Johns Hopkins University

BREAKTHROUGH ACTION

INTERNATIONAL MATERNAL PEDIATRIC ADOLESCENT AIDS CLINICAL TRIALS (IMPAACT) GROUP

NATIONAL STUDY OF DISABILITY TRENDS AND DYNAMICS

ECHODAC (ENVIRONMENTAL INFLUENCES ON CHILD HEALTH OUTCOMES DATA ANALYSIS CENTER)

REGIONAL ONCOLOGY RESEARCH CENTER

HEALTHCOMM CAPACITY

HIV PREVENTION TRIALS NETWORK: NETWORK LABORATORY

STRENGTHENING SAFE HOSPITALS AND CLINICS IN HIV/AIDS PREVENTION ACTIVITIES, SERVI

A COLLABORATIVE PROGRAM FOR THE MULTISCALE MODELING AND DESIGN OF MATERIALS FOR EXTREME DYNAMIC ENVIRONMENTS

ENHANCING GLOBAL HEALTH SECURITY: EXPANDING EFFORTS AND STRATEGIES TO PROTECT AND IMPROVE PUBLIC HEALTH GLOBALLY

TECHNICAL SUPPORT IN HIV TREATMENT, CARE AND PREVENTION IN ETHIOPIA

PROVIDE SUPPORT TO TREATMENT PROGRAM

THE JOHNS HOPKINS CENTER FOR AIDS RESEARCH (JHU CFAR)

NORTH AMERICAN AIDS COHORTS COLLABORATION ON RESEARCH AND DESIGN

NEW HORIZONS IN THE PREVENTION AND TREATMENT OF FOOD ALLERGY

INSTITUTE FOR CLINICAL AND TRANSLATIONAL RESEARCH (UL1)

INSTITUTE FOR CLINICAL AND TRANSLATIONAL RESEARCH

THE PROJECT WILL DEVELOP EFFECTIVE NEW TOOLS AND APPROACHES TO FIND, TREAT AND PREVENT TB, AS WELL AS TESTING NOVEL STRATEGIES FOR IMPLEMENTING THE DELIVERY OF NEW DRUGS AND DIAGNOSTIC PRODUCTS IN REAL-WORLD, LOW RESOURCE SETTINGS.

PREVENTION OF MALARIA THROUGH VECTOR CONTROL

DATA DISPARITIES SUPPLEMENT TO JOHNS HOPKINS INSTITUTE FOR CLINICAL AND TRANSLATIONAL RESEARCH

MATERIALS SCIENCE IN EXTREME ENVIRONMENTS

NEUROTECH HARBOR: OUR NATION'S FIRST EQUITECH ECOSYSTEM FOR NEUROMEDICAL TECHNOLOGIES - PROJECT SUMMARY OVERALL THE TWO AIMS OF NEUROTECH HARBOR ARE: (AIM 1) TO ACCELERATE EARLY DEVELOPMENT OF THE MOST PROMISING NEUROMEDICAL SOLUTIONS, AND (AIM 2) TO INCREASE THE NUMBER OF WOMEN & URM INNOVATORS THROUGH OUTREACH AND EDUCATION, AND TO IMPROVE EQUITY AND ACCESSIBILITY OF NEUROMEDICAL SOLUTIONS. NEUROTECH HARBOR (NTH), LED BY JOHNS HOPKINS AND HOWARD UNIVERSITIES, WILL ACCELERATE THE DEVELOPMENT OF HIGHLY PROMISING SOLUTIONS TO IMPROVE NEUROLOGICAL HEALTH FOR ALL. SOLUTIONS FOR ALL MEANS ALSO FOR THE UNDERSERVED, OFTEN SYNONYMOUS WITH MINORITY GROUPS. DIVERSE INNOVATORS SHOULD SIT AT THE TABLE ON DAY ONE, BUT VERY FEW MINORITY ENTREPRENEURS EXIST. TO ADDRESS THESE INEQUITIES, WE WILL BUILD NTH WITH AN EQUITECH PHILOSOPHY, WHICH IS THE BELIEF THAT DIVERSITY OF TEAMS, LEADERSHIP, AND PERSPECTIVES IS A FORCE MULTIPLIER TO FUEL INNOVATION, PRODUCING SOLUTIONS ACCESSIBLE TO ALL COMMUNITIES. HOPKINS & HOWARD ARE UNIQUELY POSITIONED TO REALIZE THIS VISION. HOPKINS BRINGS A FOUNDATION OF RESEARCHERS, PRESTIGIOUS RESEARCH CENTERS, AND PROGRAMS AND HAS A TRANSLATION TRACK RECORD ($3B INVESTED IN START-UPS IN THE LAST 7 YEARS). HOWARD COMPLEMENTS THIS WITH A LARGE PIPELINE OF ASPIRING UNDER-REPRESENTED MINORITY (URM) INNOVATORS BOTH WITHIN AND OUTSIDE THE HOWARD COMMUNITY. HOWARD HAS NURTURED THIS COMMUNITY WITH EARLY-STAGE MENTORSHIP, A SUCCESSFUL INCUBATOR PROGRAM, AND RECENTLY RECEIVED A $17M GRANT TO CREATE A CENTER FOR ENTREPRENEURSHIP AIMED AT BUILDING RESOURCES AND SUPPORT FOR BLACK BUSINESS OWNERS ACROSS THE COUNTRY. NTH WILL SOLICIT PROPOSALS FROM INNOVATORS NATIONWIDE ADDRESSING PRESSING PROBLEMS. ALTHOUGH THE AREAS SUPPORTED WILL BE BROAD, COVERING ALL PARTICIPATING NIH INSTITUTES AND CENTERS, THE EXPERTISE OF NTH WILL BE INCLUSIVE BUT FOCUSING ON NEUROPROSTHESIS (CORTICAL, SPINAL, PERIPHERAL, VISION, AND AUDITORY), BRAIN MACHINE INTERFACE, NEURO SENSORS AND DEVICES, NEURO INFORMATICS, NEUROMODULATION, AND MENTAL HEALTH. FOR FUNDED PROJECTS, RESOURCES WILL BE PROVIDED, AND A DREAM TEAM OF SPECIALISTS WILL OFFER MENTORSHIP AND TOOLS TO GUIDE SUCCESSFUL TRANSLATION TO FIRST-IN-HUMAN PROTOTYPE. SPECIALISTS WILL BE DRAWN FROM A DIVERSE STEERING COMMITTEE, ADVISORY BOARD, AND CONSULTANT NETWORK, COMPOSED OF HIGHLY REGARDED CLINICIANS, SCIENTISTS, TECHNOLOGISTS, COMMERCIALIZATION EXPERTS, AND PATIENT ADVOCATES. TO EXPAND DIVERSITY AMONGST INNOVATORS, NTH HAS FORMED STRATEGIC OUTREACH PARTNERSHIPS WITH ACCESS TO HISTORICALLY BLACK COLLEGES AND UNIVERSITIES AND MINORITY SERVING INSTITUTIONS ACROSS THE NATION. WE HAVE CREATED AN NTH INSTITUTE, A CENTER FOR INNOVATOR LEADERSHIP DEVELOPMENT TO EDUCATE INNOVATORS IN BUSINESS DEVELOPMENT, TRANSLATION AND PROJECT MANAGEMENT. IMPORTANTLY, OUR NEEDS ASSESSMENTS WILL BE GUIDED BY THE PRINCIPLES OF EQUITY AND ACCESSIBILITY FOR ALL COMMUNITIES AND WILL INCLUDE THE INPUT OF UNDERSERVED STAKEHOLDERS. OUR 5-YEAR GOALS ARE TO (I) SOLICIT OVER 500 APPLICATIONS AND LAUNCH 45 PROJECTS, WHERE AT LEAST 15 HAVE 1 WOMAN OR URM INNOVATOR ON THE TEAM, AND (II) BLAZE A TRAIL TO ALLEVIATE SUFFERING FROM NEUROLOGICAL CONDITIONS FOR ALL, INCLUDING THE UNDERSERVED...THE EQUITECH WAY.

ONE COMMUNITY

BIOMARKERS OF COGNITIVE DECLINE AMONG NORMAL INDIVIDUALS: THE BIOCARD COHORT

THE PURPOSE OF THIS MODIFICATION IS TO PROVIDE INCREMENTAL FUNIDNG OF $2,622,000.00 INTO THE INSTRUMENT TO COVER COSTS FOR MALARIA INITIATIVE UNDER P

THE MALAWI CLINICAL TRIALS UNIT

MULTICENTER AIDS COHORT STUDY- PART B (BALTIMORE SITE)

BEING NEW CA IN THE AMOUNT OF $45 000 000 TO PROVIDE SUPPORT FOR THE PROGRAM 'TANZANIA CAPACITY AND COMMUNICATION PROJECT. THE AMOUNT OBLIGATION IS $

INCREASE COVERAGE AND USE OF KEY LIFE SAVING MALARIA INTERVENTIONS IN SUPPORT OF THE UGANDA NATIONAL MALARIA STRATEGY AND THE NATIONAL MALARIA CONTRO

THE MALAWI CLINICAL TRIALS UNIT

SPORE IN CERVICAL CANCER

UNIV. TECHNICAL ASSISTANCE PROJECTS IN SUPPORT OF THE GLOBAL AIDS PROGRAM

NEW HORIZONS IN THE PREVENTION AND TREATMENT OF FOOD ALLERGY - LEADERSHIP CENTER SUMMARY/ABSTRACT FOOD ALLERGY RESEARCH HAS INCREASED DRAMATICALLY OVER THE PAST 20 YEARS, IN LARGE PART TO THE EFFORTS OF COFAR. NEW APPROACHES FOR BOTH TREATMENT AND PREVENTION HAVE BEEN INTRODUCED, AS HAVE THE UNDERSTANDING OF THE IMMUNOLOGIC BASIS OF FOOD ALLERGY. THE OVERARCHING GOAL OF THE RESEARCH AGENDA PROPOSED IN THIS APPLICATION IS TO MAINTAIN COFAR'S POSITION AS AN INTERNATIONAL LEADER IN THE STUDY OF FOOD ALLERGY, INCLUDING OPTIMAL CHARACTERIZATION OF THE DISEASE AND DEVELOPMENT OF THE NEXT GENERATION OF TREATMENTS AD PREVENTION. THE RESEARCH AGENDA WILL BE BASED FIRST AND FOREMOST ON THE BEST POSSIBLE SCIENCE, BUT TO MAXIMIZE PRODUCTIVITY WE WILL ALSO NEED TO PLAN JUDICIOUSLY SO THAT ALL AVAILABLE RESOURCES CAN BE USED TO THEIR UTMOST CAPACITY. THEREFORE, THE RESEARCH AGENDA WILL NEED TO CAREFULLY SELECT AND STAGE PROTOCOLS BASED NOT JUST ON THEIR POTENTIAL TO ADVANCE THE FIELD, BUT ALSO WITH CAREFUL CONSIDERATION REGARDING OTHER NOVEL TREATMENTS THAT MAY BE UNDER DEVELOPMENT, AND HOW ONE STUDY MAY INFORM THE NEXT. FINALLY, THE OVERALL RESEARCH STRATEGY WILL NEED TO WORK IN UNISON WITH THE NIAID, THE SACCC AND EACH CRC IN THE CONSORTIUM. THIS OVERALL AGENDA WILL BE ACCOMPLISHED THROUGH THE FOLLOWING MAJOR COMPONENTS: 1) TO IMPLEMENT A LEADERSHIP TEAM CAPABLE OF PROVIDING OPTIMAL ADMINISTRATION OF THE CONSORTIUM, INCLUDING FINANCIAL, OPERATIONAL, AND MANAGERIAL ASPECTS, AS WELL AS PROTOCOL DEVELOPMENT AND IMPLEMENTATION, DATA COLLECTION AND ANALYSIS, AND PUBLICATIONS AND PRESENTATIONS, WITH JUDICIOUS FINANCIAL MANAGEMENT. DR. ROBERT WOOD WILL LEAD THIS TEAM, WITH CO-PIS DRS. SCOTT SICHERER AND SUPINDA BUNYAVANICH. THE TEAM WILL INCLUDE EXPERTS IN CLINICAL TRIALS AS WELL AS THE LABORATORY STUDY OF FOOD ALLERGY. THE TEAM WILL ALSO INCLUDE A FINANCIAL ADMINISTRATOR AS WELL AS A HIGHLY EXPERIENCED GRANTS MANAGEMENT GROUP AT JOHNS HOPKINS. THE LEADERSHIP TEAM WILL WORK CLOSELY WITH THE NIAID AND SACCC, TOGETHER PROVIDING DAY-TO-DAY MANAGEMENT OF ALL CLINICAL OPERATIONS WITHIN THE CONSORTIUM. 2) TO DEVELOP THE NECESSARY COMMITTEE STRUCTURE TO GUIDE AND IMPLEMENT THE CONSORTIUM'S ADMINISTRATIVE AND CLINICAL OPERATIONS. 3) TO DEVELOP A STRUCTURE OF FINANCIAL MANAGEMENT THAT WILL MAKE OPTIMAL USE OF ALL COFAR FUNDS AND RESOURCES. 4) TO INTEGRATE THE BIOMARKER FACILITY INTO EACH CLINICAL PROTOCOL. IT IS ANTICIPATED THAT A MINIMUM OF 2 MAJOR PROTOCOLS, INCLUDING BOTH CLINICAL TRIALS AND NON-INTERVENTIONAL STUDIES, WILL BE INITIATED AND COMPLETED OVER THE SEVEN-YEAR FUNDING PERIOD, AND THIS COULD RISE TO 4 OR EVEN 5 PROTOCOLS DEPENDING ON THE SIZE, DURATION, AND COMPLEXITY OF EACH STUDY. IF SUCCESSFUL, THIS RESEARCH AGENDA WILL DEFINE NOT JUST THE NEXT 7 YEARS OF COFAR, BUT WILL ALSO ESTABLISH THE PLATFORM FOR THE NEXT DECADE(S) OF FOOD ALLERGY RESEARCH.

PURPOSE: THE PURPOSE OF THIS COOPERATIVE AGREEMENT TO PROVIDE UNDERGRADUATE/GRADUATE RESEARCHERS, INDIVIDUALS WITH BACHELORS OR MASTER'S DEGREES, POST-DOCTORAL ASSOCIATES, SENIOR RESEARCH FELLOWS AND ACADEMIC AFFILIATES WITH FELLOWSHIP OPPORTUNITIES AND FINANCIAL ASSISTANCE TO OBTAIN LABORATORY EXPERIENCES AND AID IN DEVELOPING COLLABORATIVE RESEARCH RELATIONSHIPS WITH NIST STAFF WITHIN THE NIST BOULDER LABORATORY.ACTIVITIES TO BE PERFORMED: PREP SEEKS TO ENCOURAGE THE GROWTH AND PROGRESS OF SCIENCE AND ENGINEERING IN THE UNITED STATES, INCLUDING THE ENCOURAGEMENT OF WOMEN AND MINORITY RESEARCHERS SEEKING TO FURTHER THEIR PROFESSIONAL DEVELOPMENT, AND TO NURTURE RESEARCHERS AND POST-DOCTORAL ASSOCIATES CONSIDERED TO BE POTENTIAL FUTURE NIST EMPLOYEES.EXPECTED OUTCOMES: THE OBJECTIVES OF THE PREP PROGRAM ARE TO: 1) ENCOURAGE THE GROWTH AND PROGRESS OF SCIENCE AND ENGINEERING IN THE UNITED STATES BY PROVIDING RESEARCH OPPORTUNITIES FOR PREP RESEARCHERS WITH NIST SCIENTISTS AND ENGINEERS AND EXPOSING THEM TO CUTTING-EDGE RESEARCH AND DEVELOPMENT (R&D); 2) PROMOTE THE PURSUIT OF DEGREES OR PROFESSIONAL DEVELOPMENT, AS APPLICABLE, FOR PREP RESEARCHERS; AND 3) PROMOTE DIVERSITY AND EQUITY IN STEM.INTENDED BENEFICIARIES: NIST AND NIST RESEARCHERS, AND UNDERGRADUATE/GRADUATE RESEARCHERS, INDIVIDUALS WITH BACHELORS OR MASTER'S DEGREES, POST-DOCTORAL ASSOCIATES, SENIOR RESEARCH FELLOWS AND ACADEMIC AFFILIATES, EMPLOYED BY OR AFFILIATED WITH THE UNIVERSITIES.SUBRECIPIENT ACTIVITIES: THE RECIPIENT DOES INTEND TO SUBAWARD FUNDS.

THIS FIVE-YEAR COOPERATIVE AGREEMENT WILL ALLOW USAID/INDIA TO SUPPORT THE GOVERNMENT OF INDIA¿S GOAL OF AN AIDS-FREE GENERATION, THIS ACTIVITY WILL RAPIDLY DEMONSTRATE AND ASSESS NEW MODELS TO INCREASE ACCESSIBILITY, AVAILABILITY, AND DEMAND OF HIGH QUALITY, COMPREHENSIVE HIV PREVENTION, CARE AND TREATMENT SERVICES; WHILE STRENGTHENING SYSTEMS AND THE ENABLING ENVIRONMENT FOR KPS, ESPECIALLY HARD-TO-REACH KPS, THEIR PARTNERS, SPOUSES AND CHILDREN TO HAVE EQUITABLE ACCESS TO HIV/AIDS AND SOCIAL SERVICES.

THE SBC ACTIVITY SEEKS TO TRANSFORM HOUSEHOLDS, COMMUNITIES AND SYSTEMS FOR IMPROVED HEALTH AND DEVELOPMENT OUTCOMES THROUGH SOCIAL AND BEHAVIOR CHANGE. IT WILL CONTRIBUTE TO THE ACHIEVEMENT OF HEALTH AND DEVELOPMENT OUTCOMES THROUGH IMPROVED ADOPTION OF HEALTH BEHAVIORS (E.G. INCREASED, CONSISTENT, AND CORRECT USE OF MOSQUITO NETS; INCREASED ADHERENCE TO ARVS) AT INDIVIDUAL, HOUSEHOLD, AND COMMUNITY LEVELS. THIS ACTIVITY WILL WORK WITH THE GOU, IMPLEMENTING PARTNERS AND STAKEHOLDERS TO IMPLEMENT AND SCALE UP QUALITY SBC INTERVENTIONS THAT DIRECTLY AFFECT THE INTERNAL, STRUCTURAL AND SOCIAL FACTORS IN ORDER TO INCREASE ADOPTION OF IMPROVED HEALTH BEHAVIORS AND ULTIMATELY IMPACT HEALTH AND DEVELOPMENT OUTCOMES. THE ACTIVITY WILL ACCOMPLISH RESULTS THROUGH FOUR INTERMEDIATE RESULTS:

COGNITION AND HIPPOCAMPAL/CORTICAL SYSTEMS IN AGING

KNOWLEDGE FOR HEALTH

JOHNS HOPKINS-TUFTS TRIAL INNOVATION CENTER

DATA ANALYSIS AND COORDINATION CENTER FOR THE MACS-WIHS COMBINED COHORT STUDY

PEDIATRIC ADOLESCENT VIRUS ELIMINATION (PAVE) MARTIN DELANEY COLLABORATORY - ABSTRACT THE IMMEDIATE ESTABLISHMENT OF THE LATENT HIV-1 RESERVOIR IN RESTING MEMORY CD4+ T CELLS PRECLUDES HIV-1 CURE, COMPELLING ART FOR A LIFETIME IN CHILDREN. THE MISSION OF THE PAVE COLLABORATORY IS TO USE CUTTING-EDGE SCIENCE TO ESTABLISH A DEEP AND BROAD UNDERSTANDING OF THE IMMUNOPATHOGENESIS OF PEDIATRIC HIV-1 RESERVOIRS, ACROSS THE AGE SPECTRUM, AND TO DEMONSTRATE PRECLINICAL SAFETY AND EFFICACY OF NOVEL THERAPEUTICS TO ERADICATE RESERVOIRS AND CONTROL REBOUND THAT WILL PAVE THE WAY FOR FUTURE INTERVENTIONAL HUMAN STUDIES TOWARD A LIFETIME OF SUSTAINED HIV-1 CONTROL OFF ART. WE HYPOTHESIZE THAT THE UNIQUE FEATURES OF THE INFANT IMMUNE SYSTEM AT THE TIME OF RESERVOIR ESTABLISHMENT IMPACT THE CHARACTERISTICS OF LONG-TERM VIRUS PERSISTENCE, SUSCEPTIBILITY TO IMMUNE- MEDIATED CLEARANCE, AND REACTIVATION THAT ARE DISTINCT FROM ADULT INFECTIONS, WARRANTING IN-DEPTH INVESTIGATION TO INFORM CURE THERAPEUTICS SUITABLE FOR CHILDREN. WE WILL TEST THIS HYPOTHESIS AND EXECUTE THE PAVE SCIENTIFIC AGENDA THROUGH ACCOMPLISHMENT OF THE FOLLOWING SPECIFIC AIMS: 1. DEFINE THE ESTABLISHMENT AND EVOLUTION OF THE HIV LATENT RESERVOIR IN PERINATAL INFECTION. 2. ENHANCE PEDIATRIC IMMUNITY AND BROADLY NEUTRALIZING ANTIBODY (BNAB) DELIVERY TO ACHIEVE POST-TREATMENT CONTROL OF HIV-1 OFF ART. 3. DEPLOY IMMUNE-TARGETED STRATEGIES TO ELIMINATE VIRUS RESERVOIRS. 4. OPTIMIZE VIROLOGIC, IMMUNOLOGIC, AND IMAGING METHODS TO ASSESS EFFICACY OF HIV-1/S(H)IV CURE INTERVENTIONS. 5. FOSTER COMMUNITY ENGAGEMENT IN PEDIATRIC HIV CURE RESEARCH. THE PAVE PROGRAM IS MULTIDISCIPLINARY, MULTICULTURAL, AND ITERATIVE WITH A NIMBLE STRUCTURE ENCOMPASSED BY FOUR HIGHLY SYNERGISTIC RESEARCH FOCI AND A DOMESTIC AND INTERNATIONAL COMMUNITY PROGRAM THAT WILL RAPIDLY INCORPORATE NEW SCIENTIFIC DIRECTIONS AND FEEDBACK FROM OUR STAKEHOLDERS. THE PAVE LEADERSHIP TEAM SPANS DIVERSE SCIENTIFIC EXPERTISE AND EXHIBITS ADDITIONAL DIVERSITY IN TERMS OF GENDER, ACADEMIC RANK, AND COUNTRY OF ORIGIN. EACH OF THE RESEARCH FOCI ALSO INCLUDES JUNIOR FACULTY CO-INVESTIGATORS TO FACILITATE THEIR CAREER DEVELOPMENT WITHIN THE HIV-1 RESEARCH SPACE. THROUGH THE COLLECTIVE EFFORTS OF OUR SCIENTIFIC LEADERSHIP, EXECUTIVE COMMITTEE, SCIENTIFIC ADVISORY BOARD, INVESTIGATORS, INDUSTRY PARTNERS, NETWORK COLLABORATIONS, AND DOMESTIC AND INTERNATIONAL COMMUNITY PROGRAM, PAVE ANTICIPATES MEETING THE FOLLOWING OVERALL MILESTONES OF: 1) UNDERSTANDING EARLY LIFE IMMUNITY AND EARLY ANTIRETROVIRAL TREATMENT ON THE COMPOSITION AND STABILITY OF THE LATENT RESERVOIR, INCLUDING IN NAÏVE T CELLS, AND POTENTIAL FOR HIV-1 REMISSION; 2) ELIMINATING OF THESE RESERVOIRS IN PRE-CLINICAL STUDIES OF IMMUNE-TARGETED STRATEGIES; 3) DEFINING THE ROLE OF MYELOID CELLS IN HIV-1 PERSISTENCE AND REBOUND, INCLUDING IN THE CNS; 4) ESTABLISHING NOVEL APPROACHES TO ENHANCE PEDIATRIC IMMUNITY THROUGH ACTIVE AND PASSIVE IMMUNIZATION; 5) DEVELOPING CUTTING-EDGE APPROACHES TO QUANTIFY AND MONITOR PROVIRAL RESERVOIRS TO MEASURE CLINICAL TRIAL EFFICACY, AND 6) PROMOTING ACTIVE COMMUNITY ENGAGEMENT IN PEDIATRIC HIV-1 CURE RESEARCH. THESE MILESTONES WILL HELP ACHIEVE THE VISION OF SUSTAINED ART-FREE CONTROL OF HIV-1 REPLICATION IN PEDIATRIC POPULATIONS.

SOCIAL BEHAVIOR CHANGE COMMUNICATIONS/SOCIAL MARKETING (SBCC/SM)

ADDRESSING UNMET NEED IN HIV TESTING SERVICES (HTS) THROUGH EFFECTIVE DELIVERY MODELS IN MALAWI UNDER PEPFAR

THE MAJOR EXTREMITY TRAUMA RESEARCH CONSORTIUM

JOHNS HOPKINS AIDS CLINICAL TRIALS UNIT

MAKERERE UNIV.-JOHNS HOPKINS UNIV. HIV CLINICAL TRIALS UNIT-KAMPALA, UGANDA

CLINICAL RESEARCH SITES FOR THE MACS/WIHS COMBINED COHORT STUDY (MACS/WIHS-CCS) - BALTIMORE/WASH DC CENTER

INVESTING IN INNOVATION -- VALIDATION GRANTS

LEADER WITH ASSOCIATES COOPERATIVE AGREEMENT

CENTER FOR POINT-OF-CARE TECHNOLOGIES RESEARCH FOR SEXUALLY TRANSMITTED DISEASES

SPORE IN GASTROINTESTINAL CANCER

NEW AWARD FOR THE NET WORKS PROJEST: BUILDING CAPACITY FOR SUSTAINED COVERAGE AND USE.

JOHNS HOPKINS OCCUPATIONAL SAFETY AND HEALTH EDUCATION AND RESEARCH CENTER

STUDIES OF OCULAR COMPLICATIONS OF AIDS - COORDINATING CENTER

NOVEL THERAPEUTICS HIV-ASSOCIATED COGNITIVE DISORDERS

UNDER THE GOAL OF THIS APS, TO IMPROVE HEALTH AND DEVELOPMENT OUTCOMES, AND THE SPECIFIC PURPOSE OF IMPROVING AND STRENGTHENING PROGRAMS AND SERVICES BY SUPPORTING INCREASED UTILIZATION OF EVIDENCE-BASED INFORMATION IN GLOBAL HEALTH PROGRAMMING, ROUND 1 FOCUSED PARTICULARLY ON SUPPORTING INCREASED UTILIZATION OF EVIDENCE-BASED INFORMATION IN INFORMED AND VOLUNTARY FP/RH PROGRAMMING, AS WELL AS KM CAPACITY BUILDING IN FIELD PROGRAMMING.

THE AIDS LINKED TO THE INTRAVENOUS EXPERIENCE (ALIVE) STUDY

JOHNS HOPKINS INSTITUTE FOR CLINICAL AND TRANSLATIONAL RESEARCH

MEDICAL SCIENTIST TRAINING PROGRAM

UTILIZING TECHNOLOGY AND AI APPROACHES TO FACILITATE INDEPENDENCE AND RESILIENCE IN OLDER ADULTS - THE OVERARCHING GOAL OF THIS APPLICATION IS TO BUILD AN ARTIFICIAL INTELLIGENCE (AI) AND TECHNOLOGY COLLABORATORY (AITC) ECOSYSTEM THAT WILL SERVE AS A NATIONAL RESOURCE TO PROMOTE THE DEVELOPMENT AND IMPLEMENTATION OF NOVEL AI AND TECHNOLOGY APPROACHES TO IMPROVE CARE AND HEALTH OUTCOMES FOR OLDER AMERICANS. THE SPECIFIC AIMS ARE: 1) TO ENGAGE AI AND GERIATRIC/GERONTOLOGY INVESTIGATORS FROM ACROSS THE COUNTRY AND TO IDENTIFY, VALIDATE, TEST, AND DEVELOP NEW AI AND TECHNOLOGIES RELEVANT TO IMPROVING THE HEALTH AND WELLBEING OF OLDER ADULTS THROUGH CRUCIAL PILOT STUDY MECHANISMS; 2) TO SERVE AS A NATIONAL RESOURCE CENTER THAT STIMULATES AND LEADS THE DEVELOPMENT AND IMPLEMENTATION OF EFFECTIVE NOVEL AI AND TECHNOLOGY APPROACHES AND PRODUCTS THAT WILL PROMOTE THE HEALTH, WELLBEING AND INDEPENDENCE OF ALL OLDER AMERICANS; 3) TO SUPPORT THE ENGAGEMENT OF STAKEHOLDERS IN AI RESEARCH; 4) TO BUILD AN ECOSYSTEM OF OVERLAPPING INNOVATION AND BUSINESS, ACADEMIC, AND COMMUNITIES- OF-PRACTICE NETWORKS ; AND 5) TO PROVIDE HIGHEST QUALITY EXPERTISE, SUPPORT, AND INFRASTRUCTURE NEEDED TO DISSEMINATE TECHNICAL AND POLICY GUIDELINES AND BEST PRACTICES FOR EFFECTIVELY INCORPORATING AI APPROACHES AND TECHNOLOGY FOR OLDER AMERICANS, IN PARTNERSHIP WITH PRIVATE INDUSTRY, ANGEL INVESTORS, VENTURE CAPITAL FIRMS, AND HEALTHCARE SYSTEMS. THIS AITC IS DIRECTED BY A MULTI-PI INTERDISCIPLINARY TEAM LED BY TWO WORLD-CLASS EXPERIENCED INVESTIGATORS WHO HAVE LONG WORKED SUCCESSFULLY IN THE FIELDS OF AI AND TECHNOLOGY DEVELOPMENT AREAS PARTNERED WITH INVESTIGATORS WHO HAVE LONG AND SUCCESSFULLY WORKED AT THE TRANSLATIONAL INTERFACE THAT CONNECTS REAL-WORLD MEDICAL, COGNITIVE, AND FUNCTIONAL DECLINES THAT IMPACT OLDER ADULTS WITH MEDICAL AND TECHNOLOGICAL SOLUTIONS. EACH OF THESE INVESTIGATORS HAS A COMPLEMENTARY SKILL SET AND A LONG TRACK RECORDS OF ORGANIZING TRANSDISCIPLINARY TEAMS AND CONSORTIUMS OF INVESTIGATORS AROUND CORE THEMES. THIS INTERDISCIPLINARY, ACCOMPLISHED, AND HIGHLY VISIBLE LEADERSHIP TEAM WILL WORK TOGETHER TO DEVELOP VISION FOR THE NEXT GENERATION OF AI IN AGING SCIENCE AND TO BUILD A SCIENTIFICALLY AND CULTURALLY DIVERSE COMMUNITY OF AI SCHOLARS AND TRAINEES AROUND AGING. TO ACHIEVE OUR GOALS, WE DESIGNED THE JHU AITC TO HAVE ROBUST SCIENTIFIC AND TECHNOLOGICAL EXPERTISE THAT ARE DESCRIBED IN EIGHT CORE COMPONENTS. THIS INFRASTRUCTURE WILL SUPPORT THE IMPLEMENTATION OF STAKEHOLDER INPUT AND THE IDENTIFICATION OF RELEVANT TECHNOLOGIES AND INVESTIGATORS LOCALLY AND NATIONALLY THROUGH A VETTING AND FEASIBILITY TESTING PROCESS OF BOTH TECHNOLOGY AND DATA PROCESSES. IT WILL INCLUDE A PILOT TESTING PHASE AND RELATED OVERSIGHT PROCESS. WE HAVE ALSO ESTABLISHED A KEY PARTNERSHIP WITH THE IOWA OFFICE OF RURAL HEALTH AND VETERANS RURAL HEALTH RESOURCE CENTERS LEADERSHIP AND WITH ORGANIZATIONS WITHIN JOHNS HOPKINS UNIVERSITY THAT FOCUS ON IMPROVEMENTS IN THE HEALTH AND WELL-BEING OF OLDER ADULTS IN UNDERSERVED URBAN COMMUNITIES. CONNECTIONS WITH KEY ACADEMIC, INDUSTRY PARTNERS HAVE ALSO BEEN ESTABLISHED TO ACCELERATE THE DEVELOPMENT OF RELEVANT TECHNOLOGIES INTO PRODUCTS. THIS TEAM IS DEDICATED TO DEVELOPING THE NEXT AI SCIENTIFIC ADVANCES AND DISSEMINATING RESULTING STRATEGIES INTO PRACTICE AND POLICY THAT WILL MAXIMIZE HEALTH, WELL-BEING, AND INDEPENDENCE FOR OLDER ADULTS.

TECHNICAL ASSISTANCE, PROGRAM IMPLEMENTATION AND CAPACITY BUILDING SUPPORT FOR MU

ACTIVITIES TO PROMOTE NORMATIVE CHANGE AND INCREASING PREVENTATIVE BEHAVIORS AMONG ADULTS IN THE GENERAL POPULATIONS IN MALAWI.

DRUG ABUSE RESEARCH CENTER

RESEARCH TO STUDY HOW TO IMPROVE UPON "REHABILITATION AND ASSISTIVE TECHNOLOGY (AT"

HOPE IN ACTION: A CLINICAL TRIAL OF HIV-TO-HIV LIVER TRANSPLANTATION

MAKERERE UNIV.-JOHNS HOPKINS UNIV. HIV CLINICAL TRIALS UNIT-KAMPALA, UGANDA

THE PURPOSE OF THIS COOPERATIVE AGREEMENT IS TO IMPLEMENT THE GHANA BEHAVIOR CHANGE SUPPORT PROGRAM.THE GHANA BEHAVIOR CHANGE SUPPORT PROGRAM IS

MALARIA TRANSMISSION AND THE IMPACT OF CONTROL EFFORTS IN SOUTHERN AFRICA

JOHNS HOPKINS ALZHEIMER'S DISEASE RESEARCH CENTER

SPORE IN HEAD AND NECK CANCER

OLDER AMERICANS INDEPENDENCE CENTER

THE PURPOSE OF THIS COOPERATIVE AGREEMENT IS TO PROVIDE SUPPORT FOR PROGRAM IN COMBINATION PREVENTION FOR THE GENERALPOPULATION OF ADULTS AND YOUT

THE MID-ATLANTIC CENTER FOR CARDIOMETABOLIC HEALTH EQUITY (MACCHE) - OVERALL PROJECT SUMMARY THE OVERARCHING GOAL OF THE MID-ATLANTIC CENTER FOR CARDIOMETABOLIC HEALTH EQUITY (MACCHE) IS TO TEST THE EFFECTIVENESS OF COMPREHENSIVE, INTEGRATED, AND MULTI-LEVEL EVIDENCE-BASED STRATEGIES FOR IMPROVING CARDIOMETABOLIC HEALTH OUTCOMES AMONG SOCIALLY DISADVANTAGED POPULATIONS IN MARYLAND, USING COMMUNITY- BASED PARTICIPATORY RESEARCH AND PATIENT-CENTERED OUTCOMES RESEARCH PRINCIPLES, AND TRANSLATE THEM INTO CLINICAL AND PUBLIC HEALTH PRACTICE AND POLICY. WE WILL LEVERAGE THE EXISTING INFRASTRUCTURE OF THE JOHNS HOPKINS CENTER FOR HEALTH EQUITY, WHICH HAS APPLIED A COMPREHENSIVE APPROACH TO HEALTH EQUITY FOR OVER 10 YEARS, A PARTNERSHIP WITH THE UNIVERSITY OF MARYLAND BALTIMORE, AND COLLABORATIONS WITH MORGAN STATE UNIVERSITY AND OTHER INSTITUTIONS IN THE REGION. MACCHE WILL INCLUDE 3 SEPARATE, BUT RELATED INTERVENTION STUDIES ADDRESSING DISPARITIES IN CARDIOMETABOLIC DISEASE; 3 INTEGRATED CORES (ADMINISTRATIVE, INVESTIGATOR DEVELOPMENT, AND COMMUNITY ENGAGEMENT); AN EXECUTIVE COMMITTEE; AND A COMMUNITY ADVISORY BOARD. STUDY 1 IS A RANDOMIZED TRIAL COMPARING THE EFFECTIVENESS OF AN EVIDENCE-BASED PREGNANCY/POSTPARTUM HEALTH COACHING/HOME VISITING INTERVENTION TO USUAL HOME VISITING SERVICES IN REDUCING POSTPARTUM WEIGHT RETENTION AMONG BLACK AND LATINX WOMEN AT HIGH RISK FOR CARDIOMETABOLIC HEALTH DISPARITIES; STUDY 2 IS A RANDOMIZED TRIAL EXAMINING THE EFFECTIVENESS OF A MULTI-LEVEL INTERVENTION OF PROBLEM-SOLVING TRAINING, COMMUNITY HEALTH WORKER (CHW) SUPPORT AND PARTNERSHIP WITH COMMUNITY FACILITIES FOR ENHANCING CARDIORESPIRATORY FITNESS IN ADULTS WITH LOW SOCIOECONOMIC STATUS, DIABETES, OBESITY AND ASYMPTOMATIC CARDIAC DYSFUNCTION; AND STUDY 3 IS A CLUSTER- RANDOMIZED TRIAL TESTING THE EFFECTIVENESS OF A MULTI-LEVEL INTERVENTION LINKING SELF-MONITORED BLOOD PRESSURE (BP) WITH TELEMONITORING, TEAM-BASED CARE WITH PHARMACISTS AND CHWS, AND PROVIDER-LEVEL INTERVENTIONS COMPARED TO ENHANCED USUAL CARE, FOR IMPROVING BP CONTROL AMONG SOCIALLY DISADVANTAGED ADULTS WITH UNCONTROLLED HYPERTENSION PLUS DIABETES OR CHRONIC KIDNEY DISEASE. THE ADMINISTRATIVE CORE WILL CARRY OUT THE OVERALL ADMINISTRATION OF THE GRANT, PROVIDING INFRASTRUCTURE AND SUPPORT FOR DATA HARMONIZATION, MANAGEMENT AND ANALYSIS, PATIENT RECRUITMENT AND RETENTION, AND INTERVENTION ADAPTATION AND IMPLEMENTATION. THE INVESTIGATOR DEVELOPMENT CORE WILL ESTABLISH A PILOT PROJECT PROGRAM FOR EARLY-STAGE INVESTIGATORS AND CREATE A MENTORING NETWORK AND COMMUNITY FOR PILOT PROJECT AWARDEES, TO SUPPORT INNOVATIVE RESEARCH RELATED TO CHRONIC DISEASE DISPARITIES. THE COMMUNITY ENGAGEMENT CORE WILL IMPLEMENT A SHARED GOVERNANCE STRUCTURE TO REINFORCE STAKEHOLDER LEADERSHIP AND OWNERSHIP; ADVANCE, FACILITATE, AND EVALUATE MACCHE’S COMMUNITY- ENGAGED RESEARCH AND INVESTIGATOR DEVELOPMENT INITIATIVES; AND EMPLOY COMMUNITY-CENTERED STRATEGIES TO TRANSLATE, DISSEMINATE, AND SUSTAIN MACCHE INITIATIVES. THE MACCHE WILL ADVANCE THE SCIENCE OF CARDIOMETABOLIC DISEASE DISPARITIES AND FACILITATE ITS TRANSLATION INTO CLINICAL AND PUBLIC HEALTH PRACTICE AND POLICY.

IMPLEMENTING THE GENOMIC DATA SCIENCE ANALYSIS, VISUALIZATION, AND INFORMATICS LAB-SPACE (ANVIL)

MATERNAL AND CHILD INTEGRATED HEALTH PROGRAM (MCHIP)

PARKINSON'S DISEASE RESEARCH CENTER OF EXCELLENCE

WIHS DATA MANAGEMENT AND ANALYSIS CENTER (WDMAC)

ALZHEIMER'S DISEASE AND ANIMAL MODELS

MISTIE III_ LEAD GRANT_ CLUSTER APPLICATION FOR THE CLINICAL COORDINATING CENTER

SPORE IN PROTATE CANCER

GRADUATE RESEARCH FELLOWSHIP PROGRAM (GRFP)

THE JOHNS HOPKINS TRANSLATIONAL SCIENCE TEAM FOR THE ET-CTN

DOLO (?DOLO??MEANING ?SMART? AND ?IN THE KNOW? IN THE LOCAL CHICHEWA LANGUAGE?SELECTED FROM A PARTICIPATORY HUMAN-CENTERED DESIGN [HCD] EXERCISE FOR JHPIEGO MALAWI?S HIV PROGRAMS)

CLOT LYSIS: EVALUATING ACCELERATED RESOLUTION OF IVH PHASE III (CLEAR III)

INCREMENTAL FUNDING FOR JOHN HOPKINS

BONE MARROW TRANSPLANTATION IN HUMAN DISEASE

MULTIDISCIPLINARY TRAINING PROGRAM IN LUNG DISEASES

DEVELOPMENT OF RECTAL ENEMA AS MICROBICIDE (DREAM)

JOHNS HOPKINS COMMUNITY HEALTH PARTNERSHIP (JHCHP)

GENE-ENVIRONMENT INTERACTIONS FOR CORTICAL DEVELOPMENT AND SCHIZOPHRENIA

JOHNS HOPKINS UNIVERSITY TRIAL INNOVATION CENTER - THE JOHNS HOPKINS UNIVERSITY (JHU) TRIAL INNOVATION CENTER (TIC) IS A WELL-ESTABLISHED, HIGHLY FUNCTIONING TEAM WITH A GOAL OF DRAMATICALLY IMPROVING THE CONDUCT, EFFICIENCY AND IMPACT OF MULTISITE RANDOMIZED CONTROLLED TRIALS. THE TIC INCLUDES EXPERIENCED TRIAL SCIENTISTS, PROJECT MANAGERS, STATISTICIANS, AND TRIAL STAFF WITH EXTERNAL COLLABORATORS FROM 5 RESEARCH INTENSIVE CTSA HUBS. BIOS, A JHU TRIALS RESEARCH GROUP, WILL OPERATIONALLY CONVENE THIS GROUP AND PROVIDE STAFF TO EXECUTE VERSION 2.0 OF THE TRIAL INNOVATION NETWORK (TIN) PROGRAM AND ITS SPECIFIC TASKS AS PREVIOUSLY AND COLLABORATIVELY DETERMINED BY THE TICS, RICS AND NCATS. DURING TIN 1.0 OUR JOINT EXPERTISE DEVELOPED AND DEMONSTRATED NEW METHODS FOR MULTICENTER TRIALS AND PROVIDED THESE METHODS VIA THE TIN PLATFORM TO INDIVIDUAL CTSA HUB PIS WISHING TO PERFORM MULTISITE RANDOMIZED TRIALS. THIS PROPOSAL IS DERIVED FROM OUR ESTABLISHED TRACK RECORD OF TRIAL EXECUTION ACCOMPLISHMENTS AND TRIAL SCIENCE INNOVATIONS, WHICH WILL FACILITATE DISSEMINATION OF THESE METHODS AND SPECIFIC TRIAL TOOLS TOWARDS THE NCATS GOAL TO SPEED TRANSLATIONAL RESEARCH. WE IDENTIFIED NEEDS NOT MET IN TIN 1.0 INCLUDING: TRIAL TRAINING OF HUB STAFF, TRAINING IN OPERATIONS RATHER THAN STRATEGY, PRECEPTORSHIP FOR HUB CCC/DCC CAPABILITIES, AND NEED FOR UP-TO-DATE OPERATIONAL METHODS/TOOLS. IN TIN 2.0 WE WILL FURTHER DEVELOP NEW TRIAL TOOLS AND METHODS FOR TESTING THEIR EASE OF IMPLEMENTATION AT CTSA HUBS, DEMONSTRATE THE EFFECTIVENESS OF THIS APPROACH, AND DISSEMINATE BROADLY TO CTSA HUBS, BY USING CASE STUDIES AND DIDACTICS. WE PROPOSE AN INTEGRATED, COORDINATED, MULTI-STAKEHOLDER TIC PROCESS TO IMPROVE THE EFFICIENCY AND QUALITY OF MULTI-SITE TRIAL INITIATION AND SUBSEQUENT EXECUTION BY CTSA SITES. OUR GROUP OF EXTERNAL COLLABORATORS WILL WORK AS A SAMPLE OF THE LARGER CTSA-TIN CONSORTIUM TO DEVELOP HUB IMPLEMENTATION AND DISSEMINATION APPROACHES ON BOTH A CASE- AND CONSORTIUM-WIDE BASIS. THE JHU TIC WILL LEVERAGE OPERATIONAL ACTIVITIES IN CTSA TRIALS IMPLEMENTATION TO STUDY NOVEL OPERATIONAL INNOVATIONS THAT IMPROVE PARTICIPANT ENGAGEMENT, INTERVENTION ADHERENCE AND MEASUREMENT OF TRIAL ENDPOINTS. WE WILL MEASURE BENEFITS USING EXPLICIT EFFICIENCY- AND QUALITY-FOCUSED METRICS TO TEST THESE INNOVATIONS. THE SCIENTIFIC PURPOSE OF OUR TEAM’S EFFORTS WILL BE TO DEMONSTRATE THAT TIC INNOVATIONS IN TRIAL DESIGN, EXECUTION, AND EVALUATION CAN LEAD TO BETTER TRIAL PERFORMANCE, INCLUDING FASTER START-UP, FASTER COMPLETION, GREATER PROTOCOL COMPLIANCE AND MORE PRECISE ENDPOINTS. WE WILL DISSEMINATE RESULTS OF VALIDATED CTSA-TIN INNOVATIONS PRODUCED FROM CONSORTIA TRIALS TO CTSA HUB CLINICAL TRIAL TEAMS AND RESEARCH TRAINEES. WE WILL COLLABORATE WITH NCATS TO UTILIZE THE PLATFORM DEMONSTRATED IN TIN 1.0 TO ENGAGE AND EQUIP A MULTISITE RANDOMIZED CLINICAL TRIAL WORKFORCE THROUGH THE CTSA HUBS TO PERFORM TRIALS FASTER AND AT A HIGHER QUALITY IN TIN 2.0.

TO AWARD NEW PROJECT SOCIAL BEHAVIORAL CHANGE COMMUNICATION (SBCC) FOR FIVE YEARS FROM JULY 13, 2015

JH/CIDR GENOTYPING FOR GENOME-WIDE ASSOCIATION STUDIES

NAC ATTACK, A PHASE-3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED TRIAL IN PATIENTS WITH RETINITIS PIGMENTOSA - ABSTRACT: RETINITIS PIGMENTOSA (RP) IS AN INHERITED RETINAL DEGENERATION CAUSED BY ONE OR MORE OF A LARGE NUMBER OF GENETIC MUTATIONS. IT IS A MAJOR CAUSE OF BLINDNESS AND SEVERE VISION LOSS IN PEOPLE AGED 20-60 YEARS. THE FIRST SYMPTOM IN RP IS LOSS OF NIGHT VISION AS A RESULT OF MUTATION-CAUSED DEATH OF ROD PHOTORECEPTORS. SUBSEQUENT LOSS OF CONE PHOTORECEPTORS LEADS TO GRADUAL CONSTRICTION OF VISUAL FIELD AND EVENTUALLY BLINDNESS. CURRENTLY, THERE IS NO TREATMENT FOR PREVENTING VISION LOSS IN RP. NAC ATTACK IS A PHASE-3 MULTICENTER, RANDOMIZED, DOUBLE MASKED, PARALLEL AND PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ORAL N-ACETYLCYSTEINE (NAC) IN PATIENTS WITH RP. PARTICIPANTS WILL BE RANDOMIZED TO RECEIVE EITHER ORAL NAC OF 1800MG/BID OR PLACEBO IN A RATIO OF 2:1 AND WILL BE FOLLOWED FOR 45-MONTHS. THE COORDINATING CENTER (CC) COLLABORATES CLOSELY WITH THE EXECUTIVE COMMITTEE TO ENSURE THE SUCCESS OF NAC ATTACK. THE CC CONTRIBUTES TO STUDY LEADERSHIP AND PROVIDES EXPERTISE ON TRIAL DESIGN, FACILITATION OF RECRUITMENT AND RETENTION OF PARTICIPANTS, COORDINATION ACROSS ALL TRIAL ENTITIES, IMPLEMENTATION AND MAINTENANCE OF A HIGH-QUALITY DATA MANAGEMENT SYSTEM, STATISTICAL ANALYSIS, AND QUALITY ASSURANCE. THE CC WILL: ENLIST AND RETAIN CLINICAL SITES WITH EXPERIENCED INVESTIGATORS AND SUFFICIENT RECRUITMENT CAPACITY; ENSURE THAT CLINICAL SITE PERSONNEL COMPLETE CERTIFICATION REQUIREMENTS AND ARE IN REGULATORY COMPLIANCE; CREATE AND MAINTAIN THE STUDY DATABASE THROUGH DESIGN AND IMPLEMENTATION OF DATA COLLECTION FORMS, SECURE WEB-BASED DATA CAPTURE USING REDCAP, DATA EDITING, AND DATA MANAGEMENT; CREATE AND MAINTAIN THE STUDY CLOUD-BASED PORTAL USING JHU ONEDRIVE TO RECEIVE AND MANAGE IMAGING AND TEST FILES FROM THE CLINICAL SITES; ADVISE CLINICAL SITES ON RESOLUTION OF REAL-TIME PROBLEMS AND OVERALL STRATEGIES FOR SUCCESSFUL IMPLEMENTATION OF THE STUDY PROTOCOL; PROVIDE AIDS TO CLINICAL SITES FOR STUDY MANAGEMENT SUCH AS APPOINTMENT SCHEDULE, REMINDERS OF UPCOMING VISITS, MISSING FORMS, AND INCOMPLETE SUBMISSION OF STUDY MATERIALS; PROVIDE REGULAR REPORTS ON STUDY PROGRESS & PERFORMANCE TO CLINICAL SITES AND ALL STUDY COMMITTEES; DESIGN AND IMPLEMENT A FULL PROGRAM OF QUALITY ASSURANCE ACTIVITIES INCLUDING CERTIFICATION OF PERSONNEL AND CLINICAL SITES, SITE VISITS, AND PERFORMANCE MONITORING; PROVIDE INTERIM AND FINAL STATISTICAL ANALYSES OF STUDY DATA; PREPARE FOR VARIOUS COMMITTEE AND STUDY MEETINGS; PARTICIPATE AND LEAD IN THE PREPARATION OF SCIENTIFIC PRESENTATIONS AND REPORTS. NAC ATTACK HAS THE POTENTIAL TO IDENTIFY A PHARMACOLOGICAL THERAPY BENEFITTING ALL PATIENTS WITH RP, IRRESPECTIVE OF THE IDENTIFICATION OF THEIR CAUSATIVE MUTATION, AND THUS TO IMPACT ON THE CLINICAL MANAGEMENT OF RP.

HEALTH COOMUNICATION PROJECT

PHASE III DOUBLE-BLIND, RANDOMIZED CONTROLLED TRIAL OF SUVOREXANT VERSUS PLACEBO TO TREAT INSOMNIA IN PERSONS WITH OPIOID USE DISORDER - OPIOID USE DISORDER (OUD) IS A RAPIDLY ESCALATING PUBLIC HEALTH CRISIS WITH RECENT EVIDENCE SUGGESTING THAT CLOSE TO 70% OF DRUG OVERDOSE DEATHS INVOLVED OPIOIDS IN THE LAST YEAR. MEDICATIONS FOR OUD (MOUDS) SUCH AS BUPRENORPHINE AND METHADONE ARE THE FRONTLINE TREATMENT FOR OUD, YET OVER HALF OF INDIVIDUALS WHO INITIATE MOUD RELAPSE OR LEAVE TREATMENT IN THE FIRST YEAR, HIGHLIGHTING THE IMPORTANCE OF ADJUNCTIVE THERAPIES THAT MIGHT IMPROVE OUD TREATMENT OUTCOMES. INSOMNIA IS A COMMON AND OFTEN RECALCITRANT ISSUE AMONG PERSONS ON MOUDS BUT THERE IS LITTLE GUIDANCE ON HOW TO AMELIORATE SYMPTOMS OF INSOMNIA DURING OUD TREATMENT. THE OREXIN (OR HYPOCRETIN) NEUROTRANSMITTER SYSTEM PLAYS A ROLE IN INSOMNIA AND IN THE ONSET, PROGRESSION, AND MAINTENANCE OF OUD. SUVOREXANT IS A DUAL-OREXIN RECEPTOR ANTAGONISTS THAT IS FDA-APPROVED FOR THE TREATMENT OF INSOMNIA, AND DATA FROM OUR GROUP SUGGESTS THAT SUVOREXANT MIGHT BE ESPECIALLY EFFICACIOUS IN TREATING INSOMNIA IN PERSONS WITH OUD AND MAY ALSO CONFER COLLATERAL BENEFITS INCLUDING DECREASED OPIOID CRAVING AND SYMPTOMS OF WITHDRAWAL. MOREOVER, SUVOREXANT HAS AN EXCELLENT SAFETY PROFILE AND DID NOT RESULT IN INCREASED ADVERSE EVENTS OR MEASURES OF ABUSE POTENTIAL WHEN COMPARED TO PLACEBO IN OUR PILOT STUDY. THE PROPOSED STUDY IS AN FDA-REGULATORY-GRADE PHASE III MULTISITE RANDOMIZED-CONTROLLED TRIAL OF SUVOREXANT VERSUS PLACEBO IN PERSONS WITH INSOMNIA WHO ARE UTILIZING LONG-TERM MOUD TREATMENT. PARTICIPANTS WHO ARE PRESCRIBED BUPRENORPHINE OR METHADONE FOR OUD WILL BE SCREENED TO DETERMINE STUDY ELIGIBILITY. ELIGIBLE INDIVIDUALS WILL BE ENROLLED FOR AN 8-WEEK STUDY THAT INCLUDES THE FOLLOWING CONDITIONS: ONE NIGHT DOUBLE-DUMMY PLACEBO LEAD-IN PRIOR TO RANDOMIZATION; ~8 WEEKS OF SUVOREXANT OR PLACEBO WHERE THE DOSE MAY BE ESCALATED FROM 10 MG TO 20 MG AFTER 3 NIGHTS (CONSISTENT WITH CURRENT SUVOREXANT LABEL INSTRUCTIONS); AND TWO-NIGHTS DOUBLE-DUMMY PLACEBO LEAD-OUT TO EXAMINE DISCONTINUATION EFFECTS. IN LAB POLYSOMNOGRAPHY (PSG) WILL BE USED TO AT THE BEGINNING AND END OF THE TRIAL TO DETERMINE THE PRIMARY ENDPOINT OF CHANGE FROM BASELINE TOTAL SLEEP TIME. ADVERSE EVENTS AND OTHER INDICATORS OF PATIENT SAFETY WILL BE MONITORED THROUGHOUT THE STUDY. PARTICIPANTS WILL ALSO BE ASSESSED FOR OUD TREATMENT OUTCOMES INCLUDING REGULAR URINE TOXICOLOGY AND TRAJECTORIES OF MENTAL HEALTH DURING THE STUDY. SPECIFIC AIMS OF THE STUDY ARE TO (AIM 1) EVALUATE THE EFFICACY OF SUVOREXANT VERSUS PLACEBO IN TREAT INSOMNIA IN PERSONS TAKING BUPRENORPHINE OR METHADONE FOR OUD TREATMENT, (AIM1) EVALUATE THE SAFETY OF SUVOREXANT VERSUS PLACEBO IN PERSONS TAKING BUPRENORPHINE OR METHADONE FOR OUD TREATMENT, (AIM 3) SUBMIT A SUPPLEMENT APPLICATION OF EFFICACY TO THE FDA TO SUPPORT AN UPDATE TO THE LABEL OF SUVOREXANT, AND (EXPLORATORY AIM 4) DETERMINE WHETHER SUVOREXANT VERSUS PLACEBO IMPROVES OUD TREATMENT OUTCOMES. THE RESULTS OF THIS IMPORTANT STUDY WILL INFORM TREATMENT PROVIDERS ON WHETHER SUVOREXANT IS SAFE AND EFFECTIVE FOR INSOMNIA IN PERSONS WITH OUD, AND EXPLORATORY RESULTS WILL FURTHER OUR SCIENTIFIC UNDERSTANDING OF THE ROLE OF THE OREXIN SYSTEM IN OUD TREATMENT AND RECOVERY.

MULTI-CENTER UVEITIS STERIOD TREATMENT (MUST) TRIAL

SPORE IN OVARIAN CANCER

THE MAJOR EXTREMITY TRAUMA AND REHABILITATION RESEARCH CONSORTIUM

JOHNS HOPKINS CARES INSTITUTIONAL