. The VA hospitals, including the James J. Peters VA Medical Center (JJP VAMC) in the Bronx, NY, have responded promptly to provide care to Veterans and employees. Veterans are typically older than the general US population, making them highly susceptible to severe disease. COVID-19 vaccines are also distributed initially to the elderly and other high-risk individuals. This provides the VA a unique opportunity to study SARS-CoV-2 infection and vaccination in the most vulnerable individuals. This VA Merit application proposes to investigate the protective role of antibodies (Abs) elicited against the SARS-CoV-2 spike protein and its receptor-binding domain (RBD) following vaccination or infection. In particular, we will examine the Ab Fc properties and functions that are not well understood and the Abs that are present in blood and in saliva as a proxy of Abs at the mucosal site of virus entry. The proposed study is built upon our published and preliminary results showing the detection of different immunoglobulin (Ig) isotypes against SARS-CoV-2 spike and RBD in saliva vs plasma of convalescent COVID-19 patients and vaccine recipients. Interestingly, our preliminary data indicate a lack of correlation of spike-specific Ig isotypes in saliva vs plasma from infected and vaccinated subjects. The data further show the binding of C1q, the first component in the classical complement cascade, to Abs from both infected and vaccinated subjects. Notably, the C1q binding activities of Abs in saliva vs plasma correlated poorly, offering the initial evidence for differential Fc functions of mucosal vs circulating anti-spike Abs elicited by infection and vaccination. To investigate further the Fc properties and functions of Abs against SARS-CoV-2, we hypothesize that Fc isotype and glycosylation are the key determinants of Fc-dependent Ab functions in protection against COVID-19. A research team that include research specialists with expertise in Abs and viral immunology (PI: Catarina Hioe at JJP VAMC; collaborators: Susan Zolla-Pazner, Chitra Upadhyay, Ray Alvarez at Mount Sinai School of Medicine/MSSM), an expert in mass spectrometry and glycan biology (Hui Zhang at Johns Hopkins Univ), and an infectious disease clinician (Co-I: Juan Bandres at JJP VAMC) will work together to test this hypothesis. We will leverage our extensive expertise in Abs against HIV envelope glycoprotein and our experience investigating Ab responses against SARS-CoV-2 in the past year. In Aim 1, we will collect longitudinal plasma and saliva samples to determine the isotypes and durability of Abs against spike and RBD in different bodily fluids of ambulatory and hospitalized COVID-19 patients and healthy uninfected recipients of COVID-19 RNA vaccines. Aim 2 will evaluate the glycan structures on the Fc regions of Abs against spike from SARS-CoV-2-infected and vaccinated subjects. Aim 3 will assess the Fc-mediated activities that these Abs mediate to destroy virus particles and virus-infected cells, i.e. complement binding/activation and FcɣR-mediated signaling, cytotoxicity, and phagocytosis. Abs of different Ig isotypes and with experimentally modified Fc glycans will also be examined for their Fc-dependent activities. The proposed study will produce data critical to advance the development of improved Ab-based arsenals for diagnostics, prophylactics, and therapeutics against COVID-19.", "keywords": [ "2019-nCoV", "Address", "Advanced Development", "Affect", "Affinity", "Animals", "Antibodies", "Antibody Response", "Antigens", "Antiviral Agents", "Binding", "Biology", "Blood", "COVID-19", "COVID-19 diagnostic", "COVID-19 intervention", "COVID-19 pandemic", "COVID-19 patient", "COVID-19 therapeutics", "COVID-19 vaccine", "Caring", "Cells", "Cessation of life", "China", "Chitra", "Communicable Diseases", "Complement", "Complement 1q", "DNA Vaccines", "Data", "Death Records", "Deposition", "Detection", "Development", "Diagnostic", "Disease", "Disease Outbreaks", "Disease Outcome", "Elderly", "Emergency Situation", "Employee", "Failure", "Glycoproteins", "Goals", "HIV", "Hospitals", "Human", "IgG1", "Immunoglobulin A", "Immunoglobulin G", "Immunoglobulin Isotypes", "Immunoglobulin M", "Immunology", "Individual", "Infection", "Inflammatory", "Lead", "Liquid substance", "Macaca mulatta", "Mass Spectrum Analysis", "Measures", "Mediating", "Medical center", "Mucous Membrane", "Myeloid Cells", "Patients", "Phagocytosis", "Plasma", "Polysaccharides", "Population", "Positioning Attribute", "Production", "Property", "Proxy", "Publishing", "RNA vaccine", "Reporting", "Research", "Risk Factors", "Role", "SARS-CoV-2 antibody", "SARS-CoV-2 infection", "SARS-CoV-2 spike protein", "Saliva", "Signal Transduction", "Specialist", "Specimen", "Structure", "Symptoms", "Testing", "Time", "Vaccinated", "Vaccination", "Vaccines", "Veterans", "Viral", "Virion", "Virus", "Vulnerable Populations", "Work", "antibody-dependent cellular phagocytosis", "base", "convalescent plasma", "cytokine", "cytotoxicity", "experience", "glycosylation", "high risk", "improved", "male", "medical schools", "mucosal site", "neutralizing antibody", "neutrophil", "novel coronavirus", "pandemic disease", "preclinical study", "prophylactic", "receptor binding", "response", "saliva sample", "severe COVID-19", "vector" ], "approved": true } }, { "type": "Grant", "id": "8201", "attributes": { "award_id": "1I01BX005490-01", "title": "COVID-19: SARS-CoV-2 Neutralizing Agents", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2021-04-01", "end_date": "2023-03-31", "award_amount": null, "principal_investigator": { "id": 24037, "first_name": "SUBHRA", "last_name": "MOHAPATRA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1638, "ror": "", "name": "JAMES A. HALEY VA MEDICAL CENTER", "address": "", "city": "", "state": "FL", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 23775, "first_name": "Shyam S", "last_name": "Mohapatra", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1638, "ror": "", "name": "JAMES A. HALEY VA MEDICAL CENTER", "address": "", "city": "", "state": "FL", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 1638, "ror": "", "name": "JAMES A. HALEY VA MEDICAL CENTER", "address": "", "city": "", "state": "FL", "zip": "", "country": "United States", "approved": true }, "abstract": "COVID-19 super pandemic is still suffering from the lack of a vaccine or infection control measures and the lack of any treatments against this new virus. One of the unique features of SARS-CoV-2 is that it has an R0=2.2 (the ability of an infected patient to spread the disease) vs R0=1 for SARS-CoV and R0=0.3 for Influenza. Due to this, individuals infected with SARS-CoV-2 remain asymptomatic and yet pass on the virus to family, friends and colleagues at work, thus expanding the COVID-19 cases. Given the impending second wave of the pandemic and the potential of SARS-CoV-2 being a seasonal virus, there is a dire urgent need to develop prophylactic vaccines and/or therapy (PV/T), which can treat the viral infection during the virus expansion in the lung and during oxygen therapy. This proposal addresses the COVID-19 pandemic by developing a PV/T, which will be a unique approach that has not been tested before. This project is inspired by discovery of a special agent, i.e., a nanoscale 10 kDa chitosan, derived using proprietary methods from chitosan used as a common diet supplement [‘generally regarded as safe’ (GRAS) by FDA] , referred to as nanoscale chitosan derivative (NCD). NCD1 and other chemical derivatives were synthesized and tested for their anti-viral activity by neutralizing RNA of viruses, such as HIV, respiratory syncytial virus (RSV) and Coxsackie virus. Thus, in preliminary studies, 5 out of 9 examined showed significant anti-viral (80-90%) effects. Further, molecular docking studies showed that NCD1 can dock to the Spike protein of SARS-CoV-2 virus. Finally, we have developed lung targeted nanomedicine methods to combine NCD1 with remdesivir for improving treatment efficacy and expanding its use for prevention. Based on data at hand, it is hypothesized that NCDs by themselves or in combination with remdesivir will provide an excellent PV/T against COVID-19. To test this hypothesis, it is planned to examine in both prophylactic and therapeutic settings: the antiviral effectiveness of NCDs in vitro lung epithelial cell cultures (aim #1), the effectiveness of select top two NCDs with or without remdesivir in EpiAlveolar 3D co-culture model (MatTek) of the air-blood barrier (aim #2), and efficacy of select NCD with or without remdesivir in in vivo mouse models (aim #3). The results will provide us in identifying one or two NCDs as a single agent or in combination with remdesivir as COVID-19 PV/T regimen(s), which will inhibit SARS-CoV-2 infection. The results of these studies will uniquely contribute to the repertoire of COVID-19 prophylactics and therapeutics and allow us to move towards regulatory approval and future clinical trials. The team is uniquely poised to conduct these studies and has appropriate expertise. The successful completion of the proposed research is expected to lead to obtaining regulatory approval for a clinical trial.", "keywords": [ "2019-nCoV", "3-Dimensional", "ACE2", "Address", "Adult Respiratory Distress Syndrome", "Affect", "Antiviral Agents", "Biological", "Biological Assay", "Blood-Air Barrier", "COVID-19", "COVID-19 pandemic", "COVID-19 patient", "COVID-19 treatment", "Cell Culture Techniques", "Cell model", "Cells", "Cessation of life", "Chemicals", "Chitosan", "Clinical Trials", "Coculture Techniques", "Combined Modality Therapy", "Country", "Coxsackie Viruses", "Data", "Diagnosis", "Disease", "Docking", "Effectiveness", "Endothelial Cells", "Enzyme-Linked Immunosorbent Assay", "Epithelial Cells", "Evolution", "FDA approved", "Family", "Fibroblasts", "Friends", "Future", "HIV", "Hand", "Human", "In Vitro", "Individual", "Infection", "Infection Control", "Influenza", "Lead", "Lung", "Measures", "Methods", "Modeling", "Molecular", "Oxygen", "Oxygen Therapy Care", "Patients", "Pharmaceutical Preparations", "Prevention", "Preventive vaccine", "Prophylactic treatment", "RNA Viruses", "Regimen", "Research", "Respiratory syncytial virus", "SARS coronavirus", "SARS-CoV-2 infection", "SARS-CoV-2 inhibitor", "SARS-CoV-2 spike protein", "Testing", "Therapeutic", "Toxic effect", "Treatment Efficacy", "Vaccines", "Viral", "Viral Load result", "Viral Physiology", "Virus", "Virus Diseases", "Work", "alveolar epithelium", "base", "crosslink", "dietary supplements", "efficacy evaluation", "efficacy testing", "immunocytochemistry", "improved", "in vivo", "innovation", "mouse model", "nanomedicine", "nanoscale", "novel coronavirus", "novel virus", "overexpression", "pandemic disease", "particle", "prophylactic", "remdesivir", "response", "tripolyphosphate" ], "approved": true } }, { "type": "Grant", "id": "14594", "attributes": { "award_id": "1I21HX003799-01A1", "title": "Systems Analysis of Healthcare-Associated Infection Prevention during the COVID-19 Pandemic", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2024-05-01", "end_date": "2025-10-31", "award_amount": null, "principal_investigator": { "id": 31260, "first_name": "Julie A", "last_name": "Keating", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2247, "ror": "", "name": "WM S. MIDDLETON MEMORIAL VETERANS HOSP", "address": "", "city": "", "state": "WI", "zip": "", "country": "United States", "approved": true }, "abstract": "Background: Effective healthcare-associated infection (HAI) prevention requires multiple complex interventions (e.g., hand hygiene, environmental cleaning, personal protective equipment use, and evidence-based patient procedure protocols such as central line maintenance). The COVID-19 pandemic’s effects on healthcare (e.g., staffing shortages, supply chain disruptions, modified protocols to reduce exposure) also impacted HAI prevention. Retrospective analyses have found differential impacts on HAI rates during the pandemic, with some HAIs increasing and others decreasing. However, there has not yet been an assessment of how the COVID-19 pandemic specifically impacted guideline-concordant HAI prevention practices. Significance: This pilot project directly addresses HSR&D’s research priority to enhance the Quality and Safety of Health Care by gathering critical information regarding the implementation of HAI prevention practices during the COVID-19 pandemic. Information gathered here will inform the effective implementation of HAI prevention activities, including resuming guideline-concordant HAI prevention practices, to reduce HAIs across VA and increase the quality and safety of the healthcare received by Veterans. Innovation and Impact: We will conduct a work systems analysis using the Systems Engineering Initiative for Patient Safety (SEIPS) framework, which allows for the assessment of barriers and facilitators within and between each individual work system element (people, tools and technology, task, organization, and environment). This granular analysis allows for identifying and addressing specific barriers to implementation, which can be difficult to identify in complex work systems like those in HAI prevention. By addressing these barriers, we can develop implementation strategies to support the resuming of guideline-concordant HAI prevention practices in work systems that were or are continuing to be affected by COVID-19-related impacts. Specific Aims: In this pilot project, we aim to: 1. Conduct a work systems analysis of HAI prevention during the COVID-19 pandemic among acute inpatient care facilities in VISN12 to identify specific impacts of the pandemic on HAI prevention and HCW-reported needs for improved HAI prevention during the pandemic. 2. Identify barriers and facilitators to resuming IPC best practices in the COVID endemic era. Methodology: We will conduct semi-structured interviews with 1) 1-2 HAI prevention stakeholders and 2) up to 5 frontline nursing personnel at each of the 8 VA medical centers in VISN12. We will use interview guides structured around the CDC’s multidrug-resistant organism prevention strategies and the SEIPS framework to probe pandemic-related changes to HAI prevention practices as well as reasons behind these changes and barriers to resuming practices. We will use a rapid qualitative inquiry approach to analyze interview data, ultimately producing 1) a specific list of HAI prevention practices that were substantially modified during the COVID-19 pandemic and require additional implementation support to resuming practices; 2) work system element barriers and facilitators to conducting these practices during the pandemic; and 3) a logic model guiding the development of a larger research project on priority HAI prevention practices. Next Steps/Implementation: This pilot project will identify specific HAI prevention practices requiring additional implementation support, leading directly to a larger research project to gather VA-wide data on the implementation of these practices. We will also then develop and test implementation strategies to maximize effectiveness of the practice in reducing HAIs while minimizing burden on healthcare workers. This work will thus improve VA’s ability to respond to major disruptions to resources and processes (as COVID-19 was) while maintaining the safety and quality of care for Veterans.", "keywords": [ "Acute", "Address", "Area", "Bathing", "COVID-19", "COVID-19 impact", "COVID-19 pandemic", "COVID-19 pandemic effects", "Catalogs", "Clostridium difficile", "Complex", "Data", "Development", "Devices", "Disease Outbreaks", "Effectiveness", "Elements", "Engineering", "Environment", "Equipment", "Event", "Future", "Goals", "Guidelines", "Hand", "Health Personnel", "Health Priorities", "Health care facility", "Healthcare", "Healthcare Systems", "Hospitals", "Hygiene", "Individual", "Infection", "Infection Control", "Infection prevention", "Inpatients", "Interruption", "Intervention", "Interview", "Logic", "Maintenance", "Measures", "Medical center", "Mental Health", "Methodology", "Modeling", "Nursing Staff", "Oral", "Outcome", "Patient Care", "Patients", "Patterns of Care", "Persons", "Phase", "Pilot Projects", "Prevention strategy", "Procedures", "Process", "Protocols documentation", "Provider", "Quality of Care", "Reporting", "Research Priority", "Research Project Grants", "Resource-limited setting", "Resources", "Risk Reduction", "Route", "Safety", "Sepsis", "Shock", "Structure", "System", "Systems Analysis", "Technology", "Testing", "Training", "United States Department of Veterans Affairs", "Ventilator", "Veterans", "Work", "acute care", "burnout", "evidence base", "healthcare-associated infections", "implementation barriers", "implementation evaluation", "implementation strategy", "implementation study", "improved", "infection rate", "information gathering", "innovation", "inpatient service", "multi-drug resistant pathogen", "pandemic disease", "pandemic impact", "pathogen", "patient safety", "personal protective equipment", "pre-pandemic", "prevent", "prevention practice", "response", "supply chain", "tool", "transmission process", "trend" ], "approved": true } }, { "type": "Grant", "id": "11529", "attributes": { "award_id": "5I01RX003622-02", "title": "Exercise-based Program for Rehabilitation of Veterans with Severe Mental Illness", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-06-01", "end_date": "2026-05-31", "award_amount": null, "principal_investigator": { "id": 23883, "first_name": "GRETCHEN L", "last_name": "HAAS", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1477, "ror": "https://ror.org/05eq41471", "name": "Veterans Health Administration", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 23884, "first_name": "Vishwajit Laxmikant", "last_name": "Nimgaonkar", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1477, "ror": "https://ror.org/05eq41471", "name": "Veterans Health Administration", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "This is a Hybrid 1, effectiveness-implementation study of yoga-based exercise (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI), defined here as schizophrenia (SZ), schizoaffective disorder (SZA) and bipolar I disorder (BP1). SMIs are common, severe and devastating conditions that cause enormous disability world-wide. Many features of SMI can be treated effectively, yet the long-term outcome has not improved much over the past century. The lack of improvement may be due to ineffective treatment of functional deficits in SMI patients, particularly in terms of community functioning, defined here as social, leisure, employment, and life skills functioning in the community. Complementary and Integrative Medicine (CIM) therapies that improve community functions are thus of great interest for treating Veterans with SMI and thereby target an area of high priority for the VA. Prior studies have shown short-term benefits of YE for improving cognitive deficits and community functions among persons with SMI. While the published studies are encouraging, the longer-term benefits of YE are untested, particularly for community functioning. The profile of Veterans with SMI who will accept and adopt YE is also unknown. We have conducted pilot studies and a randomized controlled trial (RCT) for individuals with SMI in India using short-term, simplified YE combined with medications. Recently, we also concluded RELIEVE, a RCT of adjunctive YE for Veterans with post-traumatic stress disorder (PTSD) in the USA (VA RR&D Merit award, PI: L Davis, PsyD). We found encouraging improvements from all our studies, but our Indian and US YE protocols are impractical for Veterans with SMI. For example, some postures may be difficult for older Veterans with amotivation and/or physical disabilities. Therefore, in Aim 1, we will design and evaluate adaptations of the Indian and US YE protocols in a non-religious context (mindfulness, stretching, toning and breathing exercises). We will consult our Indian and US colleagues, our Veterans with SMI and their VA therapists to adapt the protocol for our SMI population. We will also adapt our control condition, the Wellness Lifestyle Program (WLP), from our recently completed RELIEVE study. In Aim 2, we will conduct a 2-armed RCT in which consenting Veterans with SMI will be randomly assigned to one of 2 arms: YE and treatment as usual (TAU, any prescribed treatment) or WLP+ TAU. Unlike prior short-term YE RCTs, the two arms will continue 12 months, including an initial 12-week training period consisting of two supervised sessions per week, followed by a 12-week training period consisting of one supervised session per week, and monthly refresher training sessions offered for the remaining 6 months. We will conform to all COVID-19 related requirements for YE and WLP. Our Hybrid 1 trial will compare the efficacy of YE versus WLP. Primary outcomes are self-report and performance-based measures of community functioning; secondary outcomes are cognition and physical fitness measures. Our goals in Aim 3 are to understand demographic/clinical features of Veterans with SMI who are more likely to accept and adopt YE to enable long-term rehabilitation, by analysis of the RCT data (Aim 3A). We will also conduct qualitative interviews with Veterans who have SMI and participated in the YE intervention arm, referring clinicians, and the Yoga instructor to identify barriers and facilitators for implementation (Aim 3B). The project thus aims to advance our long-term goals for improving the quality of life for Veterans with SMI and to provide evidence to guide home- based and over the longer term, community-based YE practice, consistent with the Mission Act and the VA Strategic Plan. Our experience in conducting a variety of SMI research for over 25 years offers strong support for successful completion of the proposal.", "keywords": [ "Adopted", "Adoption", "Affect", "Area", "Award", "Bipolar I", "Breathing Exercises", "COVID-19", "Characteristics", "Clinic", "Clinical", "Cognition", "Cognitive deficits", "Communities", "Community Integration", "Complementary Medicine", "Consent", "Consolidated Framework for Implementation Research", "Consult", "Data", "Disease", "Elements", "Employment", "Ensure", "Exercise", "Family", "Frequencies", "Goals", "Health", "Health Personnel", "Healthcare", "Home", "Hybrids", "Impaired cognition", "Impairment", "India", "Individual", "Integrative Medicine", "Intervention", "Interview", "Leisures", "Life", "Life Style", "Measures", "Mental Health", "Mission", "Muscle Contraction", "Outcome", "Participant", "Patient Self-Report", "Patients", "Pattern", "Persons", "Pharmaceutical Preparations", "Physical Fitness", "Pilot Projects", "Population", "Post-Traumatic Stress Disorders", "Posture", "Prevalence", "Protocols documentation", "Publishing", "Quality of life", "Randomized", "Randomized Controlled Trials", "Recording of previous events", "Refractory", "Regulation", "Rehabilitation therapy", "Relaxation", "Research", "Research Design", "Role", "Rural Community", "Safety", "Schedule", "Schizoaffective Disorders", "Schizophrenia", "Services", "Social Functioning", "Socialization", "Strategic Planning", "Stretching", "Substance Use Disorder", "Suicide prevention", "Symptoms", "Techniques", "Testing", "Time", "Training", "Veterans", "Yoga", "alcohol use disorder", "arm", "cognitive benefits", "comorbidity", "comparative efficacy", "cost", "design", "disability", "effectiveness/implementation study", "efficacy study", "exercise intervention", "exercise program", "exercise training", "experience", "future implementation", "implementation efforts", "implementation facilitators", "improved", "ineffective therapies", "instructor", "interest", "long-term rehabilitation", "mindfulness", "performance based measurement", "physically handicapped", "primary outcome", "programs", "secondary outcome", "severe mental illness", "skills", "social", "study characteristics", "tool", "treatment arm", "treatment as usual", "uptake", "virtual", "whole health" ], "approved": true } }, { "type": "Grant", "id": "6917", "attributes": { "award_id": "1I21RX003738-01A1", "title": "A Novel Cognitive Remediation Intervention Targeting Poor Decision-Making and Depression in Veterans at High Risk for Suicide: A Safe,Telehealth Approach During the COVID-19 Pandemic", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-01-01", "end_date": "2023-12-31", "award_amount": null, "principal_investigator": { "id": 22755, "first_name": "ERIN A.", "last_name": "HAZLETT", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1533, "ror": "", "name": "JAMES J PETERS VA MEDICAL CENTER", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1533, "ror": "", "name": "JAMES J PETERS VA MEDICAL CENTER", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Despite large-scale, nationwide efforts to better address suicidal behavior (defined as thoughts and behavior) in high-risk Veterans with major depressive disorder (MDD), the development of interventions that target some of the key risk factors associated with suicide in Veterans with MDD remains limited. That is, while much intervention research continues to investigate treatments like cognitive behavioral therapy (CBT) that target behavioral patterns, emotion processing problems, and cognitive styles associated with suicide risk in MDD, deficits in the neurocognitive substrates that underlie these CBT targets remain under-addressed. Cognitive remediation (CR) and rehabilitation have long been a primary treatment for patients with other psychiatric illnesses, like schizophrenia, for improving cognitive functioning and facilitating transfer of cognitive skills to every-day functioning. However, scant work has examined CR that addresses the neurocognitive deficits underlying suicidal behavior in individuals with MDD. Empirical work has identified key executive functioning (EF) deficits that may be specific to MDD patients with suicidal behavior, and meta-analytic work indicates that CR has moderate effect sizes on cognitive functioning, depression, and daily functioning in MDD. Thus, the field is in dire need of work that examines CR as a recovery-oriented treatment approach for MDD patients at risk for suicide. The proposed study aims to collect pilot data to test the feasibility and acceptability of adjunctive neuroplasticity-based CR on key treatment targets delivered via telehealth during this time of COVID-19 in a sample of 36 Veterans with MDD and a history of suicide attempt(s). Specifically, it will test the effects of an adjunctive evidence-based cognitive remediation (CR) therapy (adjunctive to treatment as usual) augmented with manualized “Bridging” sessions on transfer and practice of cognitive control and decision-making/problem- solving strategies for real-world situations and problems, including those that trigger suicidal thoughts. We propose to administer the Neuropsychological Educational Approach to Cognitive Remediation (NEAR, termed CR plus “Bridging” session, CR+Bridging) to a total of 36 Veterans with MDD and a history of suicide attempt(s). The intervention will be delivered in 20 90-minute sessions (2x/week for 10 weeks). Pre-treatment assessments of neurocognitive, clinical, social, and real-world functioning will be conducted, including measures that examine the impact of COVID-19 and its accompanying “social-distancing” restrictions. Post- treatment assessments of the same targets will be conducted to determine clinical response to and feasibility of this therapeutic intervention immediately following conclusion of the intervention (Week 10) and at a follow- up assessment (Week 20). This application is novel in that it constitutes the first implementation of this intervention in Veterans with MDD and suicidal behavior. Consistent with RR&D’s SPiRE mechanism, this study is high risk, but it has high potential impact and promise to help improve quality of life for Veterans at high risk for suicide.", "keywords": [ "Address", "Aftercare", "Behavior", "Behavioral", "COVID-19", "COVID-19 pandemic", "Client satisfaction", "Clinical", "Cognitive", "Cognitive Therapy", "Cognitive remediation", "Data", "Decision Making", "Elderly", "Emotions", "Evaluation", "Executive Dysfunction", "Feeling suicidal", "Gambling", "Goals", "Impairment", "Individual", "Intervention", "Intervention Studies", "Iowa", "Language", "Major Depressive Disorder", "Measures", "Mental Depression", "Mental disorders", "Names", "Neurocognitive", "Neurocognitive Deficit", "Neuronal Plasticity", "Neuropsychology", "Participant", "Patients", "Pattern", "Performance", "Pilot Projects", "Problem Solving", "Public Health", "Quality of life", "Questionnaires", "Recording of previous events", "Recovery", "Rehabilitation therapy", "Reporting", "Risk Factors", "Sampling", "Schizophrenia", "Semantics", "Services", "Severities", "Social Adjustment", "Social Distance", "Suicide", "Suicide attempt", "Testing", "Therapeutic Intervention", "Thinking", "Time", "Veterans", "Work", "acceptability and feasibility", "base", "cognitive control", "cognitive function", "cognitive rehabilitation", "cognitive skill", "cognitive testing", "daily functioning", "depressive symptoms", "evidence base", "executive function", "feasibility testing", "follow up assessment", "follow-up", "high risk", "implementation intervention", "improved", "innovation", "military veteran", "novel", "recruit", "response", "skills", "social", "stressor", "suicidal behavior", "suicidal risk", "symptomatology", "targeted treatment", "telehealth", "therapy development", "tool", "treatment as usual", "virtual" ], "approved": true } }, { "type": "Grant", "id": "14853", "attributes": { "award_id": "1I01CX002739-01", "title": "Characteristics and Determinants of Post-COVID Neurocognitive Dysfunction", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2024-07-01", "end_date": "2028-06-30", "award_amount": null, "principal_investigator": { "id": 31536, "first_name": "Roger", "last_name": "Bedimo", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 31537, "first_name": "Amy Yomiko", "last_name": "Vittor", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2503, "ror": "https://ror.org/01nzxq896", "name": "VA North Texas Health Care System", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "Neurologic symptoms are among the most common post-acute sequelae of COVID-19 (PASC). Recent studies show that there is a very high rate of neurocognitive changes among Veterans surviving acute COVID- 19 infection. The long-term neurocognitive changes of this infection could be even worse and remains incompletely characterized. Moreover, neurological sequelae have been considered the most disabling of the long-term complications. Possible mechanisms of neuronal damage from SARS CoV-2 infection include direct viral CNS invasion through the cribriform plate or hematogenous route, or retrograde neuronal dissemination, or indirect injury mediated by systemic inflammation, and secondary degenerative mechanisms. Whether neurocognitive changes can be predicted by biomarkers – or imaging evidence of – inflammation, neuronal damage or disruption of blood brain barrier has never been evaluated in a well-characterized cohort. Furthermore, no treatment strategies exist at present, but preliminary data suggests that antivirals may prevent the occurrence of cognitive impairment in PASC. VHA has established a nationwide COVID-19 cohort early in the pandemic. This objective of this cohort – called Epidemiology, Immunology and Clinical Characteristics of COVID-19 (EPIC3) – is to characterize the natural history, clinical outcomes, and the development of immunity while also gathering biospecimens for future study as questions emerge about this new pathogen. We will leverage the data and samples from this study to compare participants who received antivirals during their acute COVID-19 illness with those who did not, by 1) conducting longitudinal cognitive assessments of participants of EPIC3 and characterize trajectories of cognitive changes, using a novel tablet-based tool; 2) carrying out detailed longitudinal analyses of biomarkers of neuronal damage, neurodegeneration and blood-brain barrier disruption or participants with and without COVID-19, and 3) performing advanced structural and functional imaging of a subset of these participants. We will then correlate biomarkers and imaging findings to the presence, degree and trajectories of neurocognitive changes in COVID-19 patients who did and did not receive antivirals. We have assembled a multidisciplinary team with expertise critical to answering the challenging questions posed by neurocognitive changes of PASC. Expected findings of our study will have immediate clinical impact: 1) they will establish whether PASC is an additional goal for antiviral therapy, 2) they will establish a benchmark for standardized, validated assessment of possible neurocognitive changes in patients with COVID-19; this will provide a basis for future interventions and management guidelines; 2) determine whether these cognitive changes could be predicted or monitored using well validated biomarkers of neuronal damage and/or blood-brain barrier disruption; 3) determine whether structural and function brain imaging could assist in further studies of mechanisms of neuronal damage and/or neurocognitive dysfunction from COVID-19 infection. Here we propose addressing current gaps in our understanding of cognitive function in PASC by following the trajectories of cognitive function over three years using validated, tablet-based neuropsychological tests, analyzing the relationship between co-morbidities prevalent amongst veterans such as PTSD and depressive disorders and cognitive impairment following COVID-19. This study will link key neurological and immunological markers, clinical outcomes, and imaging of cerebral blood flow and demyelination, thereby contributing a cohesive understanding of the mechanisms of neurological injury.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "10779", "attributes": { "award_id": "1I21RX004376-01", "title": "Impact of Veteran Voices & Visions Peer Support Groups on Social Integration for Veterans with SMI/Psychosis", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-12-01", "end_date": "2024-11-30", "award_amount": null, "principal_investigator": { "id": 26853, "first_name": "Ippolytos Andreas", "last_name": "Kalofonos", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1708, "ror": "https://ror.org/05xcarb80", "name": "VA Greater Los Angeles Healthcare System", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Veterans with Serious Mental Illness (SMI) struggle with social integration - participation in work, housing, and citizenship - due to symptoms, stigma, and psychosocial functioning deficits. This has a tremendous impact on mortality, comparable to that of smoking and greater than obesity and alcohol abuse. Despite considerable VA efforts to provide mental health care to Veterans with SMI, programs that promote social integration are lacking. Veterans with SMI are at especially high risk for poor social integration and suicidal ideation during the COVID-19 pandemic. There is an urgency to advance treatments targeting Veterans' social integration. This project addresses this need with a group-based, peer specialist (PS) co-facilitated psychosocial intervention for Veterans with SMI, called “Veteran Voices and Visions” (VVV). VVV targets Veterans with SMI who experience psychosis, a group particularly in need of support with social integration. Virtual VVV groups are co-led by VA mental health clinicians (MHCs) and PSs via online video conference. VVV is an adaptation of a community-based support group model called the Hearing Voices (HV) approach that was developed over 30 years ago in the Netherlands. It has since spread to over twenty-five countries, representing hundreds of support groups worldwide. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of SMI: hallucinations, delusions, and social isolation. Despite its global scope, this approach has neither been formally adapted nor rigorously studied in public health systems, including the VA. This intervention has the potential to create and foster a supportive community that improves the social integration of participants by reducing their distress and self-stigma, and increasing self-efficacy. These three process outcomes are strongly associated with social integration. This proposal is directly aligned with VA priorities to advance the breadth of existing psychosocial interventions for Veterans with SMI, improve access via telehealth services, and support Veterans' independence, wellbeing, empowerment, and whole health. The goal of this proposal is (1) to develop a manual, training guidelines, and a fidelity scale for VVV, (2) to assess the feasibility and acceptability of VVV, and (3) collect pilot outcome data. The manual, training guidelines, and fidelity scale will be developed by the research team in collaboration with 4 advisory panels: Veterans with SMI, MHCs, PSs, and non-VA experts in HV. Then, 5 MHCs and 5 PSs will be trained to use the new VVV manual, and each MHC-PS pair will conduct a group with the new protocol. Thirty Veterans will be recruited to participate in these 5 groups and assessments will be conducted at baseline, midpoint, and post- intervention. Baseline assessments include measurement of psychiatric symptoms, level of distress from psychosis, internalized self-stigma, self-efficacy, sense of belonging, recovery, and social integration. Follow- up assessments conducted at 10 and at 20 weeks will include these same measurements as baseline, as well as a survey and qualitative interview on intervention acceptability. Feasibility data on numbers approached, enrolled, and retained, and treatment fidelity will be collected. Fidelity will be assessed in two ways: (1) facilitators will complete self-administered reflection worksheets after each session and (2) research team members will rate 5 randomly selected audio-recorded sessions from each group for formal fidelity ratings. The goal of the within-subjects trial evaluating feasibility and acceptability of the manualized VVV protocol for improving self-efficacy, self-stigma and social functioning in Veterans with psychosis. To that end, the study will be run using the full collection of measures that would be included in a subsequent RCT. However, since the study is designed to assess whether the proposed intervention can be successfully implemented in the target population and to evaluate the properties of a candidate set of outcome measures, rather than demonstrate efficacy, most of the analyses will be descriptive. This will lay the groundwork for a future Merit that will support a controlled efficacy study.", "keywords": [ "Address", "Alcohol abuse", "Belief", "COVID-19 pandemic", "Caring", "Collaborations", "Collection", "Communities", "Country", "Curiosities", "Data", "Delusions", "Development", "Distress", "Education", "Employment", "Enrollment", "Feeling suicidal", "Fostering", "Frequencies", "Friendships", "Future", "Geography", "Goals", "Grant", "Guidelines", "Hallucinations", "Health", "Health system", "Hearing", "Housing", "Improve Access", "Intervention", "Interview", "Life", "Link", "Loneliness", "Manuals", "Marriage", "Measurement", "Measures", "Mental Health", "Mental Health Services", "Meta-Analysis", "Modeling", "Netherlands", "Obesity", "Occupations", "Outcome", "Outcome Measure", "Participant", "Personal Satisfaction", "Phase", "Population", "Process", "Property", "Protocols documentation", "Psychoses", "Psychotic Disorders", "Public Health", "Quality of life", "Recovery", "Research", "Running", "Safety", "Self Administration", "Self Efficacy", "Services", "Smoking", "Social Functioning", "Social isolation", "Specialist", "Standardization", "Support Groups", "Surveys", "Symptoms", "Target Populations", "Training", "Training Programs", "Transportation", "Trust", "Veterans", "Videoconferencing", "Vision", "Voice", "Vulnerable Populations", "Work", "acceptability and feasibility", "adverse outcome", "base", "cohesion", "design", "efficacy study", "empowerment", "experience", "follow up assessment", "health related quality of life", "high risk", "improved", "innovation", "insight", "internalized stigma", "member", "mortality", "peer", "peer support", "pilot trial", "post intervention", "programs", "psychiatric symptom", "psychosocial", "psychotic symptoms", "recruit", "remediation", "service engagement", "severe mental illness", "social integration", "social movement", "social stigma", "suicidal risk", "telehealth", "virtual", "virtual platform" ], "approved": true } }, { "type": "Grant", "id": "8217", "attributes": { "award_id": "1IK6BX005692-01", "title": "BLRD Research Career Scientist Award Application", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2021-04-01", "end_date": "2026-03-31", "award_amount": null, "principal_investigator": { "id": 24051, "first_name": "Robert", "last_name": "Raffai", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1522, "ror": "", "name": "VETERANS AFFAIRS MED CTR SAN FRANCISCO", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1522, "ror": "", "name": "VETERANS AFFAIRS MED CTR SAN FRANCISCO", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "The overall goal of this Research Career Scientist award is to foster the nominee’s ongoing research program that is focused on the study of extracellular vesicles (EVs) and their extracellular RNA (exRNA) cargo as biomarkers and effectors of human health and disease including among Veterans. Through participation in a national NIH-funded consortium research program, the nominee is working to develop novel methods to study EVs and other carriers of exRNA for biomarker development projects. The nominee also recently reported the first evidence of intercellular signaling between macrophage EVs and hematopoietic progenitor cells to control the process of systemic and vascular inflammation and atherosclerosis cardiovascular disease. Ongoing funding from a VA Merit grant is supporting the nominee’s goal of exploring the role of circulating EVs isolated from Veterans treated for advanced vascular disease as biomarkers and contributors to disease progression including via microRNA cargo. Experiments in the lab will also test if EVs produced from anti- inflammatory macrophages can serve to control inflammation and atherosclerosis in diabetic rodent models. Furthermore, funding from a VA Invention-based Supplement Award will support pre-clinical studies testing such anti-inflammatory EVs as therapeutics to control cardiac inflammation and heart failure in a rodent model system developed and patented for the VA by the nominee. Findings from these studies could provide much needed new therapeutics in the form of EV-biologics to treat inflammatory diseases including in the cardiovascular system that is a major healthcare need among the Veteran patient population. The nominee’s internationally recognized program on EV biology has led to new collaborative research projects with VA clinician investigators at the local and offsite stations. This includes a collaborative project to test EVs produced by cultured stem cells as therapeutic mediators of skeletal muscle regeneration. Such studies have been proposed in a VA Merit grant proposal with the nominee serving as co-Investigator, which is being revised for a resubmission. The nominee is also engaged in collaborative studies with VA clinician investigators to develop biomarkers of adverse outcomes of surgical procedures used to treat advanced vascular disease among Veterans. Finally, projects proposed by the nominee through grants pending at the Department of VA and the NIH make use of EV technology and expertise developed by the nominee to address the COVID19 disease crisis. This includes by making use of new methods of EV detection in biofluids to develop biomarkers for clinical outcomes of COVID19 disease. It also includes developing new forms of engineered EVs designed to serve in improving host immune response against SARS-CoV-2 viral infection as well as to control lung inflammation. Together, the award will serve to sustain the nominee’s momentum to developing a first-in-class research program centered on the study of EVs as biomarkers and biologics to control tissue inflammation and remodeling including in the cardiovascular system. It will also allow to expand the nominees network of collaborators with clinician and basic scientists within the VA intramural research program, as well as at local, national and international sites to widely disseminate and implement expertise in the study of EVs as biologics to improve the diagnosis and treatment of diseases in priority areas to the VA. 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