THE JOHNS HOPKINS UNIVERSITY

INTERNATIONAL MATERNAL PEDIATRIC ADOLESCENT AIDS CLINICAL TRIALS (IMPAACT) GROUP

NATIONAL STUDY OF DISABILITY TRENDS AND DYNAMICS

REGIONAL ONCOLOGY RESEARCH CENTER

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

HIV PREVENTION TRIALS NETWORK: NETWORK LABORATORY

TAS::75 0885::TAS - OTHER FUNCTIONS - CLINICAL RESEARCH

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

THE JOHNS HOPKINS CENTER FOR AIDS RESEARCH (JHU CFAR)

NORTH AMERICAN AIDS COHORTS COLLABORATION ON RESEARCH AND DESIGN

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.

MATERIALS SCIENCE IN EXTREME ENVIRONMENTS

THE MALAWI CLINICAL TRIALS UNIT

THE PURPOSE OF THE TVCA IS TO IDENTIFY AND IMPLEMENT PROVEN, EVIDENCE-BASED VECTOR CONTROL APPROACHES IN TANZANIA. THE TVCA FOCUSES ON INSECTICIDE TREATED BEDNETS (ITNS) THAT INCLUDES DETERMINING THE QUANTITY OF ITNS NEEDED ANNUALLY TO MAINTAIN HIGH

BIOMARKERS OF COGNITIVE DECLINE AMONG NORMAL INDIVIDUALS: THE BIOCARD COHORT

SPORE IN CERVICAL CANCER

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.

COGNITION AND HIPPOCAMPAL/CORTICAL SYSTEMS IN AGING

JOHNS HOPKINS AIDS CLINICAL TRIALS UNIT

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.

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

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

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

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

BIOMEDICAL (BASIC)

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.

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

JOHNS HOPKINS OCCUPATIONAL SAFETY AND HEALTH EDUCATION AND RESEARCH CENTER

IGF::OT::IGF NIAID CENTERS OF EXCELLENCE FOR INFLUENZA RESEARCH AND SURVEILLANCE (CEIRS)

AWARD OF THE BASE TO HOPKINS FOR CEIRR CONTRACT 75N93021C00045. THIS CONTRACT WILL SUPPORT THE NIAID CENTERS OF EXCELLENCE FOR INFLUENZA RESEARCH AND RESPONSE (CEIRR).

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.

MALARIA TRANSMISSION AND THE IMPACT OF CONTROL EFFORTS IN SOUTHERN AFRICA

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

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

OLDER AMERICANS INDEPENDENCE CENTER

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)

THE PURPOSE OF THE THIS CONTRACT IS TO PROVIDE A COMPREHENSIVE AND UNIFORM APPROACH TO EVALUATE INITIAL AND ON-GOING LABORATORY CAPABILITY AND READINESS TO CARRY OUT NIAID-FUNDED CLINICAL TRIAL PROTOCOLS (PROTOCOLS) BY (1) MONITORING COMPLIANCE WITH

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.

BIOMEDICAL (APPLIED/EXPLORATORY)

JOHNS HOPKINS ALZHEIMER'S DISEASE RESEARCH CENTER

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.

COLDSTICK

TASC 3-PROJECT SEARCH HIV PREVENTION PROGRAM RESEARCH & EVALUATION TASK ORDER

MULTIDISCIPLINARY TRAINING PROGRAM IN LUNG DISEASES

ADVANCING SUSTAINABLE IMPLEMENTATION OF COMPREHENSIVE HIV/TB SERVICES FOR EPIDEMIC CONTROL IN THE REPUBLIC OF MOZAMBIQUE UNDER THE PRESIDENT'S EMERGENCY FUND FOR AIDS RELIEF (PEPFAR)

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.