NIH_SPENDING_CATS: Bioengineering;Biotechnology;HIV/AIDS;Immunization;Infectious Diseases;Nanotechnology;Prevention;Vaccine Related;Vaccine Related - AIDS

PROJECT_TERMS: Antigens;Clinical Trials;Contractor;Contracts;Databases;Development;Documentation;efficacy study;Equipment and supply inventories;HIV envelope protein;HIV vaccine;HIV-1;Human;immunogenicity;In Vitro;Investigational Drugs;Laboratories;Laboratory Animals;manufacture;nanoparticle;National Institute of Allergy and Infectious Disease;Phase;plasmid DNA;preclinical development;Preclinical Testing;Preventive vaccine;product development;Production;programs;Proteins;Protocols documentation;prototype;quality assurance;Quality Control;research clinical testing;stability testing;Testing;Toxicology;Vaccines;Viral Vector

PROJECT_TITLE: Long Term Stability Testing of a Nanoparticle Based HIV Envelope Containing Vaccine


ADMINISTERING_IC: AI

ARRA_FUNDED: N

FUNDING_MECHANISM: NON SBIR/STTR CONTRACTS

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Immunization;Prevention;Vaccine Related;Vaccine Related - AIDS

ORG_CITY: BETHESDA

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: TECHNICAL RESOURCES INTERNATIONAL, INC.

ORG_STATE: MD

PROJECT_TITLE: DAIDS Quality Assurance, Quality Control and Inspection Readiness Support Services


NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Immunization;Infectious Diseases;Prevention;Vaccine Related;Vaccine Related - AIDS

PI_NAMEs: HOLDEN, JESSICA  (contact)

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Clinical;Clinical Research;Clinical Trials;Contracts;Electronics;Funding;HIV/AIDS;International;National Institute of Allergy and Infectious Disease;operation;Research;Research Personnel;Services;Training

PROJECT_TITLE: NIAID/Division of AIDS: Regulatory Support Center


ADMINISTERING_IC: EY

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Clinical Research;Eye Disease and Disorders of Vision;Neurosciences

ORG_CITY: SAN FRANCISCO

ORG_NAME: SMITH-KETTLEWELL EYE RESEARCH INSTITUTE

ORG_STATE: CA

PHR: Results of the proposed experiments could refine strabismus diagnosis and intervention by suggesting that there is diagnostic value in characterizing separately each eye’s rotation dynamics. Furthermore, because the component mechanisms in our framework likely have different neural loci, their malfunction should manifest as distinct symptoms. Moreover, those different neural loci could vary in plasticity potential, and hence could respond differently to therapy, knowledge of which could improve intervention strategies for ocular misalignment disorders.

PI_NAMEs: HEINEN, STEPHEN J (contact)

PROGRAM_OFFICER_NAME: ARAJ, HOUMAM H

PROJECT_TITLE: Cortical and Brainstem Contributions to Binocular Eye Movements


ADMINISTERING_IC: AA

IC_NAME: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Basic Behavioral and Social Science;Behavioral and Social Science;Clinical Research;Pediatric;Substance Misuse;Underage Drinking

ORG_CITY: SANTA MONICA

ORG_NAME: RAND CORPORATION

PHR: Narrative The current supplement is submitted in response to NOFO PA-20-272, and will be utilized to cover unanticipated costs from the project related to participant retention, which required us to increase our incentive costs. The supplement will preserve the likelihood for the grant to successfully complete all aims and the original Council-approved scope of research.

PI_NAMEs: D'AMICO, ELIZABETH J. (contact)

PROGRAM_OFFICER_NAME: CASTLE, I-JEN

PROJECT_TERMS: Address;Adolescence;Adult;Age;alcohol and other drug;Alcohol consumption;cohort;Communities;cost;Data;Data Collection;Disparity;Drug usage;Education;ethnic diversity;Ethnic Origin;Gender;gender diverse;Grant;health related quality of life;Incentives;Individual;Life Cycle Stages;Longitudinal Studies;Outcome;participant retention;payment;Persons;Policy Maker;preservation;Publications;Race;racial diversity;Research;response;retention rate;Risk Behaviors;Role;Sampling;Surveys;Time;Work;young adult

PROJECT_TITLE: Life Course Perspective on Alcohol and Drug Use Trajectories from Adolescence into Adulthood


ADMINISTERING_IC: DK

FUNDING_MECHANISM: INTERAGENCY AGREEMENTS

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Kidney Disease;Palliative Care

PROJECT_TERMS: Address;American;Area;career;Caring;Chronic;Chronic Kidney Failure;Clinical;Communities;Congresses;cost;Country;Data;Data Reporting;Descriptive Epidemiology;Disease Surveillance;end of life care;End stage renal failure;Epidemiology;Incidence;Information Systems;Journals;Kidney;Kidney Diseases;meetings;Mentors;Mission;mortality;National Institute of Diabetes and Digestive and Kidney Diseases;Nephrology;Neptune;online resource;palliative;Paper;Patient Care;Pattern;Peer Review;Persons;Population;Prevalence;Publishing;Registries;Research;Research Personnel;Research Project Grants;Research Training;Resources;response;Role;Slide;Societies;Source;Statutes and Laws;Support System;Time trend;Training Programs;United States;Update

PROJECT_TITLE: United States Renal Data System (USRDS) CMS File Acquisition


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Prevention;Vaccine Related

ORG_CITY: IRVINE

ORG_NAME: UNIVERSITY OF CALIFORNIA-IRVINE

PI_NAMEs: FELGNER, PHILIP  (contact)

PROJECT_TITLE: Adjuvant Comparison and Characterization in Influenza , Chlamydia muridarum, and Coxiella burnetii Vaccines


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Vaccine Related

PROJECT_TERMS: adaptive immune response;Adjuvant;Antigens;Chlamydia muridarum;clinically relevant;Coxiella burnetii;Data Analyses;data management;Fingerprint;flu;Goals;Human;Immune;Immunologics;Influenza;Innate Immune Response;Mus;Organoids;programs;Side;Tissues;Tonsil;Vaccines;Work

PROJECT_TITLE: ADJUVANT COMPARISON AND CHARACTERIZATION


PROJECT_TITLE: Adjuvant Comparison and Characterization


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Asthma;Climate-Related Exposures and Conditions;Food Allergies;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Effects of Indoor Air Pollution;Lung;Machine Learning and Artificial Intelligence;Social Determinants of Health

ORG_CITY: SILVER SPRING

ORG_NAME: SOCIAL AND SCIENTIFIC SYSTEMS,  INC.

PI_NAMEs: FEINSTEIN, LYDIA  (contact)

PROJECT_TERMS: Acids;Air Pollution;airborne allergen;Allergens;Allergic;Allergic rhinitis;ambient air pollution;Analysis of Covariance;Antioxidants;Arithmetic;Asthma;asthma exacerbation;atopy;Autoimmunity;Biometry;C-reactive protein;Cardiopulmonary;Chronic Obstructive Pulmonary Disease;clinical practice;Complex;Confidence Intervals;Contractor;cost effectiveness;Data;Data Analyses;data centers;Data Collection;design;Development;Disease Outcome;Dust;Eczema;Endotoxins;Ensure;environmental health disparity;environmental tobacco smoke exposure;eosinophil;Epidemiologic Methods;Epidemiology;experience;Exposure to;food allergen;Funding;Future;Geographic Locations;gradient boosting;Health;Hypersensitivity;IgE;Inflammation;inflammatory marker;Least-Squares Analysis;Life;Linear Models;Logistics;Machine Learning;Manuscripts;meetings;Methods;Modeling;Morbidity - disease rate;mortality;National Health and Nutrition Examination Survey;National Institute of Environmental Health Sciences;Odds Ratio;Outcome;Pesticides;Pharmaceutical Preparations;Population Characteristics;Predictive Value;Prevalence;Procedures;programs;Publications;Quality Control;Research;Respiratory Disease;respiratory morbidity;response;Sampling;Secure;Series;Serum;Services;Sleep Disorders;Spirometry;Statistical Data Interpretation;Statistical Methods;Statistical Models;statistics;Stratification;Structure;Surveys;Symptoms;Techniques;United States;United States National Center for Health Statistics;Vitamins;Weight;Wheezing;working group

PROJECT_TITLE: TASK ORDER 6R - ASTHMA AND RESPIRATORY DISEASE RESEARCH (ARDR)


ADMINISTERING_IC: AG

ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Aging;Nutrition;Prevention

ORG_CITY: CLEVELAND

ORG_DEPT: BIOLOGY

ORG_NAME: CLEVELAND STATE UNIVERSITY

ORG_STATE: OH

PHR: Project Narrative. This project investigates connection between circadian clocks and mTOR signaling rhythms in calorie restriction. The circadian clock, mTOR pathway and calorie restriction are major regulators of metabolism and aging. The obtained data will help to develop a strategy for the treatment and prevention of age-associated diseases.

PI_NAMEs: KONDRATOV, ROMAN V (contact)

PROGRAM_OFFICER_NAME: FU, YI-PING

PROJECT_TERMS: Acute;Address;Affect;age-related disease;Aging;Amino Acids;Animals;ARNTL gene;Behavior;Behavioral;Blood;Caloric Restriction;Calories;cardiometabolism;circadian;circadian pacemaker;Circadian Rhythms;Complex;Data;detection of nutrient;Diabetes Mellitus;Diet;Dietary Intervention;dietary restriction;Disease;Energy Intake;Equilibrium;experimental study;extracellular;Fasting;feeding;Food;FRAP1 gene;Gene Expression;Genes;Glucose;Growth Factor;Health;Hour;improved;in vivo;Incidence;Insulin;Intake;Longevity;Malignant Neoplasms;Mammals;Metabolic;Metabolism;Modeling;Molecular;mTOR Signaling Pathway;Mus;Mutant Strains Mice;Nutrient;Organism;Pathway interactions;Periodicals;Phosphotransferases;Physiological;Physiology;Play;prevent;Prevention;programs;public health relevance;Publishing;Regulation;response;Role;Signal Transduction;System;Testing;Tissues;transcriptional reprogramming;treatment strategy;TSC1 gene;TSC1/2 gene

PROJECT_TITLE: Circadian Clock and Dietary Restriction

STUDY_SECTION: CSRS

STUDY_SECTION_NAME: Cellular Signaling and Regulatory Systems Study Section[CSRS]


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Breast Cancer;Cancer;Immunization;Prevention;Vaccine Related;Women's Health Research

ORG_CITY: OKLAHOMA CITY

ORG_NAME: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR

ORG_STATE: OK

PI_NAMEs: RAO, CHINTHALAPALLY V. (contact)

PROJECT_TERMS: advanced disease;Animal Model;Autoantigens;Biological Markers;Breast;cancer type;CCNE2 gene;cyclin E2;Data;design;Dose;Epitopes;ERBB2 gene;Estrogen Receptors;Evaluation;Genes;Immune response;Immunization;immunogenicity;Immunosuppression;in vivo evaluation;Individual;Isogenic transplantation;Malignant Breast Neoplasm;Malignant Neoplasms;Modeling;Molecular;mouse model;Mus;novel;novel vaccines;overexpression;Patients;Peptide Vaccines;Preclinical Drug Development;preclinical efficacy;prevent;Prevention;Preventive vaccine;Production;Progesterone Receptors;Program Development;Proteins;receptor;RNA vaccine;Route;Schedule;Survival Rate;TOP2A gene;triple-negative invasive breast carcinoma;tumor;Vaccine Antigen;Vaccines

PROJECT_TITLE: TO TITLE: A NOVEL MRNA VACCINE TO PREVENT TRIPLE NEGATIVE BREAST CANCERIDIQ TITLE: PREVENT CANCER PRECLINICAL DRUG DEVELOPMENT PROGRAM: PRECLINICAL EFFICACY AND INTERMEDIATE ENDPOINT BIOMARKERS


ADMINISTERING_IC: TW

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: FOGARTY INTERNATIONAL CENTER

NIH_SPENDING_CATS: Anxiety Disorders;Behavioral and Social Science;Brain Disorders;Clinical Research;Depression;HIV/AIDS;Infectious Diseases;Mental Health;Mental Illness;Pediatric;Physical Injury - Accidents and Adverse Effects;Post-Traumatic Stress Disorder (PTSD);Prevention;Social Determinants of Health;Women's Health Research

ORG_CITY: NAIROBI

ORG_COUNTRY: KENYA

ORG_FIPS: KE

ORG_NAME: UNIVERSITY OF NAIROBI

PHR: Project narrative There is a high prevalence of undiagnosed post-traumatic stress disorder (PTSD) and depression among women, conditions that are associated with poor adherence to antiretroviral therapy (ART) and poor retention in care. Evidence from observational and intervention studies demonstrates that trauma-focused cognitive behavioral therapy (TF-CBT) ameliorates symptoms of PTSD and depression and is an effective psychotherapeutic intervention for adults who have experienced interpersonal or complex trauma and sexual violence. Our study seeks to Determine prevalence of PTSD, depression and demoralization syndrome among women who are mothers of children exposed to or living with HIV and admitted to Kenyatta National Hospital (KNH) and Mbagathi County Hospital, their associations with women’s knowledge of HIV status, adherence to treatment and retention in care and whether TF-CBT is acceptable and effective in ameliorating the symptoms of these conditions on follow-up at 3 and 6 months post-intervention and improving HIV viral suppression.

PI_NAMEs: FARQUHAR, CAREY ;NDUATI, RUTH WANJIRU;WAMALWA, DALTON CHEKOKO (contact)

PROGRAM_OFFICER_NAME: BANSAL, GEETHA PARTHASARATHY

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Adherence;Admission activity;Adolescent;Adult;AIDS prevention;antiretroviral therapy;Anxiety Disorders;career;Caregivers;Caring;Characteristics;Child;Cognitive Therapy;Complex;County Hospitals;Depression screen;Diagnosis;Effectiveness;experience;Exposure to;Faculty;Feeling;follow-up;Foundations;Goals;High Prevalence;HIV;Hospitals;improved;Individual;innovation;Inpatients;Institution;Intervention Studies;Interview;Kenya;Knowledge;Life;Measures;Mediating;member;Mental Depression;Mental Health;Mothers;Observational Study;Outpatients;Parents;Personal Satisfaction;Post-Traumatic Stress Disorders;Prevalence;primary caregiver;psychologic;reduce symptoms;Research;Research Training;Resolution;Services;sexual violence;sociodemographics;Standardization;Syndrome;therapy adherence;tool;transmission process;Trauma;Universities;Viral;Woman

PROJECT_TITLE: Research Training on HIV Prevention and Treatment in Children and Adolescents


NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;HIV/AIDS;Prevention;Women's Health Research

ORG_CITY: NASHVILLE

ORG_NAME: VANDERBILT UNIVERSITY MEDICAL CENTER

ORG_STATE: TN

PHR: PROJECT NARRATIVE Gaps exist in use of biomedical informatics (BMI) approaches for research relevant to women living with HIV in Mozambique. The proposed research training program will address these gaps by building relevant research capacity at the intersection of BMI, HIV and women’s health using two approaches, namely: (1) a week-long research training workshop, and (2) a nine-month research certificate training program.

PI_NAMEs: CHILUNDO, BALTAZAR ;MOSSE, EMILIO LUIS;WERE, MARTIN CHIENG (contact);WESTER, C. WILLIAM

PROJECT_TERMS: Academic Medical Centers;Address;biomedical informatics;certificate program;Collaborations;Country;Educational workshop;Epidemic;Faculty;Funding;Goals;Health;Health Sciences;HIV;Informatics;informatics training;Information Sciences;Interdisciplinary Study;interest;life span;member;Mozambique;parent project;Parents;Participant;programs;Public Health Informatics;Research;Research Personnel;Research Project Grants;Research Training;Scientist;skills;Teacher Professional Development;Training;United States National Institutes of Health;Woman;Women's Health

PROJECT_TITLE: Vanderbilt-Mozambique Biomedical Informatics (VM-BMI) Training and Research capacity-building program on BMI approaches relevant to women living with HIV (WLWH) in Mozambique


ADMINISTERING_IC: FD

ED_INST_TYPE: SCHOOLS OF PHARMACY

IC_NAME: FOOD AND DRUG ADMINISTRATION

ORG_CITY: SAN JUAN

ORG_NAME: UNIVERSITY OF PUERTO RICO MED SCIENCES

ORG_STATE: PR

PHR: PROJECT NARRATIVE This proposal seeks the establishment of the Puerto Rico Racial & Ethnic Minority Acceleration Consortium for Health Equity (PR-REACH) to support the advancement of Hispanic Puerto Ricans health equity, this is a first step in a research agenda to collaborate with the Food and Drug Administration (FDA) Office of Minority Health and Health Equity (OMHHE) across REACH research projects and activities by first building an administrative research and communication infrastructure; leadership team, three EQUITY research cores (Clinical Trials, Voices and Data), a training and mentoring core, and an advisory team. A pilot study under this consortium will be conducted to advance the understanding of substance use disorder patients’ journey as perspectives, preferences and unmet needs regarding substance use disorder (SUD) treatment with FDA approved medications in PR to be able to improve its outcomes and launch PR-REACH in PR. The PR-REACH will initiate with Hispanics living in Puerto Rico as a model than can inform and guide subsequent extrapolation to Hispanics in the US in collaboration with the FDA.

PI_NAMEs: MARTINEZ GONZALEZ, KAREN G.;SANTIAGO, DARLENE I (contact)

PROGRAM_OFFICER_NAME: LEE, CHRISTINE


ADMINISTERING_IC: AR

ED_INST_TYPE: SCHOOLS OF MEDICINE

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Clinical Research;Microbiome

ORG_CITY: LOS ANGELES

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIVERSITY OF CALIFORNIA LOS ANGELES

PHR: RELEVANCE TO PUBLIC HEALTH Acne, the most common human skin disease, is associated with C. acnes, affects over 50 million people in the U.S., and has a significant psychological impact on patients affecting their self-esteem. This study will provide greater fundamental insights into mechanisms of how T helper cells primed by healthy skin commensals serve as a line of defense against breaching pathogens in acne. The discovery of C. acnes ligands will lead to the development of novel therapeutic approaches dysbiosis. for controlling acne and other human skin diseases caused by

PI_NAMEs: AGAK, GEORGE W (contact)

PROGRAM_OFFICER_NAME: UNDALE, ANITA H

PROJECT_TERMS: Acne;Acne Vulgaris;Affect;Affinity;anti-microbial peptide;Antigen-Presenting Cells;antimicrobial;Bacteria;Binding;Biological;Biopsy;Carbohydrates;Cell Differentiation process;cell type;Cells;Chromatin;Chronic;clinical investigation;Clone Cells;Complex;Coupled;Cutaneous;Data;Defense Mechanisms;Dendritic Cells;design;Development;disability;Disease;DNA;dysbiosis;Education;Equilibrium;experimental study;Exposure to;extracellular;Future;Gene Expression Profile;Genes;genetic element;genetic signature;Goals;Helper-Inducer T-Lymphocyte;Histone H2B;Histones;Homeostasis;Host Defense;Human;IL17 gene;Image;Immune;Immune response;Immune system;Immunologic Techniques;improved;Inflammasome;Inflammation;Inflammatory;Inflammatory Response;innovation;insight;Interferons;Interleukin-10;Journals;keratinocyte;Lesion;Ligands;lipidomics;Lipoproteins;Mass Spectrum Analysis;Mediating;Medical Care Costs;Metagenomics;Methodology;microbial;microbiome;microbiome sequencing;Modeling;Molecular;monocyte;neutrophil;Nonlytic;novel;novel strategies;novel therapeutic intervention;Nucleotides;pathogen;pathogenic bacteria;Pathway interactions;Patients;Persons;Play;potential biomarker;Probiotics;Proteomics;Psychological Impact;Psychological Stress;Public Health;receptor;Research;Resolution;response;Role;Scanning Electron Microscopy;self esteem;Signal Transduction;single-cell RNA sequencing;Skin;skin biopsy;skin disorder;skin lesion;skin microbiome;Specificity;Staphylococcus aureus;Stimulus;T-Lymphocyte;targeted treatment;Testing;therapeutic target;TLR1 gene;TLR2 gene;TLR6 gene;transcriptomics;whole genome

PROJECT_TITLE: Th17 extracellular trap-mediated antimicrobial host defense in acne vulgaris

STUDY_SECTION: ACTS

STUDY_SECTION_NAME: Arthritis, Connective Tissue and Skin Study Section[ACTS]


NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Clinical Research;Contraception/Reproduction;HIV/AIDS;Health Services;Infectious Diseases;Menopause;Prevention;Women's Health Research

ORG_NAME: KENYATTA  NATIONAL  HOSPITAL

PHR: This research aims to inform integration of menopause screening and management in HIV care in Kenya. The project will determine acceptability, barriers and facilitators of the integration of menopausal syndrome screening among women receiving HIV care, and develop a care package through a stakeholder-driven process. The proposed study will provide an opportunity for research training and mentorship for Dr. James Amenge and provide preliminary data for his K43 application.

PI_NAMEs: FARQUHAR, CAREY ;KINUTHIA, JOHN  (contact)

PROJECT_TERMS: Adherence;Age;cardiovascular disorder risk;Caring;Complement;Data;debilitating symptom;Diabetes Mellitus;Diagnosis;Disproportionately impacts women;Gynecologist;Health;Health Care Costs;health related quality of life;high risk;Highly Active Antiretroviral Therapy;HIV;Hospitals;improved;Kenya;Menopausal Symptom;Menopausal Syndrome;Menopause;Menstruation;Mentorship;Methods;Obesity;Persons;Physical activity;Process;Productivity;programs;Quality of life;Research Training;screening;Severities;Training;United States National Institutes of Health;Woman

PROJECT_TITLE: Acceptability, barriers and facilitators to integrating menopausal syndrome screening at Kenyatta National Hospital


NIH_SPENDING_CATS: Behavioral and Social Science;Cancer;Clinical Research;HIV/AIDS;Infectious Diseases;Mental Health;Women's Health Research

ORG_CITY: NEW ORLEANS

ORG_NAME: LSU HEALTH SCIENCES CENTER

ORG_STATE: LA

PHR: NARRATIVE Despite the progress in the fight against HIV/AIDS for over the last 40 years, women around the world remain disproportionately affected by HIV, especially in sub-Saharan Africa (SSA) where women living with HIV (WLWH) experience mental health illnesses like stress, depression, anxiety, and posttraumatic stress symptoms at higher rates than their male counterparts and more often than HIV-unaffected women. The overall objective of this supplement is to mentor and support a recently graduated female oncologist, Dr. Queen Tarimo and bridge her into HIV, mental health, and women’s health research, to characterize severity of depression and its impact on WLWH and how this condition affects their health outcomes. The proposed study is significant as it provides a unique opportunity for a new investigator to acquire new research skills in HIV, mental health, and women’s health as a stepping-stone to embark on HIV/AIDS research career, and the generated preliminary data will be important for future research and crucial in designing strategies to improve health outcomes for WLWH in SSA and beyond.

PI_NAMEs: MWAISELAGE, JULIUS DAVID;WOOD, CHARLES  (contact)

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Adherence;Affect;AIDS related cancer;Anxiety;Assessment tool;Biological Factors;career;CD4 Lymphocyte Count;comorbidity;Country;Data;design;Diagnosis;Disease;Enrollment;experience;fighting;Future;General Population;Health;HIV;HIV/AIDS;improved;Lead;male;Malignant Neoplasms;Mental Depression;Mental disorders;Mental Health;Mentors;Oceans;Oncologist;Outcome;Personal Satisfaction;Plasma;post-traumatic symptoms;Prevalence;Prevention;programs;Quality of life;Reproductive Health Services;Research;Research Personnel;Risk;Severities;sexual and reproductive health;skills;social factors;social norm;social stigma;Stress;Tanzania;Testing;Training;Training Programs;transmission process;Viral Load result;Woman;women faculty;Women's Health;women's outcomes;young man;young woman

PROJECT_TITLE: Tanzania AIDS Malignancies Training and Research Program (TAMTRP)


NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Dissemination and Implementation Research;HIV/AIDS;Prevention;Social Determinants of Health;Violence Against Women;Violence Research;Women's Health Research

ORG_CITY: ABUJA

ORG_COUNTRY: NIGERIA

ORG_FIPS: NI

ORG_NAME: INSTITUTE OF HUMAN VIROLOGY

PHR: PROJECT NARRATIVE Achieving HIV epidemic control includes actions to educate and mitigate against structural vulnerabilities such as male violence against women and girls especially intimate partner violence (IPV). We propose a survivor- provider co-creation approach to engage Women and Girls Living with HIV who are survivors of IPV to co-review and co-revise existing tools with IPV providers to effect context-specific, survivor-centered changes to improve IPV service appropriateness and impact.

PI_NAMEs: ABIMIKU, ALASH'LE G. (contact);SAM-AGUDU, NADIA A.

PROJECT_TERMS: Address;Adopted;Advocacy;Africa;African;aged;Bilateral;design;Ensure;Evaluation;evidence base;experience;federal policy;Female Adolescents;General Population;girls;High Risk Woman;HIV;HIV Infections;implementation science;intimate partner violence;Lateral;Legal;male;Methods;Nigeria;Persons;Policies;Pregnant Women;Prevalence;programs;Provider;Research Personnel;Research Training;Risk;service delivery;Services;sex;social culture;Structure;Survivors;tool;Woman;young woman

PROJECT_TITLE: Expanding the pool of Independent Investigators in Implementation Science in Nigeria throug h HIV research training (EXPAND)


ADMINISTERING_IC: DA

ED_INST_TYPE: OTHER SPECIALIZED SCHOOLS

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Clinical Research;Drug Abuse (NIDA only);Substance Misuse

ORG_CITY: CAMBRIDGE

ORG_DEPT: MISCELLANEOUS

ORG_NAME: MASSACHUSETTS INSTITUTE OF TECHNOLOGY

ORG_STATE: MA

PHR: Project Narrative Creating and maintaining a community of peers for SUD researchers is key to helping them advance the inception of new products that deliver effective solutions to address substance use disorders. This supplement aims to add ongoing interventions that will curate participation of peers from multiple cohorts, even when the program is not actively running, and will add industry experts to promote a self-driven community model. We will generate and track key metrics that quantify the emergence of self-driven interactions and their connection to curated activities

PI_NAMEs: BREAZEAL, CYNTHIA  (contact)

PROGRAM_OFFICER_NAME: LUKACS, JESSICA MICHELLE

PROJECT_TITLE: Program on Entrepreneurship and Innovation for Biomedical Product Development (EI4BPD)


ADMINISTERING_IC: EB

ED_INST_TYPE: UNIVERSITY-WIDE

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Disability Research;Patient Safety;Physical Rehabilitation;Rehabilitation

ORG_CITY: ANN ARBOR

ORG_NAME: UNIVERSITY OF MICHIGAN AT ANN ARBOR

ORG_STATE: MI

PHR: PROJECT NARRATIVE The proposed research is relevant to public health because the clinical application of powered prosthetic legs can significantly improve community mobility and therefore quality of life for nearly a million American amputees. As sit-to-stand motion is a particularly important indicator of mobility, this project will generate a method to safely control sit-to-stand motion for above-knee amputees using a powered knee-ankle prosthesis while developing novel techniques to quantify safety. This aligns with the missions of the Mathematical Modeling, Simulation and Analysis program area of the NIBIB and the Devices and Technology Development program area of the NICHD National Center for Medical Rehabilitation Research.

PI_NAMEs: RAZ, DAPHNA RAQUEL (contact)

PROGRAM_OFFICER_NAME: GUTEKUNST, DAVID JOSEPH

PROJECT_TERMS: Address;Adopted;Adoption;Agreement;Algorithms;American;Amputation;Amputees;ankle prosthesis;Area;Artificial Leg;Back Pain;Behavior;Benchmarking;Biological;Certification;Characteristics;clinical application;Communication;Communities;Computer software;Computer Systems;Data Set;design;Development;Device or Instrument Development;Device Safety;Devices;Dimensions;Ensure;Environment;Exhibits;Failure;falls;Feedback;Force of Gravity;Formulation;Goals;Hip region structure;Human;human subject;improved;Individual;Infusion Pumps;insight;Joints;kinematics;Knee;Leg;Link;Literature;Lower Extremity;Mathematical Model Simulation;Mathematics;Measures;Mechanics;Medical center;Medical Device;Medical Device Safety;meetings;Methods;Mission;Modeling;Motion;Movement;Muscle;National Institute of Biomedical Imaging and Bioengineering;National Institute of Child Health and Human Development;novel;Outcome;Pacemakers;parent project;patient mobility;Performance;Phase;Physics;powered prosthesis;Procedures;Process;Production;Program Development;programs;Prosthesis;prosthesis wearer;Public Health;Quality of life;rehabilitation research;Research;Residual state;Risk;Safety;Side;simulation;sound;Source;Specific qualifier value;System;Techniques;technology development;Testing;Thigh structure;time interval;tool;Torque;Validation;Walking;Work

PROJECT_TITLE: Supplement: Design and Model-Based Safety Verification of a Volitional Sit-Stand Controller for a Powered Knee-Ankle Prosthesis


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Diabetes;Emerging Infectious Diseases;Infectious Diseases;Prevention;Wound Healing and Care

ORG_CITY: CORAL GABLES

ORG_NAME: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE

ORG_STATE: FL

PHR: Narrative Diabetic foot infection is one of the most detrimental complications in diabetic population and along with impaired wound healing a main contributor of lower leg amputations in diabetic patients, resulting in a major impact to patients’ quality of life and significant burden and associated costs to the health care system. Our long term goal is to target intracellular pathogens in patients with diabetic foot ulcers (DFUs) by understanding mechanisms by which human skin fights intracellular infection and participates in wound healing. We will implement this knowledge to develop novel advanced therapeutic approaches to prevent and treat diabetic wound and skin infections.

PI_NAMEs: PASTAR, IRENA ;STRBO, NATASA ;TOMIC-CANIC, MARJANA  (contact)

PROGRAM_OFFICER_NAME: LI, YAN

PROJECT_TERMS: Acceleration;Acute;acute wound;Adult;Affect;Agonist;Amputation;Animal Model;Anti-Bacterial Agents;antimicrobial;Bacteria;Cells;Chronic;Clinical;comparative genomics;Complications of Diabetes Mellitus;cost;Cutaneous;Data;Data Set;Development;diabetic;Diabetic Foot;Diabetic Foot Ulcer;Diabetic mouse;diabetic patient;diabetic ulcer;diabetic wound healing;Down-Regulation;effective therapy;Epithelium;Evaluation;Exposure to;extracellular;fighting;FOXM1 gene;Functional disorder;Gene Expression Profile;Genetic Transcription;Genus staphylococcus;Goals;healing;Healthcare Systems;Human;human model;Immune;Impaired wound healing;Impairment;in vivo;Infection;Infection prevention;Infectious Skin Diseases;Inflammasome;Inflammation;Inflammatory Response;Innate Immune Response;insight;Intervention;keratinocyte;Knowledge;Leg;limb amputation;Lower Extremity;Macrophage;Mediating;methicillin resistant Staphylococcus aureus;microbiome;microorganism;Modeling;Molecular;Morbidity - disease rate;mortality;mouse model;Mus;neutrophil;new therapeutic target;non-diabetic;novel;novel therapeutic intervention;Outcome;pathogen;Pathogenesis;Pathogenicity;Pathway interactions;Patients;perforin 2;Phagocytes;Population;prevent;Prevention;Process;Proteins;Quality of life;Recurrence;response;Risk;Role;Sampling;Skin;Small Interfering RNA;Staphylococcus aureus;Staphylococcus aureus infection;Staphylococcus epidermidis;Testing;Therapeutic;Tissue Preservation;Tissue Sample;Tissues;TLR1 gene;TLR2 gene;TLR6 gene;Transcriptional Regulation;transcriptomics;treatment strategy;Ulcer;Work;wound;wound environment;wound healing;Wound Infection;Wound models;γδ T cells

PROJECT_TITLE: Prevention of intracellular infection in diabetic wounds by commensal Staphylococcus epidermidis


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Mental Health;Neurosciences

ORG_CITY: WORCESTER

ORG_DEPT: NEUROSCIENCES

ORG_NAME: UNIV OF MASSACHUSETTS MED SCH WORCESTER

PHR: Project Narrative The goal of the proposed project is to elucidate and characterize neurons and circuits in the brain that, in response to stress, increase motivation for reward seeking as a coping behavior. It is anticipated that this work will yield new insights into stress-activated brain areas that drive reward behavior and consumption to reduce the effects of stress in the brain and potentially contribute to neuropsychiatric disorders where these coping behaviors are dysregulated.

PI_NAMEs: TAPPER, ANDREW R (contact)

PROGRAM_OFFICER_NAME: FERNANDEZ, FERNANDO R

PROJECT_TERMS: Acute;acute stress;addiction;Animals;Anxiety;anxiety-like behavior;Area;Aversive Stimulus;avoidance behavior;base;Behavior;behavioral response;Binge Eating;Biological Assay;Brain;Brain region;Calcium Signaling;Consumption;coping;Coping Behavior;coping mechanism;Coping Skills;Data;Development;Dopamine;dopaminergic neuron;drug of abuse;drug withdrawal;Electrophysiology (science);Exhibits;experimental study;Exposure to;Fiber;fighting;Foundations;Goals;Grooming;Hypothalamic structure;in vivo;insight;Instinct;Intake;interpeduncular nucleus;laterodorsal tegmentum;Link;maladaptive behavior;Measures;Medial;Mediating;Mental Depression;Monitor;motivated behavior;Motivation;Mus;neural circuit;Neurons;Neuropeptides;neuropsychiatric disorder;neurotransmission;Nicotine;novel;novel therapeutic intervention;Optics;optogenetics;Pathway interactions;Pharmaceutical Preparations;Photometry;Population;preference;Proxy;response;Rewards;Risk Factors;Rodent Model;Role;selective expression;Self Administration;sensor;single cell sequencing;Slice;Somatostatin;Stimulus;Stress;Stress and Coping;stress reduction;Stress Tests;stressor;Sucrose;Testing;Ventral Tegmental Area;Viral;Work

PROJECT_TITLE: Neurocircuitry of motivated reward-seeking after stress

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-ICN-Y(02)M]


ED_INST_TYPE: SCHOOLS OF NURSING

ORG_CITY: TALLAHASSEE

ORG_NAME: FLORIDA STATE UNIVERSITY

PHR: PROJECT NARRATIVE  The advent of remote technologies such as video conferencing and secure web-portals have revolutionized approaches to health data collection and access to healthcare, where these technologies can be deployed in fully remote and hybrid approaches for clinical trials which could help promoting more participation among under-represented groups as well as by bridging geographic distance and reducing participant burden (e.g., less travel time, more flexibility and confidentiality). However, these approaches have yet to be optimized for all possible beneficiaries of technological advances in clinical trials and healthcare, especially targeting under- represented populations that are disproportionately experiencing social and geographic isolation. To address these concerns, the current proposal seeks to leverage the team’s existing community connections in states across 4 different regions of the U.S. among the Asian American and Pacific Islander (including Native Hawaiian), American Indian, Hispanic/Latino, and sexual and gender minority populations to: (1) (a) co-create and maintain 4 virtual and hybrid advisory groups to address health issues and (b) develop materials for the conduct of remote advisory groups; (2) co-develop and administer a national needs assessment survey for the referenced 4 groups (N = 800) addressing the use of home self-testing technology (up to 3 types) and remote data collection for healthcare research and healthcare provision; and (3) pilot community driven approaches to introducing home self-testing technology and remote data collection to potential participants from these groups to assess feasibility and acceptability.

PI_NAMEs: FLORES MILLENDER, EUGENIA  (contact);WONG, FRANK Y.;XAVIER HALL, CASEY DANIEL

PROJECT_TITLE: Elevating Community Voices by Developing a User-centered Approach to Enable Self-testing and Remote Data Collection among Under-represented Populations (Project Elevate)


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Aging;Cystic Fibrosis;Genetics;Lung;Orphan Drug;Pediatric;Rare Diseases

ORG_CITY: NORFOLK

ORG_NAME: OLD DOMINION UNIVERSITY

ORG_STATE: VA

PHR: Project Narrative: Chronic inflammation in Cystic Fibrosis (CF) impairs mucociliary clearance and creates an aging environment that further damages the lung. This proposal will evaluate the efficacy of using an epigenetic modulator to target cellular senescence in the CF lung as a novel therapeutic strategy, which is independent of CFTR modulator therapy and suitable for an aging CF population.

PI_NAMEs: KRICK, STEFANIE ;SANDERS, YAN  (contact)

PROGRAM_OFFICER_NAME: LACHOWICZ-SCROGGINS, MARRAH ELIZABETH

PROJECT_TERMS: Acceleration;Adult;Affect;Age;age acceleration;age related changes;age-related disease;Aging;aging mechanism;aging population;aging process;Air;Airway Disease;airway inflammation;anti aging;ATAC-seq;Binding;Binding Sites;Bromodomain;bronchial epithelium;Caring;Cell Aging;Cell Physiology;Cells;cellular targeting;Characteristics;Chemicals;Child;Childhood;Chromatin;Chronic;Chronic Disease;combat;Cystic Fibrosis;cystic fibrosis airway;cystic fibrosis patients;Cystic Fibrosis Transmembrane Conductance Regulator;cytokine;Data;demographics;Disease;drug development;efficacy evaluation;Elements;enhancer-binding protein AP-4;Enhancers;Environment;Epigenetic Process;epigenetic regulation;Epithelial Cells;experience;Family;Fibrosis;Functional disorder;Gene Expression;Gene Expression Profile;Genes;Genetic;Genetic Transcription;hallmarks of aging;Hematology;Histone Acetylation;Impairment;improved;Inflammaging;Inflammation;Inflammation Mediators;Inflammatory;inhibitor;insight;Interleukin-1 alpha;Interleukin-6;Knock-out;Life Expectancy;Liquid substance;Lung Diseases;lung injury;lung preservation;Mediating;member;Methods;Modeling;Morbidity - disease rate;mortality;Mucociliary Clearance;Mus;Noise;novel;novel therapeutic intervention;novel therapeutics;Pathogenesis;Patients;Persons;Phase I/II Clinical Trial;Population;Process;Production;programs;promoter;Proteins;Pulmonary Cystic Fibrosis;pulmonary function;Rattus;Reader;recruit;Regenerative capacity;Regulatory Element;Reporting;Role;senescence;senescence associated secretory phenotype;senescent cell;Solid Neoplasm;Testing;therapeutic target;Tissues;Transcription Coactivator;transcription factor;Transcription Factor AP-1;Transforming Growth Factor beta

PROJECT_TITLE: Epigenetic Modulation of Cellular Senescence in the Cystic Fibrosis Lung

STUDY_SECTION: LCMI

STUDY_SECTION_NAME: Lung Cellular, Molecular, and Immunobiology Study Section[LCMI]


ORG_CITY: BALTIMORE

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF MARYLAND BALTIMORE

PHR: PROJECT NARRATIVE This two-phase “health equity acceleration” U01 application is submitted to participate in the FDA OMHHE Health Equity Innovation Award for “Racial & Ethnic Minority Acceleration Consortium for Health Equity (REACH) (U01)” focused on advancing “minority health and health equity focused research, outreach, and communications as well as support training and mentoring of diverse HBCU advanced students, fellows, and researchers.” Two pilot projects/programs submitted in this application will be developed under Phase 1, and subsequently implemented under Phase 2: a) A Pilot curriculum on “Regulatory Issues and Health Equity” and potential FDA OMHHE rotations for advanced students and faculty in HBCUs in Pharmacy (XULA College of Pharmacy) and Nursing (Helene Fuld School of Nursing CSU); and b) A Pilot research project which will move the discussion beyond barrier identification to develop strategies to address barriers to clinical trial diversity, in order to increase trustworthiness, enhance transparency in sponsors and researchers, and bolster willingness to participate for African Americans, thereby strengthening equity in participation of underrepresented minority racial and ethnic groups in clinical trials.

PI_NAMEs: BAQUET, CLAUDIA R0SE (contact)

PROJECT_TITLE: Racial and Ethnic Minority Acceleration for Health Equity Consortium U01


ORG_CITY: HONOLULU

ORG_NAME: QUEEN'S MEDICAL CENTER

ORG_STATE: HI

PHR: Project Narrative Our project will create a “Hawai‘i Health Equity Research and Outreach Network (HAWAI‘I HERON)” that will provide resources to support efforts to improve health equity for Asian American, Native Hawaiian and other Pacific Islander (AA-NHPI) populations. This work will be in collaboration with the Food and Drug Administration and other minority-serving institutions and will include a pilot study examining AA-NHPI patient preferences for diabetes medications. HAWAI‘I HERON has the potential to strengthen health equity focused research, outreach and communications, and training and mentoring of diverse students and junior researchers.

PI_NAMEs: SETO, TODD B (contact);TAIRA, DEBORAH ANN


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Biotechnology;Clinical Research;Conditions Affecting the Embryonic and Fetal Periods;Gene Therapy;Genetics;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Human Genome;Pediatric;Precision Medicine;Prevention;Social Determinants of Health

ORG_CITY: SAN FRANCISCO

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

PHR: Project Narrative This “Pathway to Independence” research training application tracks the emergence of fetal gene therapy, and it is designed to improve knowledge about the complex intersection between scientific, clinical, patient and societal values and longer-term health (in)equity. For the mentored portion, in-depth ethnographic observations (including interviews) will be augmented by 1) education in clinical genetics, genomics, and therapeutics, 2) methodological training in normative analysis, and 3) political science training in deliberative community engagement. The research examines immediate clinical and patient concerns, followed by community engagement with the public, to determine how fetal gene therapy is or is not socially inclusive – as a key step in ensuring attention to health equity goals in preventive precision medicine based on prenatal gene therapy.

PI_NAMEs: BROWN, JULIA E.H. (contact)

PROGRAM_OFFICER_NAME: LOCKHART, NICOLE C

PROJECT_TERMS: Affect;Animal Model;Area;Attention;Award;Bioethics;California;career;Child;Clinic;Clinical;clinical decision-making;Collaborations;Communities;community consultation;community engagement;Complement;Complex;cost;Data;Decision Making;design;Diagnosis;Diagnostic;Disease;Education;Ensure;Environment;Enzymes;Equity;Ethical Analysis;ethical, legal, and social implication;Ethics;Ethnography;Exclusion;Exercise;Expectancy;experience;Feedback;fetal;Fetal Research;Fetus;frontier;Future;Gene Modified;gene therapy;Gene therapy trial;Genes;Genetic;genetic counselor;Genetic Diseases;Genome;genome editing;Genomic medicine;Genomics;Germ Lines;Goals;Health;health care availability;health care disparity;health disparity;health equity;health inequalities;Healthcare;Human Genetics;human genomics;improved;in utero;Inequity;Infrastructure;innovation;innovative technologies;Intervention;Interview;Knowledge;knowledge translation;maternal morbidity;Maternal Mortality;maternal risk;Medical Genetics;member;Mentors;Mentorship;Methodology;Methods;Molecular;Morbidity - disease rate;National Human Genome Research Institute;Outcome;Parents;Pathway interactions;Patient Preferences;Patients;Phase I Clinical Trials;Politics;postnatal;pre-clinical;precision medicine;Pregnancy;prenatal;prenatal therapy;Preventive;Preventive treatment;Process;programs;prospective;Public Participation;repaired;Reproductive Health;Reproductive Technology;Research;Research Training;Sampling;San Francisco;Scholarship;Science;Scientific Advances and Accomplishments;Shapes;Site;skills;social;social disparities;social inclusion;Social support;Social Values;socioeconomics;stem cells;Strategic vision;Structure;Technology;Therapeutic;therapy development;Thinking;Time;Training;Uncertainty;Universities

PROJECT_TITLE: The Emergence of Prenatal Gene Therapy: An "Embedded Ethics" Ethnography investigating Clinical, Scientific and Societal Values

STUDY_SECTION: NSS

STUDY_SECTION_NAME: NSS


ORG_CITY: RALEIGH

ORG_NAME: NORTH CAROLINA COMMUNITY HEALTH CTR/ASSN

ORG_STATE: NC

PHR: NARRATIVE: Increasing the diversity of clinical trial participants is key to advancing health equity. This project aims to increase the recruitment of diverse participants in research through established provider and community health worker relationships in minority communities using new, interactive community driven curricula.

PI_NAMEs: HAYES, REBECCA  (contact)

PROJECT_TITLE: Improving Multicultural Engagement in Clinical Research through Partnership with Federally Qualified Health Centers and Community Health Worker Programs


ADMINISTERING_IC: DE

ED_INST_TYPE: HOSPITALS

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Clinical Research;Dental, Oral, and Craniofacial Disease;Digestive Diseases;Prevention;Rare Diseases

ORG_CITY: HOUSTON

ORG_DEPT: SURGERY

ORG_NAME: UNIVERSITY OF TX MD ANDERSON CAN CTR

ORG_STATE: TX

PHR: PUBLIC HEALTH RELEVANCE  Oral cavity cancers are preceded by precursor lesions and are preventable if diagnosed early. However, it is challenging to maintain high-frequency clinical follow-ups for every patient with these very common precursor lesions, most of which will never become cancers, and the current pathology grading is often inconsistent and does not predict cancer risks. Thus, this program will leverage high-fidelity pre-clinical modeling, human specimens, precision engineering, and single-cell technologies to develop transformative on- slide and optical biopsy tools for the earliest detection of high-risk pre-malignant oral cavity lesions.

PI_NAMEs: CHINN, STEVEN BENNETT;LEI, YU LEO (contact);WANG, THOMAS D

PROGRAM_OFFICER_NAME: WAN, JASON

PROJECT_TERMS: Affinity;Agreement;American Dental Association;Ancillary Study;Automobile Driving;base;Benign;Binding;Biology;Biopsy;Cancer Patient;cancer risk;Caring;CD8-Positive T-Lymphocytes;Cells;Clinical;clinical examination;clinical translation;clinically significant;cohort;Collection;Color;Complement;Cytology;Detection;Development;Diagnostic;diagnostic criteria;Discriminant Analysis;Disease;Early Diagnosis;Engineering;Epidermal Growth Factor Receptor;Epithelial Cells;Epithelium;Evaluation;Event;Exclusion;Exhibits;FDA approved;Frequencies;Genetically Engineered Mouse;glucose metabolism;Glycolysis Pathway;Goals;Head and Neck Squamous Cell Carcinoma;high risk;Histologic;Histology;Histopathologic Grade;HPV-negative head and neck cancer;Human;Image;Immune;improved;in vivo;Induration;Inflammatory;Interferon Type I;Intraepithelial Neoplasia;Keratosis;Lasers;Learning;Lesion;Leukoplakia;Lichen Planus;Link;Longitudinal cohort;Machine Learning;Malignant - descriptor;malignant mouth neoplasm;Malignant Neoplasms;Marker Discovery;mechanical signal;Mechanics;Membrane;Metabolic;Methods;microendoscopy;Microscopic;Modality;Modeling;Molecular;molecular marker;Molecular Target;Monitor;Myeloid Cells;Myeloid-derived suppressor cells;non-invasive monitor;novel;Oncogenes;Oncogenic;Optical Biopsy;Oral cavity;oral cavity epithelium;Oral Leukoplakia;Oral Lichen Planus;Oral mucous membrane structure;oral premalignancy;overexpression;Pathology;Pathway interactions;Patients;Persons;Phase;Pre-Clinical Model;premalignant;Prevention;prognostic;prognostic value;programs;public health relevance;Resolution;Resources;response;Risk;Risk Marker;Signal Transduction;single cell technology;SLC2A1 gene;Slide;spatial relationship;Specimen;standard of care;success;suicide rate;Surface;Survival Rate;T-Lymphocyte;Tactile;Technology;Tissues;tool;tumor DNA;Tumor Escape;United States Food and Drug Administration;Up-Regulation;Validation

PROJECT_TITLE: Advancing On-Slide and Optical Biopsy Tools to Detect High-Risk Oral Premalignancy


NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;HIV/AIDS;Infectious Diseases;Prevention;Women's Health Research

ORG_CITY: NEW HAVEN

ORG_NAME: YALE UNIVERSITY

ORG_STATE: CT

PHR: Currently, Georgia struggles to reach women at high risk of HIV with PrEP, a powerful preventive intervention. This pre-implementation project employs nominal group technique focus groups and a choice-based conjoint approach to survey women with elevated HIV risk—including partners of people who inject drugs, women sex workers, transgender women, and women who use drugs—to understand barriers and preferred delivery methods for PrEP. The goal is to design a more accessible and women-friendly program that empowers these women to protect their health and remain HIV-negative.

PI_NAMEs: ALTICE, FREDERICK LEWIS (contact);ESSERMAN, DENISE ;KIRTADZE, IRMA

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Adherence;AIDS prevention;Computer Assisted;design;Effectiveness;Eligibility Determination;Focus Groups;Friends;Goals;High Risk Woman;HIV;HIV Infections;HIV risk;Injecting drug user;insight;Interview;Location;Methadone;Methodology;Needles;parent grant;peer;Pharmaceutical Preparations;pre-exposure prophylaxis;preference;prevent;prevention service;programs;recruit;Research;Risk;Sample Size;screening;sex;social engagement;Social Workers;Syringes;System;transgender women;uptake;Visit;Woman

PROJECT_TITLE: Identifying Challenges and Opportunities for PrEP Uptake Among Women at Elevated HIV Risk in Georgia


ED_INST_TYPE: SCHOOLS OF EDUCATION

ORG_CITY: MINNEAPOLIS

ORG_NAME: UNIVERSITY OF MINNESOTA

ORG_STATE: MN

PHR: Project Narrative Above-normal systolic blood pressure is a highly prevalent chronic condition that increases risk for cardiovascular diseases, stroke, cognitive decline/dementia, and other chronic disorders, due in part to blood pressure-associated vascular dysfunction mediated by increased oxidative stress and consequent reductions in nitric oxide (NO)-bioavailability. Healthy lifestyle practices are first-line therapies to lower systolic blood pressure; however, adherence to time-intensive lifestyle interventions is poor, due in large part to time- availability related barriers. This clinical trial seeks to establish the efficacy of high-resistance inspiratory muscle strength training, a novel time-efficient lifestyle intervention, for lowering systolic blood pressure; improving endothelial, cerebrovascular, and cognitive function; decreasing oxidative stress; and increasing NO bioavailability in adults age 50 years and older with above-normal systolic blood pressure.

PI_NAMEs: CRAIGHEAD, DANIEL HARRISON (contact)

PROGRAM_OFFICER_NAME: PRICE, CANDICE

PROJECT_TERMS: Acute;Adherence;Adult;Aerobic Exercise;Age;aged;arterial stiffness;Ascorbic Acid;Biological Availability;Biomedical Research;Biopsy;Blood flow;Blood Flow Velocity;Blood Pressure;blood pressure elevation;blood pressure reduction;Blood Vessels;brachial artery;Canada;Cardiovascular Diseases;cardiovascular disorder risk;Cardiovascular Physiology;cardiovascular risk factor;career development;cerebral artery;cerebrovascular;Cerebrovascular Disorders;Cerebrovascular Physiology;cerebrovascular reactivity;Chronic;Chronic Disease;Clinical;Clinical Trials;clinically relevant;Cognitive;cognitive enhancement;cognitive function;cognitive performance;Colorado;comorbidity;Conduct Clinical Trials;Data;Dementia;Development;Development Plans;Diastolic blood pressure;disorder risk;Doctor of Philosophy;Double-Blind Method;Dropout;efficacy evaluation;efficacy testing;Elasticity;Endothelial Cells;endothelial dysfunction;Endothelium;Environment;evidence base;experience;Extramural Activities;Faculty;Femur;Functional disorder;Funding;Goals;Guidelines;healthy lifestyle;Hour;Hypercapnia;Hypertension;hypertensive;Impaired cognition;improved;Infusion procedures;Inhalation;innovation;Internal carotid artery structure;International;Intervention;Journals;lifestyle intervention;Link;Mediating;Medical;Medicine;meetings;men;Mentors;middle cerebral artery;modifiable risk;Molecular;muscle strength;Nature;new epidemic;Nitric Oxide;novel;Obstructive Sleep Apnea;older adult;Oxidative Stress;Patients;Peripheral;Physiologic pulse;Physiology;pilot trial;Population;Postdoctoral Fellow;pressure;prevent;Process;Production;professor;programs;Proteins;Protocols documentation;Randomized Controlled Clinical Trials;Records;Research;Research Personnel;Research Priority;Research Project Grants;Research Training;Resistance;response;Rest;Risk;Scientist;seal;Secondary to;Serum;Signaling Molecule;skill acquisition;skills;Sodium-Restricted Diet;strength training;Stroke;Superoxides;Techniques;therapy development;Time;Training;treatment duration;United States;United States National Institutes of Health;Universities;Vascular Diseases;Vascular Endothelium;Woman;Work

PROJECT_TITLE: Novel time-efficient inspiratory muscle strength training for lowering systolic blood pressure and improving endothelial, cerebrovascular, and cognitive function

STUDY_SECTION: MCBS

STUDY_SECTION_NAME: NHLBI Mentored Clinical and Basic Science Study Section[MCBS(MA)]


NIH_SPENDING_CATS: HIV/AIDS;Infectious Diseases

ORG_CITY: SAINT LOUIS

ORG_NAME: WASHINGTON UNIVERSITY

ORG_STATE: MO

PHR: PROJECT NARRATIVE Finding a permanent cure for people living with HIV is a key priority of the NIH and requires broad and inclusive basic science research into how the virus remains latent in people on antiretroviral therapy. However, although over 70% of HIV patients live in Africa, very little of the basic science of cure research involves African patients who are predominantly women, a key gap that needs urgent remedy. This D43 training supplement will support a post-doctoral fellow and a master's level trainee to perform basic science and cure research relevant to women living with HIV.

PI_NAMEs: KYEI, GEORGE  (contact);SHAN, LIANG

PROJECT_TERMS: Affect;Africa;African;African Women;Basic Science;Caucasians;CD4 Positive T Lymphocytes;co-infection;Collaborations;design;Doctor of Philosophy;Enrollment;Europe;Exclusion;experience;Funding;Genetic Transcription;Ghana;graduate student;Grant;Hepatitis;HIV;Human Papillomavirus;Immunologics;Laboratory Research;Medical Research;memory CD4 T lymphocyte;men;Mentors;Mentorship;parent grant;Patients;Persons;Postdoctoral Fellow;programs;Proviruses;Research;Research Infrastructure;Research Personnel;Research Project Grants;Research Training;Scientist;skills;Students;success;T cell response;Training;Training Programs;Tuberculosis;United States National Institutes of Health;Universities;Viral;Washington;Woman

PROJECT_TITLE: HIV Basic Science and Cure Research Training for Scientists at the University of Ghana (H-Cure-RT)


NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Drug Abuse (NIDA only);Harm Reduction for Substance Misuse;Health Services;Methamphetamine;Physical Injury - Accidents and Adverse Effects;Prevention;Social Determinants of Health;Stimulant Use and Misuse;Substance Misuse;Substance Misuse Prevention

ORG_CITY: BLOOMINGTON

ORG_NAME: CHESTNUT HEALTH SYSTEMS, INC.

ORG_STATE: IL

PHR: PROJECT NARRATIVE Oregon’s decision makers (e.g., community service providers, public health, justice, advocacy groups, payers) are calling for comprehensive, current, and trusted data to inform how they allocate resources to improve substance use services and mitigate the growing opioid and methamphetamine epidemics in their state. Consistent with the HEAL Data2Action call for Innovation projects that drive action with data in real-world settings, this study will refine and test the impact of a novel policy implementation strategy to engage cross- sector decision makers and make data that they identify as relevant to their decisions available to them in easy- to-use products. The proposed study aims to not only address critical knowledge gaps regarding how and when data can inform impactful, transparent decision-making, but to provide decision makers with the data that they need to achieve community-wide substance use prevention and treatment goals, including the increased delivery of evidence-based, culturally-responsive services and the prevention of overdoses.

PI_NAMEs: CRUDEN, GRACELYN  (contact)

PROGRAM_OFFICER_NAME: LYNCH, SEAN EDWARD WINTERS

PROJECT_TERMS: Address;Advocacy;Advocate;authority;behavioral health;Charge;Collaborations;Communities;community partners;Community Services;comparative;Consult;Contracts;County;Criminal Justice;dashboard;Data;Data Collection;data dissemination;data infrastructure;data repository;data sharing;data standards;Decision Making;design;Epidemic;evidence base;Funding;Goals;Harm Reduction;Health;Health Resources;Helping to End Addiction Long-term;Housing;human centered design;Hybrids;implementation strategy;improved;Individual;Infrastructure;innovation;Interview;Justice;Knowledge;Law Enforcement;lens;Link;Measures;Methamphetamine;methamphetamine use;Methods;Monitor;novel;Opioid;opioid misuse;opioid overdose;opioid use;Oregon;Outcome;Outcome Measure;Output;Overdose;overdose death;overdose prevention;peer;Pharmaceutical Preparations;Phase;pilot test;Policies;Population;population health;Preparation;prevent;Process;programs;Protocols documentation;Public Health;Randomized;Recommendation;Recovery Support;reduced substance use;Reporting;Resource Allocation;satisfaction;scale up;service delivery;service gap;service providers;Services;simulation;Statutes and Laws;Structure;substance use;substance use prevention;substance use treatment;success;System;Testing;Time;Trust;United States;United States National Institutes of Health;usability;user-friendly;Wait Time

PROJECT_TITLE: Supporting data-driven decision-making to support substance use service expansion policies and to prevent overdoses


NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Cocaine;Drug Abuse (NIDA only);Eating Disorders;Genetics;Mental Health;Mental Illness;Neurosciences;Nutrition;Obesity;Stimulant Use and Misuse;Substance Misuse

ORG_CITY: ROCHESTER

ORG_NAME: MAYO CLINIC ROCHESTER

PHR: PROJECT NARRATIVE The purpose of this project is to elucidate genes responsible for compulsive appetite – an overlapping ramification of drug and obesogenic diet histories – in rats. Candidate genes will be identified and validated in food-reactive neurons thought to function as “accelerators” on food motivation. Our hope is that such knowledge can be used to identify novel therapeutic targets for compulsive behavior across eating disorders and drug addiction.

PI_NAMEs: SUTO, NOBUYOSHI  (contact)

PROGRAM_OFFICER_NAME: POLLOCK, JONATHAN D

PROJECT_TERMS: Ablation;Acceleration;addiction;adverse outcome;Affect;Alcohols;Amygdaloid structure;Animal Model;Appetite Regulation;Appetitive Behavior;Behavioral;Binge eating disorder;Brain;Brain region;Bulimia;Calories;Candidate Disease Gene;Cell Separation;Cells;Cocaine;comorbidity;Compulsive Behavior;Data;Desire for food;detection platform;Diet;Dietary History;Down-Regulation;Drug Addiction;drug craving;Drug usage;Eating;Eating Disorders;Etiology;Fatty acid glycerol esters;Food;food craving;Gene Expression;Gene Expression Profiling;gene induction;General Population;Genes;Genetic Risk;genetic risk factor;Genetic Transcription;hedonic;Homeostasis;Incentives;inducible Cre;Intake;Knowledge;Life;Link;Liquid substance;Metabolic;Methods;Motivation;neural;neurobiological mechanism;Neuronal Plasticity;Neurons;new therapeutic target;Nucleus Accumbens;obesogenic;Patients;Pharmaceutical Preparations;Pilot Projects;Publishing;Punishment;Rattus;Recording of previous events;recruit;Regulation;Research;Resistance;Rewards;Saccharin;Shock;Site;Stimulus;Study models;sugar;System;Testing;transcriptome sequencing;vapor;Weight Gain

PROJECT_TITLE: Neural activity-based candidate gene identification to link eating disorders and drug addiction

STUDY_SECTION: MCNP

STUDY_SECTION_NAME:
Molecular and Cellular Neuropharmacology Study Section
[MCNP]


NIH_SPENDING_CATS: Brain Disorders;Clinical Research;Data Science;Drug Abuse (NIDA only);Emergency Care;Harm Reduction for Substance Misuse;Health Services;Opioid Misuse and Addiction;Opioids;Physical Injury - Accidents and Adverse Effects;Prevention;Substance Misuse;Substance Misuse Prevention

ORG_DEPT: EMERGENCY MEDICINE

PHR: Project Narrative We propose, in collaboration with the American College of Emergency Physicians (ACEP), to accelerate the development of emergency care data systems within a national data registry and advance national overdose prevention efforts. Our proposal will create a data system that automates extraction of data from emergency departments across the US to create research datasets and Emergency Department (ED) opioid used disorder (OUD) dashboards for quality improvement and a national web-based dashboard for public health surveillance. Our proposal will result in access to high quality, standardized, near-real time ED OUD care measure data that can improve care and outcomes across clinical, research and surveillance dimensions.

PI_NAMEs: HAWK, KATHRYN ;TAYLOR, RICHARD ANDREW;VENKATESH, ARJUN KRISHNA (contact)

PROGRAM_OFFICER_NAME: KURAMOTO-CRAWFORD, SATOKO JANET

PROJECT_TERMS: Acceleration;Accident and Emergency department;acute care;Acute myocardial infarction;Address;Algorithms;American;Automation;Benchmarking;Buprenorphine;Caring;Centers for Disease Control and Prevention (U.S.);Cessation of life;Clinical;clinical care;Clinical Trials;Clinical Trials Network;Collaborations;college;cost effectiveness;dashboard;Data;data access;Data Collection;data dashboard;Data Element;data infrastructure;data modeling;data registry;Data Set;design;Development;digital;Dimensions;Drug usage;Ecosystem;Education;Electronic Health Record;Emergency Care;Emergency Department patient;Emergency Department Physician;Epidemic;Evaluation;FAIR principles;Future;General Population;Healthcare Systems;High Prevalence;implementation research;improved;improved outcome;Individual;Information Systems;Infrastructure;Intervention;Maps;Measures;Medical;Methadone;mortality;Naloxone;naloxone dispensing;National Institute of Drug Abuse;Observational Study;Online Systems;opioid mortality;opioid overdose;opioid use disorder;Outcome;Overdose;overdose death;overdose prevention;Patient-Focused Outcomes;Patients;Pharmaceutical Preparations;Phase;Population Surveillance;Prevention;Prevention education;Process;prototype;Public Health;Quality of life;Readiness;Registries;Research;response;Safety;Sepsis;Site;Standardization;Stroke;Substance Use Disorder;Surgeon;System;therapy development;Time;Translating;Translational Research;United States;Vertebral column;Work

PROJECT_TITLE: Leveraging Data to Action: Accelerating Emergency Department OUD Care by Improving Data Access and Infrastructure


NIH_SPENDING_CATS: Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;Drug Abuse (NIDA only);Harm Reduction for Substance Misuse;Opioid Misuse and Addiction;Opioids;Physical Injury - Accidents and Adverse Effects;Prevention;Substance Misuse;Substance Misuse Prevention

ORG_CITY: INDIANAPOLIS

ORG_DEPT: PEDIATRICS

ORG_NAME: INDIANA UNIVERSITY INDIANAPOLIS

ORG_STATE: IN

PHR: PROJECT NARRATIVE The continued rise in overdose rates and sheer number of preventable overdose deaths suggest a need to improve practices of widely-established overdose fatality review (OFR) teams by shifting OFRs away from case review and toward using timely, population-level data to better inform their recommendations and actions. Thus, we will provide OFRs with a real time overdose-related dashboard and data-driven decision making training. We anticipate that our proposed intervention will lead to better quality, actionable OFR recommendations; increased OFR actions to implement evidence-based overdose strategies based on dashboard data; and long term reductions in both fatal and nonfatal overdoses.

PI_NAMEs: AALSMA, MATTHEW  (contact);RAY, BRADLEY ;REDA, KHAIRI

PROJECT_TERMS: Accidents;Address;Adherence;Affect;Attitude;Centers for Disease Control and Prevention (U.S.);Cessation of life;Charge;Child;Childhood;Collection;Communities;comorbidity;contextual factors;County;dashboard;Data;Data Aggregation;data dashboard;data infrastructure;data repository;Decision Making;design;Development;Drug usage;effectiveness outcome;emotional trauma;Ensure;Epidemic;Event;evidence base;Evidence based treatment;Fatality rate;Goals;Guidelines;Harm Reduction;Health;Helping to End Addiction Long-term;implementation outcomes;implementation process;Imprisonment;improved;Indiana;Individual;Intervention;Interview;Legal;Link;member;Modeling;mortality;multidisciplinary;multiple data sources;neglect;Opiate Addiction;Opioid;opioid misuse;opioid use disorder;Outcome;Overdose;overdose death;overdose prevention;Overdose reduction;overdose risk;Performance;Pharmaceutical Preparations;Pharmacotherapy;Phase;Philosophy;Pilot Projects;Policy Making;Population;Practice Guidelines;Prevention strategy;programs;Proliferating;Public Health;Public Health Practice;Qualifying;Randomized;Recommendation;Recording of previous events;Research;Research Design;Resources;Risk Factors;Rural;service gap;Services;social;Social Work;Source;Speed;stimulant use disorder;success;Surveys;System;systems research;Testing;Time;time use;tool;Training;Translating;trial comparing;United States National Institutes of Health;uptake;usability;user centered design;Visualization

PROJECT_TITLE: Fatal Overdose Review Teams - Research to Enhance Surveillance Systems (FORTRESS)


ADMINISTERING_IC: VA

IC_NAME: Veterans Affairs

ORG_CITY: NASHVILLE

ORG_NAME: VETERANS HEALTH ADMINISTRATION

PHR: Millions of patients survive care in medical and surgical Intensive Care Units (ICUs) every year, only to suffer from a new or accelerated dementia-like process, called post-ICU long-term cognitive impairment (ICU-LTCI). ICU-LTCI causes considerable problems with personal relationships, return to work, and everyday tasks, such as managing medicines and money. No treatment for these patients is currently available. Technology using computerized cognitive rehabilitation could improve ICU-LTCI by harnessing the healing potential of the brain (i.e., neuroplasticity). This intervention is scalable, portable, and economical. We will evaluate the effectiveness of computerized cognitive rehabilitation in a randomized controlled trial of 160 VA patients with ICU-LTCI. We hypothesize that this intervention could improve cognition, and brain structure shown by MRI. This research has high potential to influence rehabilitation strategies for Veteran and civilian ICU survivors.

PI_NAMEs: ELY, E WESLEY (contact);PATEL, MAYUR B

PROJECT_TERMS: Acceleration;active duty;Admission activity;Affect;aging brain;Air;Alzheimer's Disease;American;Anatomy;arterial spin labeling;Automobile Driving;Award;Blinded;blood oxygenation level dependent response;Brain;brain dysfunction;Brain Injuries;brain research;Caring;Case Series;cerebral atrophy;Cerebrovascular Circulation;Cessation of life;Chronic;clinical center;Cognition;Cognitive;cognitive rehabilitation;computer game;computerized;Critical Illness;Data;Dementia;Diagnosis;Disabling;Dose;Education;effectiveness evaluation;Elderly;Employment;Enrollment;Epidemiology;Episodic memory;Executive Dysfunction;executive function;Functional disorder;Funding;healing;Healthcare Systems;Hospitals;Hour;Image;Impaired cognition;Impairment;improved;Incidence;Independent Living;innovation;Intensive Care Units;Intervention;Life;Magnetic Resonance Imaging;marine;Measures;Medical;Medication Management;Medicine;Memory;Methods;Neuronal Plasticity;Neuropsychology;novel;Operative Surgical Procedures;Outcome;Patients;Phase;portability;primary outcome;Process;processing speed;Protocols documentation;Public Health;Randomized;randomized, clinical trials;Randomized, Controlled Trials;rehabilitation strategy;Rehabilitation therapy;Research;Research Personnel;Research Training;Resources;Risk Factors;Severities;Short-Term Memory;Signal Transduction;Structure;Surgical Intensive Care;Survivors;survivorship;Tablets;Technology;Tennessee;Testing;Time;Training Programs;Translating;Traumatic Brain Injury;United States Department of Veterans Affairs;Veterans;Work

PROJECT_TITLE: Returning to Everyday Tasks Utilizing Rehabilitation Networks-III Pilot Randomized Clinical Trial (RETURN-III Pilot RCT)

STUDY_SECTION_NAME: Behavioral Health & Social Reintegration[RRD4]


ORG_STATE: MD

PHR: Narrative Statement We propose continuation of M-CERSI that fosters FDA-oriented research, as well as regulatory science information sharing opportunities. The Center's mission is to foster the development of regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Activities leverage the close geographic proximity between University of Maryland and FDA's main campus.

PI_NAMEs: BENTLEY, WILLIAM E.;POLLI, JAMES E (contact)

PROGRAM_OFFICER_NAME: SEPULVEDA, KRISTIN

PROJECT_TITLE: University of Maryland Center of Excellence in Regulatory Science and Innovation


NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Drug Abuse (NIDA only);Health Services;Opioid Misuse and Addiction;Opioids;Pediatric;Recovery Support Services;Substance Misuse

ORG_CITY: NEW YORK

ORG_NAME: PARTNERSHIP TO END ADDICTION

ORG_STATE: NY

PHR: Project Narrative Opioid use disorder (OUD) prevalence rates have reached unprecedented levels among adolescents and emerging adults, and treatment engagement and retention for this population are alarmingly poor. For youth with substance use disorders, developmental theory underscores the primacy of family-level risk and protective factors, and family-based interventions have the strongest empirical support. This study will systematically build a research and technical assistance infrastructure designed to develop and evaluate innovative family- based recovery support services for youth with OUD that span the all phases of the services cascade: screening and referral, treatment initiation, treatment delivery, and continuing care.

PI_NAMEs: HOGUE, AARON  (contact)

PROGRAM_OFFICER_NAME: MARTIN, LINDSEY ANN

PROJECT_TERMS: acute care;Adolescent;Affect;Assertiveness;Behavior;Behavioral;behavioral health;Caregivers;Caring;Child Rearing;Client;Clinical;Clinical Protocols;Companions;Decision Making;Dedications;design;Development;digital intervention;Dimensions;Education;Electronic Mail;emerging adult;Enrollment;Environment;Evaluation;Expectancy;Family;family support;Focus Groups;Fortification;Goals;Government;Health Professional;Health Services Research;Individual;Infrastructure;innovation;Institution;Intervention;Measurement;Measures;medication-assisted treatment;meetings;Mental Health;Mentors;Modeling;Morbidity - disease rate;Motivation;Network Infrastructure;novel;opioid use disorder;Outcome;outreach;Parents;Pathway interactions;peer;Persons;Phase;Physicians;pilot trial;Population;Prevalence;Product Labeling;protective factors;Protocols documentation;Provider;psychoeducation;R24;Readiness;Recovery;recovery services;Recovery Support;Research;Research Activity;Research Infrastructure;Research Institute;Research Personnel;Research Support;Resource Development;Resources;Risk Factors;satisfaction;Scientist;screening;service engagement;service intervention;service providers;service uptake;Services;skills;Specialist;Substance Use Disorder;success;Telephone;Testing;Text;theories;Training;treatment adherence;Youth

PROJECT_TITLE: Family-based Recovery Support Service Network for Youth OUD


ORG_CITY: LA JOLLA

ORG_NAME: SCRIPPS RESEARCH INSTITUTE, THE

ORG_STATE: CA

PHR: Type 1 diabetes (T1D), a prototypic CD4 T cell mediated autoimmune disease, is believed to have a prolonged pre-clinical phase that lasts many years. We will use circulating anti-insulin CD4 T cells as a real-time biomarker of islet autoimmunity to diagnose subclinical disease in at-risk population and decide of therapeutic intervention. The proof of principle of this approach has been established in a small cohort of patients enrolled in the TrialNet consortium.

PI_NAMEs: TEYTON, LUC  (contact)

PROGRAM_OFFICER_NAME: SPAIN, LISA M

PROJECT_TERMS: Autoimmune Diseases;Biological Markers;Blood;Blood donor;C-Peptide;CD4 Positive T Lymphocytes;CD8-Positive T-Lymphocytes;Cells;Childhood;Clinical;cohort;Collection;Color;Compensation;Diagnosis;Disease;Early Diagnosis;Engineering;Epitope spreading;Equation;Family;Frequencies;Funding;G6PC2 gene;Genes;Goals;HLA-A1 Antigen;HLA-A2 Antigen;HLA-DQ2;HLA-DQ8 antigen;HLA-DR4 Antigen;Human;Hybridomas;Individual;Insulin;Insulin-Dependent Diabetes Mellitus;islet autoimmunity;Longitudinal Studies;Measures;Mediating;Mus;Outcome;Participant;participant enrollment;Patients;Peptides;Phase;Populations at Risk;pre-clinical;Process;Production;Proteins;prototype;Reagent;Recommendation;Research Design;Risk;Sampling;Schedule;Series;single cell analysis;Stains;T-Cell Activation;T-Cell Receptor;T-Lymphocyte;Testing;Text;Therapeutic Intervention;Time;Validation;Variant

PROJECT_TITLE: Early diagnosis and mechanistic studies of type 1 diabetes using single cell analysis

STUDY_SECTION: HAI

STUDY_SECTION_NAME: Hypersensitivity, Autoimmune, and Immune-mediated Diseases Study Section[HAI]


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Eye Disease and Disorders of Vision;Physical Injury - Accidents and Adverse Effects

ORG_CITY: CHICAGO

ORG_DEPT: DERMATOLOGY

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

PHR: PROJECT NARRATIVE  Information from this project will impact on our understanding of pathological mechanisms of corneal mustard gas keratopathy (MGK), which has been associated with persistent epithelial defect, corneal haze, neovascularization, conjunctivalization, and even blindness. These studies will provide insight into how specific inhibition of induced autophagy may relieve or even reverse such detrimental conditions.

PI_NAMEs: PENG, HAN  (contact)

PROGRAM_OFFICER_NAME: ARAJ, HOUMAM H

PROJECT_TERMS: Acute;Adverse effects;Affect;Alkylating Agents;analog;Attenuated;Autophagocytosis;BCL-2 Protein;Binding;Biological Assay;Blindness;Cell Physiology;cell type;Cells;Chemical Exposure;Chemical Warfare Agents;Chronic;Classification;Clinical;Co-Immunoprecipitations;Complex;Cornea;corneal epithelium;Corneal Injury;Corneal Neovascularization;Data;Defect;Development;Disease;Dissociation;Endothelium;Epithelial Cells;Epithelium;Exposure to;Eye;eye dryness;Foundations;gain of function;Gases;Gene Modified;Goals;Graft Rejection;Homeostasis;Human;immune cell infiltrate;improved;In Vitro;in vivo;Inflammation;Injury;insight;Keratopathy;Knowledge;Laboratories;Lesion;Ligation;Lighting;limbal;loss of function;Maintenance;Measures;Mechlorethamine;Mediating;Microscopy;Modeling;Molecular;mouse model;Mus;Mustard;Mustard Gas;mutant;Mutant Strains Mice;neovascularization;novel;novel therapeutics;ocular surface;Organelles;Pathologic;Pathway interactions;patient subsets;Phase;Play;prevent;Process;Proteins;Recycling;Reporter;Repression;Research Personnel;response;Role;single-cell RNA sequencing;Stimulus;Stress;Symptoms;Testing;three dimensional structure;Tissues;ultra high resolution;Vision;Wild Type Mouse

PROJECT_TITLE: Ocular mustard keratopathy elicits induced autophagy, which is detrimental to the cornea


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Genetics;Infectious Diseases;Malaria;Rare Diseases;Vector-Borne Diseases

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: WEILL MEDICAL COLL OF CORNELL UNIV

PHR: Project Narrative Malaria is an infectious disease that continues to cause extensive morbidity and mortality throughout tropical and sub-tropical regions of the developing world, especially among young children in sub-Saharan Africa. This project focuses on the ability of malaria parasites to avoid the human immune response and to cause severe disease. A better understanding of these processes will lead to new forms of treatment that will help to relieve the enormous public health burden that malaria inflicts on the developing world.

PI_NAMEs: DEITSCH, KIRK W (contact)

PROGRAM_OFFICER_NAME: MCGUGAN, GLEN C

PROJECT_TERMS: Adhesions;Adhesives;Africa;Africa South of the Sahara;African;Anemia;Antibodies;Antibody Response;Antigenic Variation;Babesia;Binding;Biological Process;Blood Vessels;Cell surface;Cells;Cerebral Malaria;Characteristics;Child;chromatin modification;chronic infection;Communicable Diseases;Communication;Data;design;Disease;Endothelium;Epigenetic Process;Epitopes;Erythrocytes;Event;exhaust;Exposure to;Family;Freezing;Gene Activation;Gene Deletion;Gene Expression;Gene Family;Gene Modified;gene network;Gene Order;Gene Silencing;Gene Structure;Genes;Genetic Transcription;Genome;Haploidy;Heart;Human;Immune response;Immune system;Individual;Infection;Infectious Agent;Length;Malaria;malaria infection;mathematical model;Mediating;member;Membrane Proteins;Modeling;Molecular;Morbidity - disease rate;mortality;Mutation;Nature;Nonsense-Mediated Decay;Open Reading Frames;parasite genome;parasite invasion;Parasitemia;Parasites;Pattern;Persons;Phenotype;Placenta;Plasmodium;Plasmodium falciparum;Play;Population;Positioning Attribute;Pregnancy;Pregnant Women;Probability;Process;Property;Proteins;Public Health;receptor;Reporter;Role;Severities;Structure;Surface;Surface Antigens;Switch Genes;Syndrome;System;Testing;Time;Trypanosoma;Virulence;Work

PROJECT_TITLE: A structured transcriptional switching network that coordinates antigenic variation by malaria parasites

STUDY_SECTION: PTHE

STUDY_SECTION_NAME: Pathogenic Eukaryotes Study Section[PTHE]


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases

ORG_CITY: ANN ARBOR

ORG_DEPT: CHEMISTRY

ORG_NAME: UNIVERSITY OF MICHIGAN AT ANN ARBOR

PHR: Project Narrative The research funded by this proposal aims to understand how changes in cellular metabolism help cells fight viral infections. Broadly, this metabolic reprograming involves changes in the activity of numerous enzymes in cell, but how this is accomplished remains to be understood. A better understanding of this process may help facilitate the development of improved treatments for viral infections and other diseases.

PI_NAMEs: MARSH, E NEIL (contact)

PROGRAM_OFFICER_NAME: SIMONOVIC, MILJAN

PROJECT_TERMS: Anti-viral Agents;Anti-viral Response;Biochemical;Biological;Cell Line;Cell membrane;Cells;Cholesterol;Complex;Development;Disease;DNA-Directed RNA Polymerase;Endoplasmic Reticulum;enzyme mechanism;Enzymes;Eukaryotic Cell;Fatty Acids;fighting;Flavivirus;Funding;HIV/HCV;Human;Immune signaling;improved;Infection prevention;Influenza A virus;Innate Immune Response;Interferons;Mammalian Cell;Metabolic;Metabolic Pathway;Metabolism;Mitochondria;Nucleotides;Outcome;oxidation;Pathway interactions;Process;Property;protein protein interaction;Proteins;Regulation;Research;Research Support;response;RNA Viruses;Signal Pathway;Transfection;ubiquitin ligase;United States National Institutes of Health;viperin;Viral;Viral Physiology;Viral Proteins;Virus;Virus Diseases;Virus Inhibitors;Virus Replication

PROJECT_TITLE: Mechanisms of Enzyme Regulation by Viperin in the Cellular Antiviral Response


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Brain Disorders;Epilepsy;Neurodegenerative;Neurosciences;Physical Injury - Accidents and Adverse Effects;Traumatic Head and Spine Injury

ORG_CITY: BIRMINGHAM

ORG_DEPT: ANATOMY/CELL BIOLOGY

ORG_NAME: UNIVERSITY OF ALABAMA AT BIRMINGHAM

ORG_STATE: AL

PHR: Project Narrative  Impaired astrocyte coupling is associated with epilepsy, but there is no consensus on whether reduced coupling promotes or counteracts abnormal neuronal activity, which precedes seizures. Targeting astrocytic Cx43 might be an option, but the first step towards therapy is determining when reduced coupling is adaptive and when it is maladaptive. This proposal uses new tools and technology to determine if the timing and duration of reduced astrocyte coupling may determine if seizures are promoted or counteracted, and will identify critical upstream signaling causing reduced astrocyte coupling as a foundation for future therapeutic targeting.

PI_NAMEs: ROBEL, STEFANIE  (contact)

PROGRAM_OFFICER_NAME: LEENDERS, MIRIAM

PROJECT_TERMS: acquired epilepsy;Affect;anti-epileptic agents;Astrocytes;Cells;Connexin 43;Consensus;Coupling;Development;Drug Targeting;Epilepsy;Foundations;Functional disorder;Future;Gap Junctions;Impairment;in vivo;Induced Neurons;Intractable Epilepsy;Knockout Mice;mild traumatic brain injury;Modeling;mutant;Mutate;Neurologic;Neurons;Pathology;Patients;Persons;Phosphorylation;Post-Translational Protein Processing;prevent;Proteins;Regulation;research and development;Seizures;Serine;Shapes;Signal Transduction;Technology;Testing;therapeutic target;tool;Traumatic Brain Injury;Viral

PROJECT_TITLE: Dynamic temporal regulation of astrocyte coupling to shape neuronal activity during acquired epilepsy development


ADMINISTERING_IC: OD

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Bioengineering;Biotechnology;Coronaviruses;Coronaviruses Vaccines;Dental, Oral, and Craniofacial Disease;Emerging Infectious Diseases;Immunization;Infectious Diseases;Nanotechnology;Prevention;Vaccine Related

ORG_NAME: J. DAVID GLADSTONE INSTITUTES

PHR: Project Narrative The COVID-19 pandemic represents the 3rd outbreak caused by zoonotic transmission of a beta-coronavirus (beta-CoV) in the last 20 years, and new vaccine strategies are urgently needed to ensure rapid global distribution, lasting protection against variants of concern (VOCs), and prevention of future CoV pandemics. The proposed research is based on the EBR nanoparticle (NP) technology that modifies membrane proteins such as the SARS-CoV-2 spike (S) protein to self-assemble into virus-resembling NPs that bud from the cell surface. The EBR technology will be applied to accomplish three goals: i) Design a hybrid mRNA vaccine that combines attributes of mRNA and protein NP vaccines by encoding the self-assembling S-EBR NP construct to enhance vaccine potency against SARS-CoV-2 and VOCs; ii) Engineer S-EBR NPs to package and deliver mRNAs encoding S or S-EBR as an alternative to lipid NPs for efficient, targeted, and cost-effective mRNA vaccine delivery; iii) Design mosaic S-EBR NP-based universal CoV vaccine candidates that present S proteins from multiple CoV strains to elicit cross-reactive immune responses against a broad spectrum of CoVs and protect against future outbreaks.

PI_NAMEs: HOFFMANN, MAGNUS ADRIAN GERO (contact)

PROGRAM_OFFICER_NAME: MILLER, BECKY

PROJECT_TERMS: 2019-nCoV;Acceleration;Amino Acid Sequence;Antibody Response;Antibody titer measurement;Applications Grants;Award;B-Cell Activation;betacoronavirus;Binding Proteins;Cell surface;Cells;Clinical;Clinical Research;Collaborations;Combined Vaccines;Complex;Coronavirus;coronavirus pandemic;Coronavirus spike protein;cost;cost effective;COVID-19 pandemic;cross reactivity;Cytoplasmic Tail;design;Development;Disease Outbreaks;Dose;Educational process of instructing;emergency preparedness;Encapsulated;Endosomes;Engineering;Ensure;Epitopes;Faculty;Financial Support;Funding;Future;future outbreak;future pandemic;Goals;graduate student;Health;HIV-1;Human;Hybrids;Immune;Immune response;Immunity;in vivo;Individual;industry partner;Infection;Injections;Institution;invention;Job Application;Laboratories;Length;lipid nanoparticle;Liquid substance;low income country;manufacture;member;Membrane;Membrane Proteins;Mentors;Messenger RNA;Monoclonal Antibodies;mosaic;mRNA delivery;Mus;nanoparticle;neutralizing antibody;novel vaccines;pandemic coronavirus;pandemic disease;Pathway interactions;Persons;Population;preclinical development;preclinical study;prevent;Prevention;Production;programs;Property;Protein Binding Domain;Proteins;Readiness;receptor binding;recruit;Research;Research Personnel;response;RNA vaccine;RNA-Protein Interaction;Robot;SARS-CoV-2 spike protein;SARS-CoV-2 variant;self assembly;Sorting;student mentoring;System;T-Cell Activation;Technology;technology platform;Therapeutic;Tissues;Translational Research;transmission process;universal coronavirus vaccine;Vaccinated;vaccine candidate;vaccine delivery;vaccine development;vaccine platform;vaccine response;vaccine strategy;vaccine-induced antibodies;Vaccines;variants of concern;Virus;Zoonoses

PROJECT_TITLE: Self-Assembling Spike-EBR Nanoparticles as a Vaccine Platform Technology Against SARS-CoV-2 and Future Pandemic Coronaviruses

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-PSE-H(70)R]


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Brain Disorders;Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;Complementary and Integrative Health;Dementia;Health Disparities and Racial or Ethnic Minority Health Research;Neurodegenerative;Neurosciences;Physical Activity;Prevention;Racial and Ethnic Minority Health Research

ORG_CITY: WINSTON-SALEM

ORG_NAME: WAKE FOREST UNIVERSITY HEALTH SCIENCES

PHR: PROJECT NARRATIVE Lifestyle interventions including physical activity appear to confer important protections to the brain that may delay the onset of symptoms of dementia. Dance movement is a form of physical activity that is promising as a potential activity to help maintain brain health, because it improves cardiorespiratory fitness and balance while providing cognitive challenge and social engagement, all important for maintaining brain health. This proposal seeks to fill key gaps in our basic understanding about the effects of the number of times per week people engage in dance movement on cardiorespiratory fitness and cognition that are essential for planning larger, definitive trials.

PI_NAMEs: HUGENSCHMIDT, CHRISTINA E (contact);SORIANO, CHRISTINA T

PROGRAM_OFFICER_NAME: HETTINGER, JANE CECELIA

PROJECT_TERMS: Accelerometer;Address;Adherence;Adult;Aerobic;Aerobic Exercise;African American;Agreement;Alzheimer's Disease;Alzheimer's disease related dementia;Alzheimer's disease risk;behavior change;Behavioral;Black race;Brain;brain health;Budgets;cardiorespiratory fitness;Cognition;Cognitive;Collection;Communities;cost;Dance Therapy;Dancing;Data;Data Collection;Dementia;Dose;Drops;Educational process of instructing;Ensure;Epidemiology;Equilibrium;Ethnic Origin;Exercise;exercise intervention;fall risk;fitness;follow-up;Frequencies;Funding;Glean;Health;Heart Rate;heart rate monitor;Hispanic;Hour;human old age (65+);Impaired cognition;improved;Intervention;Intervention Studies;intrinsic motivation;Knowledge;Latino;Leisures;lifestyle intervention;Longterm Follow-up;Maintenance;Measures;Meta-Analysis;Methods;motor learning;Movement;Music;Neurocognitive;Nonpharmacologic Therapy;older adult;Outcome;Outcome Assessment;Outcome Measure;parent grant;parent project;Parents;Participant;Patient Self-Report;Persons;Phase;phase III trial;Physical activity;post intervention;programs;Published Comment;recruit;Reporting;Research;response;Risk;Sample Size;satisfaction;screening;secondary outcome;sedentary;Self Efficacy;social;social engagement;Social Interaction;Specificity;strength training;Structure;success;Symptoms;Testing;theories;Time;treadmill;trial design;trial enrollment;United States National Institutes of Health;Visit;Walking;white matter;Withdrawal

PROJECT_TITLE: Admin Supplement - Establishing the optimal frequency of dance movement for neurocognitive and physical outcomes in people atrisk of Alzheimer's disease


NIH_SPENDING_CATS: Data Science

ORG_CITY: BOSTON

ORG_NAME: HARVARD MEDICAL SCHOOL

PHR: Project Narrative The SMaHT Data Analysis Center (DAC) will contribute to the resources developed by Common Fund Data Ecosystems to increase the usefulness of its datasets.

PI_NAMEs: PARK, PETER J (contact)

PROGRAM_OFFICER_NAME: LOSSIE, AMY C

PROJECT_TERMS: Acceleration;Data;Data Analyses;data ecosystem;Data Set;FAIR principles;Funding;Glean;human tissue;Knowledge;Metadata;Mosaicism;Ontology;Resources;Specific qualifier value;Standardization;Work

PROJECT_TITLE: Data Analysis Center for Somatic Mosaicism Across Human Tissues Network


ED_INST_TYPE: GRADUATE SCHOOLS

NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Brain Disorders;Caregiving Research;Clinical Research;Clinical Trials and Supportive Activities;Dental, Oral, and Craniofacial Disease;Digestive Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Neurodegenerative;Neurosciences;Parkinson's Disease;Patient Safety;Physical Rehabilitation;Rehabilitation;Telehealth

ORG_DEPT: PSYCHOLOGY

ORG_NAME: COLUMBIA UNIVERSITY TEACHERS COLLEGE

PHR: PROJECT NARRATIVE Airway protective disorders are a prevalent and progressive consequence of Parkinson’s Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD, yet few efficacious treatments are available for people with PD and additionally many patients with PD do not access to specialized services to address these critical deficits. This critical clinical-research gap must be addressed by a diverse workforce of scholars with expertise in airway protection and its rehabilitation. As a Landis Mentorship supplement, our parent award (R01 NS126319-01) will serve as a living classroom from and through which research and enriching training opportunities will be developed to enrich the training experiences of current and future trainees in airway protection and its rehabilitation.

PI_NAMEs: TROCHE, MICHELLE S (contact)

PROGRAM_OFFICER_NAME: SIEBER, BETH-ANNE

PROJECT_TERMS: 2 arm randomized control trial;Address;Affect;Area;arm;Aspiration Pneumonia;Award;barrier to care;care burden;Caregiver Burden;Caring;Cause of Death;Client satisfaction;Clinical;clinical center;Clinical Research;clinical translation;Clinical Trials;cognitive function;Coughing;Dedications;Deglutition;Deglutition Disorders;Development;Disease;Diverse Workforce;efficacious intervention;efficacious treatment;Elderly;Equity;experience;Functional disorder;Future;Geographic Locations;Geography;Goals;Health;health care disparity;Impaired cognition;Improve Access;improved;Individual;Invaded;Learning;Life;Maintenance;Mentorship;Modality;mortality;muscle strength;Nature;Neurodegenerative Disorders;Outcome;parent project;Parents;Parkinson Disease;Patient-Focused Outcomes;Patients;Peak Expiratory Flow Rate;Persons;Physiological;poor health outcome;Population;pressure;programs;Quality of life;rehabilitation service;Rehabilitation therapy;Research;response;Role;scale up;Service delivery model;Services;Severity of illness;skills training;standard of care;strength training;telehealth;Training;training opportunity;Translational Research;treatment adherence;United States;urban area;Work

PROJECT_TITLE: Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-Person and Telehealth Service Delivery Models

STUDY_SECTION: MFSR

STUDY_SECTION_NAME: Motor Function, Speech and Rehabilitation Study Section[MFSR]


ADMINISTERING_IC: HD

IC_NAME: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Cost Effectiveness Research;Depression;Dissemination and Implementation Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Infectious Diseases;Mental Health;Mental Illness;Pediatric;Pediatric - AIDS;Prevention;Sexually Transmitted Infections;Stimulant Use and Misuse;Substance Misuse

ORG_CITY: TALLAHASSEE

ORG_NAME: FLORIDA STATE UNIVERSITY

PI_NAMEs: HIGHTOW-WEIDMAN, LISA B (contact)

PROGRAM_OFFICER_NAME: RUSSO, DENISE

PROJECT_TERMS: Address;Adherence;Administrator;Adolescent and Young Adult;Adolescent Medicine Trials Network;Adoption;Age;AIDS prevention;antiretroviral therapy;arm;Behavior;Behavior Therapy;Behavioral;behavioral disinhibition;Biological Markers;Bisexual;Caring;Characteristics;cisgender;Clinic;Clinical;Cocaine;Cognitive;Cognitive Therapy;Communities;Competence;condomless anal sex;Consultations;cost effectiveness;cost estimate;Counseling;Depressed mood;depressive symptoms;design;Development;Distress;economic impact;ecstasy;Educational workshop;Effectiveness;effectiveness evaluation;effectiveness outcome;effectiveness/implementation trial;evidence base;Evidence based intervention;experience;Feedback;Feeling;field study;Funding;Gays;Geography;Health;Heterosexuals;HIV;HIV risk;HIV/AIDS;HIV/STD;Hybrids;implementation evaluation;implementation strategy;improved;Individual;Intervention;intervention delivery;intervention effect;Interview;Leadership;life time cost;Maintenance;Manuals;Measures;Mediating;Mediator;men who have sex with men;Mental Depression;Methamphetamine;Methods;Modeling;Motivation;multidisciplinary;non-drug;Outcome;Participant;Patient Self-Report;Persons;Pharmaceutical Preparations;pilot trial;pleasure;pre-exposure prophylaxis;Prevalence;prevention service;Primary Care;primary outcome;Professional counselor;Psychological reinforcement;psychosocial;Public Health;Quality-Adjusted Life Years;Random Allocation;Randomized;Randomized, Controlled Trials;Reach, Effectiveness, Adoption, Implementation, and Maintenance;relapse prevention;Reporting;Research;Resources;response;Risk;Risk Reduction;satisfaction;secondary outcome;Secure;sex;Sex Behavior;sexual risk behavior;sexual risk reduction;Sexual Transmission;sexually active;Site;skills;standard of care;Stimulant;stimulant use;Structure;substance use;substance use treatment;Testing;therapy adherence;Training;Training Activity;translational impact;Translations;transmission process;treatment as prevention;treatment services;United States;United States National Institutes of Health;Unsafe Sex;uptake;Urinalysis;Viral;Viral Load result;virtual

PROJECT_TITLE: RP7 Impact


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Digestive Diseases;Food Allergies;Infectious Diseases;Nutrition;Pediatric;Prevention;Tickborne Diseases;Vector-Borne Diseases

ORG_NAME: VANDERBILT UNIVERSITY MEDICAL CENTER

ORG_STATE: TN

PHR: PROJECT NARRATIVE Food allergy exerts substantial impact on affected individuals, their families, and society, including lifestyle limitations and reductions in quality of life. This application from the Vanderbilt University Medical Center (VUMC), will address the following goals: (1) establish the VUMC CoFAR CRC, which will rapidly implement and execute single site and multi-center clinical trials, with high quality and fidelity, focused on the prevention and management of patients with food allergy, supplemented by studies to better elucidate the mechanisms underlying food allergies; (2) develop and conduct a consortium-wide, multi-center, clinical trial to evaluate the comparative effectiveness of once weekly peanut feeding (low weekly peanut protein dose) versus thrice weekly peanut feedings (standard weekly peanut protein dose) in the prevention of peanut allergy in infants at high risk for the development of peanut allergy; and (3) to better understand the alpha-gal syndrome (AGS), specifically why some patients in tick-endemic areas develop clinically evident AGS after a bite, while others do not, and why the clinical expression of AGS is variable amongst patients and changes over time.

PI_NAMEs: BACHARIER, LEONARD B (contact);ROBISON, RACHEL GLICK

PROGRAM_OFFICER_NAME: DONG, GANG

PROJECT_TERMS: Academic Medical Centers;Address;Adolescent;Adult;Affect;Allergic;Allergy to peanuts;alpha-gal syndrome;Ambylomma americanum;Area;Bioinformatics;Biology;Biometry;Bite;career;Caring;Child;Clinical;clinical heterogeneity;clinical practice;Clinical Research;Clinical Trials;comparative effectiveness;Complex;Dedications;Development;Disease;Dose;Electronic Health Record;Elements;Environment;experience;Faculty;Family;feeding;Food;Food Hypersensitivity;Goals;high risk;high risk infant;Hypersensitivity;Immune System Diseases;Immunology;Individual;Infant;Infrastructure;innovation;Lead;Life Style;Meat;Morbidity - disease rate;Multi-Institutional Clinical Trial;National Institute of Allergy and Infectious Disease;next generation;Nurse Practitioners;Oral;Participant;Patients;Phenotype;Physicians;Play;Prevalence;Prevention;Primary Prevention;programs;Proteins;Quality of life;Reaction;Readiness;Research;Research Personnel;response;Risk;Risk Factors;Role;Science;Site;Societies;stem;symptomatology;Symptoms;Syndrome;synergism;Tennessee;tick bite;Ticks;Time;Translational Research;Work

PROJECT_TITLE: Vanderbilt University Medical Center (VUMC) CoFAR Clinical Research Center


NIH_SPENDING_CATS: Cancer;Genetics;Orphan Drug;Ovarian Cancer;Rare Diseases;Women's Health Research

ORG_CITY: PITTSBURGH

ORG_NAME: UNIVERSITY OF PITTSBURGH AT PITTSBURGH

ORG_STATE: PA

PHR: Project Narrative CCNE1 is amplified in 20-30% of uterine serous carcinoma (USC), but little is understood about how CCNE1 drives the aggressiveness of this disease. In this study, we will assess the DNA repair proficiency of these tumors in addition to exploring new metabolic therapeutic strategies to sensitize these tumors to standard-of-care chem- otherapy. The results will have a direct impact on the development of novel strategies to obtain a therapeutic response in CCNE1hi USC.

PI_NAMEs: AIRD, KATHERINE MARIE (contact);SNYDER, NATHANIEL W.

PROGRAM_OFFICER_NAME: WEINREICH, MICHAEL DALE

PROJECT_TERMS: Acetyl Coenzyme A;Address;Automobile Driving;Carcinoma;Carnitine;CCNE1 gene;Cell Cycle;Cell Line;Cessation of life;Chemoresistance;chemotherapy;Clustered Regularly Interspaced Short Palindromic Repeats;Combined Modality Therapy;Data;Development;Disease;Disease Progression;DNA Damage;DNA Repair;Drops;Endometrial Carcinoma;Epigenetic Process;Future;Genomics;Goals;Guide RNA;Histone Acetylation;homologous recombination;improved;Incidence;inhibitor;insight;interest;Knowledge;Libraries;Malignant neoplasm of ovary;Mediating;Metabolic;Metabolic Pathway;Metabolism;Modeling;Molecular;novel;novel strategies;novel therapeutic intervention;Oncogenes;Pathway interactions;Patients;Phenotype;Platinum;Poly(ADP-ribose) Polymerase Inhibitor;programs;repaired;Research;Resistance;response;Role;Serous;standard of care;synergism;Therapeutic;therapy outcome;therapy resistant;treatment response;tumor;Uterus

PROJECT_TITLE: Metabolic and epigenetic reprogramming in cyclin E high ovarian cancer