{"success":true,"result":{"grants":[{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"RESEARCH TRIANGLE INSTITUTE","value":716790486,"savings":428698791,"link":null,"description":"ACTIV INTEGRATION OF HOST-TARGETING THERAPIES FOR COVID-19 ADMINISTRATIVE COORDINATING CENTER - RTI INTERNATIONAL IS PLEASED TO PROVIDE THIS APPLICATION AS REQUESTED BY THE RESEARCH OPPORTUNITIES ANNOUNCEMENT OTA-20-011 ACTIV INTEGRATION OF HOST-TARGETING THERAPIES FOR COVID-19 FOR THE ROLE OF ADMINISTRATIVE COORDINATING CENTER (ACC). THE TITLE OF OUR APPLICATION IS ACTIV INTEGRATION OF HOST-TARGETING THERAPIES FOR COVID-19 ADMINISTRATIVE COORDINATING CENTER. THE INTEGRATION OF HOST-TARGETING THERAPIES FOR COVID-19 PROGRAM AIMS TO IDENTIFY COVID-19 INTERVENTIONS RELEVANT TO HEART, LUNG, BLOOD, AND CARDIOVASCULAR OUTCOMES THAT CONTRIBUTE TO THE SCIENTIFIC KNOWLEDGE BASE ARE LIKELY TO INFORM CLINICAL PRACTICE. THIS PROGRAM WILL RAPIDLY AND EFFICIENTLY CONDUCT ADAPTIVE PLATFORM TRIALS VIA A COORDINATED EFFORT OF DATA COORDINATING CENTERS AND CLINICAL SITES FROM EXISTING CLINICAL STUDY NETWORKS. THE ACC IS A CRITICAL COMPONENT OF THE PROGRAM. WE WILL COORDINATE WITH NHLBI TO ENSURE COLLABORATION AMONG NETWORKS INCLUDING THE USE OF STANDARDIZED APPROACHES IN CLINICAL TRIAL DESIGN AND CONDUCT, DATA COLLECTION AND VALIDATION, AND STATISTICAL ANALYSIS SUCH THAT STUDIES ARE LAUNCHED, IMPLEMENTED AND ANALYZED SWIFTLY; AND STUDY FINDINGS ARE SCIENTIFICALLY SOUND AND MEET REGULATORY NEEDS FOR MEDICAL THERAPY DEVELOPMENT. AS THE ACC, WE WILL ALSO SERVE THE VITAL ROLE OF FACILITATING COMMUNICATION AND INFORMATION SHARING AMONG ALL RELEVANT STAKE HOLDERS AND HELPING NHLBI IN TRACKING STUDY-SPECIFIC AND PROGRAM-WIDE MILESTONES. SONIA THOMAS, DRPH, WILL LEAD THE ACC AS PRINCIPAL INVESTIGATOR. SHE IS AN EXPERIENCED CC PI AND STATISTICIAN WITH 25 YEARS OF EXPERIENCE IN THE DESIGN, IMPLEMENTATION, AND ANALYSIS OF MULTICENTER NIHAND INDUSTRY-SPONSORED PHASE 2-4 CLINICAL TRIALS OF DRUGS, BIOLOGICS, DEVICES, SURGICAL AND BEHAVIORAL INTERVENTIONS IN MORE THAN A DOZEN THERAPEUTIC INDICATIONS. DR. THOMAS WILL BE SUPPORTED BY TRACY NOLEN, DRPH AS ALTERNATE PI, AN EXPERIENCED CONSORTIUM AND CC PI AND CLINICAL TRIAL STATISTICIAN, AND SUBJECT MATTER EXPERTS STEVE NISSEN, MD, CLEVELAND CLINICAL CHIEF ACADEMIC OFFICER, HEART AND VASCULAR INSTITUTE, SHANNON CARSON, MD, UNIV. OF NORTH CAROLINA CHIEF OF PULMONARY AND CRITICAL CARE MEDICINE, AND ANASTASIA IVANOVA, PHD, UNIV. OF NORTH CAROLINA PROFESSOR OF BIOSTATISTICS UNDER DR THOMAS’S DIRECTION, OUR TEAM WILL LEAD, SUPPORT, AND COLLABORATE WITH PROGRAM NETWORKS THROUGH ORGANIZATION INTO 6 ACC CORES: PROGRAM OPERATIONS, SCIENTIFIC LEADERSHIP AND PRIORITIZATION, INFORMATICS, DATA STANDARDS, STUDY DESIGN, IMPLEMENTATION, & ANALYSIS, AND REGULATORY AND QA. WE HAVE IDENTIFIED MILESTONES FOR THE ESSENTIAL ACTIVITIES OF THE ACC WITHIN EACH OF THESE 6 CORES WITH A DETAILED FOCUS ON THE ACTIVITIES IN THE FIRST 6 MONTHS AS ACTIVITIES COMPLETED DURING THIS TIME ARE MOST IMPORTANT FOR ENSURING THE COORDINATED, EXPEDITED AND EFFICIENT LAUNCH OF THIS PROGRAM. DR. THOMAS, OUR SUBJECT MATTER EXPERTS, SENIOR STATISTICAL SCIENTISTS, AND MANY OF THE CORE LEADS HAVE SUBSTANTIAL EXPERIENCE WITH NHLBI AND THUS UNDERSTAND THE NEEDS AND PRIORITIES OF THE INSTITUTE AND WILL USE THIS KNOWLEDGE TO BETTER COLLABORATE WITH NHLBI AND FURTHER SPEED UP THE LAUNCH OF THIS PROGRAM. WE ARE WILLING TO COLLABORATE WITH ALL INVOLVED ENTITIES AS PART OF THE OVERARCHING TRANS-NIH ACTIV PROGRAM AS IT EVOLVES. WE RECOGNIZE AND ANTICIPATE THAT SWIFT ADAPTATION WILL BE REQUIRED TO RAPIDLY RESPOND TO THE URGENT CLINICAL RESEARCH NEEDS TO ADDRESS THE COVID-19 PANDEMIC. RTI IS UNIQUELY AND SUBSTANTIALLY QUALIFIED FOR THE ACC. WE WILL USE OUR TEAM’S BROAD EXPERIENCE FROM MANY COMPLEX COORDINATING CENTER PROJECTS TO ANTICIPATE THE NEEDS FOR THIS PROGRAM AND “HIT THE GROUND RUNNING”. PROVEN INFORMATICS TECHNOLOGY IN USE BY EXISTING NIH PROGRAMS WILL BE SWIFTLY MODIFIED BY OUR ANALYSTS FOR SPEEDY DEPLOYMENT OF COMMUNICATIONS PLATFORMS. OUR ORGANIZATIONAL SIZE AND FLEXIBILITY WILL ALLOW US TO RAMP UP QUICKLY AND MODIFY PERSONNEL RESOURCES FLEXIBLY. LASTLY, RTI"},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"RESEARCH TRIANGLE INSTITUTE","value":171499647,"savings":112464531,"link":null,"description":"ACTIV INTEGRATION OF HOST-TARGETING THERAPIES FOR COVID-19 ADMINISTRATIVE COORDINATING CENTER - RTI INTERNATIONAL IS PLEASED TO PROVIDE THIS APPLICATION AS REQUESTED BY THE RESEARCH OPPORTUNITIES ANNOUNCEMENT OTA-20-011 ACTIV INTEGRATION OF HOST-TARGETING THERAPIES FOR COVID-19 FOR THE ROLE OF ADMINISTRATIVE COORDINATING CENTER (ACC). THE TITLE OF OUR APPLICATION IS ACTIV INTEGRATION OF HOST-TARGETING THERAPIES FOR COVID-19 ADMINISTRATIVE COORDINATING CENTER. THE INTEGRATION OF HOST-TARGETING THERAPIES FOR COVID-19 PROGRAM AIMS TO IDENTIFY COVID-19 INTERVENTIONS RELEVANT TO HEART, LUNG, BLOOD, AND CARDIOVASCULAR OUTCOMES THAT CONTRIBUTE TO THE SCIENTIFIC KNOWLEDGE BASE ARE LIKELY TO INFORM CLINICAL PRACTICE. THIS PROGRAM WILL RAPIDLY AND EFFICIENTLY CONDUCT ADAPTIVE PLATFORM TRIALS VIA A COORDINATED EFFORT OF DATA COORDINATING CENTERS AND CLINICAL SITES FROM EXISTING CLINICAL STUDY NETWORKS. THE ACC IS A CRITICAL COMPONENT OF THE PROGRAM. WE WILL COORDINATE WITH NHLBI TO ENSURE COLLABORATION AMONG NETWORKS INCLUDING THE USE OF STANDARDIZED APPROACHES IN CLINICAL TRIAL DESIGN AND CONDUCT, DATA COLLECTION AND VALIDATION, AND STATISTICAL ANALYSIS SUCH THAT STUDIES ARE LAUNCHED, IMPLEMENTED AND ANALYZED SWIFTLY; AND STUDY FINDINGS ARE SCIENTIFICALLY SOUND AND MEET REGULATORY NEEDS FOR MEDICAL THERAPY DEVELOPMENT. AS THE ACC, WE WILL ALSO SERVE THE VITAL ROLE OF FACILITATING COMMUNICATION AND INFORMATION SHARING AMONG ALL RELEVANT STAKE HOLDERS AND HELPING NHLBI IN TRACKING STUDY-SPECIFIC AND PROGRAM-WIDE MILESTONES. SONIA THOMAS, DRPH, WILL LEAD THE ACC AS PRINCIPAL INVESTIGATOR. SHE IS AN EXPERIENCED CC PI AND STATISTICIAN WITH 25 YEARS OF EXPERIENCE IN THE DESIGN, IMPLEMENTATION, AND ANALYSIS OF MULTICENTER NIHAND INDUSTRY-SPONSORED PHASE 2-4 CLINICAL TRIALS OF DRUGS, BIOLOGICS, DEVICES, SURGICAL AND BEHAVIORAL INTERVENTIONS IN MORE THAN A DOZEN THERAPEUTIC INDICATIONS. DR. THOMAS WILL BE SUPPORTED BY TRACY NOLEN, DRPH AS ALTERNATE PI, AN EXPERIENCED CONSORTIUM AND CC PI AND CLINICAL TRIAL STATISTICIAN, AND SUBJECT MATTER EXPERTS STEVE NISSEN, MD, CLEVELAND CLINICAL CHIEF ACADEMIC OFFICER, HEART AND VASCULAR INSTITUTE, SHANNON CARSON, MD, UNIV. OF NORTH CAROLINA CHIEF OF PULMONARY AND CRITICAL CARE MEDICINE, AND ANASTASIA IVANOVA, PHD, UNIV. OF NORTH CAROLINA PROFESSOR OF BIOSTATISTICS UNDER DR THOMAS’S DIRECTION, OUR TEAM WILL LEAD, SUPPORT, AND COLLABORATE WITH PROGRAM NETWORKS THROUGH ORGANIZATION INTO 6 ACC CORES: PROGRAM OPERATIONS, SCIENTIFIC LEADERSHIP AND PRIORITIZATION, INFORMATICS, DATA STANDARDS, STUDY DESIGN, IMPLEMENTATION, & ANALYSIS, AND REGULATORY AND QA. WE HAVE IDENTIFIED MILESTONES FOR THE ESSENTIAL ACTIVITIES OF THE ACC WITHIN EACH OF THESE 6 CORES WITH A DETAILED FOCUS ON THE ACTIVITIES IN THE FIRST 6 MONTHS AS ACTIVITIES COMPLETED DURING THIS TIME ARE MOST IMPORTANT FOR ENSURING THE COORDINATED, EXPEDITED AND EFFICIENT LAUNCH OF THIS PROGRAM. DR. THOMAS, OUR SUBJECT MATTER EXPERTS, SENIOR STATISTICAL SCIENTISTS, AND MANY OF THE CORE LEADS HAVE SUBSTANTIAL EXPERIENCE WITH NHLBI AND THUS UNDERSTAND THE NEEDS AND PRIORITIES OF THE INSTITUTE AND WILL USE THIS KNOWLEDGE TO BETTER COLLABORATE WITH NHLBI AND FURTHER SPEED UP THE LAUNCH OF THIS PROGRAM. WE ARE WILLING TO COLLABORATE WITH ALL INVOLVED ENTITIES AS PART OF THE OVERARCHING TRANS-NIH ACTIV PROGRAM AS IT EVOLVES. WE RECOGNIZE AND ANTICIPATE THAT SWIFT ADAPTATION WILL BE REQUIRED TO RAPIDLY RESPOND TO THE URGENT CLINICAL RESEARCH NEEDS TO ADDRESS THE COVID-19 PANDEMIC. RTI IS UNIQUELY AND SUBSTANTIALLY QUALIFIED FOR THE ACC. WE WILL USE OUR TEAM’S BROAD EXPERIENCE FROM MANY COMPLEX COORDINATING CENTER PROJECTS TO ANTICIPATE THE NEEDS FOR THIS PROGRAM AND “HIT THE GROUND RUNNING”. PROVEN INFORMATICS TECHNOLOGY IN USE BY EXISTING NIH PROGRAMS WILL BE SWIFTLY MODIFIED BY OUR ANALYSTS FOR SPEEDY DEPLOYMENT OF COMMUNICATIONS PLATFORMS. OUR ORGANIZATIONAL SIZE AND FLEXIBILITY WILL ALLOW US TO RAMP UP QUICKLY AND MODIFY PERSONNEL RESOURCES FLEXIBLY. LASTLY, RTI"},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"STANFORD UNIVERSITY","value":2997978,"savings":418282,"link":null,"description":"OVERALL: SUMMARY We propose the Stanford U54 SARS-CoV-2 Serological Sciences Center of Excellence (SUSS-COE) as a member of the SeroNet consortium gathered to address the urgent need for better understanding of human immune responses to the SARS-CoV-2 coronavirus pandemic that has engulfed the U.S. and the world. Our Center will be based on four scientific pillars:  Deep mechanistic analysis of the adaptive immune responses of COVID-19 patients, spanning serological, B cell and T cell responses,  Analysis of immune responses in the blood as well as mucosal sites,  Comparing immune responses induced by infection to those induced by candidate vaccines, and  Studying medically underserved, underrepresented and at-risk patient populations Within these parameters, we will attempt to determine the factors that result in effective and durable immunity to SARS-CoV-2 infection. We are dedicated to broad collaboration, rapid sharing of data and technical knowledge, nimbleness in responding to the rapidly changing pandemic, and rapid translation of research findings to CLIA Lab clinical testing and development of new therapeutic approaches. We feel these are the best routes forward for addressing gaps in our understanding of the determinants of protective immunity to SARS-CoV-2, and providing useful tools for physicians and patients."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"THE CHEROKEE NATION","value":1317488,"savings":965570,"link":null,"description":"PROJECT SUMMARY Through the RADx-UP program, the Cherokee Nation Community-Driven Program for Testing and Contact Tracing (Cherokee PROTECT) unites tribal, academic, and community partners under the leadership of Cherokee Nation (CN) to solve a dire need for COVID-19 testing, contact tracing, and culturally informed education in underserved and vulnerable rural populations. As of August 4, Cherokee Nation Health Services (CNHS) has confirmed >850 cases of COVID-19 in the tribal populations served across mainly rural northeastern Oklahoma. Community spread of COVID-19 exists throughout all 14 counties in the CN reservation, but with CN’s limited capacity for community testing, screening, and contact tracing, the true impact of COVID-19 is unknown. Roughly 34% of American Indian/Alaska Native (AI/AN) adults aged 18-64 years are at risk of severe COVID-19 due to comorbidities, more than any other racial/ethnic group in the US. Five counties in CN are in the top 20% of US counties for the prevalence of adults at risk of severe COVID-19 due to underlying medical conditions; this vulnerability is compounded by high poverty rates and geographic barriers. People living in rural areas of CN may have to travel as many as 60 miles round-trip for viral testing. Most COVID-19 testing in CN to date has been conducted through CNHS, the largest tribally compacted health system in the US that serves all AI/AN people living within the CN reservation. Although CNHS accounts for approximately 8.5% of all IHS active user population and 38% of active user population of Oklahoma service area, not all tribal members residing in the reservation access CNHS, and therefore, may not be tested by CNHS. Other than CNHS clinics, 7 of 14 counties in this area have only one public testing site, and results may not be returned for 2-3 weeks. CNHS and its closely integrated CN Public Health program have an exemplary 20-year record of delivering public health interventions, including a groundbreaking Hepatitis C Virus elimination program with the University of Oklahoma Health Sciences Center, and ongoing projects with >40 rural K-12 schools. Through collaborative clinical research and molecular studies, CN and the Oklahoma Medical Research Foundation have identified new immune biomarkers in tribal populations. Drawing on these existing strengths and infrastructure, Cherokee PROTECT will (1) Build infrastructure and increase FDA-EUA COVID-19 viral and antibody testing for clinical care in CNHS; (2) Enable community-based COVID-19 testing, contact tracing, and education with CN Public Health; (3) Identify barriers and facilitators to COVID-19 testing in the CN reservation to inform a tailored educational campaign to increase testing and contact tracing, and decrease spread; and (4) Implement a rigorous evaluation to ensure quality improvement and sustainability."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"THE CHEROKEE NATION","value":2906085,"savings":282879,"link":null,"description":"PROJECT SUMMARY Through the RADx-UP program, the Cherokee Nation Community-Driven Program for Testing and Contact Tracing (Cherokee PROTECT) unites tribal, academic, and community partners under the leadership of Cherokee Nation (CN) to solve a dire need for COVID-19 testing, contact tracing, and culturally informed education in underserved and vulnerable rural populations. As of August 4, Cherokee Nation Health Services (CNHS) has confirmed >850 cases of COVID-19 in the tribal populations served across mainly rural northeastern Oklahoma. Community spread of COVID-19 exists throughout all 14 counties in the CN reservation, but with CN’s limited capacity for community testing, screening, and contact tracing, the true impact of COVID-19 is unknown. Roughly 34% of American Indian/Alaska Native (AI/AN) adults aged 18-64 years are at risk of severe COVID-19 due to comorbidities, more than any other racial/ethnic group in the US. Five counties in CN are in the top 20% of US counties for the prevalence of adults at risk of severe COVID-19 due to underlying medical conditions; this vulnerability is compounded by high poverty rates and geographic barriers. People living in rural areas of CN may have to travel as many as 60 miles round-trip for viral testing. Most COVID-19 testing in CN to date has been conducted through CNHS, the largest tribally compacted health system in the US that serves all AI/AN people living within the CN reservation. Although CNHS accounts for approximately 8.5% of all IHS active user population and 38% of active user population of Oklahoma service area, not all tribal members residing in the reservation access CNHS, and therefore, may not be tested by CNHS. Other than CNHS clinics, 7 of 14 counties in this area have only one public testing site, and results may not be returned for 2-3 weeks. CNHS and its closely integrated CN Public Health program have an exemplary 20-year record of delivering public health interventions, including a groundbreaking Hepatitis C Virus elimination program with the University of Oklahoma Health Sciences Center, and ongoing projects with >40 rural K-12 schools. Through collaborative clinical research and molecular studies, CN and the Oklahoma Medical Research Foundation have identified new immune biomarkers in tribal populations. Drawing on these existing strengths and infrastructure, Cherokee PROTECT will (1) Build infrastructure and increase FDA-EUA COVID-19 viral and antibody testing for clinical care in CNHS; (2) Enable community-based COVID-19 testing, contact tracing, and education with CN Public Health; (3) Identify barriers and facilitators to COVID-19 testing in the CN reservation to inform a tailored educational campaign to increase testing and contact tracing, and decrease spread; and (4) Implement a rigorous evaluation to ensure quality improvement and sustainability."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"THE UNIVERSITY CORPORATION","value":1044049,"savings":181802,"link":null,"description":"PROJECT SUMMARY Unlike other ethnic minority groups, data on the impacts of COVID-19 on Southeast Asian Americans (SEAAs) are limited, oftentimes aggregated with other Asian American groups, thus limiting targeted assistance efforts. Without adequate data to inform best practices around testing and vaccination, many SEAAs become invisible Americans who have difficulties navigating a health care system that inadvertently excludes them. SEAAs have large disparities gap due to a combination of historical trauma, discrimination, harsh immigrant policies, and language barriers. Many are undocumented, hold low wage jobs, and less likely to attend college. Social isolation, anxiety, and financial hardships resulting from COVID-19 have intensified existing health and mental health issues. Lack of disaggregated data and under-reporting of race/ethnicity data, potentially masks the true impacts of COVID-19 on SEAAs and thus exemplifies systemic barriers and structural racism that keep them invisible and hinder targeted assistance. The goal of this project, “Social, Ethical, Behavioral Implications of COVID-19 among Southeast Asian Americans” is to understand and address multi-level social, ethical, and behavioral implications of COVID-19 testing, vaccination, and its sequelae among Cambodians, Filipinos, Thais, and Vietnamese Americans in Greater Los Angeles through a community-based approach. Our central hypothesis is that provision of data-informed and community-informed best practices/guidelines will improve evidence-based COVID-19 testing, vaccination, and its sequelae among their communities. We aim to: 1. Conduct multi-level formative research using a mixed methods approach to validate, refine, and tailor existing SEBI measures and potentially develop new, more culturally-relevant, measures for SEAAs. 2. Collect individual-level data about social, ethical, and behavioral implications (SEBI) of COVID-19 testing, vaccination, and its sequelae among SEAAs (N=1000) in the Greater Los Angeles area through a prospective longitudinal study. 3. Conduct interviews with community leaders and stakeholders (N=60) within the SEAA communities to understand their perceptions, attitudes, beliefs, and intentions towards COVID-19 testing and vaccination. We intend to gather information which can be used to identify critical points of intervention, gaps in existing health service delivery or policies, and provide voice to a community that has long been silent."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"TULANE UNIVERSITY, SCHOOL OF MEDICINE","value":3135887.22,"savings":1076685,"link":null,"description":"TULANE UNIVERSITY COVID ANTIBODY AND IMMUNITY NETWORK (TUCAIN)"},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"TULANE UNIVERSITY, SCHOOL OF MEDICINE","value":1370464,"savings":306052,"link":null,"description":"PSYCHOSOCIAL FACTORS AND LUPUS DISEASE PROGRESSION AMONG AFRICAN AMERICAN WOMEN"},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF ALABAMA AT BIRMINGHAM","value":1512103,"savings":1107353,"link":null,"description":"Project Summary/Abstract The pandemic caused by the novel coronavirus, SARS-CoV-2 (SARS2) has so far infected greater than 3.5 million individuals and resulted in >138,000 deaths in the US. Although it has been suggested that adaptive immunity plays an important role in improving clinical outcomes of patients infected with SARS2, protective immune responses have not been specifically defined. Also, the variability in clinical disease and outcome in patients with SARS2 infection has not been explained based on qualitative and quantitative antiviral immune responses. Interestingly, a significant proportion of children with presumed deficits in immune competence secondary to cancer chemotherapy and hematologic disorders have been observed to shed virus from the upper respiratory tract for prolonged periods of time (>4 weeks), even after complete resolution of clinical symptoms. This finding raises the possibility that specific qualitative or quantitative deficits in adaptive immune responses in some individuals can result in incomplete control of virus replication and prolonged virus shedding. Therefore, an understanding of the immune responses that lead to control of virus shedding could help define correlates of protective immunity and perhaps more importantly, determine the potential value of vaccines to limit spread of SARS2 to unvaccinated populations. The major goal of our studies is to quantify adaptive immune responses to SARS2 in a cohort of children with varying levels immune responsiveness and to relate these responses to the control of virus shedding in the upper respiratory tract, thus allowing stratification immune reactivity and control of virus replication. Defining relationships between variations in immune competence and virus shedding could provide novel insight into the level and nature of adaptive immunity, more specifically antiviral antibodies, that can restrict or eliminate viral shedding in SARS2 infected patients. Our studies will also identify SARS2 variants that arise during poorly controlled virus replication in these patients as prolonged virus replication coupled with ineffective immunity offers an ideal opportunity for the generation of viral variants. Analysis of these variants in terms of the quality and quantity of SARS2 antibody responses will help elucidate the role of SARS2 sequence variation and persistent virus replication as a mechanism for prolonged virus replication. Together, these studies will test our hypothesis that variations in immune responsiveness contribute to prolonged viral replication and shedding."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF ARKANSAS SYSTEM","value":1269547.69,"savings":542908,"link":null,"description":"DISCOVAR:DISPARITIES IN IMMUNE RESPONSE TO SARS-COV-2 IN ARKANSAS"},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF CALIFORNIA","value":1528426,"savings":113118,"link":null,"description":"PROJECT SUMMARY - Overall The mission of the UC Davis Environmental Health Sciences Center (EHSC) is to advance understanding of environmentally induced disease and disability and to translate this knowledge into interventions, new practices or policy changes that reduce those exposures or mitigate their effects on health. The EHSC brings together faculty from seven schools and colleges engaged in environmental health sciences (EHS) research spanning molecular biosciences, environmental science, engineering, pathophysiology, biostatistics, epidemiology, and community development, with relevance to human conditions. The EHSC has made huge strides in less than 4 years. Among its notable achievements, the EHSC has: broken through silos, transformed interdisciplinary collaboration into the standard modus operandi among our members, attracted both new and established investigators, and placed environmental health on the radar of other Centers throughout UC Davis. Increasingly, EHSC members are engaging with community stakeholders and seeking to address community-driven questions. A few highlights of EHSC accomplishments are: 1) a novel vivarium facility for air pollution health studies using real-time air pumped from a heavily trafficked tunnel; 2) a program of research on exposures and health effects in response to hugely destructive wildfires now commonplace throughout the western U.S.; 3) recruitment of many new investigators, including two underrepresented minority women; establishment of a strong presence on social media. Guided by the NIEHS 2018-2023 Strategic Plan and the NIEHS Translational Research Framework, we adopted three overarching theme areas: 1) interdisciplinary translational EHS linking molecular/cell culture experiments, whole animal assays, human epidemiologic research, interventions, and policy; 2) integration of environment, social justice and health to understand vulnerability and resilience; 3) building bridges with communities, clinicians, and policy- makers. Layered on those broad themes, we continue to cultivate the historic UCD strengths in research on respiratory, nervous, immune, metabolic, endocrine, and reproductive systems, and recently expanded into cancer and climate-related health research. The Center has a Pilot Projects Program and four cores: Administration, Integrative Health Sciences, Exposure Sciences and Community Engagement, as well as various advisory committees. In the coming funding period, the UC Davis EHSC will expand its scope and impact by 1) advancing cutting-edge research in exposure characterization, environmental health effects, their molecular biologic mechanisms, and technology development for improving measurement of exposures and biomarkers; 2) enlarging the cadre of EHS researchers, and 3) engaging with policy-makers, community stakeholders and health professionals, to ensure relevance of our research and to translate findings into public health improvement. The Center emphasizes inter-disciplinary and translational approaches to environmental health issues and is developing partnerships with other Centers throughout UC Davis."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF CALIFORNIA-LOS ANGELES, BOARD OF REGENTS","value":6015134,"savings":1987611,"link":null,"description":"METABOLIC AND EPIGENETIC REPROGRAMMING OF VITAL ORGANS IN SARS-COV-2 INDUCED SYSTEMIC TOXICITY - PROJECT SUMMARY/ABSTRACT SARS-COV-2 PRIMARILY AFFECTS THE RESPIRATORY SYSTEM BUT EXTRA-PULMONARY MANIFESTATIONS IN INDIVIDUALS WITH COVID-19 ARE COMMONLY SEEN. ALL MAJOR ORGAN SYSTEMS HAVE BEEN REPORTED TO BE AFFECTED BY SARS-COV-2 AND COMPLICATIONS ARISING FROM ENSUING ORGAN DYSFUNCTION SIGNIFICANTLY INCREASE THE MORTALITY RATE OF COVID-19. YET, DESPITE THE CLINICAL IMPORTANCE OF SYSTEMIC INVOLVEMENT OF SARS-COV-2, LITTLE IS KNOWN ABOUT THE PATHOGENESIS OF EXTRA-PULMONARY COMPLICATIONS OF COVID-19. HERE, WE CREATE A MURINE MODEL OF SARS-COV-2 INDUCED SEVERE SYSTEMIC TOXICITY AND MULTI-ORGAN INVOLVEMENT AND INVESTIGATE THE ROLE OF METABOLIC AND EPIGENETIC REPROGRAMMING OF VITAL ORGANS IN THE PATHOGENESIS OF SYSTEMIC TOXICITY OF COVID-19. WE DEMONSTRATE THAT FOLLOWING A ROBUST ANTI-VIRAL IMMUNE RESPONSE, THERE IS METABOLIC SUPPRESSION OF OXIDATIVE PHOSPHORYLATION AND THE TRI-CARBOXYLIC ACID (TCA) CYCLE IN MULTIPLE ORGANS. THE ANIMALS DEVELOP A PROFOUND PHENOTYPE WITHIN 7 DAYS OF SARS-COV-2 INFECTION WITH SEVERE WEIGHT LOSS, MORBIDITY AND FAILURE TO THRIVE. EXAMINATION OF MULTIPLE INTERNAL ORGAN SYSTEMS DEMONSTRATED NEUTROPHILIA, LYMPHOPENIA, SPLENIC ATROPHY, WITH CARDIOMYOCYTE CELL DEATH, MYOCARDIAL EDEMA AND EXTREME MYOFIBRILLAR DISARRAY OBSERVED IN THE HEART AND MIRRORING REPORTED HUMAN CLINICAL PHENOTYPES IN COVID-19. AN ORGAN WIDE METABOLIC REPROGRAMMING CONSISTENT WITH DEPRESSION OF OXIDATIVE PHOSPHORYLATION LEADS TO UTILIZATION OF PERIPHERAL FAT STORES AND GROSS ACCUMULATION OF FAT IN THE HEART, KIDNEY, LIVER AND OTHER VITAL ORGANS. WE PERFORM METABOLOMIC PROFILING OF PERIPHERAL BLOOD AND IDENTIFY A PANEL OF TCA CYCLE METABOLITES THAT SERVE AS BIOMARKERS OF DEPRESSED OXIDATIVE PHOSPHORYLATION, SEVERAL OF THESE MARKERS BEEN NOTED IN HUMAN CLINICAL STUDIES TO BE ASSOCIATED WITH ADVERSE PROGNOSIS. FINALLY, WE DEMONSTRATE THAT DESPITE THE ABSENCE OF VIRAL GENOMES IN TISSUES, TRANSCRIPTIONAL CHANGES PERSIST AND ARE ASSOCIATED WITH SIGNIFICANT DIFFERENTIALLY METHYLATED REGIONS IN VITAL ORGANS ACROSS THE HOST CELL GENOMES. CONSIDERING THESE OBSERVATIONS, WE DISSECT THE MECHANISTIC BASIS OF SUCH METABOLIC REPROGRAMMING IN SARS-COV-2. WE HAVE CREATED A MULTI-DISCIPLINARY TEAM COMPRISING, METABOLOMICS EXPERTS, VIROLOGISTS, PHYSIOLOGISTS AND GENETICISTS TO STUDY METABOLIC FLUXES AND ORGAN WIDE TRANSCRIPTOMICS TO STUDY IN THE DEPTH THE ROLE OF METABOLIC AND EPIGENETIC REPROGRAMMING IN CAUSING SARS-COV-2 INDUCED SEVERE SYSTEMIC TOXICITY."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE","value":2458129,"savings":125687,"link":null,"description":"LOCALIZED MHEALTH APPROACH TO BOOSTING COVID-19 TESTING AND VACCINE LITERACY, ACCESS, AND UPTAKE AMONG WOMEN WITH CRIMINAL LEGAL SYSTEM INVOLVEMENT - ABSTRACT PEOPLE WITH CRIMINAL LEGAL SYSTEM INVOLVEMENT (CLSI) HAVE EXPERIENCED FIVE TIMES AS MANY COVID-19 INFECTIONS AND HAVE THREE TIMES THE RISK OF DEATH COMPARED TO GENERAL POPULATION IN THE U.S. HEAVILY IMPACTED BY COVID-19 AND SQUARELY WITHIN NIH HEALTH DISPARITIES POPULATIONS, PEOPLE WITH CLSI ARE OFTEN POOR AND DISPROPORTIONATELY FROM RACIAL AND ETHNIC MINORITY GROUPS. DESPITE THE INCREASED RISK OF COVID-19, WE EXPECT THAT ONLY ONE-HALF OF PEOPLE WITH CLSI WILL GET VACCINATED. ONGOING COVID-19 TESTING IN COMMUNITIES AND AMONG GROUPS THAT ARE NOT VACCINATED WILL BE KEY TO CONTAINING THE PANDEMIC. THE MESSAGING THAT COVID-19 TESTING WILL STILL BE IMPORTANT MAY NOT BE GETTING THROUGH TO PEOPLE WHO ARE AT RISK – A CRITICAL DRIVER OF DISPARITIES. OUR TEAM HAS A UNIQUE OPPORTUNITY TO BOOST TESTING LITERACY, ACCESS, AND UPTAKE USING MOBILE HEALTH (MHEALTH) TECHNOLOGIES (TEXT AND WEB) TO REACH WOMEN WITH CLSI IN COMMUNITY SETTINGS WHO ARE PART OF THE EXISTING TRI-CITY COHORT DRAWN FROM GEOGRAPHICALLY AND SOCIO-POLITICALLY DIVERSE CITIES: BIRMINGHAM, AL, KANSAS CITY, MO/KS, AND OAKLAND, CA. THIS APPLICATION IS HIGHLY RESPONSIVE TO THE RADX-UP PHASE II CALL FOR RESEARCH THAT TESTS INTERVENTIONS TO REDUCE COVID-19 DISPARITIES AMONG UNDERSERVED POPULATIONS. OUR TEAM IS POSITIONED TO EMBED THE PROPOSED STUDY INTO AN EXISTING WEB-BASED WOMEN’S HEALTH LITERACY INTERVENTION PLATFORM (WWW.SHEWOMEN.ORG, 2R01CA181047) FOR WOMEN LEAVING JAIL. WE ARE ALSO ABLE TO IMMEDIATELY PUSH THE MHEALTH COVID-19 TESTING LITERACY INTERVENTION TO 508 WOMEN WE HAVE ALREADY RECRUITED TO A THREE-CITY CERVICAL HEALTH STUDY OF WOMEN WITH CLSI (R01CA226838), AND TO PROMPTLY MAKE THIS SCALABLE INTERVENTION WIDELY AVAILABLE TO PEOPLE WITH CLSI. WE WILL ENGAGE THE WOMEN AS STAKEHOLDERS TO STUDY REGIONAL AND INDIVIDUAL DIFFERENCES IN COVID-19 TESTING AND VACCINE LITERACY, ACCESS, AND UPTAKE. WE WILL USE FINDINGS TO RAPIDLY DEVELOP AN MHEALTH INTERVENTION FOCUSED ON COVID-19 LITERACY, AND THEN PUSH THE INTERVENTION TO CLSI WOMEN IN THE THREE CITIES TO BOOST COVID-19 LITERACY, TESTING, ACCESS, AND UPTAKE, AND VACCINATION. FINDINGS WILL BE USED TO DEVELOP DISSEMINATION STRATEGIES WITH STAKEHOLDERS TO PUSH THE MHEALTH INTERVENTION TO THE TWO MILLION WOMEN AND 11 MILLION MEN WHO INTERFACE WITH THE CRIMINAL LEGAL SYSTEM ANNUALLY IN THE U.S."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE","value":1546299,"savings":136525,"link":null,"description":"Wastewater Assessment for Coronavirus in Kentucky – Implementing Enhanced Surveillance Technology Surveillance for SARS-CoV-2 is hindered by the availability of testing, particularly in remote and rural areas. Screening of wastewater for SARS-CoV-2 viral biomarkers offers a viable alternative to individual testing and it can identify communities and facilities that are at risk of becoming hotspots.Wastewater surveillance overcomes several limitations of clinical surveillance, such as the need for robust healthcare and laboratory infrastructure and the lack of representative and comprehensive testing within communities. Conventional wastewater surveillance takes samples from sewer systems or wastewater treatment facilities and uses a series of extraction steps prior to advanced PCR technology to quantitate the viral biomarker (RNA). This approach is time and resource-intensive, which limits its wide-scale application. Developing next generation technology to simplify wastewater RNA extraction and quantitation will make it feasible to use more broadly at facilities and in rural communities. The limited clinical testing for COVID-19 in rural Southeastern Kentucky hampers disease surveillance and prevents informed public action to mitigate and contain the spread of disease. Wastewater testing for SARS-CoV- 2 in these communities using field-friendly technology will provide important information to local authorities and citizens about the spread and trend of SARS-CoV-2 infection in their communities. Our project will accomplish two aims: 1) Develop next generation wastewater assessment technology and 2) Implement and evaluate the next generation wastewater assay. For Aim 1 we adapt technology invented by our team termed exclusion-based sample preparation (ESP) to simplify and improve RNA extraction from wastewater. We will pair ESP with loop-mediated isothermal amplification (LAMP) technology for RNA detection to create a sensitive, robust, and field-friendly platform for testing wastewater for SARS- CoV-2 RNA. We will compare the next generation assay with established techniques on metrics of sensitivity, specificity, and usability (e.g., assay time, number of assay steps). For Aim 2 we will first validate the next generation assay in the field at congregate living facilities in a side-by-side comparison with conventional wastewater surveillance. Next, building on existing relationships in Appalachian Kentucky, we will recruit and train a purposive group of wastewater treatment plant operators, watershed watch citizen scientists, and school science teachers to test wastewater in their communities and schools using the field-friendly next generation wastewater assay. Field results will be validated in the lab. A robust mixed methods evaluation using the RE-AIM framework will assess community perceptions of feasibility, acceptability, and utility of wastewater surveillance for SARS-CoV-2 and identify community measures taken in response to test results."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL","value":3215345.56,"savings":1065403,"link":null,"description":"Abstract. The UNC Center for Excellence in SARS-CoV2 Serologic Research uses basic and applied research strategies to improve our understanding of the molecular and cellular mechanisms driving serological and humoral immune responses after SARS-CoV2 infection. Our overall goals are to 1) characterize the immune responses elicited to SARS-CoV2 infection, 2) understand the mechanisms driving the serological, humoral and cellular immune responses, 3) determine modifiers of the serologic memory and 4) determine the serological correlates of disease pathogenesis, and protection against future infection. The program includes three Research Projects led by internationally renowned exerts in coronavirus emergence, pathogenesis and immunity (Project 1: Baric), clinical and translational mucosal and systemic immune correlates of disease (Project 2: Bartelt & Margolis) and host-pathogen interactions driving innate and serological immunity (Project 3: Wallet & Maile). Program-wide support is provided by an Administrative Core A and two Shared Resource Cores B and C. Core A includes a robust infrastructure for programmatic oversight as well as participant recruitment, sample collection, tracking and sharing (Core A: Baric & Wallet). Core B is led by world renowned experts in characterization of human antibodies in protection and pathogenesis of disease (Core B: de Silva & Lakshmanane) and will provide recombinant spike protein antigens from SARS-CoV-2 as well as antigen- specific serological assays required for accomplishing the aims of all three Research Projects. Core C is led by serological experts (Core C: Ippolitto, Georgiou & Lavinder) who have revolutionized techniques to comprehensively analyze the molecular composition of the serological antibody repertoire (IgG and IgA) and the cellular antibody repertoire (i.e. B cell receptor) and thus will delineate these repertoires in and isolate human monoclonal antibodies from SARS-CoV-2+ individuals in cohorts defined in each Research Project. All three Research Projects are integrated, and each require the support of all three Cores. To this end, Project 1 will characterize the breadth and potency of polyclonal neutralizing antibody responses as well as determine the kinetics, magnitude and durability of the type-specific and cross neutralizing responses in both the systemic and mucosal compartments. Project 2 will determine the durability and the breadth of anti-SARS-CoV-2 serum antibodies and memory B-cells generated among convalescent plasma donors as well as determine the effect of convalescent plasma on the innate, adaptive and antibody repertoire in recipients. Project 3 will reveal innate immune signatures as a function of serology across the span of natural disease, as well as identify signatures which promote development of protective vs. pathogenic antibody repertoires, while delineating mechanisms of antibody mediated activation and suppression of innate immune function which drives severe vs. mild disease respectively. The integrated expertise of our Team is necessary and sufficient to address the novel cross-cutting hypotheses put forth which will improve our understanding of SARS-CoV2 serological and humoral immunity."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF OREGON","value":2564647,"savings":1607167,"link":null,"description":"7. PROJECT SUMMARY/ABSTRACT The United States is experiencing an opioid epidemic of historic significance, with over 40,000 deaths from overdose in the past year. The economic costs of the epidemic in 2015 alone were estimated at over $500 billion, and in 2017 the US Department of Health and Human Services designated the opioid epidemic as a public health emergency. National-level epidemiological data indicate that the rates opioid misuse, addiction, overdose, and fatalities are increasing at a particularly fast rate among women, and among individuals in child- bearing and child-rearing age groups. Opioid-using behaviors among women who are parenting can have significant detrimental effects on their parenting, parent-child relationships, and downstream effects on child brain development, health, and subsequent risk for drug use. The lack of a strong scientific knowledge base about effective strategies for reducing opioid abuse and addiction in this population is a gap of enormous consequences given the well-established effects of substance use on parenting skills, and the known effects of maternal opioid use on infant development. The limited research on this topic that does exist suggests that family-focused treatment approaches may hold the greatest promise, but the interventions that have been developed to date have limitations in terms of scalability. In addition to a need for scientific research on this topic, there is a parallel need to make reliable information available to researchers, policy makers, and the general public. The overall goal of the Prevention Research Center: Parenting Among Women Who Are Opioid Users (PWO Center) is to improve the well-being of individuals, families, and communities affected by the opioid crisis through a focus on behavioral (parental responsivity, warmth) and neurocognitive systems (e.g., executive functioning, reward responsiveness) that are underlying mechanisms common to both addiction issues and parenting challenges. The PWO Center's Research Projects and Cores are based upon a unifying conceptual model and employ a translational science approach in which basic science investigations of underlying mechanisms are leveraged in the development and evaluation of scalable interventions that are designed to deliver population-level impacts on policy and practice. Our multidisciplinary investigative team has been conducting research on family-based parenting interventions for families with substance use histories for the past 20 years and has a long and productive history of collaboration and productivity. We have strong support for the proposed PWO Center from our state governor, our community partners, and our university leadership. The anticipated long-term, public health outcomes of the PWO Center are to improve evidence- based prevention of substance abuse, reduce maternal opioid misuse and addiction, reduce intergenerational transmission of drug addiction, increase scientific understanding and public awareness of how opioids impact maternal parenting practices via underlying behavioral and neurocognitive mechanisms, ready the next generation of researchers and practitioners in this area, and increase evidence-based policy."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF OREGON","value":997902,"savings":595861,"link":null,"description":"SUPPORTED EMPLOYMENT TO CREATE A COMMUNITY CULTURE OF SARS-COV-2 RAPID TESTING AMONG PEOPLE WHO INJECT DRUGS: PEERCONNECT2TEST - PROJECT SUMMARY THIS PHASE III PROJECT BUILDS ON THE SUCCESSES OF OUR PHASE I AND PHASE II PROJECTS BUT USES A NOVEL APPROACH TO ADAPT TO THE CHANGING PANDEMIC CONTEXT; FACILITATION OF RAPID TESTING BY PEOPLE WHO INJECT DRUGS (PWID) VIA A SUPPORTED EMPLOYMENT PROGRAM THAT TRAINS PWID AS PEER HEALTH WORKERS (PHW). PWID ARE VULNERABLE TO CONTRACTING SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) AND TO THE EFFECTS OF THE DISEASE CAUSED BY SARS-COV-2, CORONAVIRUS DISEASE 2019 (COVID-19) DUE TO STRUCTURAL DISADVANTAGE, HEALTH VULNERABILITIES, AND STIGMATIZATION THAT PREVENTS ADEQUATE ACCESS TO MEDICAL CARE. WHILE OUR PROJECT HAS PREVIOUSLY PROCESSED MORE THAN 6,000 SELF-COLLECTED POLYMERASE CHAIN REACTION (PCR) TESTS FOR PWID ACROSS THE STATE OF OREGON, THE EVER-CHANGING NATURE OF THE PANDEMIC, INCLUDING NEW VARIANTS AND THE AVAILABILITY OF SARS-COV-2 VACCINES, CALLS FOR ADDITIONAL STRATEGIES THAT CAN INCREASE ACCESS TO AND UPTAKE OF TESTING AMONG PWID. RAPID TESTS MAY OFFER AN ADVANTAGE OVER PCR TESTS FOR PWID EXPERIENCING STRUCTURAL VULNERABILITIES SUCH AS HOUSELESSNESS AND LACK OF ACCESS TO TECHNOLOGY SO THAT THEY CAN RECEIVE RESULTS IN REAL-TIME AND BE QUICKLY CONNECTED TO NEEDED RESOURCES. ACCESSIBILITY OF RAPID TESTING FOR PWID HAS BEEN PREVIOUSLY LIMITED BY WORKFORCE SHORTAGES AND THE INABILITY TO REACH PWID WHO NEED TESTING. WE PROPOSE A NOVEL COMMUNITY- ENGAGED STRATEGY TO IMPROVE THE ACCESSIBILITY OF RAPID TESTS THROUGH A SUPPORTED EMPLOYMENT PROGRAM FOR PWID, PEER CONNECT2TEST (PEERC2T), TO BECOME PHW TO DISTRIBUTE SARS-COV-2 RAPID TEST KITS TO OTHER PWID. WE EXPECT THAT PEERC2T WILL IMPROVE KNOWLEDGE, SELF-EFFICACY, AND HEALTH BEHAVIORS AMONG PHW (AIM 1). WE WILL USE THE RE-AIM FRAMEWORK IN AIMS 2 AND 3 TO EVALUATE WHETHER PEERC2T IMPROVES SARS-COV-2 TESTING UPTAKE AMONG OTHER PWID (RE; AIM 2) AND IDENTIFY INTERVENTION CONSIDERATIONS (AIM; AIM 3). THE OVERALL GOAL OF THIS PROJECT IS TO BUILD ON OUR PARTNERSHIP WITH HIVA TO DEVELOP A TRANSFORMATIVE COMMUNITY- DRIVEN INTERVENTION TO PROMOTE WIDESPREAD ACCESS TO RAPID TESTING AMONG PWID. WE WILL CONTINUE TO COLLABORATE WITH THE RADX-UP COORDINATION AND DATA COLLECTION CENTER. FINDINGS WILL CLARIFY THE IMPLICATIONS OF SUPPORTED EMPLOYMENT PROGRAMS FOR PWID FOR SARS-COV-2 TESTING UPTAKE AMONG PWID AND OTHER PUBLIC HEALTH EFFORTS TO IMPROVE HEALTH OUTCOMES AMONG PWID. THUS, FINDINGS FROM THIS STUDY MAY HAVE BROAD PUBLIC HEALTH IMPLICATIONS FOR LEVERAGING SUPPORTED EMPLOYMENT PROGRAMS FOR PWID TO PREVENT THE TRANSMISSION OF OTHER INFECTIOUS DISEASES."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF PUERTO RICO - MEDICAL SCIENCE CAMPUS","value":2091295,"savings":363997,"link":null,"description":"In Puerto Rico, the COVID-19 burden in the elderly population is significant as 23% of the confirmed COVID-19 cases and 75% of the deaths have been reported in this group with a low testing rate (3.4 per 100,000) in those > 65 years. The knowledge, beliefs, attitudes, and practices about the risk of infection from COVID-19, symptoms, testing and vaccination, remain a public health concern in Puerto Rico. In 2019, 21.3% of the population living in PR were elderly (> 65 years) with 43.3% living in poverty, were isolated, and medically vulnerable due to their chronic diseases. Isolation for elders has been exacerbated due to the high rate of migration of their family members that culturally cared and lookout for them. The Puerto Rico Community Action Research and Engagement (PR-CARE) initiative aims to focus on the elderly communities in PR who are disadvantaged by geography, sexual and/or gender identification, homelessness and/or income to identify how multiple factors serve to disadvantage this at-risk population in COVID-19 testing and vaccine uptake. Our well-established community partner network, using a mixed methods research strategy, has the goal of examining how social determinants of health, in addition to critical policy and environmental factors, address testing and vaccine access and uptake in elderly (> 65 years old) populations in Puerto Rico who suffer from high levels of social vulnerability (i.e., homeless), who are geographically isolated (i.e., living in isolated or rural areas), living in poverty, and gender or sexual diverse (i.e., L.G.B.T.T.Q.I.A.+). Our strategies are guided by four theoretical frameworks: Community Engagement Continuum, Intersectionality-Informed Approach, Anderson’s Behavioral Model of Health, and Historical Trauma. These models will enable us to portray a critical array of multi-domain determinants of health to understand health disparities and healthcare utilization, specifically COVID-19 testing, and vaccinations, in vulnerable elderly communities. Our aims are to: 1) assess federal and Puerto Rico Commonwealth policy implications on COVID-19 testing in low-resourced and socially vulnerable elderly in Puerto Rico; 2) examine individual and social determinants of health that influence the uptake of the COVID-19 diagnostics among low-resourced and socially vulnerable elderly in Puerto Rico and 3) combine results from the systematic policy review and key informants (Aim 1: qualitative) and elderly individuals (Aim 2: quantitative and qualitative) to identify challenges, barriers and effective strategies and language to support and improve COVID-19 testing and other related health outcomes in this vulnerable population. The community engagement research that comprises PR-CARE will work to expand the scope, reach, access to and uptake of COVID-19 testing for vulnerable elderly populations in Puerto Rico. Concurrently, it will identify and create permanent pathways in health policy that increase the availability of health services for vulnerable populations, promoting health equity using the lens of social, ethical, and behavioral implications."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"UNIVERSITY OF VERMONT","value":1228640,"savings":215393,"link":null,"description":"EVIDENCE BASED INTERVENTIONS TO ADDRESS STRUCTURE, SYSTEM AND POPULATION INEQUITIES IN COVID-19 SCREENING - THE PURPOSE OF THIS PROPOSAL IS TO IDENTIFY INDIVIDUAL, COMMUNITY (POPULATION) AND STRUCTURAL FACTORS ASSOCIATED WITH LOWER RATES OF COVID-19 TESTING IN NORTHERN NEW ENGLAND (NNE), WITH A FOCUS ON UNDERSERVED AND VULNERABLE POPULATIONS. OUR STUDY INCLUDES SEVERAL COVID-19 MEDICALLY AND/OR SOCIALLY VULNERABLE POPULATIONS: COMMUNITIES WITH HIGH LEVELS OF SOCIAL VULNERABILITY; COMMUNITY-DWELLING OLDER ADULTS; INDIVIDUALS WITH MEDICAL COMORBIDITIES KNOWN TO INCREASE RISK OF SEVERE COVID-19 AND, PARTICULARLY, RURAL AND REMOTE COMMUNITIES. ANALYTICALLY, WE WILL FIRST QUALITATIVELY ESTIMATE INDIVIDUAL, POPULATION AND STRUCTURAL FACTORS ASSOCIATED WITH HIGHER OR LOWER PROBABILITY OF HAVING BEEN TESTED FOR COVID-19 BY COMBINE COMPREHENSIVE ALL- PAYER CLAIMS DATA ACROSS TWO STATES WITH STATE-LEVEL COVID-19 TESTING DATA AND THE CDC VULNERABLE COMMUNITY INDEX. WE WILL ALSO ASSESS THE GEOSPATIAL DISTRIBUTION OF DISPARITIES IN COVID-19 TESTING IN NNE USING GEOGRAPHIC INFORMATION SYSTEM METHODS TO EXAMINE FACTORS LIKE TESTING CENTER DENSITY AND DISTANCE ON TESTING RATES. WE WILL EXPLOIT DIFFERENCES IN STRUCTURE BETWEEN VERMONT AND MAINE TO IDENTIFY SYSTEM LEVEL FACTORS, INCLUDING PROVIDER ACCESSIBILITY, TESTING AVAILABILITY AND PROVIDER PAYMENT RULES. OUR KEY OUTCOMES WILL BE COVID-19 TESTING, HOSPITALIZATIONS AND EXCESS MORTALITY AMONG UNDERSERVED AND VULNERABLE POPULATIONS IN NNE. WE WILL AUGMENT THE QUANTITATIVE ANALYSIS WITH FOCUS GROUPS TO IDENTIFY ADDITIONAL BARRIERS TO TESTING. WE WILL CONDUCT MULTIPLE FOCUS GROUPS WITH INDIVIDUALS FROM VULNERABLE POPULATIONS TO IDENTIFY BARRIERS TO COVID-19 TESTING. ONCE WE HAVE IDENTIFIED THE INDIVIDUAL, COMMUNITY (POPULATION) AND STRUCTURAL FACTORS THAT CREATE BARRIERS TO COVID-19 TESTING AND EXCESS MORTALITY, WE WILL TEST POTENTIAL INTERVENTIONS IN TWO DIFFERENT WAYS, FIRST, WE WILL DEVELOP AND DEPLOY A DISCRETE CHOICE EXPERIMENT (DCE) BOTH IN VULNERABLE COMMUNITIES IN NNE AND IN A NATIONALLY REPRESENTATIVE SAMPLE OF RURAL ADULTS TO TEST OPTIMAL STRATEGIES TO INCREASE TESTING USING HYPOTHETICAL SCENARIOS. SECOND, WE WILL TEST THE EFFECT OF TARGETED COMMUNICATION USING A RURAL COMMUNICATION NETWORK USING OPTIMAL COMMUNICATION STRATEGIES TO FACILITATE INCREASED TESTING AND TEST IF THE COMMUNICATIONS CHANGE INDIVIDUAL BEHAVIOR AND REDUCE HEALTH DISPARITIES. THIS STUDY WILL BE CONDUCTED IN PARTNERSHIP WITH THE DEPARTMENT OF HEALTH IN BOTH VERMONT AND MAINE AND NUMEROUS COMMUNITY PARTNERS."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"WASHINGTON STATE UNIVERSITY","value":1442425,"savings":396440,"link":null,"description":"ABSTRACT Marshallese Pacific Islanders bear a disproportionate burden of COVID-19 infection, hospitalization, and death, with rates 4 to 25 times higher than those of other US racial and ethnic groups in the Continental US.2,3 For example, in Northwest Arkansas Marshallese people represent less than 3% of the total population, but they account for 1 out of 5 COVID-19 cases in this area.2 Similarly, Marshallese represent just 1% of the population in Spokane County, Washington, but were nearly 30% of COVID-19 cases between March and May, 2020.4 Social determinants of health have powerful influences on community and individual risks for COVID-19.18 Culturally, the Marshallese community is extremely tight-knit, self-contained, and highly clustered; they often live in multi-generational households; and they traditionally value close contact and large social events, all of which increase vulnerability to the COVID-19 pandemic.19,20Marshallese are important recipients of effective surveillance efforts given the disproportionate impact of COVID-19 on this population and the long- standing disparities in health and health care. The MASC-UP study will generate novel data that reflect variation in risk of COVID-19 infection based on one’s place in the highly clustered Marshallese community. For Specific Aim 1, bilingual Marshallese Community Health Workers will recruit and train a longitudinal cohort of 800 Marshallese adults, ages 18 and older, in participatory disease surveillance methods that include using a wireless thermometer to continuously track body temperature; social media and text messaging in which participants (aka citizen scientists) can report symptoms; and a CHW helpline to report symptoms and request COVID-19 information. Participatory disease surveillance complements traditional surveillance systems by engaging communities in reporting COVID-19 symptoms and events. Its strengths lie in the speed at which data can be made available, the ability to scale the technology to obtain data at low cost, and the ability to cover populations that might not otherwise be tracked. For Specific Aim 2 participants will complete an ego-centric contact survey to characterize the social contact networks of members in the disease surveillance cohort from Aim 1. The networks will allow identification of people at highest risk of COVID-19 infection and elucidate targets for high-impact preventive intervention. For Specific Aim 3 we will integrate findings from Aims 1 and 2 into the existing test-based disease surveillance currently being performed at the state and local levels. This Aim will augment existing surveillance systems that have proved insufficient to stem the pandemic in Marshallese people. The proposed study will be generalizable to other high risk, clustered underserved populations."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"YALE UNIVERSITY","value":5687219,"savings":1873602,"link":null,"description":"ABSTRACT     Preparing SARS-­CoV-­2 testing data for reuse requires making the data syntactically and semantically equivalent.  Standardization  of  terminologies  and  a  common  data  model  accomplish  the  former,  while  the  latter  is  accomplished  through  understanding  the  data  and  making  it  comparable  across  RADx-­rad  awardees  by  benchmarking against known gold standards. The standardization of samples is as important as standardizing  the data, particularly in the highly innovative RADx-­rad program, where new technologies will be developed or  optimized for deployment in various settings. Highly motivated RADx-­rad awardees will receive advice on how  their diagnostics compare to FDA-­approved ones, with each other, how their diagnostic performs in independent  testing,  as  well as how  to ensure  the  tests  are usable  in  real  world  settings.  In  collaboration  with  University  of  Texas  Health  Science  Center  at  Houston,  University  of  California San  Diego  researchers  in  informatics/data  science and infectious diseases with ample experience in leading large consortia have designed a unique RADx-­ rad  Consortium  Data  and  Coordination  Center  (radCDCC).  This  center  is  based  on  three  pillars:  (1)  effective  administration and coordination among awardees, NIH, and other programs;; (2) innovative approaches and tools  to  collect  and  standardize  data  and  metadata  to  promote  findability,  accessibility,  interoperability  and  reuse  (FAIR)  for  data  sharing;;  and  (3)  principled  preparation  of  standardized  samples  with  known  quantities  of  viral  loads, and standardized procedures for testing new diagnostics to allow comparison across tests and calibration  of  new  technologies.  Backed  by  sophisticated  HIPAA-­compliant  cloud  services,  user  friendly  web-­tools,  and  extensive  support  from  UCSD’s  facilities  for  computation and  for  clinical  research,  the  radCDCC will  interface  with other RADx programs and other COVID-­19 focused programs at NIH to ensure alignment of awardees, NIH  and the public in the pursuit of effective, affordable, and deployable new technologies for testing.  "},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"YALE UNIVERSITY","value":1933875,"savings":566332,"link":null,"description":"Project Abstract Despite prolonged suppression of HIV on antiretroviral therapy (ART), eradication or sustained remission of the infection has not been achieved. Low levels of HIV DNA are still detectable in peripheral blood mononuclear cells (PBMC) from people living with HIV (PWH) taking ART, and cells containing rebound-competent virus can reside in sanctuary tissue sites, including lymph nodes, gut, genital tract and the central nervous system (CNS). In a study conducted within the AIDS Clinical Trials Group, we have recently used highly sensitive virologic assays in living donors to detect HIV DNA in cerebrospinal fluid (CSF) cells in up to 50% on long-term ART. Importantly, those with detectable CSF HIV DNA had poorer global cognitive function that those in whom CSF HIV DNA was not detected. We have subsequently shown higher concentrations of HIV DNA in CD4+ T cells from CSF compared to contemporaneous PBMC, and that atypical cell lineages including myeloid cells may be infected in CSF. Finally, we have successfully used single cell transcriptomics to identify unique and rare cell types in the CSF in PWH associated with HIV disease status and have further demonstrated the ability to identify cellular transcripts enriched in PWH versus healthy controls. Critical gaps in understanding CNS HIV persistence include what the characteristics and function of infected immune cells are in CSF, whether HIV proviruses in CSF are intact and genetically compartmentalized compared to proviruses in blood, and how these features relate to neuropsychiatric function of long-term HIV. Since the number of cells present in CSF is low in PWH suppressed on ART, thorough, simultaneous characterization of the immunologic and virologic landscape of the CNS has not been achieved. Using optimized lumbar puncture procedures and novel molecular techniques, we have overcome these obstacles to both rigorously examine the phenotype of CSF cells and thoroughly characterize the size, stability, intactness, and sequence diversity of persistent HIV in CSF compared to blood. We will use single cell technology to measure the transcriptional and cytokine profile of CNS cells combined with novel quantification of intact HIV DNA and single genome sequencing to discover new correlations within the CNS reservoir. Most importantly, we propose to rigorously examine the cognitive function and mental health of people living with HIV using sophisticated implementation of the new NIMH Research Domain Criteria (RDoC) framework, and how differences in neuropsychiatric outcomes relate to specific immunological and virological characteristics of the CNS in a diverse cohort of participants with a range of neuropsychiatric comorbidity."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"YALE UNIVERSITY","value":1137992,"savings":314336,"link":null,"description":"SUMMARY Patients with hematologic malignancies appear to have a higher risk of SARS-CoV-2 infection. Disease courses are variable in severity, influenced by immunosuppression due to the malignancy and its treatment determining the degree of immune-mediated hyperinflammation implicated in lung damage, multi-organ failure, and death. This highlights the need for comprehensive clinical tests to monitor COVID19 patients, specifically, with hematologic malignancies. We propose to develop and validate two novel immuno-serological assays that will be deployed to conduct longitudinal measurement of plasma markers and peripheral blood immune cells from COVID patients with different hematologic malignancies. First, we will develop an automated 32-plexed plasma protein assay to quantify SARS-COV-2 IgG/IgM antibodies, cytokines/chemokines, angiogenesis markers, endotheliopathy markers, and pro-thrombotic markers all combined in a high-density antibody barcode array microchip. Second, we will develop a microchip assay for single-cell immune function measurement to quantify cell types and 30+ immune effector proteins in peripheral blood immune from patients. Single-cell transcriptome sequencing will be performed on select samples to cross-validate the results and reveal the mechanisms of action in COVID-induced immune activation. Third, these new assays will be deployed to measure a cohort of COVID19 patients with or without hematological malignancies and healthy donors in order to identify potential molecular correlates with immune-mediated pathology and COVID disease severity uniquely in hematological cancer patients. As the COVID19 vaccines become available, we will apply these assays to monitoring vaccine-induced humoral, cellular, and immunological response in hematological cancer patients and compare to non-cancer populations to understand differences and ways to improve the success of vaccination in patients with hematologic malignancies – a vulnerable group of patients who may not follow the same mechanisms as general populations in COVID19."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"YALE UNIVERSITY","value":1139906,"savings":141300,"link":null,"description":"PROJECT SUMMARY The opioid epidemic is inextricably intertwined with our nation’s criminal justice system. At least 20% of people with opioid use disorder (OUD) were involved in the criminal justice system in 2016, and individuals just released from jail have an eight times higher risk of drug overdose compared with the general population after adjustment for age, gender, race, and residential neighborhood. Given this risk, several jails now treat OUD with medications, but these efforts will be ineffective if they fail to connect people to OUD treatment upon release. Housing instability, food insecurity, lack of social support, mistrust in the health system, and co-morbid physical and mental health conditions threaten a person’s ability to engage and remain in community OUD treatment. Prior work has not identified effective strategies to engage justice-involved individuals in OUD care that are feasible and honor patients’ values, preferences, and needs. Until this knowledge gap addressed, it will be difficult to reduce opioid-related morbidity and mortality in the United States. Our long-term goal is to reduce morbidity and mortality from OUD among justice-involved individuals. The overall objective of this study is to assess whether the Transitions Clinic Network (TCN) program, which provides enhanced primary care and OUD treatment for people recently released from incarceration, improves measures in the opioid treatment cascade. In TCN, formerly incarcerated community health workers are embedded within primary care teams and address social determinants of OUD, provide social support, help patients build trust in the health system and advocate in interactions with the criminal justice system. The central hypothesis of Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) study is that TCN program participation improves opioid treatment cascade measures among those just released from jails on medications for OUD. The underlying rationale for this study is that social needs must be addressed, in this case through a community health worker, to support OUD treatment engagement, and a primary care home provides an agile structure for people’s shifting priorities, needs, and preferences for OUD treatment following release. We will conduct a hybrid type I effectiveness-implementation trial and randomize 800 people on medications for OUD released from 6 local jails (Minneapolis, MN, Rochester, NY, Bridgeport, CT, Durham, NC, Caguas, PR, and Bronx, NY) to compare the effectiveness of the TCN intervention versus referral to standard primary care on opioid treatment cascade outcomes and whether housing, food access, criminal justice contact, and social support mediate this association. We will also study the cost effectiveness of the TCN, as well as barriers and facilitators to transitioning the care of people with OUD to the TCN. TCN PATHS is highly innovative in its partnership with and prioritization of the values of formerly incarcerated people. Together, the knowledge produced by this proposal will have a positive impact by evaluating the effectiveness of a new primary care-based approach to improving the health of justice-involved individuals with OUD."},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"AK ST DHSS","value":4767166,"savings":1535068,"link":null,"description":"SUBSTANCE ABUSE PREVENTION & TREATMENT BLOCK GRANT"},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"AK ST DHSS","value":5519877,"savings":127652,"link":null,"description":"SUBSTANCE ABUSE PREVENTION & TREATMENT BLOCK GRANT"},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"AL ST DEPARTMENT OF MENTAL HEALTH & MENTAL RETARDATION","value":18690785,"savings":6361543,"link":null,"description":"SUBSTANCE ABUSE PREVENTION & TREATMENT BLOCK GRANT"},{"date":"3/23/2025","agency":"Department of Health and Human Services","recipient":"AL ST DEPARTMENT OF MENTAL 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