Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1392&sort=program_officials
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=program_officials", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1424&sort=program_officials", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1393&sort=program_officials", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1391&sort=program_officials" }, "data": [ { "type": "Grant", "id": "15226", "attributes": { "award_id": "1U01AI184132-01", "title": "Clinical and mechanistic studies defining optimal preparative approaches to infants with IL2RG/JAK3/RAG1/RAG2 SCID: a randomized trial of busulfan dosage", "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": 31806, "first_name": "Margaret A.", "last_name": "Morris Fears", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-13", "end_date": "2029-05-31", "award_amount": 1072951, "principal_investigator": { "id": 31807, "first_name": "JEFFERY J", "last_name": "AULETTA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 31808, "first_name": "Michael A", "last_name": "Pulsipher", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2522, "ror": "https://ror.org/016cke005", "name": "National Marrow Donor Program", "address": "", "city": "", "state": "MN", "zip": "", "country": "United States", "approved": true }, "abstract": "Severe combined immunodeficiency (SCID) is a group of genetic disorders that abrogate T cell development and function. Allogeneic hematopoietic cell transplantation (HCT) is the standard treatment for the disease and can be performed successfully in SCID patients without the high dose pre-HCT busulfan conditioning due to the unique capacity for progenitors to engraft in the empty thymus and reconstitute T cell development. Without conditioning, lineages other than T cells remain of host origin. The CSIDE protocol was funded with an earlier grant to test the efficacy and safety of a regimen of low dose, individualized targeted busulfan compared to moderate dose in SCID patients at risk of poor humoral outcome undergoing non-matched sibling donor HCT. We hypothesize that patients randomized to receive low dose busulfan will achieve similar outcomes compared to those receiving moderate dose (myeloablative) busulfan, achieving both T and B cell immune reconstitution. Due to COVID and competition with gene therapy, accrual slowed, but with 50 centers open and a redesigned approach, additional enrollment facilitated by this grant will ensure that the trial reaches meaningful conclusions. In Aim 1, patients have been randomized to cumulative area-under-the-curve (cAUC) exposure of busulfan of 30 mg*h/L versus 60 mg*h/L. IL2RG/JAK3 patients also receive rATG, while RAG1/2 patients receive rATG, fludarabine, and thiotepa. Stem cell sources include unrelated and haploidentical related donor products that have been TCRαβ+/CD19+ depleted with no post-HCT GVHD prophylaxis. The safety profile of the trial has been excellent to date. The original primary endpoint was protective antibody response to tetanus by 2 years post-HCT. Because of enrollment challenges, we redesigned the primary endpoint into an ordinal ranked win comparison, which allows higher power even if we cannot fully enroll. The primary outcome will center around the IL2RG/JAK3 cohort, which should achieve full accrual, randomizing 32 patients. The RAG1/2 cohort will close once the IL2RG/JAK3 cohort closes, likely accruing up 18-20 patients which we will analyze descriptively. In Aim 2, We hypothesize that donor HSC engraftment measured by the surrogate of myeloid donor chimerism will be associated with superior quality of T cell reconstitution and improved adaptive immune responses to vaccination. We hypothesize that T cell exhaustion and poor T cell receptor (TRB) diversity seen in patients undergoing HCT in the absence of conditioning will be diminished or absent in CSIDE participants due to improvements in thymic output associated with engraftment of donor-derived HSC. We hypothesize that IL2RG/JAK3 patients receiving moderate dose busulfan and/or with high level donor chimerism will exhibit multiple in vitro biomarkers of IL-21 response, as this cytokine signals via IL2RG/JAK3. We hypothesize that vaccine response will correlate with normalization of IGH CDR3 diversity in RAG1/2 patients with mixed chimerism due to strong selective advantage for antigen-specific B cells. We hypothesize that T cell tolerance will occur by different mechanisms (central deletion versus peripheral regulation) according to donor type. Finally, we hypothesize that analysis of pK samples for elements of our preparative approaches (rATG, thiotepa, and fludarabine) will allow targeted treatment of infants undergoing HCT for SCID or other disorders moving forward.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15228", "attributes": { "award_id": "1R21HD112011-01A1", "title": "Novel Designed Multi-Ligands as Tocolytics for Dysregulated Myometrial Pathways in the Treatment of Preterm Labor", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 31810, "first_name": "KATIE MARIE", "last_name": "Vance", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-08", "end_date": "2026-07-31", "award_amount": 219592, "principal_investigator": { "id": 31811, "first_name": "Scott Danielson", "last_name": "Barnett", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 953, "ror": "https://ror.org/01keh0577", "name": "University of Nevada Reno", "address": "", "city": "", "state": "NV", "zip": "", "country": "United States", "approved": true }, "abstract": "Preterm birth is a major medical problem resulting in disability and death for very preterm infants. Therapeutic approaches to manage preterm labor are off-label and ineffective. No tocolytic therapy in use today is satisfactory beyond 48 hours, and none is FDA approved. Preterm labor more often impacts African American women than their Caucasian counterparts and is exacerbated by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which leads to preterm birth in COVID- 19 affected pregnancies. Our central hypotheses are that designed multi-ligand (DML) drugs to be generated in this research that target dysregulated pathways in preterm myometrium will provide a therapeutic benefit in cases of preterm labor while decreasing fetal exposure to the compounds, and that co-administration of the DML’s ‘constituent single entities’ will exhibit synergistic tocolysis. In addition to providing a potential synergistic benefit, we expect that our DMLs will be poorly transported across the placenta due to favorable pharmacokinetic properties of the DMLs, and thus will protect the fetus from exposure. Decreased placental transfer will improve dose-ranging for clinical benefit to prevent preterm labor. This research will justify novel DMLs as potential new tocolytics to prevent preterm birth. This proposal will generate novel DMLs using advanced Medicinal Chemistry techniques and will make extensive use of ex vivo and in vivo experimentation using both human and mouse tissue. The long term goal of this project is to generate first-in-class tocolytics that will delay or halt early labor and prevent preterm birth.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15233", "attributes": { "award_id": "1R21AI181677-01", "title": "Synergizing neutralization and non-neutralization antibody targets at the HIV/SIV viral spike apex", "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": 31817, "first_name": "Nancy R.", "last_name": "Miller", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-09", "end_date": "2026-06-30", "award_amount": 228825, "principal_investigator": { "id": 21421, "first_name": "TIMOTHY J", "last_name": "CARDOZO", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 832, "ror": "", "name": "NEW YORK UNIVERSITY SCHOOL OF MEDICINE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 832, "ror": "", "name": "NEW YORK UNIVERSITY SCHOOL OF MEDICINE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "An HIV vaccine remains a critical and as yet unrealized asset in the 40-year fight against the HIV/AIDS pandemic. New insights towards achieving vaccine protection from HIV acquisition may be gained by a comparative case study of COVID-19 vaccines, which achieved nearly 100% efficacy against a similarly enveloped, RNA virus with a similarly architected, trimeric, Class I fusion viral spike mechanism. Neutralization B-cell epitopes exposed at the apex of the SARS-CoV-2 trimeric viral spike correlated clearly and strongly with protection from viral acquisition, both in humans in the real world/circulating virus setting and in non-human primate (NHP) preclinical models. We hypothesized that vaccine immunogens could be improved by focusing antibody responses to two equivalent B-cell epitopes at the HIV/SIV viral spike apex, one an epitope targeted by neutralizing antibodies (V2b) and one a purely non-neutralization epitope (V2c). In preliminary results, we showed that removal of the viral spike apical V1 loop segment (DV1-Env) masking the V2c epitope enhanced protection against viral challenge in both a highly stringent SIV and matched SHIV challenge model, achieving >90% vaccine efficacy. In further preliminary results, we designed an immunogen displaying only this V2c epitope in isolation and proved that it was highly immunogenic as an isolated epitope and indeed elicited purely non-neutralizing antibodies in vivo. The study revealed that V2c contributed to, but was not sufficient on its own, for protection. In this exploratory study, we pursue the new hypothesis that the combination of the two HIV, viral-spike apical, B-cell epitopes in a single vaccine can reconstitute an increased level of protection as observed with COVID-19 vaccines, by synergizing V2c with the V2b neutralization epitope. We will 1) design and validate a V2b-focused immunogen, and 2) test the precise combination of neutralizing, vaccine-elicited anti-V2b antibodies with non-neutralizing, cytotoxic, vaccine-elicited V2c antibodies, along with coordinated cellular immune responses in vivo for their ability to delay viral acquisition as compared to the V2c epitope alone. Successful results in these two aims could justify a research project on the design and translational development of a novel, viral-spike-apex-focused, efficacious HIV vaccine.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15243", "attributes": { "award_id": "1U19AI181968-01", "title": "The UCI Vaccines for Pandemic Preparedness Center (VPPC)", "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": 31830, "first_name": "Genevieve Anne", "last_name": "Holzapfel", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-20", "end_date": "2027-07-31", "award_amount": 33116067, "principal_investigator": { "id": 31831, "first_name": "PHILIP Louis", "last_name": "FELGNER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 971, "ror": "", "name": "UNIVERSITY OF CALIFORNIA-IRVINE", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Overall: The UCI Vaccines for Pandemic Preparedness Center (VPPC) The Mission: \"To contribute to human health and well-being by developing agile, safe, effective and accessible vaccines that protect the vulnerable against future pathogens of pandemic importance and by educating the next generation of vaccine scientists that will tackle such challenges.” Joshua Lederberg envisioned the world as a battlefield between microbes and man, famously saying, “The future of humanity and microbes likely will unfold as episodes of a suspense thriller that could be titled Our Wits Versus Their Genes” (Lederberg, 2000). Although the genes of the microbial world have been evolving much longer than our wits, we have come up with efficient ways to respond to infectious diseases, but regrettably evolving microorganisms keep managing to challenge and outsmart us. The latest COVID episode in this series sensitized the world again to the importance of learning from the outbreak experience and challenges us to better prepare for the next one. The 100 Days Mission (100DM), endorsed by government and non-government organizations worldwide is a proposed response to the next “Disease X” by making safe, and effective vaccines available within 100 days of the pathogen’s identification. Achieving that goal could defuse the threat of a pathogen with pandemic potential. The International Pandemic Preparedness Secretariate (IPPS), the Coalition for Epidemic Preparedness Innovations (CEPI), the HHS Administration for Strategic Preparedness and Response (ASPR Next) and the NIH/NIAID have embraced the concept of studying prototype pathogens as a critical element of preparedness. By developing vaccines on rapid-response platforms against examples of a given viral genus or family, researchers can address scientific challenges characteristic of that family in advance, providing an important head start on developing vaccines against related threats. Universal programmable vaccine platforms that can be rapidly employed against broad virus families can be evaluated in clinical trials to provide confidence in their safety, and manufacturing, and regulatory considerations can be managed ahead of the next outbreak. The UC Irvine Vaccines for Pandemic Preparedness Center (VPPC) aims to conduct basic and translational research to develop vaccines against prototype members of the Bunyavirus, Paramyxovirus and Picornavirus families with demonstrated immunogenicity and efficacy in animal models. Two universal, programmable, rapid response vaccine platforms will be characterized and compared in this study: the i) Adjuvanted Recombinant Protein (ARP) Vaccine, and ii) mRNA/Lipid Nanoparticle (LNP) Vaccine. Such prototype vaccines will need to be tested in advance, at a minimum, for clinical safety and immunogenicity, and efficacy where possible, so that emerging viruses in the same family can be rapidly and safely deployed. Gathering such data and experience will build confidence in these rapid response platforms and inform regulators as they make decisions about the emergency authorization of vaccines against related pathogens.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15251", "attributes": { "award_id": "3OT2OD037636-01S1", "title": "AOU WI Area of Interest 1: Community, Participant and Provider Engagement, Enrollment...", "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": 31839, "first_name": "Stephanie Melania", "last_name": "Alexander-troupe", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-01", "end_date": "2025-07-31", "award_amount": 2000000, "principal_investigator": { "id": 21340, "first_name": "ELIZABETH S", "last_name": "BURNSIDE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 799, "ror": "", "name": "UNIVERSITY OF WISCONSIN-MADISON", "address": "", "city": "", "state": "WI", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 31438, "first_name": "Lisa Anne", "last_name": "CadmusBertram", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31441, "first_name": "Scott Joseph", "last_name": "Hebbring", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31442, "first_name": "Todd A", "last_name": "Mahr", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31443, "first_name": "SANJAY K", "last_name": "SHUKLA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31840, "first_name": "Zeno E", "last_name": "Franco", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2495, "ror": "", "name": "MARSHFIELD CLINIC RESEARCH FOUNDATION", "address": "", "city": "", "state": "WI", "zip": "", "country": "United States", "approved": true }, "abstract": "1. ABSTRACT The All of Us Research Program (AoURP) has experienced dramatic change over the last five years. To list just a few of the many examples: AoURP conducted multiple retention eligible campaigns (e.g., mental health campaign), began distributing genetic results to participants, initiated the first ancillary study (Nutrition for Precision Health), and made available the Research Workbench to scientists. Throughout the many changes that have occurred over the years, the most challenging was the SARS-Cov-2 pandemic which disrupted every facet of society and impacted how AoURP's partnering institutions functioned. But with change comes opportunity, and opportunity is possible for organizations that are highly adaptable and innovative. This includes the All of Us Wisconsin Consortium (AoU-WI). AoU-WI was one of the last RMCs to join the national program. As time progressed, AoUWI matured, strengthened close collaborations across WI and nation, and developed diverse strategies in engagement, enrollment, and retention. The diversity at all levels of AoU-WI is something we are most proud of and has allowed our program to flourish in the ever-changing AoURP. To maintain AoU-WI's momentum, we will leverage lessons learned from the last five years. AoU-WI will constantly reassess, modify, and diversify its strategies to ensure AoURP is available to all. Continued diversity in our program will be essential as AoURP persistently changes over the next five years. In this application, we will describe how AoU-WI will not only maintain successful activities that has allowed our program to be leaders in engagement, enrollment, and retention, but how we intend to innovate. We will conduct outreach and engagement activities to promote the enrollment of communities who are historically underrepresented in biomedical research (Aim 1). AoU-WI will also engage, enroll, and retain participants who reflect the rich diversity of the US (Aim 2). This will be done with both adults and pediatrics (Aim3) while ensuring participants have access to technology for study activities (Aim 4). Lastly, AoU-WI will engage and collaborate with health care providers serving communities that are historically underrepresented in biomedical research to facilitate enrollment and retention (Aim5). We will do this by expanding the AoU-WI consortium to include Advocate Aurora Health, the ninth largest not-for-profit integrated healthcare system in the U.S. By successfully achieving these aims, AoU-WI ensures our continuous contribution to the mission of \"accelerating health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us.\"", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15258", "attributes": { "award_id": "1R01MD019094-01A1", "title": "Modeling Health Equity and Economic Impacts of National Strategies to Address Food and Nutrition Insecurity", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Minority Health and Health Disparities (NIMHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 31846, "first_name": "VANESSA J", "last_name": "Marshall", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-23", "end_date": "2028-02-28", "award_amount": 750910, "principal_investigator": { "id": 31847, "first_name": "David Daeho", "last_name": "Kim", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 289, "ror": "https://ror.org/024mw5h28", "name": "University of Chicago", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true }, "abstract": "With worsening food insecurity in the COVID-19 pandemic and rising food prices, a 2022 White House initiative sought to address diet-related diseases (e.g., obesity, diabetes, cardiovascular disease) and disparities through food and nutrition insecurity interventions. However, Policymakers lack critical evidence on the effects of promising interventions to address food and nutrition insecurity because of no available evidence on long-term population health, effects on health disparities, and cost-effectiveness. This proposal seeks to fill these gaps by improving our understanding of the health equity and economic effects of different food and nutrition interventions and providing important evidence to support national priorities around diet-related diseases and health disparities. Based on three criteria: (a) strategies outlined in the 2022 White House report, (b) conceptual framework based on a health impact pyramid and NIMHD research framework regarding the domains of influence (population- vs. individual-based), and (c) availability of supporting evidence, we have identified four highly promising interventions to address food and nutrition insecurity: (1) expanding the USDA-supported Gus Schumacher Nutrition Incentive Program and (2) expanding the SNAP benefits and eligibility, (3) accelerating uptake of food/nutrition security screening and (4) enhancing access to nutrition/obesity counseling. Using our NIH-funded, validated, state-of-the-art, and dynamic microsimulation model, this project will measure the longer-term health outcomes, health equity, and economic impact of these four highly promising policy interventions to address food and nutrition insecurity on the US adult population and across racial/ethnic and socioeconomic groups. Through robust sensitivity and scenario analyses, our analytic framework allows us to examine the heterogeneous effects of these diverse interventions on long-term effectiveness and cost-effectiveness across population subgroups and whether such heterogeneous effects reflect differences in baseline risks (e.g., food insecurity) or vulnerability to the risk (e.g., effects of food insecurity on outcomes) or intervention’s effects across subgroups. Our innovative approach and multidisciplinary expert research team uniquely position us to measure long-term population health effects of food and nutrition insecurity interventions (Aim 1), estimate long-term effects on health disparity across population subgroups of food and nutrition insecurity interventions (Aim 2), quantify economic effects and cost- effectiveness of food and nutrition insecurity interventions (Aim 3). An independent dissemination aim will improve knowledge translation to end-users by conducting legal and administrative feasibility analysis and developing a web-based interactive platform (National Food and Nutrition Policy Impact Simulator). With the growing need for more robust evidence to address food and nutrition insecurity, our project will generate policy-relevant evidence on optimal policy choices that may depend on how different interventions affect long-term population health, certain key groups (i.e., reducing disparities), and overall cost-effectiveness. Using such evidence, policymakers can prioritize evidence-based national food and nutrition policies.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15268", "attributes": { "award_id": "1R21DA061281-01", "title": "Xylazine exposure and transitions to low-frequency injecting and injection cessation", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Drug Abuse (NIDA)" ], "program_reference_codes": [], "program_officials": [ { "id": 31855, "first_name": "ERIN MARGARET", "last_name": "Parker", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-15", "end_date": "2026-07-31", "award_amount": 266742, "principal_investigator": { "id": 20756, "first_name": "Ryan", "last_name": "McNeil", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1422, "ror": "https://ror.org/0213rcc28", "name": "Simon Fraser University", "address": "", "city": "", "state": "BC", "zip": "", "country": "CANADA", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 452, "ror": "https://ror.org/03v76x132", "name": "Yale University", "address": "", "city": "", "state": "CT", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary: We propose a two-year qualitative study that will characterize transitions to low-frequency injecting and injection cessation among people using xylazine-adulterated fentanyl in one of the states (Connecticut) most impacted by this drug supply change. America's drug supply has grown become more volatile since the outset of the COVID-19 pandemic, particularly the proliferation of xylazine-adulterated fentanyl in Northeast and Mid-Atlantic states, and is driving drug-related harms, including increases in non-fatal and fatal overdoses and severe injection-related soft tissue infections. Amidst the emergence of xylazine-adulterated fentanyl, researchers have begun to document reductions in injection drug use and injection cessation among people continuing to use fentanyl. Transitions to low-frequency injecting and injection cessation represent key strategies for reducing the potential for soft tissue infections associated with xylazine-injecting, as well as the transmission of infectious diseases (e.g., hepatitis C, HIV). However, the growing proportion of overdose deaths across the country attributed to non-injection drug use raise significant concerns about overdose awareness and the responsiveness of harm reduction services to the needs of people transitioning to low-frequency injecting and injection cessation. Contextualized understandings of how the proliferation of xylazine-adulterated fentanyl intersects with social, structural, and environmental influences to shape these transitions to low-frequency injecting and infection cessation and their implications for harm reduction services are urgently needed to optimize harm reduction approaches. Building on our extensive experience studying the impacts of drug supply changes, including on drug use behaviors and harm reduction services, we propose the following specific aims: Aim 1: To characterize how exposure to xylazine-adulterated fentanyl intersects with social-structural influences (e.g., homelessness, poverty) to shape transitions to low-frequency injecting (≤10 times per month) and injection cessation (>30 days). Aim 2: To explore perceptions of overdose vulnerability associated with non-injection drug use of xylazine-adulterated fentanyl, and examine their implications for overdose prevention messaging and harm reduction service delivery. Aim 3: To explore challenges and opportunities for harm reduction strategies, including syringe exchange, naloxone, and community health programs, in addressing overdose vulnerability among people exposed to xylazine-adulterated fentanyl transitioning to low-frequency injection drug use or injection cessation. Informed by the equity-focused Intersectional Risk Environment framework, we will conduct qualitative interviews with people using xylazine-adulterated fentanyl across Connecticut (n=50) who have transitioned to low-frequency injecting or injection cessation (Aims 1&2), as well as focus groups with harm reduction workers (n=30) from across the state (Aim 3). Findings will be mobilized to develop evidence-informed, scalable research, policy and program recommendations to address harms associated with xylazine-adulterated fentanyl, including the design of new interventions.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15398", "attributes": { "award_id": "1R01DA061309-01", "title": "Employment Insecurity and Substance Use in U.S. Adults", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Drug Abuse (NIDA)" ], "program_reference_codes": [], "program_officials": [ { "id": 31855, "first_name": "ERIN MARGARET", "last_name": "Parker", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-07-15", "end_date": "2028-04-30", "award_amount": 373485, "principal_investigator": { "id": 31997, "first_name": "Jungeun Olivia", "last_name": "Lee", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 152, "ror": "https://ror.org/03taz7m60", "name": "University of Southern California", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Employment insecurity (EI; unemployment or underemployment) may escalate substance use as a maladaptive coping mechanism for distress. The COVID-19 pandemic triggered a rapid surge in EI for millions of Americans, hitting racial and ethnic minority and low socioeconomic status workers harder. The long-term impacts of the recent surge in EI on substance use are unknown. Employment recovery has been observed, but the speed has varied across subgroups and regional areas and future economic volatility looms. Despite robust cross-sectional associations of EI with substance use, prior studies have produced mixed results regarding the prospective effect of EI on substance use, its causal nature, and its differential impacts across racial and ethnic minority and low- SES workers. Moreover, the science base is unclear regarding which person-level factors are critical to address in interventions and how context-level factors intersect with person-level factors to buffer or amplify the impact of EI on substance use. National drug use surveys typically follow an annual or longer survey schedule that is not temporally granular enough to address these critical questions, leaving public officials without critical information to establish sound policies and practices related to EI as a means to reduce substance use. The proposed secondary data analysis study will address this challenge by isolating transitions in employment status (including underemployment) to elucidate the time course of effects (i.e., timing, duration, and trajectory of EI) on substance use. The study also will examine a targeted set of systemic environmental and individual factors that moderate the effects of EI on substance use and the mechanisms through which it affects substance use. We will anchor the inquiry in a novel conceptual model that synthesizes behavioral economic models of substance use with an ecological perspective. The model hypothesizes that people are motivated to engage in rewarding activities, and when critical sources that can bring rewards, such as full-time employment, are taken away, a cascading risk process is triggered, involving loss of financial and nonfinancial rewards, distress, mental health, and increased substance use. Environmental stressors and resources in the neighborhood may amplify or mitigate these forces. We will leverage the Understanding America Study (UAS), a nationally representative panel of 9,000-plus individuals. UAS involves high-frequency (biweekly from March 2020 to March 2021 and monthly thereafter until June 2022; 39 waves; 237,849 total observations) assessment of EI, substance use, financial and nonfinancial rewards, distress, and mental health. We will augment these intensive longitudinal data with neighborhood context data. The recent rapid surge in EI, its unknown long-term impacts on substance use, economic uncertainty, decades-long but unresolved debates regarding the causal nature of the EI– substance use link, and unknown interplay between person- and context-level factors that shapes the association of EI with substance use at the national level underscore the urgency and timeliness of this proposed study.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15273", "attributes": { "award_id": "1R01HD115580-01", "title": "Neonatal, Lactation, and Child Health Outcomes Following RSV Vaccination During Pregnancy", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 31860, "first_name": "CAMILLE", "last_name": "FABIYI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-09", "end_date": "2029-04-30", "award_amount": 732591, "principal_investigator": { "id": 25567, "first_name": "Kristin", "last_name": "Palmsten", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1861, "ror": "", "name": "HEALTHPARTNERS INSTITUTE", "address": "", "city": "", "state": "MN", "zip": "", "country": "United States", "approved": true }, "abstract": "Respiratory Syncytial Virus (RSV) can cause severe illness in young children and is the leading cause of infant hospitalization in the United States. Prenatal RSV prefusion F protein−based (RSVpreF) vaccine efficacy is 69% for severe RSV-associated lower respiratory tract illness in infants through 6 months. In August 2023, the Food and Drug Administration approved the vaccine for use at 32 through 36 gestational weeks with a Prescribing Information warning about preterm birth given an imbalance in preterm birth risk observed between the vaccine and placebo groups in the clinical trial. However, pregnant people at high risk for preterm birth were excluded from the trial, the trial did not assess the effect of the vaccination on lactation-related outcomes, and there are limited safety data on neonatal outcomes and longer-term infant and child outcomes including growth, neurodevelopment, and allergic conditions. On September 22, 2023, the Advisory Committee on Immunization Practices (ACIP) recommended seasonal administration of either prenatal RSVpreF vaccine or nirsevimab, a long-acting monoclonal antibody administered to infants, to prevent severe RSV infection. Lack of safety data decreases vaccine confidence and could contribute to poor uptake of RSVpreF during pregnancy. Though there is little biologic plausibility of harmful effects of prenatal RSVpreF vaccination on neonatal, lactation, and child health outcomes, rigorous real-world safety data are needed to guide informed decision-making. To address the need for comprehensive safety data on prenatal RSVpreF, we propose to study the effects of RSVpreF vaccination on neonatal, lactation, and child health outcomes in up to 20,000 mother-infant dyads using electronic health record data supplemented with vaccinations from state immunization information systems across four large health systems in Hawaii, Oregon, Washington, Minnesota, and Wisconsin. We will use rigorous epidemiologic methods, including propensity scores to address confounding, inverse probability of censoring weighting (IPCW) to address selection bias, and target trial emulation to address immortal time bias. For associations suggesting harm, we will explore the direct effects of RSVpreF independent of preterm birth and infant nirsevimab exposure. The exploratory mediation analysis will use a causal inference approach. We will build on the data structure and methods that we developed through a National Institutes of Health (NIH)-funded study of COVID-19 vaccination and lactation outcomes and expertise developed through Centers for Disease Control and Prevention-funded research on antenatal vaccination safety. We are uniquely positioned to study lactation and child health outcomes and overcome reporting and volunteer bias in other studies by using routinely collected information on breastfeeding, growth, and developmental screening at well- child visits for a defined population as we have done in prior NIH-funded research. The study will provide timely real-world evidence to inform clinical guidelines and decision making regarding prenatal RSV vaccination.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15288", "attributes": { "award_id": "1OT2DA061138-01", "title": "Commitment to Recovery: Alaska Native Community Needs for Substance Use Treatment", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Neurological Disorders and Stroke (NINDS)" ], "program_reference_codes": [], "program_officials": [ { "id": 31876, "first_name": "JACLYN D'ANNE", "last_name": "Smith", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-26", "end_date": "2025-07-31", "award_amount": 252745, "principal_investigator": { "id": 31877, "first_name": "Georgia J", "last_name": "Michlig", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 26195, "first_name": "Susan Brown", "last_name": "Trinidad", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31878, "first_name": "Aliassa", "last_name": "Shane", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1903, "ror": "https://ror.org/033c6ba10", "name": "Southcentral Foundation", "address": "", "city": "", "state": "AK", "zip": "", "country": "United States", "approved": true }, "abstract": "Southcentral Foundation (SCF) is a successful Tribally-owned and -operated healthcare organization in southcentral Alaska, a region spanning 104,713 square miles, 55 rural villages, and serving 70,000 ANAI peoples representing 229 federally-recognized tribes. In 2018, SCF completed a community health needs assessment (CHNA) with the intention to improve existing services and develop new programs. The CHNA included quantitative and qualitative methods to gather cross-sectional information about the health needs of the AN/AI peoples served by SCF to assess performance and identify any gaps across seven domains (manuscript in preparation). Participants included healthcare system leadership, staff, and customer-owners. Two of the top three health needs identified through the CHNA were substance use (alcohol, drug, and tobacco misuse) and behavioral health. More specifically, participants reported needs for more prevention, addiction awareness, and both short-term and long-term treatment for SUD. Behavioral health needs included increased access to services, expanded treatment for behavioral health issues (e.g., depression, anxiety) and suicide prevention, awareness, and support. Since these results were shared with SCF key stakeholders, leadership has made significant efforts to improve access to services and address some of the needs identified by CHNA participants. However, since the COVID-19 pandemic led to an increase in the use of telemedicine for all services, there is a need to engage the AN/AI community served by SCF to better understand whether attempts to improve access and address the specified needs have been met, or if additional needs been identified since the pandemic. The goal of the proposed project is to complete a CHNA focused on substance use treatment services offered to SCF customer-owners, both urban and rural. While the literature suggest that co-occurring substance use and mental health disorders can impact service utilization, and this is a component of interest of the investigative team, the design and scope of this CHNA will be established in collaboration with the proposed project’s steering committee. Our Specific Aims are to: 1.\tAssess the needs for substance use treatment services at Southcentral Foundation. This will be achieved through 20 interviews with clinicians and leadership, 250 customer-owner surveys, and 4 focus groups with rural clinics and one community- based treatment program external to SCF. 2.\tBuild capacity of one Alaska Native investigator (Ms. Aliassa Shane) with ongoing mentorship by local and academic investigators with expertise in substance use disorders. This will be achieved through monthly mentoring meetings, annual attendance at one professional conference, and one training focused on development of substance use disorder or indigenous methods. 3.\tDraft health system recommendations and conceptual framework for a Phase II study. This will be achieved through a report and meetings with the steering committee for Southcentral Foundation leadership. These aims will contribute to the limited knowledge about effective treatment and recovery services among AN/AI peoples in a real-world environment. These activities have potential applicability in other tribal health systems across the nation and other health systems that seek to provide culturally grounded treatment and recovery services.", "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 1392, "pages": 1424, "count": 14236 } } }