Harvard Pilgrim Health Care Inc

PRE- AND PERI-NATAL PREDICTORS OF CHILDHOOD OBESITY

COMMON AND DISTINCT EARLY ENVIRONMENTAL INFLUENCES ON CARDIOMETABOLIC AND RESPIRATORY HEALTH: MECHANISMS AND METHODS

INSPIRE (INTELLIGENT STEWARDSHIP PROMPTS TO IMPROVE REAL-TIME EMPIRIC ANTIBIOTIC SELECTION FOR PATIENTS): THE INSPIRE-ASP TRIAL FOR INTRA-ABDOMINAL AND SKIN AND SOFT TISSUE INFECTIONS

EPICENTER IV: HARVARD PILGRIM-UCI CENTER FOR HAI PREVENTION

EPICENTER V: HARVARD PILGRIM HEALTH CARE INSTITUTE CENTER FOR EXCELLENCE IN HAI SURVEILLANCE AND PREVENTION

NEW INSIGHTS INTO THE FEDERAL CALORIE LABELING LAW

PRECISION MEDICINE AND TREATMENT (PREEMPT)

EPICENTERS III: TRANSLATIONAL RESEARCH TO PREVENT HEALTHCARE ASSOCIATED INFECTION

NEIGHBORHOODS AND HEALTH ACROSS THE LIFE COURSE: EARLY LIFE FOOD SECURITY, DIET QUALITY, AND CHEMICAL EXPOSURES - TITLE: NEIGHBORHOODS AND HEALTH ACROSS THE LIFE COURSE: EARLY LIFE FOOD SECURITY, DIET QUALITY, AND CHEMICAL EXPOSURES FOOD INSECURITY HAS BEEN LINKED TO ADVERSE HEALTH OUTCOMES IN CHILDREN AND ADULTS, INCLUDING OBESITY AND CARDIOVASCULAR DISEASE (CVD). MUCH LESS IS KNOWN ABOUT HEALTH EFFECTS OF FOOD INSECURITY AROUND PREGNANCY, BUT THERE IS SUBSTANTIAL REASON FOR CONCERN, ESPECIALLY GIVEN THAT MORE THAN 1 IN 10 PREGNANCIES ARE AFFECTED. FOOD INSECURITY OFTEN RESULTS IN HIGHER INTAKE OF FAST AND HIGHLY PROCESSED FOODS, LEADING TO AN UNHEALTHFUL, PRO- INFLAMMATORY DIETARY PATTERN. INTAKE OF HIGHLY PROCESSED FOODS ALSO MAY LEAD TO GREATER EXPOSURE TO SYNTHETIC ENDOCRINE DISRUPTING CHEMICALS (EDCS) CONTAMINATING THESE FOODS OR THEIR PACKAGING. PRO-INFLAMMATORY DIETS AND EDC EXPOSURES EACH PREDICT PREGNANCY COMPLICATIONS, INCLUDING EXCESSIVE GESTATIONAL WEIGHT GAIN (GWG), GESTATIONAL DIABETES MELLITUS (GDM), HYPERTENSIVE DISORDERS OF PREGNANCY (HDP), DEPRESSIVE SYMPTOMS, AND SMALL OR LARGE FOR GESTATIONAL AGE BIRTH (SGA AND LGA). THESE PRENATAL COMPLICATIONS PRESAGE EXCESS LONG-TERM CVD RISK FOR MOTHER AND CHILD ALIKE. NEIGHBORHOODS HAVE EMERGED AS HIGHLY RELEVANT CONTEXTS BECAUSE THEY POSSESS BOTH PHYSICAL (E.G., ACCESS TO HEALTHY FOOD CHOICES) AND SOCIAL (E.G., AVAILABILITY OF SOCIAL SERVICES) ATTRIBUTES THAT CAN DRIVE AND INTERACT WITH INDIVIDUAL-LEVEL FOOD INSECURITY, WHICH TRANSLATES INTO POORER HEALTH. UNDERSTANDING THESE RELATIONSHIPS WILL HELP INFORM POLICIES THAT AIM TO REDUCE EXCESS CVD RISK IN BOTH MOTHERS AND CHILDREN. LEVERAGING OUR TEAM’S EXPERTISE IN NUTRITIONAL, SOCIAL, AND ENVIRONMENTAL EPIDEMIOLOGIC RESEARCH IN THE PERIPARTUM PERIOD AND EARLY CHILDHOOD, WE PROPOSE TO INITIATE A NEW COHORT THAT WILL PARTICIPATE IN THE NATIONWIDE ENVIRONMENTAL INFLUENCES ON CHILD HEALTH OUTCOMES (ECHO) PROGRAM. WE WILL RECRUIT 800 PREGNANT WOMEN AND THEIR OFFSPRING FROM NEIGHBORHOODS IN THE BOSTON, MA AREA AND COLLECT DATA FROM EARLY PREGNANCY ONWARDS, INCLUDING ENROLLING REPEAT PREGNANCIES WITH PRECONCEPTION MEASURES. WE WILL CONDUCT SOLUTION-ORIENTED SCIENCE WITHIN THE UNPARALLELED ECHO DATA PLATFORM, WITH THE OVERALL GOAL OF BETTER UNDERSTANDING HOW FOOD INSECURITY AND RELATED NEIGHBORHOOD AND INDIVIDUAL CHARACTERISTICS CONTRIBUTE TO PREGNANCY CONDITIONS THAT LEAD TO LATER OBESITY AND CVD RISK.

POST-PCV PNEUMOCOCCAL POPULATION GENETICS AND RESISTANCE

SEXUAL ORIENTATION-RELATED DISPARITIES IN OBSTETRICAL AND PERINATAL HEALTH - PROJECT SUMMARY/ABSTRACT COMPARED TO HETEROSEXUAL WOMEN, SEXUAL MINORITY WOMEN (I.E., THOSE WITH SAME-SEX ATTRACTIONS, SAME-SEX BEHAVIOR, AND/OR A LESBIAN/GAY/BISEXUAL IDENTITY) ARE VULNERABLE TO POOR GYNECOLOGICAL HEALTH; FOR EX- AMPLE, THEY ARE MORE LIKELY TO EXPERIENCE SEXUAL ASSAULT AND TO ENCOUNTER BARRIERS TO CARE. YET, DESPITE THE MOUNTING EVIDENCE OF THESE GYNECOLOGICAL DISPARITIES, LITTLE IS KNOWN ABOUT THE EXTENT TO WHICH OBSTETRICAL AND PERINATAL HEALTH DIFFER ACROSS SEXUAL ORIENTATION GROUPS. THIS GAP IS ESPECIALLY TROUBLING SINCE SEXUAL MINORITIES HAVE MORE RISK FACTORS (E.G., DEPRESSION, SUBSTANCE USE, OBESITY) FOR ADVERSE OBSTETRICAL AND PERINATAL OUT- COMES COMPARED TO HETEROSEXUALS. FEW DATA ARE AVAILABLE TO ADEQUATELY QUANTIFY SEXUAL ORIENTATION-RELATED OBSTETRICAL AND PERINATAL HEALTH DISPARITIES, BUT PRELIMINARY RESULTS FROM SMALL, CROSS-SECTIONAL DATASETS REVEAL STRIKING DISPARITIES: SEXUAL MINORITY WOMEN EXPERIENCE TWICE THE NUMBER OF PREGNANCIES ENDING IN MISCARRIAGE AND STILLBIRTH AND TWICE THE NUMBER OF CHILDREN BORN EXTREMELY PRETERM AND LOW BIRTHWEIGHT COMPARED TO HETERO- SEXUAL WOMEN. QUANTIFYING SUCH DISPARITIES NECESSITATES THE USE OF LARGE, LONGITUDINAL DATASETS TO BETTER INFORM INTERVENTIONS. THIS PROJECT'S OBJECTIVE IS TO ADDRESS THE KNOWLEDGE GAPS IN SEXUAL ORIENTATION-RELATED OBSTETRICAL AND PERINATAL HEALTH BY COLLECTING AND ANALYZING NATIONAL DATA FROM THREE UNIQUE, LONGITUDINAL, INTERGENERATIONAL COHORTS. THE NURSES' HEALTH STUDY 2 (NHS2) BEGAN IN 1989 WHEN OUR RESEARCH GROUP ENROLLED FEMALE NURSES AGED 25–42 YEARS (NOW 56–73 YEARS). IN 1996 AND 2004, OUR RESEARCH GROUP ENROLLED NHS2 OFFSPRING AGED 9– 16 YEARS (NOW 25–39 YEARS) INTO THE GROWING UP TODAY STUDY (GUTS). THESE COHORTS COMPRISE ALMOST 150,000 PARTICIPANTS WITH NEARLY AS MANY PREGNANCIES, INCLUDING >30,000 PREGNANCIES AMONG SEXUAL MINORI- TIES. THE PROPOSED PROJECT WILL LEVERAGE EXISTING DATA—INCLUDING NUANCED SEXUAL ORIENTATION DATA—TO IDENTIFY NEW PREGNANCIES AMONG GUTS PARTICIPANTS DURING THE HEIGHT OF THEIR REPRODUCTIVE YEARS AND COLLECT DATA ABOUT A THIRD GENERATION: THE OFFSPRING OF GUTS PARTICIPANTS. COMBINING THESE NEW AND EXISTING DATA WILL ENABLE US TO FILL CRITICAL GAPS, FOR EXAMPLE BY DETAILING OUTCOMES ACROSS DIFFERENT GENERATIONS AND SEXUAL ORIENTATION SUB- GROUPS (E.G., BISEXUALS, LESBIANS). THIS STUDY WILL QUANTIFY THE OBSTETRICAL HEALTH OF SEXUAL MINORITY AND HETERO- SEXUAL WOMEN AS WELL AS THE PERINATAL HEALTH OF CHILDREN BORN TO SEXUAL MINORITY AND HETEROSEXUAL WOMEN. DRAWING ON THE MINORITY STRESS MODEL, THE STUDY WILL ALSO IDENTIFY MEDIATORS AND MODERATORS OF SEXUAL ORIENTA- TION-RELATED DIFFERENCES IN OBSTETRICAL AND PERINATAL HEALTH. BY COLLECTING DETAILED, LONGITUDINAL DATA ACROSS THREE GENERATIONS WITH DATA ON OBSTETRICAL/PERINATAL OUTCOMES AS WELL AS MEDIATORS AND MODERATORS, THE PROPOSED RESEARCH IS A SUBSTANTIVE, INNOVATIVE DEPARTURE FROM THE STATUS QUO. THIS PROJECT WILL PRODUCE THE FIRST THOROUGH EVALUATION OF OBSTETRICAL AND PERINATAL HEALTH OF A NEGLECTED POPULATION—SEXUAL MINORITY WOMEN AND THEIR OFF- SPRING—AND WILL HAVE A POSITIVE IMPACT BY REVEALING THE NEEDS OF THESE VULNERABLE GROUPS, INFORMING TARGETED INTERVENTIONS AND IMPROVING THE HEALTH OF SUBSEQUENT GENERATIONS.

THE POPULATION-BASED EFFECTIVENESS IN ASTHMA AND LUNG DISEASES (PEAL) NETWORK

BUILT ENVIRONMENT ASSESSMENT THROUGH COMPUTER VISION (BEACON): APPLYING DEEP LEARNING TO STREET-LEVEL AND SATELLITE IMAGES TO ESTIMATE BUILT ENVIRONMENT EFFECTS ON CARDIOVASCULAR HEALTH

LONGITUDINAL ASSOCIATION OF PFCS WITH OBESITY, DIABETES, AND METABOLIC SYNDROME

NEIGHBORHOOD AND INDIVIDUAL ENVIRONMENTAL RISK FACTORS IN EARLY LIFE AND -OMICS BIOMARKERS FOR KIDNEY FUNCTION TRAJECTORIES ACROSS CHILDHOOD AND ADULTHOOD - PROJECT SUMMARY/ABSTRACT CHRONIC KIDNEY DISEASE (CKD) AND HYPERTENSION (HTN) ARE SUBSTANTIAL PUBLIC HEALTH CONCERNS IN THE US AND ARE IMPORTANT RISK FACTORS FOR OTHER ADVERSE OUTCOMES INCLUDING ACUTE KIDNEY INJURY AND PREMATURE MORTALITY. CKD AND HTN ARE TYPICALLY DIAGNOSED LATER IN LIFE, YET OUR UNDERSTANDING OF THE PRENATAL AND EARLY LIFE ENVIRON- MENTAL DETERMINANTS OF REDUCED KIDNEY FUNCTION AND HTN ACROSS CHILDHOOD AND EARLY ADULTHOOD REMAINS INCIPI- ENT. THIS RESEARCH, HOWEVER, FACES SEVERAL BARRIERS INCLUDING LACK OF ASSESSMENT OF BOTH NEIGHBORHOOD- AND INDIVIDUAL-LEVEL ENVIRONMENTAL STRESSORS AT SPECIFIC EARLY LIFE STAGES COUPLED WITH LONG-TERM FOLLOW-UP FROM BIRTH TO EARLY ADULTHOOD. THIS PROJECT WILL ADDRESS THESE RESEARCH GAPS BY LEVERAGING HIGH-QUALITY DATA FROM PROJECT VIVA, AN ONGOING LONGITUDINAL PROSPECTIVE PRE-BIRTH COHORT OF MOTHER-CHILD PAIRS FOLLOWED SINCE PREGNANCY. THE OVERALL GOALS OF THE PROPOSED PROJECT ARE TO EXAMINE THE EXTENT TO WHICH EARLY-LIFE EXPOSURE TO DISADVANTAGED NEIGHBORHOOD CONTEXTS AND NEPHROTOXICANTS (I.E., AIR POLLUTANTS AND METALS) LEADS TO LATER LIFE KIDNEY DYSFUNC- TION AND HIGHER BLOOD PRESSURE (BP). THE INVESTIGATORS WILL: (AIM 1) EXAMINE ASSOCIATIONS OF EARLY-LIFE NEIGHBOR- HOOD ENVIRONMENT WITH KIDNEY FUNCTION AND BP ACROSS CHILDHOOD AND EARLY ADULTHOOD; (AIM 2) ASSESS ASSOCIA- TIONS OF INDIVIDUAL-LEVEL EARLY-LIFE EXPOSURE TO CANDIDATE NEPHROTOXICANTS WITH KIDNEY FUNCTION AND BP FROM MID- CHILDHOOD TO EARLY ADULTHOOD; AND (AIM 3) CHARACTERIZE URINARY PROTEOMIC SIGNATURES UNDERLYING ALTERED KIDNEY FUNCTION AND BP TRAJECTORY FROM CHILDHOOD TO EARLY ADULTHOOD, AND EXAMINE THESE SIGNATURES AS POTENTIAL MARK- ERS OF TOXICANT EXPOSURE. THIS INNOVATIVE PROPOSAL WILL BE THE FIRST TO EXAMINE BOTH NEIGHBORHOOD- AND INDIVID- UAL-LEVEL ENVIRONMENTAL DETERMINANTS OF KIDNEY FUNCTION AND BP TRAJECTORIES. WE WILL IDENTIFY ACTIONABLE RISK FAC- TORS AND MOLECULAR SIGNATURES TO IDENTIFY HIGH-RISK INDIVIDUALS AND PINPOINT WHEN PRIMORDIAL PREVENTION EFFORTS HAVE THE GREATEST POTENTIAL TO PREVENT FUTURE CKD AND HTN.

A LIFECOURSE APPROACH TO WOMEN'S CARDIOMETABOLIC AND BONE HEALTH: FROM FERTILITY TO PERIMENOPAUSE

GESTATIONAL DIABETES PATHOPHYSIOLOGY UNCOVERED BY PLACENTAL TRANSCRIPTOMICS

COMMON AND DISTINCT EARLY ENVIRONMENTAL INFLUENCES ON CARDIOMETABOLIC AND RESPIRATORY HEALTH: MECHANISMS AND METHODS

PRE- AND PERI-NATAL PREDICTORS OF CHILDHOOD OBESITY

INTENDED AND UNINTENDED CONSEQUENCES OF NONPAYMENT FOR PREVENTABLE COMPLICATIONS

SYSTEMS SCIENCE TO GUIDE WHOLE-OF-COMMUNITY CHILDHOOD OBESITY INTERVENTIONS

CABOTEGRAVIR PREP: ACTIONABLE ROBUST EVIDENCE FOR TRANSLATION INTO PRACTICE (CABARET) - PROJECT SUMMARY DESPITE HIGH EFFICACY, ORAL PREEXPOSURE PROPHYLAXIS (PREP) HAS HAD LIMITED POPULATION IMPACT ON HIV INCIDENCE IN THE US, IN PART BECAUSE OF CHALLENGES WITH PILL-TAKING. BIMONTHLY INJECTIONS OF CABOTEGRAVIR WERE RECENTLY FOUND TO HAVE SUPERIOR EFFICACY TO DAILY ORAL PREP AMONG MEN WHO HAVE SEX WITH MEN (MSM), TRANSGENDER WOMEN, AND CISGENDER WOMEN. LONG-ACTING INJECTABLE (LAI) PREP COULD MITIGATE BARRIERS TO ADHERENCE AND PERSISTENCE, THEREBY INCREASING PREP COVERAGE. INTEREST IN LAI PREP HAS BEEN HIGH IN SOME GROUPS THAT ARE AT DISPROPORTIONATELY HIGH RISK OF HIV INFECTION AND UNDERREPRESENTED AMONG ORAL PREP USERS, INCLUDING BLACK WOMEN AND BLACK AND LATINO MSM, SUGGESTING THAT LAI PREP COULD ALSO REDUCE RACIAL, ETHNIC, AND GENDER INEQUITIES IN PREP USE. HOWEVER, BARRIERS TO LAI PREP USE MAY BE MORE COMMON IN UNDERSERVED COMMUNITIES, POTENTIALLY EXACERBATING INEQUITIES. LAI PREP MAY ALSO INCREASE RISK OF DRUG RESISTANCE DUE TO ITS LONG HALF-LIFE OR DELAYED DETECTION OF HIV INFECTIONS. THIS RISK MAY BE MITIGATED BY AN ORAL PREP RAMP-DOWN PHASE OR VIRAL LOAD TESTING DURING USE, BUT THE FEASIBILITY AND IMPACT OF THESE STRATEGIES ARE UNKNOWN. ROBUST EVIDENCE ON EARLY USE AND OUTCOMES OF LAI PREP IS NEEDED TO DESIGN IMPLEMENTATION STRATEGIES TO MINIMIZE HIV INFECTIONS, INEQUITIES IN USE, AND DRUG RESISTANCE. LARGE-SCALE ORAL PREP STUDIES HAVE HISTORICALLY RELIED ON PRESCRIPTION DATA, WITH LIMITED ABILITY TO EVALUATE KEY DETERMINANTS (E.G., RACE), BARRIERS TO USE, OR CLINICAL OUTCOMES. RESEARCH IN HEALTHCARE SYSTEMS CAN COMBINE THE BREADTH OF ELECTRONIC HEALTH RECORD (EHR) DATA WITH THE DEPTH OF QUALITATIVE STUDIES TO GUIDE EFFICIENT AND EQUITABLE IMPLEMENTATION OF PREP. OUR STUDY, CABOTEGRAVIR PREP: ACTIONABLE ROBUST EVIDENCE FOR TRANSLATION INTO PRACTICE (CABARET), WILL EVALUATE REAL-WORLD USE, POPULATION IMPACT, AND OPTIMAL INVESTMENT OF RESOURCES TO FACILITATE THE IMPLEMENTATION OF LAI PREP. THE SETTINGS ARE 3 RACIALLY AND ETHNICALLY DIVERSE REGIONS OF KAISER PERMANENTE—NORTHERN CALIFORNIA, MID-ATLANTIC (DC, VIRGINIA, MARYLAND), AND GEORGIA—SERVING 5.6 MILLION MEMBERS AND 13,000 PREP USERS. AIM 1 WILL EXTRACT AND ANALYZE EHR DATA TO EVALUATE LAI PREP UPTAKE AND PERSISTENCE, INCLUDING RACIAL AND ETHNIC INEQUITIES IN USE, AND HIV INCIDENCE AND DRUG RESISTANCE. FOCUS GROUPS WITH PROVIDERS AND POTENTIAL, CURRENT, AND FORMER LAI PREP USERS WILL EXPLORE FACILITATORS AND BARRIERS TO LAI PREP PRESCRIBING AND USE, WITH OVERSAMPLING OF BLACK WOMEN AND BLACK AND LATINO MSM. AIM 2 WILL USE MATHEMATICAL MODELING PARAMETERIZED WITH EHR DATA TO ESTIMATE THE 10-YEAR IMPACT OF LAI PREP ON HIV INCIDENCE, INEQUITIES IN INCIDENCE, AND DRUG RESISTANCE. AIM 3 WILL USE ECONOMIC DECISION MODELING TO DETERMINE THE COST AND EFFECTIVENESS FEATURES THAT LAI PREP UPTAKE AND PERSISTENCE INTERVENTIONS MUST HAVE TO BE PRIORITIZED IN AN EFFICIENT AND EQUITABLE HIV-PREVENTION STRATEGY. A STAKEHOLDER ADVISORY GROUP WILL INFORM STUDY DESIGN, INTERPRETATION, AND DISSEMINATION TO MAXIMIZE IMPACT. THIS STUDY WILL PRODUCE A BODY OF EVIDENCE TO GUIDE THE TRANSLATION OF LAI PREP INTO PRACTICE, WITH RESEARCH INFRASTRUCTURE THAT CAN INTEGRATE NEW PREP PRODUCTS AS THEY EMERGE.

ENHANCING PUBLIC HEALTH THORUGH ELECTRONIC MEDICAL AND PERSONAL HEALTH REC

AGE-DEPENDENT PHARMACOGENOMICS OF ASTHMA TREATMENT (ADAPT)

HMO RESEARCH NETWORK CERT III

HIGH DEDUCTIBLE INSURANCE: IMPACT ON BREAST CANCER CARE AND OUTCOMES

NEIGHBORHOODS AND HEALTH ACROSS THE LIFE COURSE: EARLY LIFE INEQUITIES IN FOOD INSECURITY, DIET QUALITY, AND CHEMICAL EXPOSURES - PROJECT SUMMARY/ABSTRACT FOOD INSECURITY HAS BEEN LINKED TO ADVERSE HEALTH OUTCOMES IN CHILDREN AND ADULTS, INCLUDING OBESITY AND CARDIOVASCULAR DISEASE (CVD). MUCH LESS IS KNOWN ABOUT HEALTH EFFECTS OF FOOD INSECURITY AROUND PREGNANCY, BUT THERE IS SUBSTANTIAL REASON FOR CONCERN, ESPECIALLY GIVEN THAT MORE THAN 1 IN 10 PREGNANCIES ARE AFFECTED. FOOD INSECURITY OFTEN RESULTS IN HIGHER INTAKE OF FAST AND HIGHLY PROCESSED FOODS, LEADING TO AN UNHEALTHFUL, PRO- INFLAMMATORY DIETARY PATTERN. INTAKE OF HIGHLY PROCESSED FOODS ALSO MAY LEAD TO GREATER EXPOSURE TO SYNTHETIC ENDOCRINE DISRUPTING CHEMICALS (EDCS) CONTAMINATING THESE FOODS OR THEIR PACKAGING. PRO-INFLAMMATORY DIETS AND EDC EXPOSURES EACH PREDICT PREGNANCY COMPLICATIONS, INCLUDING EXCESSIVE GESTATIONAL WEIGHT GAIN (GWG), GESTATIONAL DIABETES MELLITUS (GDM), HYPERTENSIVE DISORDERS OF PREGNANCY (HDP), DEPRESSIVE SYMPTOMS, AND SMALL OR LARGE FOR GESTATIONAL AGE BIRTH (SGA AND LGA). THESE PRENATAL COMPLICATIONS PRESAGE EXCESS LONG-TERM CVD RISK FOR MOTHER AND CHILD ALIKE. PEOPLE OF COLOR, ESPECIALLY NON-HISPANIC BLACK AND HISPANIC WOMEN AND THEIR CHILDREN, ARE AT HIGHEST RISK FOR FOOD INSECURITY AS WELL AS PREGNANCY COMPLICATIONS. RACIAL AND ETHNIC INEQUITIES IN THESE RISKS, AND IN CVD ITSELF, ARE WIDENING WITH TIME. NEIGHBORHOODS HAVE EMERGED AS HIGHLY RELEVANT CONTEXTS BECAUSE THEY POSSESS BOTH PHYSICAL (E.G., ACCESS TO HEALTHY FOOD CHOICES) AND SOCIAL (E.G., AVAILABILITY OF SOCIAL SERVICES) ATTRIBUTES THAT CAN DRIVE AND INTERACT WITH INDIVIDUAL-LEVEL FOOD INSECURITY, WHICH TRANSLATES INTO POORER HEALTH THAT CONTRIBUTES TO HEALTH INEQUITIES. UNDERSTANDING THESE RELATIONSHIPS WILL HELP INFORM POLICIES THAT AIM TO REDUCE EXCESS CVD RISK IN BOTH MOTHERS AND CHILDREN. LEVERAGING OUR TEAM’S EXPERTISE IN NUTRITIONAL, SOCIAL, AND ENVIRONMENTAL EPIDEMIOLOGIC RESEARCH IN THE PERIPARTUM PERIOD AND EARLY CHILDHOOD, WE PROPOSE TO INITIATE A NEW COHORT THAT WILL PARTICIPATE IN THE NATIONWIDE ENVIRONMENTAL INFLUENCES ON CHILD HEALTH OUTCOMES (ECHO) PROGRAM. WE WILL RECRUIT 800 PREGNANT PEOPLE AND THEIR OFFSPRING FROM RACIALLY, ETHNICALLY, AND SOCIOECONOMICALLY DIVERSE NEIGHBORHOODS IN THE BOSTON, MA AREA AND COLLECT DATA FROM EARLY PREGNANCY ONWARDS, INCLUDING ENROLLING REPEAT PREGNANCIES WITH PRECONCEPTION MEASURES. WE WILL CONDUCT SOLUTION-ORIENTED SCIENCE WITHIN THE UNPARALLELED ECHO DATA PLATFORM, WITH THE OVERALL GOAL OF BETTER UNDERSTANDING HOW FOOD INSECURITY AND RELATED NEIGHBORHOOD AND INDIVIDUAL CHARACTERISTICS CONTRIBUTE TO PREGNANCY CONDITIONS THAT LEAD TO LATER OBESITY AND CVD RISK.

MEDICATIONS AND WEIGHT GAIN IN PCORNET: THE MEDWEIGHT STUDY

ENHANCING PUBLIC HEALTH THROUGH ELECTRONIC MEDICAL & PERSONAL HEALTH RECORDS II

REDUCING MATERNAL HEALTH DISPARITIES: EFFECTS OF RECENT HEALTH WORKFORCE POLICIES - PROJECT SUMMARY/ABSTRACT THE U.S. IS FACING A SERIOUS CRISIS OF RISING RATES OF MATERNAL MORTALITY AND SEVERE MORBIDITY, WHICH ARE ATTRIBUTABLE TO MULTIPLE FACTORS, SUCH AS THE PERSISTENT, DEEP SHORTAGES OF MATERNAL CARE WORKFORCE IN DISADVANTAGED URBAN COMMUNITIES AND RURAL AREAS. SINCE HALF OF U.S. COUNTIES DO NOT HAVE A SINGLE OBSTETRICIAN-GYNECOLOGIST (OB-GYN), ACCESS TO MATERNAL CARE IS A DAUNTING CHALLENGE FACING THE NEARLY SEVEN MILLION REPRODUCTIVE-AGE WOMEN LIVING IN THOSE COUNTIES. TO ADDRESS THE PROBLEM OF UNEQUAL DISTRIBUTION OF CLINICIANS, POLICYMAKERS HAVE TAKEN CONSIDERABLE EFFORTS IN RECENT DECADES. AMONG THE EFFORTS, THE NATIONAL HEALTH SERVICE CORPS (NHSC) REMAINS THE SINGLE LARGEST POLICY INTERVENTION THAT HAS BEEN LAUNCHED TO RECRUIT CLINICIANS TO HEALTH PROFESSIONAL SHORTAGE AREAS (HPSAS). THE NHSC HAS EXPERIENCED A DRAMATIC EXPANSION DURING THE PAST DECADE, FIRST THROUGH THE AMERICAN RECOVERY AND REINVESTMENT ACT IN 2009 AND THEN BY THE AFFORDABLE CARE ACT IN 2010. PRIOR STUDIES HAVE FOUND THAT THESE TWO ACTS HAVE RAISED THE NHSC’S ANNUAL BUDGET BY OVER 100% AND LED TO A SIGNIFICANT EXPANSION OF THE NHSC’S CLINICIAN WORKFORCE, SUCH AS OB-GYNS AND CERTIFIED NURSE-MIDWIVES. HOWEVER, NO STUDY TO DATE HAS EVALUATED THE IMPACT OF THE NHSC EXPANSION ON DISPARITIES IN MATERNAL CARE AND OUTCOMES BETWEEN THE HPSAS AND OTHER AREAS. THIS PROPOSED PROJECT AIMS TO EXAMINE THESE ISSUES AND FILL THE GAP IN THE LITERATURE. TO OUR KNOWLEDGE, IT WILL BE THE FIRST STUDY TO EXAMINE THE EFFECT OF THE RECENT NHSC EXPANSION ON DISPARITIES IN MATERNAL CARE AND OUTCOMES. SPECIFICALLY, THE PROJECT AIMS TO ASSESS HOW THE RECENT NHSC EXPANSION AFFECTS DISPARITIES IN (1) MATERNAL MORTALITY OVERALL AND IN-HOSPITAL MORTALITY IN PARTICULAR, (2) SEVERE MATERNAL MORBIDITY DURING CHILDBIRTH HOSPITALIZATIONS AND THE ASSOCIATED HOSPITAL DELIVERY COSTS AND LENGTH OF STAY, (3) LABOR AND DELIVERY CARE, AND (4) TIMING AND ADEQUACY OF PRENATAL CARE AND BIRTH OUTCOMES. TO EXAMINE THESE AIMS, WE WILL USE MULTIPLE LARGE, NATIONAL DATA FILES OVER AN EXTENDED PERIOD OF 15 YEARS BETWEEN 2005 AND 2019. TO ANALYZE THE DATA, WE WILL TAKE TWO COMPLEMENTARY APPROACHES, INCLUDING A DIFFERENCE-IN-DIFFERENCES METHOD, AND AN INSTRUMENTAL VARIABLE APPROACH. OUR ANALYSES ARE EXPECTED TO PROVIDE RIGOROUS QUASI-EXPERIMENTAL EVIDENCE ABOUT THE EFFECTS OF WORKFORCE POLICY CHANGES ON DISPARITIES IN MATERNAL MORTALITY AND SEVERE MORBIDITY, WHICH ARE KEY OBJECTIVES OF THE HEALTHY PEOPLE 2030. OUR STUDY FINDINGS WILL HAVE IMPORTANT IMPLICATIONS FOR THE UPCOMING IMPLEMENTATION OF THE 2018 IMPROVING ACCESS TO MATERNITY CARE ACT, THE LATEST NHSC POLICY CHANGE INTENDED TO BETTER SERVE REPRODUCTIVE-AGE WOMEN IN HPSAS BY FURTHER INCREASING THE NHSC SUPPORTED MATERNAL CARE PROVIDERS.

BREASTFEEDING PROMOTION RCT AND CHILD METABOLIC SYNDROME

WEIGHT AND WEIGHT-RELATED BEHAVIORS IN YOUTH: INFLUENCE OF THE FAMILY CONTEXT

IMPACT OF MEDICARE DRUG BENEFIT ON USE AND COST-RELATED UNDERUSE OF MEDICINES

BIG DATA APPROACHES FOR SAFE THERAPEUTICS IN HEALTHY PREGNANCIES (BOOST-HP) - PROJECT SUMMARY/ABSTRACT IN THE US, PREGNANT PATIENTS USE 4 MEDICATIONS ON AVERAGE, AND 70% USE AT LEAST ONE. YET, MOST DRUGS LACK CONCLUSIVE EVIDENCE ABOUT SAFETY DURING PREGNANCY: OF 290 NEW FDA LABELS APPROVED BETWEEN 2010 TO 2019, 90% CONTAIN NO HUMAN DATA ON THE RISKS OR BENEFITS FOR PREGNANT PATIENTS. WITH CURRENT EVIDENCE GENERATION SYSTEMS, THE MEAN TIME FOR EVIDENCE DEVELOPMENT IN PREGNANCY HAS BEEN ESTIMATED AT 27 YEARS, WHICH IS TOO LONG. CURRENT EVIDENCE GENERATION RELIES LARGELY ON OBSERVATIONAL STUDIES, TYPICALLY PROMPTED BY SIGNALS FROM ANIMAL STUDIES OR EXTRAPOLATION FROM KNOWN PHARMACOLOGICAL PATHWAYS, WHICH MAY MISS PREGNANCY-SPECIFIC CONTEXT. INSUFFICIENT ATTENTION IS ALSO GIVEN TO IDENTIFYING CAUSAL MECHANISMS IN VULNERABLE SUB-POPULATIONS AT GREATEST RISK. BUILDING ON OUR PRIOR WORK IN DATA-MINING IN FDA’S SENTINEL SYSTEM AND CDC’S VACCINE SAFETY DATALINK, CONDUCT OF PHARMACOEPIDEMIOLOGIC STUDIES TO EVALUATE PRENATAL MEDICATION SAFETY, AND PILOT WORK WITH SPECIAL FOCUS ON DRUG SCANS IN PREGNANCY, WE WILL IMPLEMENT A THREE-STAGE NOVEL REVERSE TRANSLATIONAL FRAMEWORK TO ACCELERATE EVIDENCE GENERATION THAT WILL USE DATA-MINING (“SCANS”) TO IDENTIFY NEW EXPOSURE- OUTCOME ASSOCIATIONS, TRIAGE SIGNALS, AND THEN FORMALLY EVALUATE TOP PRIORITIZED SIGNALS. TO ACCOMPLISH OUR GOALS, WE WILL USE OUR INFRASTRUCTURE DEVELOPED FOR DRUG EVALUATIONS IN PREGNANCY, INCLUDING CURATED BILLING RECORDS FROM THE NIH COLLABORATORY’S DISTRIBUTED RESEARCH NETWORK AND THE NATIONAL MEDICAID INFORMATION SYSTEM, REPRESENTING A BROAD CROSS-SECTION OF PRIVATELY AND PUBLICLY INSURED PREGNANT PATIENTS AND THEIR OFFSPRING. OUR SPECIFIC AIMS ARE: (AIM 1) TO SCAN FOR ASSOCIATIONS BETWEEN (1A) PREGNANCY LOSS AND ANTECEDENT PRENATAL EXPOSURES ON THE INDIVIDUAL DRUG, CHEMICAL AND THERAPEUTIC CLASS LEVEL; AND (1B) THE 50 MOST PREVALENT DRUGS IN PREGNANCY WITH INCOMPLETE INFORMATION ON TERATOGENIC RISK AND A BROAD SELECTION OF LIVE BIRTH ADVERSE OUTCOMES; AND (1C) TO PRIORITIZE SIGNALS VIA EXPERT PANEL REVIEW. (AIM 2) TO EMPLOY CAREFUL PHARMACOEPIDEMIOLOGIC DESIGNS TO EVALUATE THE TWO TOP PRIORITIZED SIGNALS INVOLVING (2A) PREGNANCY LOSS, AND (2B) AN ADVERSE LIVEBIRTH OUTCOME. TO CONTROL FOR CONFOUNDING AND MEASUREMENT BIASES, THESE STUDIES WILL EMPLOY PREVIOUSLY VALIDATED MEASURES, WHICH ARE FURTHER ENHANCED VIA LINKAGE TO FETAL DEATH AND BIRTH CERTIFICATE DATA FOR A COHORT SUBSAMPLE TO EVALUATE UNMEASURED CONFOUNDING AND CONDUCT PROBABILISTIC SENSITIVITY ANALYSES ON OUTCOME AND EXPOSURE MISCLASSIFICATION. BIG DATA APPROACHES FOR SAFE THERAPEUTICS IN HEALTHY PREGNANCIES (BOOST-HP) WILL OFFER AN INNOVATIVE ADVANCEMENT IN EVIDENCE GENERATION BY EVALUATING NUMEROUS EXPOSURES AND OUTCOMES SIMULTANEOUSLY. OUR LONG-TERM GOAL IS TO BUILD A REUSABLE, SCALABLE APPROACH AND INFRASTRUCTURE TO ACCELERATE EVIDENCE GENERATION ON THE SAFETY AND EFFECTIVENESS OF MEDICATION USE DURING PREGNANCY. BY LEVERAGING DATA-MINING METHODOLOGIES SUCCESSFULLY DEPLOYED IN PUBLIC HEALTH SURVEILLANCE ALONG WITH INFRASTRUCTURE USED BY MULTIPLE FEDERAL GOVERNMENT AGENCIES, WE WILL FOCUS RESEARCH EFFORTS ON NOVEL, HIGH-PRIORITY SIGNALS THAT POSE THE GREATEST RISK TO HEALTHY PREGNANCIES.

IMPACT OF THE EXPIRATION OF TEMPORARY PANDEMIC SNAP BENEFITS ON THE HEALTHFULNESS OF SUPERMARKET FOOD PURCHASES - PROJECT SUMMARY THE SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM (SNAP) IS THE LARGEST FOOD SECURITY PROGRAM FOR LOWER-INCOME HOUSEHOLDS IN THE U.S., PROVIDING FINANCIAL BENEFITS FOR GROCERY PURCHASES TO NEARLY 42 MILLION PEOPLE (1 IN 8). SNAP BENEFIT AMOUNTS INCREASED SUBSTANTIALLY STARTING IN MARCH 2020, MOST OF WHICH WAS DRIVEN BY TEMPORARY EMERGENCY ALLOTMENTS (I.E., SUPPLEMENTAL BENEFITS), TO BOLSTER FOOD SECURITY IN RESPONSE TO THE COVID-19 PANDEMIC AND TO ENSURE PARTICIPANTS COULD AFFORD A HEALTHY DIET. THESE EMERGENCY BENEFITS EXPIRED ACROSS ALL STATES IN MARCH 2023, A POLICY THAT IS ESTIMATED TO HAVE REDUCED BENEFITS BY AN AVERAGE OF $175 PER HOUSEHOLD, A ~33% DECLINE. THE SUDDEN END OF SNAP EMERGENCY ALLOTMENTS REPRESENTS THE LARGEST-EVER UNIVERSAL REDUCTION IN SNAP BENEFITS AND COULD HAVE A MAJOR IMPACT ON HOUSEHOLDS’ FOOD PURCHASES AND THEIR SUBSEQUENT HEALTH. HOWEVER, THIS HAS NOT BEEN INVESTIGATED TO DATE. THIS STUDY WILL MAKE A SIGNIFICANT CONTRIBUTION BY EVALUATING THE IMPACT OF THE EXPIRATION OF SNAP EMERGENCY ALLOTMENTS ON PARTICIPANTS’ FOOD PURCHASE QUALITY OVERALL, AMONG HISTORICALLY UNDERSERVED GROUPS WITH WORSE FOOD ACCESS AND PRE-PANDEMIC INEQUITIES IN NUTRITION-RELATED CHRONIC DISEASE, AND IN THE CONTEXT OF CONCURRENT ECONOMIC, SOCIAL, COMMUNITY, AND RETAIL FACTORS. WE WILL USE A MIXED- METHODS APPROACH THAT COMBINES A NATURAL EXPERIMENT OF HOUSEHOLD PURCHASES WITH QUALITATIVE INTERVIEWS OF SNAP PARTICIPANTS AND THOSE WORKING IN THE LARGER FOOD SYSTEM. IN AIM 1, WE WILL ANALYZE LONGITUDINAL, LOYALTY- LINKED SALES DATA ON >440,000 CUSTOMERS OF A LARGE NORTHEAST SUPERMARKET CHAIN WHO MADE PURCHASES FROM NOVEMBER 2021-FEBRUARY 2023 (16 MONTHS BEFORE THE END OF SNAP EMERGENCY ALLOTMENTS). WE WILL USE CONTROLLED INTERRUPTED TIME SERIES (CITS), A QUASI-EXPERIMENTAL METHOD, TO ESTIMATE THE EFFECT OF THE END OF SNAP EMERGENCY ALLOTMENTS ON SEVERAL INDICES OF FOOD PURCHASE QUALITY FROM APRIL 2023-MARCH 2024 (12 MONTHS AFTER THE END OF ALLOTMENTS) AMONG SNAP-PARTICIPATING HOUSEHOLDS (INTERVENTION) VS. NON-PARTICIPATING HOUSEHOLDS (CONTROL). IN AIM 2, WE WILL ENROLL A COHORT OF 2,500 LOWER-INCOME SHOPPERS WHO SHOP AT THE CHAIN AND WHOSE PURCHASES CAN BE IDENTIFIED BY LOYALTY NUMBER. WE WILL ASSESS HOUSEHOLD-LEVEL DATA VIA ONLINE SURVEYS AND USE CITS TO EXAMINE ASSOCIATIONS BETWEEN THE END OF SNAP EMERGENCY ALLOTMENTS AND SUPERMARKET FOOD PURCHASE QUALITY BY RURALITY, RACE/ETHNICITY, AND ECONOMIC STABILITY. IN AIM 3, WE WILL EXPLORE INDIVIDUAL-LEVEL FACTORS (E.G., USE OF OTHER ASSISTANCE PROGRAMS, COOKING NORMS, FOOD PREFERENCES) BY CONDUCTING SEMI-STRUCTURED QUALITATIVE INTERVIEWS AMONG 45-75 PARTICIPANTS FROM THE COHORT IN AIM 2 WHO PARTICIPATE IN SNAP AND REPRESENT RURAL, BLACK, AND HISPANIC DEMOGRAPHIC SEGMENTS OF THE STUDY POPULATION. WE WILL EXPLORE SYSTEM-LEVEL FACTORS (E.G., FOOD AVAILABILITY, SUPPLY CHAINS, PANDEMIC ERA SNAP POLICY ROLLOUT) VIA INTERVIEWS WITH REPRESENTATIVES FROM SNAP IMPLEMENTING AGENCIES, SUPERMARKET RETAILERS, AND FOOD PANTRIES FROM WITHIN EACH OF THE COMMUNITIES OF INTEREST. THIS RESEARCH WILL GENERATE TIMELY, RIGOROUS EVIDENCE ON THE NUTRITIONAL IMPACT OF THIS SUBSTANTIAL CHANGE TO SNAP BENEFITS, WHICH WILL BE USEFUL TO POLICYMAKERS TO HELP GUIDE FUTURE PROGRAM CHANGES.

DEVELOPING EVIDENCE-BASED SEPSIS TIME ZERO CRITERIA AND QUALITY METRICS USING ELECTRONIC HEALTH RECORD DATA

CLINICAL AND HEALTH CARE USE OUTCOMES FOR VERTICAL SLEEVE GASTRECTOMY VS. ROUX-EN-Y GASTRIC BYPASS USING A NATIONAL COMMERCIAL INSURANCE CLAIMS DATASET

NATIONAL CLAIMS-BASED QUALITY MEASURES FOR SURGICAL SITE INFECTIONS

MATERNAL VITAMIN D, ADIPOSITY IN EARLY LIFE, AND RISK OF CHILDHOOD ASTHMA.

STATE TELEHEALTH POLICIES AND MENTAL CARE FOR CHILDREN IN UNDERSERVED AREAS - PROJECT SUMMARY/ABSTRACT UNMET NEED FOR CHILD MENTAL HEALTH SERVICES IS A PERSISTENT AND PRESSING PUBLIC HEALTH PROBLEM IN THE US. ONE OF THE KEY DRIVERS OF THE UNMET NEED IS HEALTH WORKFORCE SHORTAGE, WHICH HAS BEEN EXACERBATED DURING THE COVID-19 PANDEMIC. THIS EXACERBATION HAS OCCURRED AGAINST THE BACKDROP OF RISING MENTAL DISORDERS AMONG CHILDREN, LEADING TO THE NATIONAL EMERGENCY IN CHILD MENTAL HEALTH DECLARED BY MULTIPLE SPECIALTY ORGANIZATIONS. AT THE SAME TIME, THE PANDEMIC HAS ALSO STIMULATED INNOVATIONS, INCLUDING THE WIDESPREAD ADOPTION OF TELEHEALTH, WHICH HAS BEEN PROMOTED BY RECENT GOVERNMENT POLICIES. ALTHOUGH TELEHEALTH HAS LONG BEEN ADVOCATED FOR IMPROVING HEALTH CARE ACCESS FOR VULNERABLE POPULATIONS, SUCH AS CHILDREN LIVING IN MENTAL HEALTH PROFESSIONAL SHORTAGE AREAS (MHPSAS), NO STUDY TO DATE HAS EXAMINED HOW THE RECENT DRAMATIC GROWTH OF TELEHEALTH AFFECTS MENTAL HEALTH CARE AVAILABILITY AND UTILIZATION FOR CHILDREN IN MHPSAS. FURTHERMORE, AMID THE RAPID TRANSITION TO TELEHEALTH DURING THE PANDEMIC, SOME EXPERTS HAVE BEEN CONCERNED WITH DISPARITIES IN TELEHEALTH ACCESS AND UTILIZATION AND CALLED FOR FURTHER RESEARCH ON THE EQUITABLE DEVELOPMENT OF TELEHEALTH. IN RESPONSE TO THAT CALL, THIS PROPOSED PROJECT AIMS TO DRAW LESSONS ABOUT TELEHEALTH ADOPTION DURING THE PANDEMIC TO INFORM FUTURE TELEHEALTH POLICIES. AS A COMPREHENSIVE EVALUATION OF STATE TELEHEALTH POLICIES ON LICENSURE, INSURANCE COVERAGE, AND REIMBURSEMENT, THE PROPOSED PROJECT HAS THREE AIMS: (1) MENTAL HEALTH TREATMENT FACILITY (MHTF) LEVEL ANALYSES TO ASSESS HOW CHANGES IN STATE TELEHEALTH POLICIES AFFECT DISPARITIES IN MENTAL HEALTH SERVICE AVAILABILITY FOR CHILDREN FROM BEFORE TO DURING THE PANDEMIC, (2) CHILD LEVEL ANALYSES TO EVALUATE HOW CHANGES IN STATE TELEHEALTH POLICIES AFFECT DISPARITIES IN MENTAL CARE ACCESS, UTILIZATION, AND SPENDING AMONG CHILDREN FROM BEFORE TO DURING THE PANDEMIC, AND (3) QUALITATIVE INTERVIEWS WITH MEDICAL DIRECTORS AT MHTFS TO UNDERSTAND THEIR EXPERIENCES USING TELEHEALTH TO SERVE CHILDREN AS WELL AS FACILITATORS AND BARRIERS THAT THEY HAVE IDENTIFIED FOR EXPANDING TELEHEALTH IN MHPSAS. FOR EACH AIM, WE WILL ANALYZE TWO TYPES OF DISPARITIES—BY AREA OF RESIDENCE (E.G., MHPSAS VS. NON- SHORTAGE AREAS), AND BY CHILD SOCIO-DEMOGRAPHIC CHARACTERISTIC (E.G., RACE/ETHNICITY). EXAMINING THESE DISPARITIES IS CRUCIAL GIVEN THE CONCERN ABOUT DIGITAL HEALTH EQUITY DURING THE PANDEMIC. TO EXAMINE THE AIMS, WE WILL ANALYZE QUANTITATIVE DATA FROM BOTH PRIMARY AND SECONDARY SOURCES, INCLUDING OUR UNIQUE LONGITUDINAL SURVEY OF NEARLY ALL MHTFS IN THE US. WE WILL ALSO COLLECT COMPLEMENTARY QUALITATIVE DATA THROUGH INTERVIEWS WITH MEDICAL DIRECTORS AT MHTFS. THE PROPOSED STUDY IS BOTH TIMELY AND IMPORTANT, AS STATE POLICYMAKERS ARE CONSIDERING ACTIONS TO REVISE THEIR TELEHEALTH POLICIES. THE STUDY FINDINGS WILL HELP THEM IDENTIFY POLICIES THAT HAVE (OR HAVEN’T) BEEN SUCCESSFUL IN EXPANDING TELEHEALTH SERVICES FOR CHILDREN WITH MENTAL DISORDERS—ESPECIALLY THOSE WHO LIVE IN MHPSAS—TO INFORM SUBSEQUENT POLICY DECISIONS.

LONG-TERM IMPACT AND VALUE OF INFANT GENOMIC SEQUENCING (LIVING) - PROJECT SUMMARY/ABSTRACT THE USE OF GENOMIC SEQUENCING AT BIRTH TO INFORM THE ONGOING CARE OF CHILDREN HAS GENERATED GREAT ENTHUSIASM. GENOMIC SEQUENCING CAN ACT AS A SCREENING TOOL FOR IDENTIFYING NEWBORNS WITH EXISTING GENETIC DISORDERS; ADDITIONALLY, RESULTS CAN IDENTIFY NEWBORNS WITH GENETIC PREDISPOSITIONS FOR FUTURE DISEASE THAT COULD BE PREVENTED OR MITIGATED THROUGH EARLY INTERVENTION. IN ADDITION, GENOMIC SEQUENCING CAN HELP HEALTH CARE PROVIDERS MANAGE THEIR PATIENTS’ MEDICATIONS BY CHARACTERIZING GENES ASSOCIATED WITH DRUG METABOLISM AND MODIFYING MEDICATION CHOICES ACCORDINGLY. THESE APPLICATIONS AND MORE HAVE RAISED HOPES THAT GENOMIC SEQUENCING COULD COMPLEMENT TRADITIONAL NEWBORN SCREENING AND PROVIDE LIFELONG BENEFITS TO INDIVIDUALS AND FAMILIES. HOWEVER, GREAT UNCERTAINTIES EXIST ON HOW GENOMIC SEQUENCING SHOULD BE IMPLEMENTED BY HEALTH SYSTEMS AND HOW STATE NEWBORN SCREENING PROGRAMS CAN HELP GENOMIC SEQUENCING ACHIEVE ITS POTENTIAL. THE LONG-TERM IMPACT OF GENOMIC SEQUENCING RESULTS ON THE FAMILY ARE UNCLEAR, AND PROJECTIONS ABOUT HOW GENOMICS SCREENING FINDINGS WILL BE MANAGED OVER TIME ARE PREDICATED ON UNVERIFIED ASSUMPTIONS THAT FAMILIES AND HEALTH CARE PROVIDERS WILL BE ABLE TO ACCESS RESULTS OVER TIME AND WILL CONTINUE TO FOLLOW BEST PRACTICE RECOMMENDATIONS FOR SURVEILLANCE OF HIGH-RISK FINDINGS AS INDIVIDUALS AGE. MOREOVER, THE EVOLVING EVIDENCE ABOUT GENE-DISEASE AND GENE-DRUG INTERACTIONS RAISES QUESTIONS ABOUT WHETHER, WHEN, AND HOW FREQUENTLY MOLECULAR LABORATORIES SHOULD REANALYZE GENOMIC INFORMATION. THIS PROPOSAL ADDRESSES THESE KEY QUESTIONS ABOUT HOW TO ENSURE NEWBORN GENOMIC SEQUENCING PROVIDES LIFELONG BENEFITS AND VALUE. WE WILL CONDUCT KEY-INFORMANT INTERVIEWS TO UNDERSTAND THE NEEDS AND CONCERNS OF CLINICIANS, HEALTH SYSTEM LEADERS, AND COORDINATORS OF NEWBORN SCREENING PROGRAMS REGARDING HOW NEWBORN GENOMIC SEQUENCING SHOULD BE IMPLEMENTED TO COMPLEMENT TRADITIONAL NEWBORN SCREENING, AND WHAT SYSTEMS NEED TO BE DESIGNED TO MAXIMIZE THEIR UTILITY OVER TIME FOR CHILDREN AND THEIR FAMILIES. WE WILL ALSO CONDUCT FOLLOW-UP STUDIES OF INDIVIDUALS WHO PARTICIPATED IN PRIOR CLINICAL TRIALS OF NEWBORN GENOMIC SEQUENCING TO DOCUMENT HOW HEALTH CARE PROVIDERS AND FAMILIES UTILIZED GENOMIC INFORMATION AS CHILDREN AGED, AND TO PROVIDE INSIGHT ABOUT THE BENEFITS AND HARMS THAT MAY HAVE ACCRUED. IN ADDITION, WE WILL DEVELOP A MATHEMATICAL MODEL TO PROJECT THE LIFELONG BENEFITS, HARMS AND COST-EFFECTIVENESS OF DIFFERENT STRATEGIES FOR REANALYZING EXISTING GENOMIC INFORMATION OVER TIME. THE GOAL OF THIS STUDY IS TO PROVIDE CRITICALLY-NEEDED EVIDENCE ABOUT HOW TO IMPLEMENT NEWBORN GENOMIC SEQUENCING, MANAGE FINDINGS, AND REANALYZE DATA TO ENSURE NEWBORN GENOMIC SEQUENCING FULFILLS ITS PROMISE AS A TOOL THAT PROVIDES LIFELONG BENEFITS TO INDIVIDUALS AND ADVANCES PUBLIC HEALTH.

THE IMPACT OF EMERGING HEALTH INSURANCE DESIGNS ON DIABETES OUTCOMES AND DISPARIT

IMPACT OF HSA COST SHARING REDUCTIONS ON HIGH-DEDUCTIBLE MEMBERS WITH DIABETES

ADVANCED BREAST IMAGING: TRENDS AND OUTCOMES ASSOCIATED WITH RECENT BREAST DENSITY REPORTING LEGISLATION

COMPARATIVE EFFECTIVENESS OF ANTI-OBESITY MEDICATIONS FOR CARDIOMETABOLIC HEALTH OUTCOMES AND HEALTH SERVICES USE - PROJECT SUMMARY/ABSTRACT OVER 40% OF US ADULTS HAVE OBESITY, MANY WITH WEIGHT-RELATED COMPLICATIONS SUCH AS HYPERTENSION AND DIABETES. CURRENT CLINICAL GUIDELINES SUGGEST LIFESTYLE CHANGE AS THE FIRST-LINE OBESITY TREATMENT APPROACH, BUT THIS DOES NOT PRODUCE SUSTAINED CLINICALLY-SIGNIFICANT WEIGHT LOSS FOR THE MAJORITY OF PATIENTS. BARIATRIC SURGERY IS AVAILABLE FOR PATIENTS WITH MORE SEVERE OBESITY, BUT DUE TO ITS COST, INVASIVENESS AND RISK, ONLY 1-2% OF ELIGIBLE PATIENTS UNDERGO A PROCEDURE. ADDRESSING THE OBESITY EPIDEMIC USING ONLY LIFESTYLE CHANGE PROGRAMS AND BARIATRIC SURGERY WILL CONTINUE TO LEAVE MOST PATIENTS WITHOUT A SUCCESSFUL LONG-TERM TREATMENT OPTION. ANTI-OBESITY MEDICATION (AOM) IS AN OPTION THAT COULD HELP TO FILL THE CURRENT OBESITY TREATMENT GAP. RECENT TRIALS HAVE DEMONSTRATED THAT AOMS LEAD TO ENDURING CLINICALLY-SIGNIFICANT WEIGHT LOSS, WITH A GOOD SAFETY PROFILE. HOWEVER, MANY PHYSICIANS REMAIN HESITANT TO PRESCRIBE AOMS DUE TO CONCERNS ABOUT THEIR EFFECTIVENESS AND SAFETY. THERE IS ALSO A COMPLETE LACK OF COMPARATIVE EFFECTIVENESS DATA ON CONTEMPORARY AOM OPTIONS. STUDIES ADDRESSING THESE ISSUES COULD INFORM TREATMENT CHOICES, GUIDELINES, AND PHARMACY BENEFIT DEVELOPMENT, SIGNIFICANTLY IMPACTING CLINICAL PRACTICE. WE WILL USE A NATIONWIDE COMMERCIAL INSURANCE CLAIMS DATASET THAT INCLUDES OVER 350,000 UNIQUE ADULTS WITH NEW AOM FILLS (DATA CURRENT THROUGH EARLY-2022) TO CONDUCT THE FIRST NATIONWIDE COMPARATIVE EFFECTIVENESS STUDY OF AOMS. WE WILL COMPARE PROPENSITY SCORE-MATCHED COHORTS OF PATIENTS PRESCRIBED ONE OF SIX FDA-APPROVED AOMS BETWEEN 2012 AND 2027: PHENTERMINE, PHENTERMINE-TOPIRAMATE-ER, LIRAGLUTIDE, BUPROPION-NALTREXONE-SR, SEMAGLUTIDE, AND TIRZEPATIDE (PENDING APPROVAL 2023). OUR PRIMARY DESIGN WILL USE INTENTION-TO-TREAT ANALYSES ON NEW USERS WITH AT LEAST ONE AOM FILL, BUT WE WILL ALSO CONDUCT ON-TREATMENT AND PER-GUIDELINES ANALYSES AMONG PATIENTS WITH PERSISTENT AOM USE. OUR SPECIFIC AIMS ARE TO COMPARE GROUPS OF PATIENTS PRESCRIBED THESE AOMS, OVER UP TO 5 YEARS OF FOLLOW-UP, WITH RESPECT TO: (1) MAJOR CARDIOVASCULAR EVENTS; (2) OTHER CLINICAL OUTCOMES RELATED TO REDUCTION IN BODY WEIGHT, INCLUDING (A) INCIDENCE OF TYPE 2 DIABETES (T2D), HYPERTENSION AND DYSLIPIDEMIA; AND (B) CHANGE IN INTENSITY OF T2D, HYPERTENSION AND DYSLIPIDEMIA PHARMACOTHERAPIES (INCLUDING DISCONTINUATION OF THERAPY); AND (3) HEALTH CARE SERVICES USE AND ASSOCIATED COSTS, INCLUDING ANNUAL HOSPITAL DAYS; EMERGENCY DEPARTMENT VISITS; OUTPATIENT VISITS; AND PHARMACY, LAB, AND MEDICAL COSTS. IN AN EXPLORATORY AIM, WE WILL EXAMINE WHETHER KEY PATIENT CHARACTERISTICS (AGE, SEX, BASELINE T2D, COMORBIDITY BURDEN) MODIFY THE RISKS OR BENEFITS SEEN WITH EACH AOM. COMPARATIVE EFFECTIVENESS STUDIES EXAMINING MAJOR CLINICAL AND HEALTH SERVICES OUTCOMES BEYOND WEIGHT LOSS ARE NEEDED TO INFORM GUIDELINES AND POLICY. OUR USE OF A LARGE, EXISTING, REGULARLY UPDATED DATASET WILL ALLOW US TO EFFICIENTLY PRODUCE RAPID-TURNAROUND REAL-WORLD RESULTS THAT ARE HIGHLY GENERALIZABLE AND LIKELY TO HAVE A SIGNIFICANT IMPACT ON TREATMENT OF A CHRONIC DISEASE THAT AFFECTS NEARLY HALF OF AMERICAN ADULTS.

INVEST1D: PROMOTING ADOLESCENT INVESTMENT IN DIABETES CARE - PROJECT ABSTRACT OVER 80% OF ADOLESCENTS WITH TYPE 1 DIABETES (T1D) STRUGGLE TO ACHIEVE GOOD GLYCEMIC CONTROL, PLACING THEM AT RISK FOR ACUTE AND CHRONIC COMPLICATIONS. INSTILLING GOOD T1D MANAGEMENT PRACTICES IN ADOLESCENCE CAN SET A PATTERN INTO ADULTHOOD, IMPROVING LONG-TERM HEALTH WHILE REDUCING FUTURE BURDEN ON PATIENT AND FAMILY QUALITY OF LIFE, ADOLESCENT PSYCHOSOCIAL DEVELOPMENT, AND THE HEALTH CARE SYSTEM. HEALTH PSYCHOLOGY AND ECONOMICS RESEARCH SUGGEST THAT FINANCIAL INCENTIVES CAN INCREASE ADOLESCENT ADHERENCE TO T1D SELF-MANAGEMENT REGIMENS. WE DEVELOPED INVEST1D, A FLEXIBLE, PATIENT CENTERED INCENTIVES INTERVENTION BASED ON RIGOROUS DEVELOPMENTAL RESEARCH THAT INCLUDED QUALITATIVE, ETHICAL, AND STATED PREFERENCE ANALYSES. A PILOT RANDOMIZED CONTROLLED TRIAL (RCT) DEMONSTRATED THAT INVEST1D WAS EFFECTIVE AT IMPROVING ADHERENCE TO SELF-MANAGEMENT GOALS AND TIME-IN-RANGE AMONG CONTINUOUS GLUCOSE MONITOR USERS. WE PROPOSE A LARGER, MORE COMPREHENSIVE STUDY TO DETERMINE THE MOST EFFICACIOUS FINANCIAL INCENTIVE STRUCTURE AND TO EVALUATE INVEST1D’S IMPACT ON TIME-IN-RANGE, HBA1C, ADVERSE EVENTS, LONG-TERM HEALTH, DIABETES DISTRESS, FAMILY CONFLICT, HEALTH CARE UTILIZATION, AND ADOLESCENT AND CAREGIVER QUALITY OF LIFE. IN THIS HYBRID EFFECTIVENESS-IMPLEMENTATION STUDY, WE WILL USE MIXED METHODS TO EVALUATE INVEST1D’S EFFICACY, LONG-TERM HEALTH BENEFITS, COST-EFFECTIVENESS, AND IMPLEMENTATION FEASIBILITY. OUR INTERDISCIPLINARY TEAM’S INNOVATIVE APPROACH INCLUDES AN RCT, TRIAL- AND MODEL- BASED ECONOMIC EVALUATIONS (FROM THE PAYER, HEALTH CARE, AND SOCIETAL PERSPECTIVES), A POLICY ANALYSIS, THE DEVELOPMENT OF A DECISION SUPPORT DASHBOARD, AND QUALITATIVE INTERVIEWS WITH PATIENT, HEALTH CARE PAYER, AND HEALTH CARE DELIVERY SYSTEM STAKEHOLDERS. METHODOLOGIC CONTRIBUTIONS OF THE INVEST1D STUDY CAN MAKE A SIGNIFICANT CONTRIBUTION TO THE SCIENTIFIC APPROACH FOR DEVELOPING INCENTIVE INTERVENTIONS FOR A RANGE OF BEHAVIORAL HEALTH-RELATED CONDITIONS.

THE ROLE OF SEX IN GENETIC ASSOCIATION STUDIES OF DEPRESSION - PROJECT ABSTRACT DEPRESSION IS THE MOST COMMON MENTAL ILLNESS IN THE U.S. AFFECTING NEARLY 40 MILLION ADULTS AGE 18 YEARS AND OLDER. WOMEN ARE MORE LIKELY TO BE AFFECTED BY DEPRESSION THAN MEN. DEPRESSION HAS BOTH GENETIC AND ENVIRONMENTAL INFLUENCES. DEPRESSION IS A POLYGENIC DISORDER (DUE TO THE COMBINED EFFECTS OF MANY GENETIC VARIANTS) AND DEPRESSION RATES DIFFER BY SEX. THE RELATIONSHIP BETWEEN GENES AND DEPRESSION IS COMPLEX AND INFLUENCED BY SEX. THUS, UNDERSTANDING THE SHARED GENETIC BASIS OF SEX-SPECIFIC DIFFERENCES FOR DEPRESSION HAS GREAT POTENTIAL TO LEAD TO NEW BIOLOGICAL UNDERSTANDING OF THE ETIOLOGY OF DEPRESSION IN FEMALES COMPARED TO MALES AND TO PROMOTE THE DEVELOPMENT OF NOVEL AND MORE EFFECTIVE PHARMACOTHERAPIES. THE UNDERLYING GOAL OF THIS PROPOSAL IS TO DEVELOP AND EVALUATE METHODS TO EXAMINE THE ROLE OF SEX IN GENETIC ASSOCIATION STUDIES OF DEPRESSION. THESE METHODS WILL BE APPLIED TO THE UK BIOBANK. THE UK BIOBANK IS ONE OF THE LARGEST BIOBANKS AVAILABLE AT PRESENT AND REPRESENTS AN EXTENSIVE RESOURCE WITH BOTH GENETIC DATA AND DEPRESSION PHENOTYPES (APPROXIMATELY 474,000 PARTICIPANTS). THE MASS GENERAL BRIGHAM BIOBANK (APPROXIMATELY 33,000 PARTICIPANTS) WILL BE USED FOR VALIDATION AND ASSESSMENT OF THE ROBUSTNESS OF THE APPROACHES. THE GRANT FOCUSES ON METHODS DEVELOPMENT APPLIED TO DEPRESSION AND THE ROLE OF SEX IN GENETIC ASSOCIATION STUDIES OF DEPRESSION; HOWEVER, OUR ULTIMATE GOAL IS TO DEVELOP APPROACHES THAT ARE APPLICABLE TO A BROAD RANGE OF MENTAL HEALTH AND ADDICTION PHENOTYPES. WE WILL ALSO CREATE PUBLICLY AVAILABLE SOFTWARE PACKAGES TO IMPLEMENT THESE NEW APPROACHES, SO THAT THEY WILL BE BROADLY ACCESSIBLE TO THE SCIENTIFIC COMMUNITY.

SURVEILLANCE FOR OUTCOMES OF GENOMIC MEDICINE POLICIES

MAINTAIN AND ENRICH RESOURCE INFRASTRUCTURE FOR PROJECT VIVA: A PRE-BIRTH COHORT WITH FOLLOW UP INTO ADOLESCENCE

IMPACT OF EMERGING HEALTH INSURANCE DESIGNS ON DIABETES COMPLICATIONS

THE IMPACT OF INCLUDING PREGNANCY AS A QUALIFYING LIFE EVENT FOR MARKETPLACE SPECIAL ENROLLMENT ON CHILD AND MATERNAL HEALTH - PROJECT SUMMARY/ABSTRACT TIMELY, HIGH-QUALITY PRENATAL CARE IS ASSOCIATED WITH IMPROVED CHILD AND MATERNAL HEALTH OUTCOMES, AND COMPREHENSIVE HEALTH INSURANCE COVERAGE DURING PREGNANCY FACILITATES ACCESS TO PRENATAL CARE. THE AFFORDABLE CARE ACT (ACA) INCLUDED PRENATAL AND MATERNITY CARE AS ONE OF THE TEN ESSENTIAL HEALTH BENEFITS THAT MUST BE COVERED IN MARKETPLACE PLANS (I.E., COMMERCIAL INSURANCE PLANS FOR INDIVIDUALS). ACA MARKETPLACES ARE AN IMPORTANT SOURCE OF HEALTH INSURANCE FOR PREGNANT PEOPLE WHO ARE NOT ELIGIBLE FOR MEDICAID OR EMPLOYER- SPONSORED INSURANCE. HOWEVER, CURRENT MARKETPLACE ENROLLMENT POLICIES MAKE IT CHALLENGING TO ENROLL IN A MARKETPLACE PLAN EARLY IN PREGNANCY, WHICH MAY HAVE ADVERSE CONSEQUENCES FOR ACCESS TO PRENATAL CARE AND CHILD AND MATERNAL HEALTH OUTCOMES. ALL MARKETPLACE PLANS HAVE AN ANNUAL OPEN ENROLLMENT PERIOD (OEP) FROM APPROXIMATELY NOVEMBER TO JANUARY. AN INDIVIDUAL CAN ENROLL IN A MARKETPLACE PLAN OUTSIDE OF THE ANNUAL OEP ONLY THROUGH A SPECIAL ENROLLMENT PERIOD (SEP), WHICH IS A LIMITED TIME WINDOW AFTER A QUALIFYING LIFE EVENT (E.G., LOSS OF INSURANCE COVERAGE, OR HOUSEHOLD CHANGE [INCLUDING CHILDBIRTH]). THE ACA DID NOT INCLUDE PREGNANCY AS A QUALIFYING EVENT FOR SEP MARKETPLACE COVERAGE. THEREFORE, PEOPLE WHO BECOME PREGNANT OUTSIDE OF THE OEP MUST DELAY MARKETPLACE ENROLLMENT UNTIL THEY HAVE AN ELIGIBLE SEP-QUALIFYING EVENT, THE NEXT ANNUAL OEP, OR GIVE BIRTH. IN RECENT YEARS, SIX U.S. STATES HAVE ENACTED POLICY TO INCLUDE PREGNANCY AS A MARKETPLACE SEP- QUALIFYING EVENT, MEANING THAT PEOPLE IN THESE STATES CAN ENROLL IN A MARKETPLACE PLAN WHEN THEY BECOME PREGNANT. WE HYPOTHESIZE THAT THIS POLICY FACILITATES MARKETPLACE ENROLLMENT EARLIER IN PREGNANCY, INCREASES THE PERCENT OF PREGNANT PEOPLE ON THE MARKETPLACE WHO RECEIVE TIMELY, HIGH-QUALITY PRENATAL CARE, AND IMPROVES MATERNAL AND INFANT HEALTH OUTCOMES FOR MARKETPLACE ENROLLEES. OUR STUDY WILL EXPLOIT A NATURAL EXPERIMENT CREATED BY STATE-LEVEL VARIATION IN MARKETPLACE SEP ELIGIBILITY RULES TO ESTIMATE THE IMPACT OF A POLICY TO INCLUDE PREGNANCY AS A SEP-QUALIFYING EVENT. SPECIFICALLY, WE WILL FIRST (AIM 1) DESCRIBE THE ROLE OF THE MARKETPLACE IN PROVIDING HEALTH INSURANCE COVERAGE AND ACCESS TO PRENATAL CARE FOR PREGNANT PEOPLE (AIM 1). WE WILL THEN USE A ROBUST QUASI-EXPERIMENTAL DESIGN TO EVALUATE THE IMPACT OF INCLUDING PREGNANCY AS AN SEP-QUALIFYING EVENT ON (AIM 2) TIMELY PRENATAL CARE AND (AIM 3) INFANT AND MATERNAL HEALTH OUTCOMES FOR PREGNANT PEOPLE WHO ENROLL IN MARKETPLACE. WE WILL USE ALL-PAYER CLAIMS DATA FROM NEW YORK (INTERVENTION STATE) AND MASSACHUSETTS (CONTROL STATE) FROM 2014-2019, WHICH PROVIDE MANY ADVANTAGES OVER DATA USED IN PRIOR RESEARCH OF PREGNANT PEOPLE ON THE MARKETPLACE. THE FINDINGS FROM OUR STUDY WILL PROVIDE CRITICAL AND TIMELY INFORMATION FOR STATE-LEVEL AND FEDERAL-LEVEL POLICY-MAKERS TO ENSURE THAT MARKETPLACE COVERAGE IS (I) ACCESSIBLE FOR PREGNANT PEOPLE WITHOUT OTHER INSURANCE COVERAGE OPTIONS, AND (II) EFFECTIVE IN IMPROVING PRENATAL CARE AND, ULTIMATELY, CHILD AND MATERNAL HEALTH OUTCOMES.

DRUG COST CONTAINMENT CHANGES AND QUALITY OF CARE FOR MENTALLY ILL DUAL ENROLLEES

VALUE OF SLEEP METRICS IN PREDICTING OPIOID-USE DISORDER TREATMENT OUTCOMES: LEADERSHIP AND DATA COORDINATING CENTER - OPIOID-USE DISORDER (OUD) IS A MAJOR PUBLIC HEALTH PROBLEM, AFFECTING OVER 2.7 MILLION PEOPLE AND RESULTING IN OVER 90,000 DEATHS IN 2020 IN THE U.S., AS WELL AS BROADLY IMPACTING THE MENTAL AND PHYSICAL HEALTH OF INDIVIDUALS SUFFERING FROM AN OUD AND THE COMMUNITIES AND FAMILIES OF AFFECTED INDIVIDUALS. TREATMENT EFFECTIVENESS FOR OUD DEPENDS ON RETENTION IN CARE. UNFORTUNATELY, A SYSTEMATIC REVIEW REPORTED THAT THE MEDIAN RETENTION RATE AT 6 MONTHS FOR MEDICATIONS FOR OPIOID USE DISORDER (MOUD) PROGRAMS ACROSS 19 STUDIES WAS ONLY 58%. SLEEP DISTURBANCES HAVE BEEN IDENTIFIED AS PREDICTORS OF TREATMENT ATTRITION AND ARE RELATED TO OUD THROUGH BI-DIRECTIONAL PATHWAYS INVOLVING PAIN, STRESS, AND EMOTIONAL DYSREGULATION, AND COULD SERVE AS FUTURE INTERVENTION TARGETS TO IMPROVE OUD OUTCOMES. HOWEVER, THERE IS A LIMITED UNDERSTANDING OF THE PREDICTIVE VALUE OF SPECIFIC MEASURES OF SLEEP AND CIRCADIAN RHYTHM DURING EARLY RECOVERY, AND ALMOST NO DATA ON HOW SLEEP AND CIRCADIAN PARAMETERS INTERACT WITH OTHER RISK FACTORS FOR MOUD OUTCOMES. WE HAVE ASSEMBLED A TEAM OF SLEEP SCIENTISTS, ADDICTION MEDICINE SPECIALISTS, BIOSTATISTICIANS, AND CLINICAL TRIALISTS AND WILL LEVERAGE THE EXCEPTIONAL RESOURCES OF BRIGHAM AND WOMEN'S HOSPITAL'S PROGRAM IN SLEEP MEDICINE EPIDEMIOLOGY, SLEEP READING CENTER, AND DIVISION OF BIOSTATISTICS AT HARVARD PILGRIM HEALTH CARE INSTITUTE TO LEAD THE LEADERSHIP AND DATA COORDINATING CENTER (LDCC) FOR THIS MULTI-SITE STUDY. THE LDCC WILL DEVELOP A COMMON PROTOCOL FOR THE COLLECTION OF STANDARDIZED DATA FOR PREDICTING MOUD OUTCOMES ACROSS FOUR RESEARCH CENTERS AND WILL LEAD, COORDINATE, AND IMPLEMENT ALL ASPECTS OF THIS COMMON PROTOCOL, PROVIDING COMPREHENSIVE, RESPONSIVE, AND INNOVATIVE DATA AND PROJECT MANAGEMENT. IT WILL FACILITATE RECRUITMENT AND DATA SHARING AND SUPPORT THE RIGOROUS COLLECTION AND ANALYSES OF COMPREHENSIVE SLEEP MEASUREMENTS. IN ADDITION TO RISK FACTORS SUGGESTED BY EXISTING PREDICTION MODELS AND HEAL INITIATIVE COMMON DATA ELEMENTS, SLEEP WILL BE ASSESSED BY EEG -- A BIOMARKER OF NEUROPHYSIOLOGY AND PSYCHIATRIC DISEASES -- AND WILL BE MEASURED ON TWO NIGHTS APPROXIMATELY ONE MONTH APART FROM 400 PATIENTS ENROLLED IN A MOUD PROGRAM. SLEEP MACRO- AND MICRO-ARCHITECTURE WILL BE DERIVED USING CENTRALIZED SLEEP SCORING AND ADVANCED EEG QUANTITATIVE SIGNAL ANALYSIS. SLEEP-DISORDERED BREATHING, PERIODIC LIMB MOVEMENTS, SLEEP-WAKE PATTERNS AND CIRCADIAN RISK FACTORS WILL BE MEASURED BY POLYSOMNOGRAPHY, VALIDATED QUESTIONNAIRES AND MULTIPLE DAY FITBIT TRACKERS. THE PRIMARY ENDPOINT WILL BE TREATMENT RETENTION AT 6 MONTHS AFTER STUDY ENROLLMENT. SECONDARY OUTCOMES WILL INCLUDE TIME TO TREATMENT DROP OUT, AND ILLICIT DRUG USE AND NON-MEDICAL OPIOID USE; OPIOID CRAVING; WITHDRAWAL SYMPTOMS; ALCOHOL USE; PAIN INTENSITY AND INTERFERENCE; PHYSICAL FUNCTIONING; SLEEP DISTURBANCE AND QUALITY MEASURED AT 6- MONTH. WE WILL ADOPT AN ENSEMBLE ALGORITHM (THE SUPER LEARNER) TO DEVELOP THE PREDICTION MODEL THAT FINDS THE OPTIMAL COMBINATION OF A COLLECTION OF STATISTICAL AND MACHINE LEARNING ALGORITHMS. THIS DATA-SCIENCE BASED PLAN AND OUR MULTI-DISCIPLINARY EXPERTISE WILL ENSURE THAT THE GOALS OF THIS STUDY ARE MET.

PREDICTIVE ANALYTICS AND CLINICAL DECISION SUPPORT TO IMPROVE PREP PRESCRIBING IN COMMUNITY HEALTH CENTERS (PREDICT) - RATES OF NEW HIV INFECTIONS ARE HIGH, AND UPTAKE OF PREEXPOSURE PROPHYLAXIS (PREP) LOW, IN POPULATIONS SERVED BY COMMUNITY HEALTH CENTERS (CHCS) IN THE US. HEALTHCARE PROVIDERS IN CHCS COULD PLAY A CRITICAL ROLE IN INCREASING PREP PRESCRIBING. HOWEVER, PROVIDERS FACE BARRIERS TO PREP PRESCRIBING, SUCH AS DIFFICULTY IDENTIFYING CANDIDATES FOR PREP, DISCOMFORT DISCUSSING SEXUAL BEHAVIOR, AND LACK OF FAMILIARITY WITH PREP CARE. WE HAVE FOUND THAT PROVIDERS ARE ENTHUSIASTIC ABOUT THE POTENTIAL BENEFITS OF DECISION SUPPORT TOOLS TO MITIGATE THESE BARRIERS TO PREP PROVISION, AND THAT PATIENTS WOULD FIND SUCH TOOLS ACCEPTABLE IF IMPLEMENTED SENSITIVELY. WE PREVIOUSLY SHOWED THAT DATA FROM ELECTRONIC HEALTH RECORDS (EHRS) CAN BE USED TO IDENTIFY PATIENTS AT INCREASED RISK OF HIV ACQUISITION IN TWO LARGE, GENERAL PRACTICE HEALTHCARE SYSTEMS. IN OUR FORMATIVE R34 RESEARCH, WE EXPANDED ON THIS APPROACH IN A SAFETY-NET SETTING, INCORPORATING STRATEGIES TO SUPPORT NOT ONLY IDENTIFICATION OF PREP CANDIDATES BUT ALSO PREP DISCUSSIONS AND PRESCRIBING. IN A NATIONAL NETWORK OF CHCS SERVING 6.2 MILLION PATIENTS IN 46 STATES (OCHIN), WE USED MACHINE LEARNING WITH EHR DATA TO IDENTIFY PATIENTS AT INCREASED RISK FOR INCIDENT HIV DIAGNOSIS (AREA UNDER THE CURVE 0.84). USING STAKEHOLDER-ENGAGED QUALITATIVE METHODS, WE THEN BUILT AN EHR-BASED DECISION SUPPORT TOOL THAT USES OUR PREDICTION MODEL TO PROMPT PREP DISCUSSIONS WITH PATIENTS LIKELY TO BENEFIT. THE TOOL FEATURES A SUITE OF RESOURCES TO SUPPORT INITIAL PREP PRESCRIBING, INCLUDING SUGGESTED LANGUAGE FOR PATIENT-CENTERED DISCUSSIONS; INFORMATION ABOUT PREP INDICATIONS, FORMULATIONS, AND DOSING; LABORATORY ORDER SETS; DIAGNOSIS CODES; AND AUTOMATED CLINICAL NOTES. WE PILOTED THIS TOOL AT 3 CHCS, ESTABLISHING FEASIBILITY AND ACCEPTABILITY. WE NOW PROPOSE PREDICTIVE ANALYTICS AND CLINICAL DECISION SUPPORT TO IMPROVE PREP PRESCRIBING IN COMMUNITY HEALTH CENTERS (PREDICT) TO EVALUATE THE IMPACT OF OUR TOOL ON PREP PROVISION IN OCHIN CHCS. OUR SPECIFIC AIMS ARE TO 1) EXPAND AND REFINE THE DECISION SUPPORT TOOL TO FACILITATE PREP FOLLOW-UP CARE, AND THEREFORE PATIENTS’ PERSISTENCE ON PREP; 2) QUANTIFY THE IMPACT OF THE DECISION SUPPORT TOOL ON PREP INITIATION AND PERSISTENCE IN A PRAGMATIC STEPPED-WEDGE TRIAL ACROSS 16 CHCS; AND 3) IDENTIFY PATIENT POPULATIONS WITH WHOM PROVIDERS ARE LESS INCLINED TO DISCUSS PREP WHEN PROMPTED TO DO SO, AND EXPLORE FACILITATORS AND BARRIERS TO SELECTION OF PATIENTS FOR PREP DISCUSSIONS. WE WILL ENGAGE AN ADVISORY GROUP OF PATIENTS FROM OCHIN CHCS IN TOOL EXPANSION, REFINEMENT, AND IMPLEMENTATION. THIS PROJECT IS INNOVATIVE IN ITS USE OF PREDICTIVE ANALYTICS AND DECISION SUPPORT TO IMPROVE PREP PROVISION IN SAFETY-NET SETTINGS. THE RESEARCH IS SIGNIFICANT BECAUSE IT HAS THE POTENTIAL TO FACILITATE LARGE INCREASES IN PREP UTILIZATION USING HIGHLY SCALABLE TOOLS. OUR INTERVENTION ADDRESSES NIH PRIORITIES, ALIGNS WITH THE FEDERAL ENDING THE HIV EPIDEMIC INITIATIVE, AND COULD BECOME A BEST PRACTICE FOR HOW CHCS AND OTHER HEALTHCARE SYSTEMS SUPPORT PREP CARE DELIVERY.

INSURANCE MANDATE GENEROSITY, COVID-19, AND HEALTH CARE FOR CHILDREN WITH AUTISM - PROJECT SUMMARY TO REDUCE THE UNMET HEALTH CARE NEEDS AMONG CHILDREN WITH AUTISM SPECTRUM DISORDERS (ASD), ONE STATE-LEVEL POLICY RESPONSE HAS BEEN LEGISLATIONS THAT REQUIRE PRIVATE HEALTH INSURERS TO PROVIDE COVERAGE FOR ASD-RELATED SERVICES, KNOWN AS STATE AUTISM INSURANCE MANDATES. BY 2019, INSURANCE MANDATES WERE ENACTED IN ALL STATES AND THE DISTRICT OF COLUMBIA. SEVERAL STUDIES HAVE DOCUMENTED SUBSTANTIAL VARIATIONS IN STATE AUTISM INSURANCE MANDATES. HOWEVER, THERE IS A PAUCITY OF EVIDENCE ABOUT WHETHER CHILDREN WITH ASD IN THE STATES WITH MORE GENEROUS MANDATES HAVE FARED BETTER THAN THOSE LIVING IN THE STATES WITH MORE LIMITED MANDATES. IDENTIFYING THIS EVIDENCE IS OF CRITICAL IMPORTANCE GIVEN THE FACT THAT CHILDREN WITH ASD HAVE COMPLEX HEALTH CONDITIONS AND REQUIRE AFFORDABLE, COMPREHENSIVE INSURANCE COVERAGE TO MEET THEIR HEALTH CARE NEEDS EITHER UNDER NORMAL CIRCUMSTANCES OR DURING UNUSUAL TIMES, SUCH AS THE COVID-19 PANDEMIC. IT IS ALSO UNKNOWN WHICH SPECIFIC MANDATE POLICY FEATURES MATTER MOST FOR REDUCING UNMET NEEDS AMONG THIS GROUP OF CHILDREN AND MAINTAINING OR INCREASING THEIR HEALTH CARE UTILIZATION DURING THE PANDEMIC. THIS PROPOSED PROJECT AIMS TO FILL THE EVIDENCE GAPS BY EXAMINING EACH OF THESE ISSUES. OUR GOAL IS TO CONTRIBUTE TO THE KNOWLEDGE BASE THAT CAN INFORM DECISION-MAKING ON HEALTH CARE FINANCING FOR CHILDREN WITH ASD. SPECIFICALLY, WE WILL CARRY OUT THE FOLLOWING AIMS: (1) USE NATIONAL SURVEY DATA TO ASSESS THE EXTENT TO WHICH MORE GENEROUS STATE AUTISM MANDATES IMPROVE HEALTH CARE ACCESS AND REDUCE UNMET NEEDS FOR CHILDREN WITH ASD BEFORE THE COVID-19 PANDEMIC, (2) USE NATION-WIDE INSURANCE CLAIMS DATA TO ASSESS THE EXTENT TO WHICH MORE GENEROUS STATE MANDATES INCREASE SERVICE UTILIZATION AND SPENDING FOR CHILDREN WITH ASD, BY SETTING (OUTPATIENT, ED, INPATIENT, HOME) AND CARE TYPE (MEDICAL, BEHAVIORAL, PHARMACY), BEFORE THE PANDEMIC, AND (3) USE BOTH NATIONAL SURVEY AND CLAIMS DATA TO ASSESS WHETHER AND TO WHAT EXTENT MORE GENEROUS STATE MANDATES HELP MAINTAIN OR INCREASE ACCESS, UTILIZATION, AND SPENDING FOR CHILDREN WITH ASD FROM BEFORE TO DURING THE PANDEMIC. TO EXAMINE THE AIMS, WE WILL ADOPT DIFFERENCE-IN-DIFFERENCES AND TRIPLE-DIFFERENCES APPROACHES, BOTH OF WHICH ARE RIGOROUS QUASI-EXPERIMENTAL DESIGNS. THE PROPOSED STUDY IS UNIQUE IN EXAMINING HOW HEALTH CARE FOR CHILDREN WITH ASD IS AFFECTED BY THE GENEROSITY OF STATE MANDATES IN GENERAL AND BY TYPE OF MANDATE POLICY FEATURE IN SPECIFIC. THE PROPOSED STUDY IS TIMELY SINCE ITS FINDINGS HAVE THE POTENTIAL TO INFORM POLICY-MAKING ON EXPANDING INSURANCE BENEFITS AND CLOSING COVERAGE GAPS FOR CHILDREN WITH ASD AS THE NATION FIGHTS THE PANDEMIC AND POTENTIALLY EMBARKS ON NEW ROUNDS OF HEALTH SYSTEM REFORM. OUR STUDY RESULTS WILL ALSO BE RELEVANT TO BROADER DEBATES AROUND OPTIMAL DESIGN OF ESSENTIAL HEALTH BENEFITS, A TOPIC OF GREAT INTEREST TO POLICY-MAKERS AND RESEARCHERS, ESPECIALLY IN THE PAST DECADE.

REDUCING DISPARITIES IN ALCOHOL USE DISORDER TREATMENT IN UNDERSERVED AREAS - PROJECT SUMMARY/ABSTRACT REDUCING THE PREVALENCE OF ALCOHOL USE DISORDER (AUD) IS A PUBLIC HEALTH PRIORITY IN THE US AS HIGHLIGHTED IN HEALTHY PEOPLE 2030. ALTHOUGH PHARMACOLOGICAL AND BEHAVIORAL TREATMENTS CAN REDUCE ALCOHOL-RELATED HARMS, A LARGE UNMET NEED FOR AUD TREATMENT EXISTS. THE UNMET NEED CAN BE ATTRIBUTED TO SEVERAL FACTORS, INCLUDING THE ONGOING SHORTAGE OF MENTAL HEALTH WORKFORCE. IN 2022, OVER 148 MILLION (45%) OF AMERICANS RESIDED IN MENTAL HEALTH PROFESSIONAL SHORTAGE AREAS (MHPSAS), FACING BARRIERS TO ACCESS TO AUD TREATMENT. TO ATTRACT MORE CLINICIANS TO MHPSAS, POLICYMAKERS HAVE LAUNCHED MANY PROGRAMS, INCLUDING THE NATIONAL HEALTH SERVICE CORPS (NHSC). SINCE 2009, FEDERAL INVESTMENT IN THE NHSC HAS EXPERIENCED A SIGNIFICANT SURGE, RESULTING IN THE NHSC CLINICIAN WORKFORCE MORE TRIPLING BY 2022. COMPARED WITH OTHER TYPES OF NHSC CLINICIANS (E.G., PRIMARY AND DENTAL CARE CLINICIANS), THE NHSC MENTAL HEALTH WORKFORCE EXPERIENCED THE LARGEST GROWTH SINCE 2009. HOWEVER, NO STUDY TO DATE HAS EVALUATED THE POTENTIAL EFFECT OF THE NHSC EXPANSION ON DISPARITIES IN AUD TREATMENT ACROSS GEOGRAPHIC AREAS. WE HYPOTHESIZED THAT THE SUBSTANTIAL GROWTH OF MENTAL HEALTH WORKFORCE BROUGHT ABOUT BY THE NHSC EXPANSION REDUCED DISPARITIES IN AUD TREATMENT AND OUTCOMES BETWEEN MHPSAS AND OTHER AREAS. FURTHER, WE POSITED THAT THE EFFECTS OF THE NHSC EXPANSION ON AUD TREATMENT DISPARITIES DIFFER BY POPULATION GROUPS AND CLINICIAN TYPES GIVEN THE FACTS THAT PEOPLE WITH LOWER SOCIO-ECONOMIC STATUS DOMINATED MHPSAS AND THAT THE GROWTH OF THE NHSC’S WORKFORCE VARIED BY CLINICIAN TYPE (E.G., PSYCHIATRISTS, CLINICAL PSYCHOLOGISTS, CLINICAL SOCIAL WORKERS, AND CLINICAL COUNSELORS). THIS PROPOSED PROJECT WILL EXAMINE THESE HYPOTHESES AND FILL THE GAP IN THE LITERATURE. SPECIFICALLY, THE PROJECT AIMS TO ASSESS THE EFFECT OF THE NHSC EXPANSION ON DISPARITIES IN AUD MORTALITY, UNMET NEED FOR AUD TREATMENT, AND UTILIZATION AND COSTS OF ALCOHOL-RELATED EMERGENCY DEPARTMENT VISITS AND HOSPITALIZATIONS. IN ADDITION TO GEOGRAPHIC DISPARITIES BETWEEN MHPSAS AND NON-SHORTAGE AREAS, THE PROJECT WILL EXAMINE EFFECT HETEROGENEITY OF THE NHSC EXPANSION ACROSS POPULATION GROUPS AND CLINICIAN TYPES. WE WILL USE MULTIPLE LARGE, NATIONAL DATA FILES. TO ANALYZE THE DATA, WE WILL TAKE TWO COMPLEMENTARY APPROACHES, INCLUDING A DIFFERENCE-IN- DIFFERENCES METHOD AND AN INSTRUMENTAL VARIABLE APPROACH, TO GENERATE RIGOROUS QUASI-EXPERIMENTAL EVIDENCE ABOUT THE IMPACT OF THE NHSC EXPANSION ON AUD TREATMENT DISPARITIES. BY FOCUSING ON HEALTH WORKFORCE ISSUES IN UNDERSERVED AREAS, THE PROPOSED STUDY IS HIGHLY RELEVANT TO NIAAA’S PAR-23-185, WHICH LISTS WORKFORCE-RELATED BARRIERS TO ACCESS TO AUD TREATMENT AS A SPECIFIC AREA OF INTEREST. THE STUDY FINDINGS WILL HAVE IMPORTANT IMPLICATIONS FOR POLICY DECISIONS RELATED TO FUTURE DIRECTIONS FOR THE NHSC AND FURTHER REDUCING DISPARITIES IN AUD TREATMENT AND OUTCOMES.

IMPACT OF THE NATIONAL HEALTH SERVICE CORPS ON HEALTH DISPARITIES

IMPROVING THE VALIDITY OF LINKED REAL-WORLD DATA STUDIES FOR DIABETES MELLITUS RESEARCH (VALIDATE-DM) - PROJECT SUMMARY/ABSTRACT INDIVIDUALS WITH DIABETES AND THEIR PRESCRIBERS OFTEN CHOOSE AMONG VARIOUS GLUCOSE-LOWERING TREATMENTS (GLTS), BUT INFORMATION ON THE COMPARATIVE EFFECTIVENESS AND SAFETY OF GLTS IS LIMITED. MOST RANDOMIZED CONTROLLED TRIALS (RCTS) ONLY COMPARE ONE GLT WITH PLACEBO OR ANOTHER GLT IN HIGHLY SELECTIVE POPULATIONS. REAL-WORLD DATA (RWD), SUCH AS HEALTHCARE CLAIMS AND ELECTRONIC HEALTH RECORDS (EHRS), HAVE BEEN USED TO FILL THIS KNOWLEDGE GAP. THE VALUE OF RWD IS FURTHER HIGHLIGHTED IN THE 21ST CENTURY CURES ACT, WHICH EMPHASIZES THE USE OF RWD AND REAL-WORLD EVIDENCE (RWE) TO ACCELERATE MEDICAL PRODUCT INNOVATION. RWD WILL LIKELY CONTINUE TO BE USED, IF NOT INCREASINGLY SO, IN COMPARATIVE EFFECTIVENESS AND SAFETY RESEARCH OF GLTS AS A COMPLEMENT TO RCTS. HOWEVER, INDIVIDUAL RWD SOURCES HAVE WELL-KNOWN LIMITATIONS. FOR EXAMPLE, CLAIMS DATA LACK CERTAIN VARIABLES (E.G., HBA1C) CRITICAL FOR DIABETES RESEARCH, WHILE EHRS DO NOT FULLY CAPTURE OUT-OF- SYSTEM CARE. LINKING COMPLEMENTARY RWD SOURCES HELPS OVERCOME SOME OF THESE LIMITATIONS, BUT LINKED DATA ARE SUSCEPTIBLE TO NUMEROUS BIASES IF NOT ANALYZED PROPERLY. GIVEN THE UBIQUITY OF AND EASE OF ACCESS TO RWD FOR DIABETES RESEARCH, IT IS IMPERATIVE TO ENSURE VALID FINDINGS FROM RWD STUDIES. THE PROPOSED STUDY WILL FOCUS ON LINKED RWD FOR COMPARATIVE EFFECTIVENESS AND SAFETY RESEARCH OF GLTS, WHICH IS EXPECTED TO BE INCREASINGLY COMMON BUT WITH UNDER-APPRECIATED DESIGN AND ANALYTIC CHALLENGES. USING A LARGE CLAIMS-EHR LINKED DATABASE AND REALISTIC EXAMPLES, THE STUDY WILL ADDRESS THE FOLLOWING AIMS: (1) DEVELOP A SYSTEMATIC APPROACH TO INVESTIGATE POTENTIAL BIASES WHEN USING LINKED RWD FOR COMPARATIVE EFFECTIVENESS AND SAFETY RESEARCH OF GLTS, (2) DEVELOP AND EVALUATE A COMPREHENSIVE DESIGN AND ANALYTIC APPROACH THAT MAXIMIZES INTERNAL VALIDITY IN COMPARATIVE EFFECTIVENESS AND SAFETY RESEARCH OF GLTS THAT USES LINKED RWD, AND (3) APPLY NOVEL GENERALIZABILITY AND TRANSPORTABILITY METHODS TO IMPROVE EXTERNAL VALIDITY AND EXTEND FINDINGS FROM LINKED RWD STUDIES TO TARGET POPULATION(S) OF INTEREST. RWD STUDIES COMPLEMENT AND DO NOT REPLACE RCTS. SOMETIMES THEY ARE THE ONLY WAY TO FILL OUR KNOWLEDGE GAP. THE PATH FORWARD IS TO NOT DISCREDIT RWD STUDIES BUT TO KEEP IMPROVING THEIR VALIDITY AND GENERALIZABILITY. THE PROPOSED STUDY IS TIMELY AND CRITICALLY NEEDED. IT ADDRESSES A KEY TOPIC IN THE 2021 NIDDK 5-YEAR STRATEGIC PLAN FOR RESEARCH – LEVERAGING EXISTING DATA FOR CLINICAL RESEARCH AND MINIMIZING BIASES ASSOCIATED WITH RWD. THE STUDY WILL HELP THE DIABETES RESEARCHERS MAXIMIZE THE POTENTIAL OF LINKED RWD, AVOID OR MINIMIZE PITFALLS ASSOCIATED WITH LINKED RWD STUDIES AND GENERATE ROBUST RWE IN DIABETES RESEARCH. THE DEVELOPED FRAMEWORK CAN BE GENERALIZED AND APPLIED TO OTHER LINKED DATA, SUCH AS LINKED CLAIMS-REGISTRIES AND LINKED EHR-REGISTRIES.

MODELING OF VIRAL LOAD TRAJECTORIES FOR HIV CURE RESEARCH - THE WORLD URGENTLY NEEDS TO ADVANCE THE HIV CURE RESEARCH AGENDA TO ADDRESS THE PERSISTENTLY HIGH GLOBAL HIV PREVALENCE AND ASSOCIATED MORTALITY. DESPITE THE SUCCESS OF COMBINED ANTIRETROVIRAL THERAPY (ART) IN ACHIEVING SUSTAINED CONTROL OF VIRAL REPLICATION, THE CONCERNS ABOUT SIDE-EFFECTS, DRUG-DRUG INTERACTIONS, DRUG RESISTANCE AND COST CALL FOR A NEED TO IDENTIFY STRATEGIES FOR ACHIEVING HIV ERADICATION OR AN ART-FREE REMISSION. FOLLOWING ART WITHDRAWAL, PATIENTS' VIRAL LOAD LEVELS USUALLY INCREASE RAPIDLY TO A PEAK FOLLOWED BY A DIP, AND THEN STABILIZE AT A VIRAL LOAD SET POINT. CHARACTERIZING FEATURES OF THE VIRAL REBOUND TRAJECTORIES (E.G., TIME TO VIRAL REBOUND AND VIRAL SET POINTS) AFTER ANALYTIC ANTIRETROVIRAL TREATMENT INTERRUPTION (ATI) AND IDENTIFYING HOST, VIROLOGICAL, AND IMMUNOLOGICAL FACTORS THAT ARE PREDICTIVE OF THESE FEATURES ARE CENTRAL TO HIV CURE RESEARCH. BUT DOING SO REQUIRES ADDRESSING A VARIETY OF ANALYTICAL CHALLENGES, INCLUDING THE NON-LINEAR VIRAL REBOUND TRAJECTORIES, COARSENED DATA DUE TO THE ASSAY'S LIMIT OF QUANTIFICATION, INTERMITTENT MEASUREMENTS OF VIRAL LOAD VALUES, SMALL SAMPLE SIZES FROM INDIVIDUAL STUDIES, AND HIGH-DIMENSIONAL CANDIDATE PREDICTORS. MOTIVATED BY OUR ONGOING COLLABORATIONS WITH HIV CURE RESEARCH INVESTIGATORS AND BUILT ON OUR PREVIOUS WORK, WE AIM TO ADDRESS KEY METHODOLOGICAL GAPS BY LEVERAGING DATA FROM MULTIPLE RANDOMIZED STUDIES CONDUCTED BY THE AIDS CLINICAL TRIALS GROUP AND FROM THE ZURICH PRIMARY HIV INFECTION COHORT. AIM 1 PROPOSES TO DEVELOP A NEW SET OF METHODS FOR PREDICTION OF TIME TO VIRAL REBOUND BASED ON COMPREHENSIVE HISTORY PROFILES, SUCH AS THE RATE OF VIRAL DECAY AFTER ART INITIATION, EXTENDING FITTING ALGORITHMS AND VARIABLE SELECTION TECHNIQUES DEVELOPED FOR INTERVAL-CENSORED OUTCOMES. AIM 2 PROPOSES TO FIT THE VIRAL REBOUND MODEL USING A SMOOTHED SIMULATED PSEUDO MAXIMUM LIKELIHOOD METHOD WHICH MAXIMIZES A SMOOTHED SIMULATED OBJECTIVE FUNCTION CONSTRUCTED BASED ON A MONTE CARLO APPROXIMATION OF THE FIRST TWO MOMENTS OF THE SMOOTHED RESPONSES, AND TO DEVELOP METHODS TO ASSESS THE ASSOCIATION BETWEEN TIME TO REBOUND AND THE VIRAL SET POINT AND TO SIMULTANEOUSLY SELECT BIOMARKERS THAT AFFECT DIFFERENT FINER FEATURES OF THE VIRAL REBOUND TRAJECTORY. AIM 3 PROPOSES TO DEVELOP METHODS THAT OPTIMALLY INTEGRATE DATA FROM MULTIPLE COHORTS AND DIFFERENT PHASES OF VIRAL LOAD TRAJECTORIES WHILE PROPERLY ACCOUNTING FOR THE HOMOGENEITY AND HETEROGENEITY IN COVARIATE EFFECTS ACROSS STUDIES. INNOVATION LIES IN THE DEVELOPMENT AND APPLICATION OF NEW METHODS FOR MODELING VIRAL REBOUND THAT ADDRESS VARIOUS INHERENT CHALLENGES IN ANALYSES OF AVAILABLE DATA. SIGNIFICANCE LIES IN THE ROLE OF THESE METHODS IN BETTER CHARACTERIZING VIRAL REBOUND TRAJECTORIES, IDENTIFYING PRE- ATI PREDICTORS, AND ASSESSING THE EFFECTS AND MECHANISMS OF NOVEL THERAPEUTIC AGENTS. THE RESULTS OF THE PROPOSED RESEARCH CAN INFORM OPTIMAL DESIGN OF FUTURE ATI STUDIES AND PROVIDE NEW TOOLS THAT CAN EXTRACT MORE INFORMATION FROM DATA COLLECTED IN COMPLETED AND ONGOING ATI STUDIES. THESE NEW INSIGHTS ARE USEFUL IN THE DISCOVERY OF PRE-ATI PREDICTORS OF BETTER VIREMIA CONTROL POST ATI AND EVALUATION OF INTERVENTIONS THAT TARGET DIFFERENT COMPONENTS OF VIRAL REBOUND PROCESS, ULTIMATELY IMPROVING OUR CAPACITY TO FIND A CURE FOR HIV.

DECISION MAKING CHALLENGES AND NEEDS FOR HEALTH INSURANCE EXCHANGE ENROLLEES

ELECTRONIC SURVEILLANCE FOR HOSPITAL-ONSET SEPSIS TO EXPAND DETECTION OF SERIOUS HEALTHCARE-ASSOCIATED INFECTIONS - PROJECT ABSTRACT HEALTHCARE-ASSOCIATED INFECTIONS (HAIS) ARE A LEADING CAUSE OF PREVENTABLE HARM IN U.S. HOSPITALS. HOSPITALS ARE THEREFORE REQUIRED TO REPORT SELECTED HAIS, INCLUDING CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTIONS, CATHETER-ASSOCIATED URINARY TRACT INFECTIONS, COLON AND ABDOMINAL HYSTERECTOMY SURGICAL SITE INFECTIONS, METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS BACTEREMIA, AND CLOSTRIDIOIDES DIFFICILE INFECTIONS, TO THE CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS) VIA CDC’S NATIONAL HEALTHCARE SAFETY NETWORK. THESE DATA ARE USED TO BENCHMARK HOSPITALS AND TO INFORM CMS’S PAY-FOR PERFORMANCE PROGRAMS. IN MANY CASES, HOWEVER, CONDUCTING SURVEILLANCE FOR HAIS IS COMPLICATED, RESOURCE INTENSIVE, AND PRONE TO HIGH LEVELS OF INTEROBSERVER VARIABILITY. FURTHERMORE, MANY OF THE MOST COMMON AND MORBID HAIS, SUCH AS HOSPITAL-ACQUIRED PNEUMONIA AND MOST NON-LINE ASSOCIATED BLOODSTREAM INFECTIONS, ARE NOT ROUTINELY TRACKED OR REPORTED AND ARE THEREFORE LARGELY NEGLECTED BY HOSPITALS. OUR UNDERLYING HYPOTHESIS IS THAT ELECTRONIC SURVEILLANCE FOR HOSPITAL-ONSET SEPSIS COULD PROVIDE A MORE COMPLETE, EFFICIENT, AND OBJECTIVE METHOD TO IDENTIFY A FULLER ARRAY OF THE MOST SERIOUS HAIS COMPARED TO CURRENT SURVEILLANCE METHODS. IN PARTICULAR, CDC’S HOSPITAL-ONSET ADULT SEPSIS EVENT DEFINITION USES ROUTINE ELECTRONIC CLINICAL DATA TO IDENTIFY PATIENTS WITH CONCURRENT CLINICAL INDICATORS OF PRESUMED SERIOUS INFECTIONS (BLOOD CULTURE ORDERS AND ANTIBIOTIC TREATMENT) AND CONCURRENT ORGAN DYSFUNCTION (INITIATION OF VASOPRESSORS OR MECHANICAL VENTILATION OR SIGNIFICANT CHANGES IN LABORATORY VALUES). PRELIMINARY DATA SUGGEST THAT CDC’S HOSPITAL-ONSET SEPSIS SURVEILLANCE DEFINITION MAY IDENTIFY MANY MORE HAIS THAN CURRENT CMS REPORTABLE METRICS AND THAT HOSPITAL-ONSET SEPSIS IS ASSOCIATED WITH VERY HIGH MORTALITY RATES EVEN WHEN REPORTABLE HAIS ARE ABSENT. BEFORE HOSPITALS AND POLICYMAKERS CONSIDER ROUTINELY TRACKING HOSPITAL-ONSET SEPSIS, HOWEVER, DATA FROM DIVERSE SETTINGS ARE NEEDED TO UNDERSTAND ITS INCIDENCE AND VARIATION ACROSS HOSPITALS, ITS IMPACT ON LONG-TERM OUTCOMES, AND THE SPECIFIC INFECTIONS LEADING TO SEPSIS. THIS PROPOSAL WILL ADDRESS THESE GAPS THROUGH THE FOLLOWING SPECIFIC AIMS: 1) CHARACTERIZE THE INCIDENCE, IN-HOSPITAL MORTALITY, AND HOSPITAL-LEVEL VARIATION FOR HOSPITAL-ONSET SEPSIS VERSUS CURRENTLY REPORTABLE HAIS, 2) DETERMINE THE IMPACT OF HOSPITAL-ONSET SEPSIS VERSUS REPORTABLE HAIS ON PATIENTS’ LONG-TERM OUTCOMES, AND 3) DEVELOP ELECTRONIC ALGORITHMS USING CLINICAL AND ADMINISTRATIVE DATA TO AUTOMATICALLY IDENTIFY THE TYPES OF INFECTIONS PRECIPITATING HOSPITAL-ONSET SEPSIS. THIS WORK WILL BE CONDUCTED USING DETAILED CLINICAL DATA FROM 145 HCA HEALTHCARE HOSPITALS THAT COLLECTIVELY CARE FOR MORE THAN 1.7 MILLION INPATIENTS PER YEAR (APPROXIMATELY 5% OF U.S. ACUTE CARE HOSPITALIZATIONS). IN AIM 2, WE WILL ALSO LINK HCA DATA TO CMS CLAIMS DATA TO ACCURATELY CAPTURE POST- DISCHARGE OUTCOMES FOR MEDICARE BENEFICIARIES. THIS PROPOSAL DIRECTLY ADDRESSES THE GOALS OF AHRQ AND ITS HAI PREVENTION PORTFOLIO BY PROVIDING THE FOUNDATION FOR A NEW HAI SURVEILLANCE PARADIGM THAT WILL HELP IDENTIFY NEW TARGETS FOR PREVENTION AND QUALITY IMPROVEMENT AND THEREBY HELP CATALYZE BETTER OUTCOMES FOR PATIENTS.

IDENTIFYING CAUSAL MECHANISMS OF METABOLITES IN FAMILY-BASED ASSOCIATION STUDIES OF CHILDHOOD ASTHMA - ABSTRACT ASTHMA IS A CHRONIC DISEASE WITH A SUBSTANTIAL PUBLIC HEALTH BURDEN. ASTHMA HAS BOTH GENETIC AND ENVIRONMENTAL RISK FACTORS; HOWEVER, METABOLOMICS HAS THE DISTINCT ADVANTAGE OF REFLECTING THE NET RESULT OF GENOMIC AND ENVIRONMENTAL INFLUENCES BY PROFILING THE SMALL MOLECULES (I.E., METABOLITES) THAT REFLECT THE COMPLEX PHYSIOLOGICAL PROCESSES MANIFESTING AS DIFFERENCE IN CLINICAL FEATURES OBSERVED IN ASTHMA. THE GLOBAL METABOLOME IS THEREFORE WELL-SUITED TO CAPTURE BOTH UNIQUE AND COMMON DISEASE MECHANISMS THAT DRIVE A RANGE OF LUNG FUNCTION. IT IS CRITICAL TO UNDERSTAND THE GENETICS UNDERLYING THE METABOLOME AND LUNG FUNCTION FOR ACCURATE CLASSIFICATION AND IMPROVED TREATMENT RESPONSIVENESS ACROSS THE SPECTRUM OF ASTHMA. THE GENETIC EPIDEMIOLOGY OF ASTHMA IN COSTA RICA (GACRS) COHORT RECRUITED CHILDREN WITH MILD-TO-MODERATE ASTHMA FROM THE CENTRAL VALLEY OF COSTA RICA. THIS AREA REPRESENTS A HISPANIC POPULATION WHICH HAS ONE OF THE HIGHEST PREVALENCES OF ASTHMA IN THE WORLD (24% IN CHILDREN), MAKING IT UNIQUELY SUITED FOR THE EXPLORATION OF THE METABOLOMIC UNDERPINNINGS OF ASTHMATIC LUNG FUNCTION. GACRS IS A FAMILY-BASED STUDY, WHICH PROVIDES A UNIQUE OPPORTUNITY TO EXAMINE THE CAUSAL RELATIONSHIP BETWEEN SNPS, METABOLITES, AND LUNG FUNCTION IN A FRAMEWORK THAT IS ROBUST TO POPULATION STRATIFICATION AND PHENOTYPIC MISSPECIFICATION AND CAN ACCOMMODATE UNBIASED SCREENING STEPS. THE OBJECTIVE OF THIS PROPOSAL IS TO IDENTIFY PLEIOTROPIC ASSOCIATIONS OF METABOLITES AND LUNG FUNCTION (I.E., SNPS ASSOCIATED WITH BOTH LUNG FUNCTION AND AT LEAST ONE METABOLITE) (AIM 1), IDENTIFY METABOLOMIC DETERMINANTS OF LUNG FUNCTION (AIM 2), AND EXAMINE THE GENETIC EFFECT ON LUNG FUNCTION AS MEDIATED BY THE METABOLITES (AIM 3) AMONG HISPANIC CHILDREN WITH ASTHMA IN GACRS AND THE CHILDHOOD ASTHMA MANAGEMENT PROGRAM (CAMP) WITH REPLICATION IN HISPANIC, BLACK, AND NON-HISPANIC WHITE CHILDREN IN VDAART AND REPLICATION/ GENERALIZABILITY TO ADULTS (HISPANIC, BLACK AND NON-HISPANIC WHITE) IN THE NHLBI TRANS-OMICS FOR PRECISION MEDICINE (TOPMED) PROGRAM.

DEFINING AND PREVENTING VENTILATOR-ASSOCIATED COMPLICATIONS IN PEDIATRICS

PREDICTIVE ANALYTICS AND CLINICAL DECISION SUPPORT TO IMPROVE PREP PRESCRIBING IN COMMUNITY HEALTH CENTERS (PREDICT) - PROJECT SUMMARY RATES OF NEW HIV INFECTIONS ARE DISPROPORTIONATELY HIGH, AND UPTAKE OF PREEXPOSURE PROPHYLAXIS (PREP) LOW, IN BLACK, LATINO/A/X, AND UNINSURED INDIVIDUALS IN THE US. HEALTHCARE PROVIDERS IN COMMUNITY HEALTH CENTERS (CHCS) COULD PLAY A CRITICAL ROLE IN INCREASING PREP PRESCRIBING TO RACIAL AND ETHNIC MINORITIES AND OTHER UNDERSERVED POPULATIONS. HOWEVER, PROVIDERS FACE BARRIERS TO PREP PRESCRIBING, SUCH AS DIFFICULTY IDENTIFYING CANDIDATES FOR PREP; DISCOMFORT DISCUSSING SEXUAL BEHAVIOR; IMPLICIT BIASES ABOUT SEXUALITY, RACE, AND SUBSTANCE USE; AND LACK OF FAMILIARITY WITH PREP CARE. WE HAVE FOUND THAT PROVIDERS ARE ENTHUSIASTIC ABOUT THE POTENTIAL BENEFITS OF DECISION SUPPORT TOOLS TO MITIGATE THESE BARRIERS TO PREP PROVISION, AND THAT PATIENTS WOULD FIND SUCH TOOLS ACCEPTABLE IF IMPLEMENTED SENSITIVELY. WE PREVIOUSLY SHOWED THAT DATA FROM ELECTRONIC HEALTH RECORDS (EHRS) CAN BE USED TO IDENTIFY PATIENTS AT INCREASED RISK OF HIV ACQUISITION IN TWO LARGE, GENERAL PRACTICE HEALTHCARE SYSTEMS. IN OUR FORMATIVE R34 RESEARCH, WE EXPANDED ON THIS APPROACH IN A SAFETY-NET SETTING, INCORPORATING STRATEGIES TO SUPPORT NOT ONLY IDENTIFICATION OF PREP CANDIDATES BUT ALSO PREP DISCUSSIONS AND PRESCRIBING. IN A NATIONAL NETWORK OF CHCS SERVING 6.2 MILLION PATIENTS IN 46 STATES (OCHIN), WE USED MACHINE LEARNING WITH EHR DATA TO IDENTIFY PATIENTS AT INCREASED RISK FOR INCIDENT HIV DIAGNOSIS (AREA UNDER THE CURVE 0.84). USING STAKEHOLDER-ENGAGED QUALITATIVE METHODS, WE THEN BUILT AN EHR-BASED DECISION SUPPORT TOOL THAT USES OUR PREDICTION MODEL TO PROMPT PREP DISCUSSIONS WITH PATIENTS LIKELY TO BENEFIT. THE TOOL FEATURES A SUITE OF RESOURCES TO SUPPORT INITIAL PREP PRESCRIBING, INCLUDING SUGGESTED LANGUAGE FOR PATIENT-CENTERED DISCUSSIONS; INFORMATION ABOUT PREP INDICATIONS, FORMULATIONS, AND DOSING; LABORATORY ORDER SETS; DIAGNOSIS CODES; AND AUTOMATED CLINICAL NOTES. WE PILOTED THIS TOOL AT 3 CHCS, ESTABLISHING FEASIBILITY AND ACCEPTABILITY. WE NOW PROPOSE PREDICTIVE ANALYTICS AND CLINICAL DECISION SUPPORT TO IMPROVE PREP PRESCRIBING IN COMMUNITY HEALTH CENTERS (PREDICT) TO EVALUATE THE IMPACT OF OUR TOOL ON PREP PROVISION IN OCHIN CHCS. OUR SPECIFIC AIMS ARE TO 1) EXPAND AND REFINE THE DECISION SUPPORT TOOL TO FACILITATE PREP FOLLOW-UP CARE, AND THEREFORE PATIENTS’ PERSISTENCE ON PREP; 2) QUANTIFY THE IMPACT OF THE DECISION SUPPORT TOOL ON PREP INITIATION AND PERSISTENCE IN A PRAGMATIC STEPPED-WEDGE TRIAL ACROSS 16 CHCS; AND 3) IDENTIFY PATIENT POPULATIONS WITH WHOM PROVIDERS ARE LESS INCLINED TO DISCUSS PREP WHEN PROMPTED TO DO SO, AND EXPLORE FACILITATORS AND BARRIERS TO EQUITABLE SELECTION OF PATIENTS FOR PREP DISCUSSIONS. WE WILL ENGAGE A DIVERSE ADVISORY GROUP OF PATIENTS FROM OCHIN CHCS IN TOOL EXPANSION, REFINEMENT, AND IMPLEMENTATION. THIS PROJECT IS INNOVATIVE IN ITS USE OF PREDICTIVE ANALYTICS AND DECISION SUPPORT TO IMPROVE PREP PROVISION IN SAFETY-NET SETTINGS. THE RESEARCH IS SIGNIFICANT BECAUSE IT HAS THE POTENTIAL TO FACILITATE LARGE INCREASES IN PREP UTILIZATION USING HIGHLY SCALABLE TOOLS. OUR INTERVENTION ADDRESSES NIH PRIORITIES, ALIGNS WITH THE FEDERAL ENDING THE HIV EPIDEMIC INITIATIVE, AND COULD BECOME A BEST PRACTICE FOR HOW CHCS AND OTHER HEALTHCARE SYSTEMS SUPPORT PREP CARE DELIVERY.

EVALUATING SEQUENTIAL STRATEGIES TO REDUCE READMISSION IN A DIVERSE POPULATION

PRIVACY-PROTECTING DISTRIBUTED ANALYSIS OF BIOMEDICAL BIG DATA

ENHANCING THE OBESITY PREVENTION PROGRAM AT HARVARD'S DACP

EFFECTS OF PRENATAL DIET AND MERCURY EXPOSURE ON CHILD BEHAVIOR AND DEVELOPMENT

METHODS FOR PROFILING HOSPITAL PERFORMANCE BASED ON HEALTHCARE-ASSOCIATEDINFECTIONS

DISTRIBUTION OF CHILD MENTAL HEALTH WORKFORCE AND HEALTH CARE FOR CHILDREN WITH AUTISM

LIMITING WEIGHT GAIN IN OVERWEIGHT PREGNANT WOMEN: EFFECTS ON MOTHER AND CHILD

IMPROVING PRIMARY CARE TO PREVENT CHILDHOOD OBESITY

IMPROVING MISSING DATA ANALYSIS IN DISTRIBUTED RESEARCH NETWORKS

EASTERN MASSACHUSETTS PREVENTION EPICENTERS PROGRAM II

EPIDEMIOLOGY & EPIGENETICS: MATERNAL DIET, DNA METHYLATION, & OFFSPRING ADIPOSITY

DATA MINING ELECTRONIC HEALTH RECORDS FOR DRUG ADVERSE EVENTS

JOINT INITIATIVE IN VACCINE ECONOMICS (JIVE) PROJECT, PHASE 3

SOCIOMARKERS TO PREDICT ASTHMA CONTROL AND EMERGENCY ROOM VISITS (SPACER) - PROJECT ABSTRACT ASTHMA IMPACTS MORE THAN 25 MILLION ADULTS AND CHILDREN IN THE U.S. WITH HIGH ASSOCIATED MORBIDITY AND SOCIOECONOMIC DISPARITIES IN OUTCOMES. BECAUSE EFFECTIVE MEDICATIONS ARE AVAILABLE TO TREAT AND PREVENT EXACERBATIONS OF ASTHMA AND EVIDENCE-BASED INTERVENTIONS EXIST TO MITIGATE THE IMPACT OF HARMFUL SOCIOECONOMIC FACTORS, EARLY IDENTIFICATION OF THOSE AT HIGHEST RISK IS CRUCIAL. HOWEVER, EFFORTS TO PREDICT FUTURE EXACERBATIONS OF ASTHMA HAVE YIELDED MODEST RESULTS WITH INFREQUENT INCLUSION OF COMPREHENSIVE INFORMATION ON SOCIAL HARDSHIPS, SUCH AS FOOD INSECURITY AND HOUSING INSTABILITY, OR FINANCIAL HARDSHIPS, SUCH AS DIFFICULTY AFFORDING THE COSTS OF CONTROLLER MEDICATIONS WHICH IS PARTICULARLY RELEVANT FOR THOSE WITH PRIVATE HEALTH INSURANCE. IDENTIFYING SOCIAL AND FINANCIAL HARDSHIPS REQUIRES BROAD-BASED SCREENINGS WHICH ARE RESOURCE INTENSIVE, DIFFICULT TO IMPLEMENT IN CLINICAL SETTINGS AND OFTEN INCOMPLETE OR LIMITED TO CARE SEEKING POPULATIONS. FURTHER, FEW ASTHMA RISK PREDICTION MODALITIES INCORPORATE TIME-VARIABLE (TEMPORAL) DATA ON IMPORTANT SOCIAL, CLINICAL, AND ENVIRONMENTAL FACTORS. MACHINE LEARNING, AN ADVANCED COMPUTATIONAL APPROACH TO RISK PREDICTION, HAS GREAT POTENTIAL TO IMPROVE UPON CONVENTIONAL APPROACHES TO RISK PREDICTION OF ASTHMA EXACERBATIONS THROUGH INDIRECT ESTIMATION OF SOCIAL HARDSHIPS AND INCLUSION OF TEMPORAL RISK FACTORS. IMPLEMENTATION OF ENHANCED ASTHMA RISK-PREDICTION MODELS IN A HEALTH PLAN SETTING OFFERS DISTINCT ADVANTAGES DUE TO EXISTING INVESTMENTS IN ASTHMA CARE MANAGEMENT AND ACCESS TO TIMELY CLAIMS DATA ACROSS THE FULL CARE CONTINUUM. ACCORDINGLY, THE AIMS OF THE SPACER STUDY (SOCIOMARKERS TO PREDICT ASTHMA CONTROL AND EMERGENCY ROOM VISITS) ARE 1) TO DESCRIBE SOCIAL AND FINANCIAL HARDSHIPS IN PRIVATELY INSURED ADULTS AND CHILDREN WITH ASTHMA, AND ASSOCIATION WITH MEDICATION ADHERENCE AND EXACERBATIONS, 2) TO INDIRECTLY ESTIMATE SELF-REPORTED SOCIAL AND FINANCIAL HARDSHIPS USING ROUTINELY COLLECTED HEALTH PLAN AND SPATIAL DATA, AND 3) TO DEVELOP AND VALIDATE A MACHINE LEARNING NETWORK MODEL, INCORPORATING TEMPORAL SOCIOMARKER, CLINICAL, AND ENVIRONMENTAL DATA, TO PREDICT ASTHMA EXACERBATIONS IN A HEALTH PLAN SETTING. THE RESEARCH LEVERAGES THE UNIQUE RESEARCH ENVIRONMENT OF THE DEPARTMENT OF POPULATION MEDICINE, AN ACADEMIC RESEARCH DEPARTMENT OF HARVARD MEDICAL SCHOOL, SITUATED IN A REGIONAL NON-PROFIT HEALTH PLAN, HARVARD PILGRIM HEALTH CARE. THE MENTORED CAREER DEVELOPMENT AWARD WILL SUPPORT DR. ALON PELTZ, A PHYSICIAN AND HEALTH SERVICES RESEARCHER, IN DEVELOPING EXPERTISE IN MACHINE LEARNING MODELING AND USE OF SOCIAL DATA TO IMPROVE PREDICTION OF ADVERSE CLINICAL OUTCOMES.

PATIENT-ORIENTED RESEARCH IN MATERNAL PERINATAL OVERNUTRITION AND CHILD ADIPOSITY

ENHANCE: ENHANCING NUTRITION IN HOME-VISITING PROGRAMS TO ADVANCE PARENT-CHILD HEALTH -   DIETARY FACTORS ARE THE NUMBER ONE MODIFIABLE HEALTH DETERMINANTS OF THE BURDEN OF CHRONIC DISEASES GLOBALLY. THERE ARE MANY BARRIERS TO ACHIEVING A HEALTHY DIET: IN ADDITION TO LACK OF KNOWLEDGE, SKILLS, AND SUPPORT TO INCORPORATE HEALTHY FOOD IN DAILY ROUTINE, ONE OF THE MAIN CHALLENGES IS ACCESS TO HEALTHY FOOD. FOOD INSECURITY AFFECTS MORE THAN ONE THIRD OF FAMILIES WITH LOWER INCOMES IN THE US. PROMOTING HEALTHIER EATING PATTERNS OR PROVIDING NUTRITIONALLY APPROPRIATE FOOD TO PEOPLE WITH EXISTING CHRONIC DISEASES CAN IMPROVE HEALTH OUTCOMES, HOWEVER, TARGETING THE PREGNANCY AND EARLY LIFE PERIODS OFFERS THE UNIQUE OPPORTUNITY OF PRIMARY PREVENTIVE INTERVENTION TO LOWER THE RISK OF DEVELOPING CHRONIC DISEASE OVER THE LIFE COURSE. WE PROPOSE A NUTRITION ENHANCEMENT THAT WILL BE INTEGRATED WITHIN ESTABLISHED, EVIDENCE-BASED, FEDERALLY FUNDED HOME VISITING (HV) PROGRAMS THAT TYPICALLY SERVE FAMILIES FROM LOWER INCOMES AND UNDERSERVED COMMUNITIES. THIS MULTI-LEVEL NUTRITION ENHANCEMENT WILL BE BASED ON NATIONAL EVIDENCE-BASED DIETARY GUIDELINES FOR PREGNANT WOMEN AND YOUNG CHILDREN, INCLUDE CULTURALLY APPROPRIATE RESOURCES AND GROUP ACTIVITIES TO SUPPORT HEALTHY EATING AND COOKING, AND DELIVER FOOD BOXES TO EACH HOUSEHOLD FOR SIX MONTHS. WE WILL CO-DESIGN AND IMPLEMENT THE INTERVENTION WITH HV PROGRAMS (HEALTHY FAMILIES MASSACHUSETTS (HFM) A NETWORK OF 23 COMMUNITY-BASED HV PROGRAMS OVERSEEN BY THE CHILDREN’S TRUST) AND MULTI-SECTORAL PARTNERS, INCLUDING COMMUNITY FOOD ASSISTANCE RESOURCES (REGIONAL FOOD BANKS AND THEIR LOCAL FOOD PANTRIES), FEDERALLY FUNDED FOOD ASSISTANCE PROGRAMS (E.G., WOMEN, INFANTS, AND CHILDREN (WIC) STATE-WIDE AND LOCALLY), AND STATE-WIDE NON-PROFIT ORGANIZATIONS THAT SUPPORT HEALTHY FOOD ACCESS. DURING THE UG3 PHASE, WE WILL CO-DESIGN, PILOT AND REFINE THE NUTRITION ENHANCEMENT WITH TWO HFM PROGRAM SITES (AIM 1) AND CONVENE MULTI-SECTORAL PARTNERS TO COORDINATE ACTIVITIES TOWARDS INITIATION OF THE UH3 PHASE (AIM 2). DURING THE UH3 PHASE, WE WILL EVALUATE THE EFFECTIVENESS (AIM 3) AND IMPLEMENTATION (AIM 4) OF THE NUTRITION ENHANCEMENT IN A STEP-WEDGE CLUSTER RANDOMIZED CONTROL TRIAL (CRCT) IN 21 HFM PROGRAM SITES. OUR PRIMARY OUTCOME IS HEALTHY EATING (AMERICAN HEART ASSOCIATION VALIDATED SCORE) IN PRIMARY PARENT-CHILD DYADS WHO RECEIVED HV SERVICES. WE WILL ALSO ASSESS FOOD SECURITY (USDA VALIDATED MODULE), OTHER HEALTH BEHAVIORS (SLEEP, PHYSICAL ACTIVITIES, TOBACCO USE), MENTAL HEALTH, AND OVERALL WELL-BEING (USING NIH-VALIDATED INSTRUMENTS). WE WILL EXPLORE IMPACT OF THE INTERVENTION IN OTHER HOUSEHOLD MEMBERS AND HV STAFF. WE WILL EVALUATE IMPLEMENTATION USING THE RE-AIM FRAMEWORK. OUR MULTI-SECTORAL PARTNERS WILL ALLOW SUCCESSFUL DISSEMINATION OF THE NOVEL NUTRITION ENHANCEMENT IN HV PROGRAMS NATIONWIDE AND PROMOTE HEALTHY EATING TO PREVENT CHRONIC DISEASE IN MULTIPLE GENERATIONS IN POPULATIONS THAT EXPERIENCE HEALTH DISPARITIES.

SUPPORTIVE AND RESTRICTIVE FACTORS AND MENTAL HEALTH IN LGBT ADOLESCENT AND YOUNG ADULT POPULATIONS - PROJECT SUMMARY/ABSTRACT AN UNPRECEDENTED NUMBER OF NEW POLICIES ACROSS THE US THREATEN THE RIGHTS OF LESBIAN, GAY, BISEXUAL, AND TRANSGENDER (LGBT) POPULATIONS. IN 2023, >500 DISCRIMINATORY LGBT BILLS WERE INTRODUCED IN STATE LEGISLA- TURES—FOUR-TIMES MORE THAN IN RECENT YEARS. SUCH BILLS INCLUDE THOSE BANNING ACCESS TO HEALTHCARE FOR TRANS- GENDER INDIVIDUALS AND THOSE CRIMINALIZING TEACHERS FOR DISCUSSING THE EXISTENCE OF LGBT PEOPLE. EMERGING DATA REVEAL THAT 70% OF LGBT PEOPLE REPORT DISCRIMINATORY BILLS ADVERSELY IMPACT THEIR MENTAL HEALTH, EVEN WHEN THE BILLS DO NOT BECOME LAW. BEFORE THIS RAPID INCREASE IN DISCRIMINATORY POLICIES, LGBT PEOPLE WERE DIS- PROPORTIONALLY BURDENED BY ADVERSE HEALTH OUTCOMES, PARTICULARLY MENTAL HEALTH OUTCOMES. THE GROWING THREAT AND ENACTMENT OF DISCRIMINATORY LGBT POLICIES WILL LIKELY WIDEN THESE DISPARITIES. HOWEVER, LITTLE IS KNOWN ABOUT HOW THE RECENT ONSLAUGHT OF DISCRIMINATORY LGBT BILLS COLLECTIVELY INFLUENCES MENTAL HEALTH, PARTICULARLY IN ADO- LESCENCE AND YOUNG ADULTHOOD WHEN MENTAL HEALTH PROBLEMS TYPICALLY ONSET AND WHEN HEALTH SERVICE USE TRA- JECTORIES ARE OFTEN ESTABLISHED. WITHOUT THIS TIME-SENSITIVE RESEARCH, WE CANNOT EVALUATE THE IMPACT OF REAL- WORLD POLICY ENVIRONMENTS AND ADDRESS THE POTENTIAL HEALTH EFFECTS OF THESE DISCRIMINATORY POLICIES. INFORMED BY THE MINORITY STRESS MODEL, THE PROPOSED PROJECT'S OBJECTIVE IS TO ELUCIDATE HOW MENTAL HEALTH DURING THE CRITICAL YEARS OF LATE ADOLESCENCE AND EARLY ADULTHOOD (AGES 18–24 YEARS) IS INFLUENCED BY FOUR TYPES OF LGBT-TARGET- ED POLICIES: 1) RELIGIOUS EXEMPTIONS, 2) GENDER-AFFIRMING HEALTHCARE BANS, 3) LGBT-RESTRICTIVE SCHOOL CURRICULA, AND 4) LGBT-SUPPORTIVE SCHOOL CURRICULA. TO SUBSTANTIATE THE LINK BETWEEN POLICIES AND MENTAL HEALTH, WE WILL USE A MULTI-METHOD APPROACH. IN THE R61 PHASE, WE WILL COLLECT TIME-SENSITIVE SURVEY DATA IN THE NATIONAL HEALTHY MINDS STUDY—THE LARGEST ONGOING SURVEY OF MENTAL HEALTH IN US COLLEGES AND UNIVERSITIES—TO QUANTIFY ASSOCIATIONS AMONG THESE POLICIES, ENACTED STIGMA (E.G., DISCRIMINATION, BULLYING, HARASSMENT), AND MENTAL HEALTH AMONG YOUNG ADULT COLLEGE STUDENTS (PREDICTED N=80,850 STUDENTS AT 105 INSTITUTIONS, INCLUDING FOUR- YEAR SCHOOLS, COMMUNITY COLLEGES, AND MINORITY-SERVING INSTITUTIONS). IN THE R33 PHASE, WE WILL USE OUR NEWLY COLLECTED HEALTHY MINDS STUDY DATA TO IDENTIFY INDIVIDUALS DIRECTLY IMPACTED BY THESE POLICIES, WITH WHOM WE WILL CONDUCT IN-DEPTH QUALITATIVE INTERVIEWS (N=120). TO UNDERSTAND THE POPULATION-LEVEL IMPACT OF THESE POLICIES AND THEIR MECHANISMS, WE WILL THEN USE NATIONALLY REPRESENTATIVE DATA FROM THE BEHAVIORAL RISK FACTOR SURVEIL- LANCE SYSTEM (BRFSS, N=89,493 YOUNG ADULTS) TO EVALUATE THE IMPACT OF LGBT-TARGETED POLICIES. WE WILL LEV- ERAGE QUASI-EXPERIMENTAL METHODS (I.E., DIFFERENCE-IN-DIFFERENCES ANALYSES) TO QUANTIFY THE CAUSAL EFFECT OF LGBT-TARGETED POLICIES AS WELL AS CAUSAL MEDIATION ANALYSES INFORMED BY MULTI-METHOD RESULTS FROM AIMS 1 AND 2. THIS PROJECT WILL PRODUCE ROBUST AND TIME-SENSITIVE NEW EVIDENCE OF HOW DISCRIMINATORY AND SUPPORTIVE LGBT POLICIES AFFECT MENTAL HEALTH. THIS WORK WILL HAVE A POSITIVE IMPACT BY INFORMING HEALTHCARE PROVIDERS, SCHOOL LEADERS, AND POLICYMAKERS ABOUT THE NECESSARY ACTIONS TO REDUCE ENTRENCHED MENTAL HEALTH DISPARITIES.

PARENT RISK COMMUNICATION

HETEROGENEITY OF PREFERENCES FOR AND OUTCOMES OF PEDIATRIC GENOMIC SEQUENCING BY RACE AND ETHNICITY - PROJECT SUMMARY/ABSTRACT THIS SUPPLEMENT EXTENDS THE PARENT GRANT, AN ELSI-INTEGRATED EVALUATION OF THE FAMILY-LEVEL UTILITY OF PEDIATRIC GENOMIC SEQUENCING (R00HG011491), TO EXPLICITLY AND MEANINGFULLY CONSIDER RACE AND ETHNICITY IN THE MODELING OF CHOICE DATA COLLECTED IN AIM 2 AND SELECTION OF PARAMETER VALUES TO POPULATE THE DECISION MODEL IN AIM 3. IT ALSO SUPPORTS TRAINING AND MENTORSHIP OF THE CANDIDATE, TAYLOR MONTGOMERY, WITH SKILLS TO PURSUE A CAREER RESEARCHING THE IMPACT OF GENOMIC MEDICINE ON POPULATION HEALTH. THE OVERALL GOAL OF THE PROPOSED RESEARCH IS TO UNDERSTAND WHETHER AND HOW PREFERENCES FOR, AND OUTCOMES OF, CLINICAL GS FOR NEWBORN AND PEDIATRIC PATIENTS DIFFER BY RACE AND ETHNICITY. THE RESEARCH PLAN HAS TWO SPECIFIC AIMS. FIRST, WE WILL EVALUATE HETEROGENEITY OF PREFERENCES FOR PEDIATRIC GENOMIC SEQUENCING BY RACE AND ETHNICITY, INCLUDING EXAMINING METHODS FOR CONSIDERATION OF PREFERENCE HETEROGENEITY BY RACE AND ETHNICITY IN PUBLISHED DISCRETE CHOICE EXPERIMENTS AND EXAMINING WHETHER AND HOW PREFERENCES DIFFER ACCORDING TO RACE AND ETHNICITY USING PRIMARY DATA COLLECTED THROUGH THE DISCRETE CHOICE EXPERIMENT IN THE PARENT GRANT. SECOND, WE WILL EXAMINE WHETHER AND HOW CLINICAL OUTCOMES OF GENOMIC SEQUENCING DIFFER BY RACE AND ETHNICITY USING A CLINICAL DATABASE MAINTAINED AT A LARGE REFERRAL HOSPITAL. THIS RESEARCH WILL HAVE IMPACT ON THE FIELD OF GENOMIC MEDICINE THROUGH INFORMING ETHICAL IMPLEMENTATION OF GS TO IMPROVE POPULATION HEALTH. ADDITIONALLY, MS. MONTGOMERY WILL OBTAIN FORMAL TRAINING AND MENTORSHIP IN LITERATURE REVIEW METHODS, QUANTITATIVE METHODS IN HEALTH ECONOMICS AND POLICY, AND GENOMIC MEDICINE, AS WELL AS MANUSCRIPT WRITING AND ORAL AND POSTER PRESENTATION SKILLS. UPON COMPLETION OF THE PROPOSED TRAINING AND RESEARCH PLANS, MS. MONTGOMERY WILL BE WELL- POSITIONED TO BEGIN A PHD PROGRAM TO PURSUE A CAREER IN PUBLIC HEALTH AND POLICY RESEARCH IN GENOMICS.

OPTIMIZING CHOICE OF HEALTH INSURANCE FOR DIABETES (ORCHID) - PROJECT ABSTRACT DIABETES AFFECTS 10% OF THE U.S. POPULATION AND IS RESPONSIBLE FOR $237 BILLION IN DIRECT MEDICAL COSTS ANNUALLY. PRIMARY CARE AND SPECIALIST VISITS, MEDICATIONS AND TESTING SUPPLIES, DURABLE MEDICAL EQUIPMENT, LAB TESTING, AND POTENTIAL EMERGENCY AND HOSPITAL VISITS CAN BE COSTLY. PATIENTS WITH DIABETES REPORT A HIGH LEVEL OF FINANCIAL BURDEN RELATIVE TO PATIENTS WITHOUT DIABETES, STRUGGLING TO PAY FOR NECESSARY HEALTH CARE, FOOD, HOUSING, AND RETIREMENT. COST-RELATED NON-ADHERENCE (DELAYING FILLING A PRESCRIPTION OR TAKING LESS MEDICINE) FOR PATIENTS WITH DIABETES IS HIGH, AND SUBSEQUENTLY, PATIENTS IN HEALTH INSURANCE PLANS WITH POOR COVERAGE FOR NEEDED SERVICES AND RESOURCES EXPERIENCE ADVERSE OUTCOMES LIKE HYPER- OR HYPOGLYCEMIA, ACUTE CEREBROVASCULAR DISEASE, AND ISCHEMIC HEART DISEASE DUE TO DELAYED OR FORGONE CARE. THEREFORE, CHOOSING A HEALTH INSURANCE PLAN THAT MEETS YOUR NEEDS IS CRITICAL TO IMPROVE HEALTH, ESPECIALLY FOR PATIENTS WITH LOW INCOME SOCIOECONOMIC STATUS. UNFORTUNATELY, MANY CONSUMERS STRUGGLE TO CHOOSE A HEALTH PLAN FROM AMONG THE MANY OFFERED, FOCUSING ON A SINGLE FACTOR LIKE COSTS, USING HEURISTICS TO MAKE DECISIONS, FALLING SUBJECT TO BIASES THAT CHALLENGE RATIONAL DECISION-MAKING THEORY, AND FAILING TO WEIGH TRADE-OFFS BETWEEN PLAN FEATURES. WE HYPOTHESIZE THAT HEALTH ECONOMIC STATED PREFERENCE METHODS LIKE DISCRETE CHOICE EXPERIMENTS AND MULTI- CRITERIA DECISION ANALYSES CAN BE USED TO ELICIT HEALTH PLAN PREFERENCES AND VALUES. THESE TOOLS SPECIFICALLY ASK PATIENTS TO WEIGH TRADE-OFFS BETWEEN MULTIPLE PLAN FEATURES AND CAN ASSESS WHICH FEATURES INFLUENCE PATIENT DECISIONS THE MOST. IN THIS OBSERVATIONAL NATURAL EXPERIMENT STUDY, WE WILL USE STATED PREFERENCE SURVEYS TO SYSTEMATICALLY ASSESS PATIENT PREFERENCES FOR HEALTH PLANS THAT ADEQUATELY COVER DIABETES CARE. WE WILL LEVERAGE OUR ACCESS TO HEALTH PLAN AND CLAIMS DATA FROM HARVARD PILGRIM HEALTH CARE AND THE TUFTS HEALTH PLAN, TWO NEW ENGLAND-BASED INSURERS WITH A COMBINED 2.2 MILLION COVERED LIVES. WE WILL ANALYZE THE CONCORDANCE BETWEEN PATIENT PREFERENCES AND THEIR REAL-WORLD HEALTH PLAN. FINALLY, WE WILL ASSESS THE RELATIONSHIP BETWEEN PREFERENCE-ALIGNED HEALTH PLAN ENROLLMENT AND ADVERSE DIABETES HEALTH OUTCOMES, COST- RELATED TREATMENT NON-ADHERENCE, RECEIPT OF APPROPRIATE HIGH-QUALITY DIABETES CARE, HEALTH CARE COSTS AND UTILIZATION, PATIENT FINANCIAL BURDEN, AND PLAN SATISFACTION. IF PREFERENCE-ALIGNED HEALTH PLANS ARE ASSOCIATED WITH BETTER HEALTH AND HEALTH CARE OUTCOMES, FUTURE WORK WILL DEVELOP A DECISION AID THAT ALLOWS PATIENTS TO CLARIFY THEIR VALUES AND PREFERENCES FOR HEALTH CARE AND CHOOSE A PLAN THAT WILL ENABLE THEM TO USE PREVENTIVE CARE THAT REDUCES ADVERSE HEALTH EVENTS AND LOWERS THEIR FINANCIAL BURDEN. IF NOT, FUTURE RESEARCH CAN USE STUDY RESULTS TO DESIGN A DECISION AID THAT DIRECTS CONSUMERS TO PLANS WITH FEATURES ASSOCIATED WITH IMPROVED HEALTH, HEALTH CARE UTILIZATION, HEALTH CARE COSTS, AND CONSUMER SATISFACTION.

NETWORK MODELING AND ROBUST ESTIMATION OF THE INTRACLASS CORRELATION COEFFICIENT TO INFORM THE DESIGN AND ANALYSIS OF CLUSTER RANDOMIZED TRIALS FOR INFECTIOUS DISEASES

WORKPLACE WELLNESS INITIATIVES TO COMBAT OBESITY

HIGH RESOLUTION MEASURES OF BEHAVIORAL CANCER RISK FACTORS FROM MOBILE TECHNOLOGY

EHR-BASED PREDICTION MODELS TO IMPROVE PREP USE IN COMMUNITY HEALTH CENTERS

AN INTEGRATIVE GENOMICS APPROACH TO GENE BY ENVIRONMENT INTERACTIONS IN ASTHMA

COMMON GENETIC PATHWAYS UNDERLYING CVD AND COPD

SUPPORTIVE AND RESTRICTIVE FACTORS AND MENTAL HEALTH IN LGBT ADOLESCENT AND YOUNG ADULT POPULATIONS - PROJECT SUMMARY/ABSTRACT AN UNPRECEDENTED NUMBER OF NEW POLICIES ACROSS THE US THREATEN THE RIGHTS OF LESBIAN, GAY, BISEXUAL, AND TRANSGENDER (LGBT) POPULATIONS. IN 2023, >500 DISCRIMINATORY LGBT BILLS WERE INTRODUCED IN STATE LEGISLA- TURES—FOUR-TIMES MORE THAN IN RECENT YEARS. SUCH BILLS INCLUDE THOSE BANNING ACCESS TO HEALTHCARE FOR TRANS- GENDER INDIVIDUALS AND THOSE CRIMINALIZING TEACHERS FOR DISCUSSING THE EXISTENCE OF LGBT PEOPLE. EMERGING DATA REVEAL THAT 70% OF LGBT PEOPLE REPORT DISCRIMINATORY BILLS ADVERSELY IMPACT THEIR MENTAL HEALTH, EVEN WHEN THE BILLS DO NOT BECOME LAW. BEFORE THIS RAPID INCREASE IN DISCRIMINATORY POLICIES, LGBT PEOPLE WERE DIS- PROPORTIONALLY BURDENED BY ADVERSE HEALTH OUTCOMES, PARTICULARLY MENTAL HEALTH OUTCOMES. THE GROWING THREAT AND ENACTMENT OF DISCRIMINATORY LGBT POLICIES WILL LIKELY WIDEN THESE DISPARITIES. HOWEVER, LITTLE IS KNOWN ABOUT HOW THE RECENT ONSLAUGHT OF DISCRIMINATORY LGBT BILLS COLLECTIVELY INFLUENCES MENTAL HEALTH, PARTICULARLY IN ADO- LESCENCE AND YOUNG ADULTHOOD WHEN MENTAL HEALTH PROBLEMS TYPICALLY ONSET AND WHEN HEALTH SERVICE USE TRA- JECTORIES ARE OFTEN ESTABLISHED. WITHOUT THIS TIME-SENSITIVE RESEARCH, WE CANNOT EVALUATE THE IMPACT OF REAL- WORLD POLICY ENVIRONMENTS AND ADDRESS THE POTENTIAL HEALTH EFFECTS OF THESE DISCRIMINATORY POLICIES. INFORMED BY THE MINORITY STRESS MODEL, THE PROPOSED PROJECT'S OBJECTIVE IS TO ELUCIDATE HOW MENTAL HEALTH DURING THE CRITICAL YEARS OF LATE ADOLESCENCE AND EARLY ADULTHOOD (AGES 18–24 YEARS) IS INFLUENCED BY FOUR TYPES OF LGBT-TARGET- ED POLICIES: 1) RELIGIOUS EXEMPTIONS, 2) GENDER-AFFIRMING HEALTHCARE BANS, 3) LGBT-RESTRICTIVE SCHOOL CURRICULA, AND 4) LGBT-SUPPORTIVE SCHOOL CURRICULA. TO SUBSTANTIATE THE LINK BETWEEN POLICIES AND MENTAL HEALTH, WE WILL USE A MULTI-METHOD APPROACH. IN THE R61 PHASE, WE WILL COLLECT TIME-SENSITIVE SURVEY DATA IN THE NATIONAL HEALTHY MINDS STUDY—THE LARGEST ONGOING SURVEY OF MENTAL HEALTH IN US COLLEGES AND UNIVERSITIES—TO QUANTIFY ASSOCIATIONS AMONG THESE POLICIES, ENACTED STIGMA (E.G., DISCRIMINATION, BULLYING, HARASSMENT), AND MENTAL HEALTH AMONG YOUNG ADULT COLLEGE STUDENTS (PREDICTED N=80,850 STUDENTS AT 105 INSTITUTIONS, INCLUDING FOUR- YEAR SCHOOLS, COMMUNITY COLLEGES, AND MINORITY-SERVING INSTITUTIONS). IN THE R33 PHASE, WE WILL USE OUR NEWLY COLLECTED HEALTHY MINDS STUDY DATA TO IDENTIFY INDIVIDUALS DIRECTLY IMPACTED BY THESE POLICIES, WITH WHOM WE WILL CONDUCT IN-DEPTH QUALITATIVE INTERVIEWS (N=120). TO UNDERSTAND THE POPULATION-LEVEL IMPACT OF THESE POLICIES AND THEIR MECHANISMS, WE WILL THEN USE NATIONALLY REPRESENTATIVE DATA FROM THE BEHAVIORAL RISK FACTOR SURVEIL- LANCE SYSTEM (BRFSS, N=89,493 YOUNG ADULTS) TO EVALUATE THE IMPACT OF LGBT-TARGETED POLICIES. WE WILL LEV- ERAGE QUASI-EXPERIMENTAL METHODS (I.E., DIFFERENCE-IN-DIFFERENCES ANALYSES) TO QUANTIFY THE CAUSAL EFFECT OF LGBT-TARGETED POLICIES AS WELL AS CAUSAL MEDIATION ANALYSES INFORMED BY MULTI-METHOD RESULTS FROM AIMS 1 AND 2. THIS PROJECT WILL PRODUCE ROBUST AND TIME-SENSITIVE NEW EVIDENCE OF HOW DISCRIMINATORY AND SUPPORTIVE LGBT POLICIES AFFECT MENTAL HEALTH. THIS WORK WILL HAVE A POSITIVE IMPACT BY INFORMING HEALTHCARE PROVIDERS, SCHOOL LEADERS, AND POLICYMAKERS ABOUT THE NECESSARY ACTIONS TO REDUCE ENTRENCHED MENTAL HEALTH DISPARITIES.

THE INTERPLAY AMONG REPRODUCTIVE, MOLECULAR, AND CHRONOLOGICAL AGE IN RELATION TO AGING-RELATED CONDITIONS IN WOMEN: A LONGITUDINAL STUDY - SUMMARY/ABSTRACT AGING CONFERS INCREASED RISK FOR MOST CHRONIC DISEASES AS WELL AS DECLINES IN COGNITIVE AND PHYSICAL FUNCTION. WHILE CHRONOLOGICAL AGE CANNOT BE ALTERED, THE PACE OF REPRODUCTIVE AND BIOLOGICAL MARKERS OF AGING MAY VARY DRAMATICALLY. HUMAN AGING IS A SEXUALLY DIMORPHIC PROCESS, WITH FEMALES HAVING A SLIGHTLY LONGER EXPECTED TOTAL LIFESPAN BUT SUBSTANTIALLY SHORTER REPRODUCTIVE LIFESPAN THAN MALES. MANY DISEASES OF AGING, INCLUDING DEMENTIA AND CARDIOVASCULAR DISEASE, SHOW SEX-SPECIFIC PATTERNS. ACROSS THEIR REPRODUCTIVE YEARS, ON AVERAGE FEMALES HAVE LOWER RISK FOR AGING-RELATED CHRONIC DISEASES AND MORE OPTIMAL MARKERS OF BRAIN AND CARDIOVASCULAR HEALTH, SUCH AS LIPIDS AND BLOOD PRESSURE. HOWEVER, COMMON RISK FACTORS INCLUDING OBESITY, TOBACCO USE, DIABETES MELLITUS, AND HYPERTENSION ARE MORE STRONGLY ASSOCIATED WITH CHRONIC DISEASES IN WOMEN COMPARED WITH MEN. MOREOVER, MENOPAUSE, WHICH SIGNALS THE END OF FEMALE REPRODUCTIVE POTENTIAL, ALSO MARKS THE START OF RAPIDLY ESCALATING TRAJECTORIES IN MULTIPLE AGING-RELATED CHRONIC CONDITIONS INCLUDING PHYSICAL FRAILTY, DEMENTIA, AND CARDIOMETABOLIC DISEASES. THE EXTENT TO WHICH REPRODUCTIVE AGING PRESAGES HEALTHY LIFESPAN BEYOND CHRONOLOGICAL AGE AMONG FEMALES REMAINS UNCERTAIN. THE OVERALL GOAL OF THE PROPOSED PROJECT IS TO DISENTANGLE DISTINCT ASPECTS OF AGING – REPRODUCTIVE, BIOLOGICAL, AND CHRONOLOGICAL – IN RELATION TO AGING-RELATED CHRONIC DISEASES AMONG FEMALES. WE WILL LEVERAGE EXISTING HIGH-QUALITY DATA AND BIOSAMPLES FROM A WELL-PHENOTYPED POPULATION OF OVER 850 WOMEN FOLLOWED FROM RECRUITMENT IN EARLY PREGNANCY IN 1999-2002 FOR OVER 2 DECADES, MAKING THIS PROPOSAL BOTH FISCALLY AND TEMPORALLY EFFICIENT AS WELL AS HIGHLY RIGOROUS AND FEASIBLE. OUR SPECIFIC AIMS ARE TO EXAMINE ASSOCIATIONS OF DIFFERENT AGING-RELATED MEASURES WITH CHRONIC DISEASE RISK FACTORS IN MIDLIFE FEMALES. EXPOSURES INCLUDE REPRODUCTIVE AGING REFLECTED BY CLINICAL MEASURES (AGES AT MENARCHE AND MENOPAUSE AND THEIR DIFFERENCE) AS WELL AS MOLECULAR MARKERS (AMH MEASURED IN THE MID- REPRODUCTIVE YEARS AND MIDLIFE) OF GONADAL AGING; BIOLOGICAL AGING REFLECTED BY EPIGENETIC AGE DEVIATION (EAD), MITOCHONDRIAL DNA COPY NUMBER, AND TELOMERE LENGTH; AND CHRONOLOGICAL AGING REFLECTED BY CALENDAR AGE AT OUTCOME. OUTCOMES INCLUDE OBJECTIVELY MEASURED AND SELF-REPORTED COGNITIVE FUNCTION, MEASURES OF PHYSICAL FRAILTY, AND CARDIOMETABOLIC RISK FACTORS. WE WILL ALSO EXAMINE INTERACTIONS AMONG REPRODUCTIVE, BIOLOGICAL, AND CHRONOLOGICAL AGING MEASURES IN RELATION TO THE OUTCOMES ABOVE. THIS APPLICATION IS DIRECTLY RESPONSIVE TO NOT-OD-24-079 AND ADDRESSES HIGH PRIORITY RESEARCH AREAS OF NIA. ITS IMPORTANCE DERIVES FROM ITS SCIENTIFIC FOCUS ON COMMON AND HIGHLY MORBID CHRONIC CONDITIONS OF AGING, WHOSE SEX-SPECIFIC PATTERNS ARE POORLY UNDERSTOOD. RESULTS WILL INFORM PRECISION ESTIMATION OF CHRONIC DISEASE RISKS FOR WOMEN THAT EXTEND BEYOND CHRONOLOGICAL AGE.

OPTIMIZING CARE FOR HIV/HCV-COINFECTED PATIENTS IN THE NEW HCV TREATMENT ERA

EFFECTIVENESS OF PHARMACOGENETIC TESTING IN ASTHMA

IMPROVING LABORATORY MONITORING IN COMMUNITY PRACTICES: A RANDOMIZED TRIAL

COST-EFFECTIVENESS OF WHOLE GENOME SEQUENCING OF HEALTHY ADULTS

IMPROVING HEALTHCARE PROVIDERS' COMMUNICATION ABOUT HPV VACCINE

CHILD HEALTH AND FAMILY EXPERIENCE UNDER HEALTH INSURANCE COST-SHARING

GENOMICS-BASED TECHNOLOGIES: ACCESS AND REIMBURSEMENT ISSUES

OPTIMIZING CARE FOR OLDER ADULTS IN THE NEW TREATMENT ERA FOR TYPE 2 DIABETES AND HEART FAILURE: STRENGTHENING CAUSAL INFERENCE THROUGH NOVEL APPROACHES AND EVIDENCE TRIANGULATION - PROJECT SUMMARY/ABSTRACT THIS APPLICATION FOR A K01 MENTORED RESEARCH SCIENTIST AWARD IS SUBMITTED BY XIAOJUAN LI, PHD IN RESPONSE TO PA-20-190. DR. LI IS A PHARMACOEPIDEMIOLOGIST AND INSTRUCTOR IN THE DEPARTMENT OF POPULATION MEDICINE AT HARVARD MEDICAL SCHOOL AND HARVARD PILGRIM HEALTH CARE INSTITUTE. HER LONG-TERM GOAL IS TO DEVELOP AN INDEPENDENT RESEARCH CAREER CONTRIBUTING TO THE APPROPRIATE AND OPTIMAL USE OF MEDICAL TREATMENTS IN PATIENTS WITH COMPLEX HEALTHCARE NEEDS. DR. LI HAS A BACKGROUND IN PHARMACOEPIDEMIOLOGIC METHODS AND CAUSAL INFERENCE. THIS MENTORED RESEARCH AND TRAINING EXPERIENCE WILL INTEGRATE HER METHODOLOGICAL RESEARCH SKILLS INTO CLINICAL GERIATRIC RESEARCH. WITHIN THE HIGHLY PRODUCTIVE AND SUPPORTIVE RESEARCH ENVIRONMENT AT THE DEPARTMENT OF POPULATION MEDICINE, DR. LI WILL WORK WITH AN INTERDISCIPLINARY TEAM OF HIGHLY COMMITTED AND COLLABORATIVE MENTORS THAT HAVE DEEP EXPERTISE AND EXTENSIVE EXPERIENCE IN THE SPECIFIC AREAS OF HER PROPOSED TRAINING: CLINICAL GERIATRICS, DIABETOLOGY, FRAILTY, SEMIPARAMETRIC METHODS, AND MACHINE LEARNING. THE OVERARCHING OBJECTIVE OF THIS K01 APPLICATION IS TO UNDERSTAND THE LONG-TERM COMPARATIVE EFFECTIVENESS AND SAFETY OF NEWER ANTIHYPERGLYCEMIC AGENTS IN OLDER ADULTS IN ROUTINE CARE WHILE APPLYING, DEVELOPING, AND DISSEMINATING STATE-OF- THE-ART ANALYTICAL AND CAUSAL INFERENCE METHODS, ULTIMATELY OPTIMIZING CLINICAL CARE DECISIONS FOR OLDER ADULTS WITH DIABETES AND HEART FAILURE. WHILE THESE NEWER ANTIHYPERGLYCEMIC AGENTS HAVE REPORTED CARDIOVASCULAR BENEFIT IN PLACEBO-CONTROLLED, RANDOMIZED CONTROLLED TRIALS (RCTS), LITTLE IS KNOWN ABOUT HOW TO CHOOSE AMONG AN EXPANDED RANGE OF MEDICATION CHOICES FOR OLDER PATIENTS WHO ARE OFTEN EXCLUDED OR UNDERREPRESENTED. THESE TRIALS DO NOT PROVIDE HEAD-TO-HEAD COMPARISONS EITHER. THIS PROPOSAL SEEKS TO FILL THE CRITICAL GAPS IN THE EVIDENCE BASE BY UTILIZING THE RICH INFORMATION IN HIGH-DIMENSIONAL ELECTRONIC HEALTHCARE DATABASES, THE TARGET TRIAL EMULATION FRAMEWORK, AND NOVEL CAUSAL INFERENCE AND STATISTICAL TOOLS. AIM 1 WILL REFINE THE TRIAL EMULATION FRAMEWORK BY EMULATING TWO PUBLISHED RCTS USING MODERN CAUSAL AND STATISTICAL APPROACHES AND BENCHMARK THESE METHODS BY COMPARING EFFECT ESTIMATES FROM EACH RCT WITH THOSE FROM THEIR OBSERVATIONAL EMULATION. THE EXTENT OF AGREEMENT BETWEEN THE EFFECT ESTIMATES MEASURES THE VALIDITY OF THE EMULATION FRAMEWORK AND ANALYTICAL METHODS AND WILL GUIDE OUR CONFIDENCE IN THE OBSERVATIONAL EMULATION OF OTHER TARGET TRIALS TO ASSESS COMPARATIVE SAFETY AND EFFECTIVENESS OF THE NEWER AGENTS WITH DIFFERENT ELIGIBILITY CRITERIA, HEAD-TO-HEAD TREATMENT COMPARISONS, AND OUTCOMES FOR WHICH ACTUAL RCTS ARE NOT AVAILABLE OR INFEASIBLE (AIMS 2 & 3). THE FINDINGS WILL IMPROVE THE EVIDENCE BASE FOR DECISION-MAKING AVAILABLE FOR CLINICIANS TREATING OLDER PATIENTS, PROMOTE EFFECTIVE AND SAFE DRUG THERAPY, AND ULTIMATELY IMPROVE THE CARE OF OLDER PATIENTS, WHICH ALIGNS WITH THE NATIONAL INSTITUTE ON AGING’S MISSIONS AND INITIATIVES. COMPLETION OF THE PROPOSED CAREER DEVELOPMENT AND MENTORED RESEARCH WILL POSITION DR. LI TO SUCCESSFULLY COMPETE FOR FUTURE R01 FUNDING AND MAKE SIGNIFICANT CONTRIBUTIONS TO GERIATRIC PHARMACOEPIDEMIOLOGY RESEARCH AND IMPROVE THE LIVES OF OLDER ADULTS.

A SYSTEM FOR MANAGEMENT OF DEPRESSION IN MEDICAL ILLNESS

OVER-THE-COUNTER PREP: ACCEPTABILITY, FEASIBILITY, AND POTENTIAL IMPACT OF ACCESS WITHOUT A PRESCRIPTION (OFFSCRIPT) - PROJECT SUMMARY THE POPULATION-LEVEL IMPACT OF HIV PREEXPOSURE PROPHYLAXIS (PREP) HAS BEEN LIMITED BY BARRIERS TO ACCESS. PEOPLE FACE CHALLENGES WITH ATTENDING FREQUENT CLINICAL VISITS, COMPLETING LABORATORY MONITORING, AND DISCLOSING SEXUAL OR SUBSTANCE USE BEHAVIORS TO PROVIDERS, DETERRING PREP INITIATION AND CONTINUATION. THESE BARRIERS TO PREP ACCESS AND USE COULD BE ALLEVIATED BY MAKING PREP AVAILABLE OVER THE COUNTER (OTC). IF PREP WERE OTC, IT COULD BE CONVENIENTLY ACCESSED WITHOUT PROVIDER VISITS, LABORATORY-BASED TESTING, OR THEIR ASSOCIATED COSTS. PEOPLE WOULD NO LONGER NEED TO DISCLOSE BEHAVIORS TO CLINICIANS, EASING ACCESS FOR ALL BUT PARTICULARLY FOR POPULATIONS EXPERIENCING STIGMA IN HEALTHCARE SETTINGS, SUCH AS BLACK MEN WHO SEX WITH MEN (MSM). HOME- BASED HIV TESTS, WHICH ARE AVAILABLE OTC AND ACCEPTABLE IN PRIORITY POPULATIONS, COULD BE BUNDLED WITH OTC PREP: ENVISION SELF-CHECKOUT AT A RETAIL PHARMACY OR ONLINE WITH A 3-MONTH PREP PACKAGE CONTAINING 90 PILLS AND AN HIV TEST. HOWEVER, FOR OTC PREP TO BE ACCEPTABLE AND FEASIBLE FROM A CLINICAL AND REGULATORY PERSPECTIVE, THE BENEFITS OF INCREASED ACCESS, SUCH AS REDUCTIONS IN HIV INCIDENCE, WOULD NEED TO OUTWEIGH THE POTENTIAL RISKS OF REDUCED MONITORING, SUCH AS INCREASES IN HIV DRUG RESISTANCE AND OTHER ADVERSE CLINICAL OUTCOMES. MOREOVER, FOR OTC PREP TO HAVE A MEANINGFUL IMPACT ON HIV INCIDENCE, PRIORITY POPULATIONS WOULD NEED TO BE INTERESTED IN USING IT AND ABLE AND WILLING TO PAY FOR IT. ORAL CONTRACEPTIVE PILLS, ANOTHER MEDICATION TO PREVENT AN UNDESIRED SEXUAL HEALTH OUTCOME, WERE GRANTED OTC STATUS IN JULY 2023 AFTER YEARS OF RESEARCH AND STRATEGIC PARTNERSHIP BUILDING, PROVIDING A ROADMAP FOR RIGOROUS FORMATIVE RESEARCH ON OTC PREP. WE PROPOSE OVER-THE-COUNTER PREP: ACCEPTABILITY, FEASIBILITY, AND POTENTIAL IMPACT OF ACCESS WITHOUT A PRESCRIPTION (OFFSCRIPT), A MIXED-METHODS STUDY TO ASSESS INTEREST IN OTC PREP IN PRIORITY POPULATIONS, EXPLORE KEY STAKEHOLDERS’ PERSPECTIVES ON ACCEPTABILITY AND FEASIBILITY, AND PROJECT LONG-TERM EFFECTS ON HEALTH BENEFITS AND RISKS. IN AIM 1, WE WILL SURVEY DIVERSE COHORTS OF CISGENDER MSM, TRANSGENDER WOMEN, AND CISGENDER WOMEN ON INTEREST IN USE OF OTC PREP, REASONS FOR POTENTIAL USE OR NON-USE, AND WILLINGNESS AND ABILITY TO PAY. WE WILL EVALUATE DIFFERENCES BY DEMOGRAPHICS, INCLUDING RACE AND ETHNICITY, AND BY CURRENT AND PRIOR PREP USE. IN AIM 2, WE WILL CONDUCT FOCUS GROUPS TO EXPLORE ACCEPTABILITY OF OTC PREP AND FACILITATORS AND BARRIERS TO IMPLEMENTATION AMONG KEY STAKEHOLDERS, INCLUDING CLINICIANS, LEADERS OF PROFESSIONAL MEDICAL ORGANIZATIONS, PUBLIC HEALTH OFFICIALS, REGULATORY EXPERTS, DRUG AND HIV SELF-TEST MANUFACTURERS, AND COMMUNITY ADVOCATES. IN AIM 3, WE WILL USE MATHEMATICAL MODELING TO PROJECT THE LONG-TERM IMPACT OF THE AVAILABILITY OF OTC PREP ON POPULATION-LEVEL OUTCOMES, INCLUDING HIV INCIDENCE, DISPARITIES, AND ADVERSE CLINICAL EVENTS, SUCH AS HIV DRUG RESISTANCE, SERIOUS RENAL EVENTS, HEPATITIS B RELAPSE, AND SEXUALLY TRANSMITTED INFECTIONS. THIS STUDY WILL BE THE FIRST TO EXPLORE THE ACCEPTABILITY, FEASIBILITY, AND POTENTIAL IMPACT OF OTC PREP, WHICH COULD SHIFT THE PARADIGM FOR PREP ACCESS IN THE U.S. AND THUS HAVE A MAJOR IMPACT ON THE HIV EPIDEMIC NATIONALLY.

PATIENT-ORIENTED RESEARCH IN EARLY LIFE ORIGINS OF CVD

IMPROVING REPRESENTATION OF RACIAL AND ETHNIC MINORITIES IN PEDIATRIC CLINICAL TRIALS - PROJECT SUMMARY/ABSTRACT IMPROVING REPRESENTATION OF RACIAL AND ETHNIC GROUPS IN US CLINICAL TRIALS HAS BEEN A FOCUS OF FEDERAL INITIATIVES FOR NEARLY 3 DECADES. YET, RACIAL AND ETHNIC MINORITY SUBGROUPS CONTINUE TO BE UNDERREPRESENTED. RACE AND ETHNICITY ENCAPSULATE A COMPLEX INTERACTION OF GEOGRAPHIC ANCESTRY (THUS CLUSTERING OF GENETIC CHARACTERISTICS), LIVING ENVIRONMENTS, AND SOCIOECONOMIC AND CULTURAL FACTORS THAT MAY PLAY PIVOTAL ROLES IN THE VARIABILITY OF SUBJECTS’ RESPONSE TO MEDICAL INTERVENTIONS. INCLUSION OF RACIALLY AND ETHNICALLY DIVERSE PARTICIPANTS IN CLINICAL TRIALS IS THEREFORE CRUCIAL TO DEFINE THE REASONS FOR DIFFERENCES IN HEALTH OUTCOMES, TO ENSURE GENERALIZABILITY AND RELEVANCE OF TRIAL RESULTS TO ALL POPULATIONS, AND TO ALLOW FOR EQUITABLE ACCESS TO MEDICAL ADVANCES. THE OVERALL OBJECTIVE OF THIS PROPOSAL IS TO INVESTIGATE THE EXTENT OF, AND FACTORS ASSOCIATED WITH, UNDER-REPRESENTATION OF RACIAL AND ETHNIC MINORITIES IN PEDIATRIC CLINICAL TRIALS. THE LONG-TERM GOAL IS TO IMPROVE EQUITABLE ACCESS TO PEDIATRIC CLINICAL TRIALS. TO DATE, STUDIES ON TRENDS IN TRIAL PARTICIPATION HAVE PRIMARILY FOCUSED ON ADULTS. THE EFFECTS OF REGULATORY EFFORTS TO ENHANCE MINORITY PARTICIPATION IN PEDIATRIC CLINICAL TRIALS REMAIN UNDERSTUDIED. CLINICAL TRIALS INVOLVING CHILDREN FACE UNIQUE CHALLENGES, INCLUDING THE COMPLEXITIES OF PARENTAL INVOLVEMENT AND THE ADAPTATIONS REQUIRED IN RESEARCH PROCEDURES AND SETTINGS TO ACCOMMODATE CHILDREN'S PHYSICAL, COGNITIVE, AND EMOTIONAL DEVELOPMENT. THE LACK OF AVAILABLE INFORMATION DOCUMENTING SUCH DISPARITIES COMPROMISES OUR ABILITY TO MONITOR AND ADDRESS THIS ISSUE. THE SPECIFIC AIMS OF THIS PROPOSAL ARE: (1) TO QUANTIFY THE REPRESENTATION OF MINORITY CHILDREN IN CLINICAL TRIALS CONDUCTED IN THE US (YEARS 2008 TO 2021); AND (2) TO IDENTIFY FACILITATORS AND BARRIERS TO MINORITY PARTICIPATION IN PEDIATRIC TRIALS, WITH AN EMPHASIS ON FACTORS THAT ARE POTENTIALLY MODIFIABLE BY TRIAL INVESTIGATORS AND SPONSORS, INCLUDING TRIAL DESIGN-RELATED AND INSTITUTIONAL-LEVEL FACTORS. THE STUDY FOCUSES ON CLINICAL TRIALS RELATED TO DISEASES LINKED TO EXCESS MORBIDITY AND MORTALITY IN MINORITY CHILDREN IN THE US, INCLUDING DIABETES, ASTHMA, PRETERM BIRTH, AND COVID-19. WHILE PRIOR RESEARCH EXAMINING TRENDS IN TRIAL ENROLLMENT TYPICALLY SURVEYED ONLY SELECT JOURNALS, THE PROPOSED WORK WILL LEVERAGE CLINICALTRIALS.GOV – A NATIONAL TRIAL REGISTRY – AS AN INNOVATIVE APPROACH TO RAPIDLY ASSESS THE STATE OF DISPARITIES IN PEDIATRIC RESEARCH AND TO IDENTIFY POTENTIAL TRIAL DESIGN-RELATED FACTORS CONTRIBUTING TO DISPARITIES. TO ENABLE INVESTIGATION OF INSTITUTIONAL FACTORS CONTRIBUTING TO DISPARITIES IN PEDIATRIC TRIALS, METHODS WILL BE DEVELOPED TO LINK CLINICALTRIALS.GOV WITH OTHER NATIONAL DATABASES TO CHARACTERIZE THE INSTITUTIONS CONDUCTING THE TRIALS (E.G. INSTITUTION TYPE, DIVERSITY OF MEDICAL FACULTY). THE PROPOSED STUDY IS SIGNIFICANT BECAUSE QUANTIFYING DISPARITIES IN TRIAL ENROLLMENT FOR SPECIFIC PEDIATRIC DOMAINS IS A FIRST STEP TO IDENTIFYING GAPS AND BEGINNING TO DESIGN OF EVIDENCE-BASED SOLUTIONS. BECAUSE THE BODY OF CLINICAL TRIALS IS CONSTANTLY EVOLVING, THIS WORK WILL PROVIDE NOT ONLY A SNAPSHOT OF CURRENT PEDIATRIC TRIALS, BUT ALSO A FRAMEWORK AND TOOLKIT FOR SURVEILLANCE GOING FORWARD.

POPULATION-LEVEL EFFECTS OF INCREASING PREP UPTAKE ON HIV AND BACTERIAL STIS

THE HOME MYCOBIOME AND CHILDHOOD ASTHMA

NONPAYMENT FOR PREVENTABLE COMPLICATIONS: IMPACT ON HOSPITAL PRACTICES AND HEALTH

IMPROVING ANTIBIOTIC TREATMENT DECISIONS THROUGH MACHINE LEARNING - PROJECT SUMMARY / ABSTRACT INFECTIONS FROM ANTIBIOTIC RESISTANT BACTERIA REPRESENT ONE OF THE BIGGEST CHALLENGES FACING MODERN MEDICAL CARE. SUBOPTIMAL ANTIBIOTIC USE IS ONE OF THE MAJOR DRIVERS FOR ANTIBIOTIC RESISTANCE, HOWEVER CLINICIANS LACK ROBUST TOOLS TO HELP THEM MAKE RATIONAL TREATMENT DECISIONS AT THE PATIENT-LEVEL. THE GOAL OF THIS 3-YEAR MENTORED CLINICAL SCIENTIST RESEARCH CAREER DEVELOPMENT PROGRAM IS TO APPLY STATE-OF-THE-ART MACHINE LEARNING MODELS TO ROUTINELY COLLECTED DATA IN THE ELECTRONIC HEALTH RECORD TO PREDICT THE RISK OF ANTIMICROBIAL RESISTANCE (AMR) PRIOR TO, AND AFTER ANTIBIOTIC TREATMENT. THE CANDIDATE, DR. SANJAT KANJILAL, HAS IDENTIFIED TWO IMPORTANT CLINICAL PROBLEMS WHERE IMPROVED RISK PREDICTION FOR AMR COULD HAVE A SIGNIFICANT IMPACT ON QUALITY OF CARE. THE FIRST IS THE OVERUSE OF BROAD-SPECTRUM ANTIBIOTICS IN PATIENTS PRESENTING WITH COMMUNITY-ONSET SEPSIS. TO ADDRESS THIS, THE CANDIDATE WILL DEVELOP A SET OF MACHINE LEARNING PREDICTION MODELS TRAINED ON ROUTINELY COLLECTED DATA IN THE ELECTRONIC HEALTH RECORD TO HELP CLINICIANS IDENTIFY WHICH ANTIBIOTIC(S) WILL EFFECTIVELY TREAT THE PATIENT'S PATHOGEN WHILE BEING OF THE NARROWEST POSSIBLE SPECTRUM. THE SECOND PROBLEM IS THE INABILITY TO ASSESS THE RISK OF A PATIENT DEVELOPING AN ANTIBIOTIC RESISTANT INFECTION AFTER BEING TREATED WITH AN ANTIBIOTIC. THE CANDIDATE PROPOSES TO BUILD A ROBUST CAUSAL INFERENCE MODEL USING TARGETED MAXIMUM LIKELIHOOD ESTIMATION COMBINED WITH MACHINE LEARNING TO ESTIMATE THE IMPACT OF TAKING VARIOUS COMMONLY USED OUTPATIENT ANTIBIOTICS ON THE RISK OF DEVELOPING A DRUG RESISTANT INFECTION IN THE 12 MONTH PERIOD AFTER TREATMENT. THE RESULTS OF THIS WORK WILL FORM THE BASIS OF A PRECISION MEDICINE APPROACH TO ANTIBIOTIC STEWARDSHIP AND TREATMENT. THE CANDIDATE IS A PRACTICING INFECTIOUS DISEASES CLINICIAN AND THE ASSOCIATE MEDICAL DIRECTOR OF THE CLINICAL MICROBIOLOGY LABORATORY AT THE BRIGHAM & WOMEN'S HOSPITAL. HE HAS PRIOR EXPERIENCE IN BUILDING MACHINE LEARNING ALGORITHMS THAT PROVIDE ROBUST ANTIMICROBIAL STEWARDSHIP. HIS UNIQUE BACKGROUND COMBINED WITH THE RICH SUPPORTING ENVIRONMENT OF THE DEPARTMENT OF POPULATION MEDICINE AT HARVARD MEDICAL SCHOOL AND HARVARD PILGRIM HEALTH CARE INSTITUTE, POSITION HIM WELL FOR THE TRANSITION TO BECOMING AN INDEPENDENTLY FUNDED CLINICIAN- SCIENTIST WORKING AT THE INTERFACE OF INFECTIOUS DISEASES AND MACHINE LEARNING. HE HAS ASSEMBLED A MULTIDISCIPLINARY MENTORSHIP TEAM CONSISTING OF EXPERTS IN SEPSIS EPIDEMIOLOGY, ANTIMICROBIAL STEWARDSHIP, IMPLEMENTATION SCIENCE, MACHINE LEARNING AND CAUSAL INFERENCE TO HELP HIM ACHIEVE HIS GOALS AND HAS IDENTIFIED A COMPREHENSIVE TRAINING PLAN THAT PROVIDES HIM THE SKILLS NECESSARY TO BECOME A LEADER IN HIS FIELD. HIS SHORT TERM GOAL IS TO BECOME AN EXPERT IN THE DEVELOPMENT OF MACHINE LEARNING ALGORITHMS THAT IMPROVE DECISION MAKING FOR ANTIBIOTIC RESISTANT INFECTIONS. HIS MEDIUM TERM GOAL IS TO DEPLOY THESE MODELS AT SCALE AND EVALUATE THEIR REAL-WORLD UTILITY WITH RANDOMIZED TRIALS. THE CANDIDATE'S LONG TERM GOAL IS TO USE THESE ALGORITHMS AND THE INFRASTRUCTURE NECESSARY TO MAINTAIN THEM AS THE TECHNOLOGIC BASIS, OF A LEARNING HEALTH SYSTEM THAT PROVIDES PERSONALIZED DECISION SUPPORT AT THE PROVIDER AND PUBLIC HEALTH LEVEL.

OBJECTIVE EVALUATION OF VARIATION IN SEPSIS INCIDENCE, MORTALITY, AND CARE

TAILORING DELIVERY OF LONGACTING PREP FOR CISGENDER (MSM) WHO USE METHAMPHETAMINE - PROJECT SUMMARY/ABSTRACT METHAMPHETAMINE (MA) USE AND RELATED MORBIDITY AND MORTALITY ARE RAPIDLY INCREASING IN THE UNITED STATES. MA USE DISPROPORTIONATELY IMPACTS CISGENDER MEN WHO HAVE SEX WITH MEN (MSM) AND IS STRONGLY ASSOCIATED WITH INCREASED RISK FOR HIV ACQUISITION. MA USE IS ALSO ASSOCIATED WITH SUBOPTIMAL PRE-EXPOSURE PROPHYLAXIS (PREP) ADHERENCE, DIMINISHING THE BENEFIT OF DAILY, ORAL PREP FOR HIV PREVENTION AMONG MSM WHO USE MA. LONG- ACTING (LA) PREP IS A PROMISING PREVENTION STRATEGY FOR MSM WHO USE MA, SINCE ITS EFFECTIVENESS DOES NOT RELY ON DAILY MEDICATION ADHERENCE. IN DECEMBER 2021, LONG ACTING CABOTEGRAVIR (CAB LA) PREP RECEIVED FDA APPROVAL, AFTER IT WAS FOUND TO BE SUPERIOR TO DAILY, ORAL TRUVADA. THERE ARE OTHER LA PREP AGENTS IN EARLIER STAGES OF DEVELOPMENT, INCLUDING BIANNUAL INJECTIONS AND SUBDERMAL IMPLANTS. TO HELP ENSURE THAT POPULATIONS AT HIGHEST RISK FOR HIV EFFECTIVELY ENGAGE IN LA PREP PROGRAMS, WE WILL ASSESS INTEREST IN DIFFERENT LA PREP FORMULATIONS, AND FACILITATORS, BARRIERS, AND PREFERENCES FOR DELIVERY OF CAB LA PREP AMONG MSM WHO USE MA. WE WILL ASSESS THE LEVEL OF INTEREST AND CORRELATES OF INTEREST IN DIFFERENT LA PREP FORMULATIONS AMONG MSM WHO USE MA VIA THE 2023 NATIONAL HIV BEHAVIORAL SURVEILLANCE (NHBS) SURVEY AT FIVE OF THE WESTERN US SITES (SAN FRANCISCO AND SAN DIEGO, CA; PORTLAND, OR; SEATTLE, WA; AND DENVER, CO) (AIM 1). WE WILL EXPLORE MULTILEVEL (I.E., ON THE PATIENT, PROVIDER, AND SYSTEM LEVEL) BARRIERS TO AND FACILITATORS OF LA PREP USE AND IMPORTANT ATTRIBUTES OF CAB LA PREP DELIVERY THROUGH IN-DEPTH INTERVIEWS (AIM 2). WE WILL INTERVIEW UP TO 40 HIV-NEGATIVE MSM WHO USE MA (UP TO 20 WHO HAVE NEVER TAKEN PREP AND 20 WHO HAVE) AND UP TO 20 KEY INFORMANTS (E.G., CLINICIANS, SERVICE PROVIDERS). WE WILL IDENTIFY IMPORTANT ATTRIBUTES AND LEVELS FOR LA PREP DELIVERY ACROSS INTERVIEWS TO INFORM A SUBSEQUENT DISCRETE CHOICE EXPERIMENT (DCE). PRIOR TO THE DCE WE WILL CONDUCT 10 COGNITIVE INTERVIEWS TO ENSURE THAT THE DCE INPUTS ACCURATELY CAPTURE THE PERSPECTIVES SHARED DURING THE INITIAL INTERVIEWS. WE WILL THEN CONDUCT A DCE (AIM 3) TO IDENTIFY PREFERENCES FOR CAB LA PREP DELIVERY AMONG MSM WHO USE MA USING THE FINAL ATTRIBUTES AND LEVELS FROM AIM 2. OUR FINDINGS WILL INFORM ENGAGEMENT OF MSM WHO USE MA IN LA PREP PROGRAMS AND THE DEVELOPMENT OF AN INTERVENTION THAT WILL BE EVALUATED IN A FUTURE TRIAL.

UNIFIED APPROACHES FOR MISSING DATA IN OBSERVATIONAL STUDIES

LONG-TERM IMPACT OF REDUCED PATIENT OUT-OF-POCKET COSTS ON DIABETES COMPLICATIONS

NOVEL CAUSAL INFERENCE METHODS TO INFORM CLINICAL DECISION ON WHEN TO DISCONTINUE SYMPTOMATIC TREATMENT FOR PATIENTS WITH DEMENTIA - PROJECT SUMMARY/ABSTRACT APPROPRIATE USE OF ACETYLCHOLINESTERASE (ACHEIS) AND MEMANTINE CAN MEANINGFULLY IMPROVE THE HEALTH OUTCOMES AND QUALITY OF LIFE AMONG PEOPLE WITH ALZHEIMER’S DISEASE-RELATED DEMENTIA (ADRD). DEPRESCRIBING OF THESE SYMPTOMATIC MEDICATIONS CAN HELP MITIGATE MEDICATION BURDEN AND ASSOCIATED ADVERSE EVENTS IN THIS POPULATION, PARTICULARLY GIVEN THE HIGH LEVEL OF MULTIMORBIDITY AND PILL BURDEN. HOWEVER, NO CURRENT US GUIDELINE EXISTS ON DEPRESCRIBING OF THESE MEDICATIONS IN ADRD. EXISTING NON-US GUIDELINE RECOMMENDATIONS ARE LARGELY CONSENSUS-BASED AND SHOULD BE STRENGTHENED THROUGH HIGHER LEVELS OF EVIDENCE. TWO PIVOTAL QUESTIONS NEED TO BE ANSWERED FIRST: 1) WHAT IS THE LONG-TERM EFFECT OF SYMPTOMATIC DEMENTIA MEDICATIONS? AND 2) WHEN IS SUITABLE TO DISCONTINUE THESE MEDICATIONS? IDEALLY, ANSWERS TO THESE QUESTIONS WOULD COME FROM RANDOMIZED CONTROLLED TRIALS, BUT CONDUCTING TRIALS EVALUATING MULTIPLE TREATMENT DURATION OR DISCONTINUATION STRATEGIES SIMULTANEOUSLY WITH LARGE ENOUGH SAMPLE SIZES IN EACH ARM WOULD BE COST-PROHIBITIVE. OBSERVATIONAL DATA FROM DEMENTIA MEDICATION USE IN THE REAL-WORLD SETTING PROVIDES A UNIQUE OPPORTUNITY. HOWEVER, TREATMENT DURATION OR DISCONTINUATION STRATEGIES NECESSARILY INVOLVE INTERVENTIONS ON TIME-VARYING TREATMENT DECISIONS. EVALUATING THE TIME-VARYING MEDICATION USE ON HEALTH AND PATIENT-CENTERED OUTCOMES MUST APPROPRIATELY CONTROL FOR COMPLEX TIME-VARYING CONFOUNDING THAT RENDERS CONVENTIONAL REGRESSION INVALID. NOVEL CAUSAL INFERENCE METHODS, INCLUDING ROBINS’ G-FORMULA AND A THREE-STEP WEIGHTING APPROACH (CLONING, CENSORING, WEIGHTING) CAN APPROPRIATELY ACCOUNT FOR SUCH TIME-VARYING CONFOUNDING AND GENERATE ESTIMATES OF ABSOLUTE RISKS WHILE PREVENTING IMMORTAL TIME BIAS. BY EMULATING THE VALID ANALYSES OF TRIALS, CAUSAL ANALYSES OF OBSERVATIONAL DATA ARE ALSO COST-EFFICIENT AND HAVE GREATER GENERALIZABILITY. USING DATA COLLECTED IN A LARGE SURVEY LINKED WITH ELECTRONIC HEALTH DATABASES, WE WILL CHARACTERIZE THE UTILIZATION PATTERN OF SYMPTOMATIC DEMENTIA MEDICATIONS AND EXAMINE FACTORS THAT INFLUENCED TREATMENT DISCONTINUATION (AIM 1). WE WILL THEN USE NOVEL CAUSAL INFERENCE METHODS TO ESTIMATE THE LONG-TERM EFFECT OF CONTINUOUS TREATMENT (AIM 2), AND TO EVALUATE DIFFERENT TREATMENT DISCONTINUATION STRATEGIES (AIM 3) WITH REGARD TO INCIDENCE OF CLINICAL AND PATIENT-CENTERED OUTCOMES AND HEALTH SERVICE UTILIZATION. WE WILL USE DATA FROM THE HEALTH AND RETIREMENT STUDY (HRS)-MEDICARE LINKED DATASET. THE NATIONALLY REPRESENTATIVE, LONGITUDINAL, NIA-FUNDED HRS SURVEY PROVIDES VALIDATED MEASURES ON COGNITIVE IMPAIRMENT AND DEMENTIA. THE LINKAGE TO MEDICARE PROVIDES EXTENSIVE INFORMATION ON MEDICATION, CLINICAL CHARACTERISTICS, AND HEALTH CARE UTILIZATION. THE EXPECTED OUTCOME OF THIS STUDY IS AN UNDERSTANDING OF THE EFFECTS OF LONG-TERM USE OF DEMENTIA MEDICATIONS AND THE IMPACT OF DIFFERENT TREATMENT DISCONTINUATION STRATEGIES ON OUTCOMES. THE FINDINGS OF THIS STUDY WILL PROVIDE A SCIENTIFIC BASIS FOR THE DEVELOPMENT OF EVIDENCE-BASED GUIDELINES AND THE PLANNING OF CLINICAL TRIALS IN THE DEPRESCRIBING OF SYMPTOMATIC DEMENTIA MEDICATIONS IN PEOPLE WITH ADRD TO IMPROVE THEIR CARE.

ASSOCIATIONS BETWEEN STRUCTURAL STIGMA AND ALCOHOL USE AMONG SEXUAL MINORITY WOMEN AND THEIR OFFSPRING - PROJECT SUMMARY SEXUAL MINORITY WOMEN (SMW) ARE TWICE AS LIKELY TO REPORT RISKY DRINKING BEHAVIORS AS HETEROSEXUAL WOMEN. ONE CAUSE OF THIS DISPARITY IS STRUCTURAL STIGMA, WHICH REFERS TO CONTEXTUAL-LEVEL CONDITIONS, NORMS, AND POLICIES THAT CONSTRAIN OPPORTUNITIES, RESOURCES, AND WELL-BEING. [STRUCTURAL STIGMA ALSO HAS INTERGENERATIONAL IMPACTS, EVIDENCED BY ITS ADVERSE EFFECTS AMONG CHILDREN AND INFANTS ACROSS MARGINALIZED GROUPS. HOWEVER, LITTLE IS KNOWN ABOUT WHEN STRUCTURAL STIGMA IS MOST HARMFUL ACROSS THE LIFECOURSE FOR SMW AND THE EXTENT TO WHICH INTERGENERATIONAL EFFECTS IMPACT OFFSPRING HEALTH BEHAVIORS. FURTHER, THE MECHANISMS OF THESE INTERGENERA- TIONAL EFFECTS ARE UNDEREXPLORED, AS ARE THE MODERATING RISK AND RESILIENCY FACTORS. THESE KNOWLEDGE GAPS CON- TRIBUTE TO PERPETUATING ALCOHOL-RELATED HEALTH DISPARITIES AND LIMIT OUR UNDERSTANDING OF WHAT FACTORS MAY RE- DUCE RISK AMONG SMW AND THEIR CHILDREN.] IT HAS NOT BEEN PREVIOUSLY POSSIBLE TO EXAMINE THESE ASSOCIATIONS BECAUSE DOING SO REQUIRES A UNIQUE DATA STRUCTURE WITH: 1) A LARGE NUMBER OF SMW LIVING IN DIFFERENT PLACES AND MEASURED OVER THEIR LIFECOURSE; 2) LONGITUDINAL STRUCTURAL STIGMA MEASURES, WHICH ARE VERY LIMITED PRIOR TO THE 1990S; AND 3) ALCOHOL MEASURES AMONG BOTH PARENTS AND OFFSPRING. THIS MENTORED RESEARCH PROPOSAL WILL PRO- VIDE THE FIRST OPPORTUNITY TO ADDRESS THESE QUESTIONS BY PAIRING TRAINING IN STRUCTURAL STIGMA MEASUREMENT OVER TIME USING NATURAL LANGUAGE PROCESSING (NLP) WITH DATA FROM TWO UNIQUE, INTERGENERATIONAL COHORT STUDIES: THE NURSES’ HEALTH STUDY 2 (N=116,429), AND THEIR OFFSPRING IN THE LINKED GROWING UP TODAY STUDY (N=27,704). [BY LEVERAGING NLP ON A CORPUS OF >9,000 UNIQUE, DIGITIZED NEWSPAPERS FROM ALL 50 US STATES DURING THE LIFECOURSE OF RESPONDENTS IN THE NURSES’ HEALTH STUDY 2 (75 YEARS), I WILL DEVELOP AND EXTENSIVELY VALIDATE A TIME-VARYING MEASURE OF STRUCTURAL STIGMA RELATED TO SEXUAL ORIENTATION (AIM 1). I WILL THEN ELUCIDATE THE ASSOCI- ATION BETWEEN STRUCTURAL STIGMA AND ALCOHOL USE ACROSS THE LIFECOURSE AMONG SMW (AIM 2) AND THEIR OFFSPRING (AIM 3) AND EXAMINE INTERVENABLE, MODIFIABLE CHARACTERISTICS MODERATE THE EFFECTS OF STRUCTURAL STIGMA. AD- VANCED TRAINING IN NLP AND LIFECOURSE EPIDEMIOLOGY WILL PROVIDE THE NECESSARY TOOLS TO DEVELOP A NOVEL STRUC- TURAL STIGMA MEASURE AND TEST ITS RELATIONSHIP WITH ALCOHOL CONSUMPTION AMONG SMW AND THEIR OFFSPRING ACROSS THE LIFECOURSE, REPRESENTING A CRITICAL NEXT STEP FOR UNDERSTANDING AND DECREASING ALCOHOL-RELATED HEALTH INEQUALITIES. THIS AWARD WILL SUPPORT ESSENTIAL CAREER DEVELOPMENT IN MY PATH TOWARD INDEPENDENCE AS AN ALCO- HOL AND STIGMA RESEARCHER AND IS HIGHLY CONSISTENT WITH NIAAA’S PRIORITIES FOR UNDERSTANDING THE SOCIAL CON- TEXTS OF DRINKING BEHAVIOR IN MINORITIZED POPULATIONS. THE PROPOSED STUDIES ARE THE ESSENTIAL NEXT STEP TOWARDS IDENTIFYING MODIFIABLE TARGETS FOR PROTECTING AGAINST THE IMPACT OF STIGMA ON RISKY DRINKING AND LAYING THE FOUN- DATION FOR SIMILAR RESEARCH IN OTHER STIGMATIZED, HIGH-RISK POPULATIONS. THIS WORK REPRESENTS AN INNOVATIVE AP- PROACH TO UNDERSTAND THE REVERBERATING IMPACT OF STRUCTURAL STIGMA NOT ONLY ON THOSE WHO ARE STIGMATIZED BUT ALSO ACROSS GENERATIONS.]

PARENT-PERCEIVED IMPORTANT TOPICS FOR CHILDHOOD OBESITY (PPITCH) - PROJECT ABSTRACT IT IS RECOMMENDED THAT OBESITY COUNSELING HAPPEN DURING PEDIATRIC PRIMARY CARE VISITS, BUT IT IS OFTEN INFEASIBLE TO ADDRESS ALL RECOMMENDED HEALTH AND WELLNESS TOPICS (E.G. ASSESSMENT OF NUTRITION AND PHYSICAL ACTIVITY HABITS, MOTIVATIONAL INTERVIEWING, SETTING GOALS) IN THE CONTEXT OF A 20-MINUTE WELL CHILD VISIT. MOREOVER, BRIEF COUNSELING IS UNLIKELY TO ENGAGE HIGH-RISK FAMILIES WHO ARE PARTICULARLY UNLIKELY TO ENGAGE IN BEHAVIOR CHANGE DUE TO CULTURAL NORMS, LOW HEALTH LITERACY, AND COMPETING CAREGIVING PRIORITIES. BEST-WORST SCALING (BWS) IS A STRUCTURED, SURVEY-BASED APPROACH THAT HAS BEEN USED TO EFFICIENTLY QUANTIFY PATIENT PREFERENCES AND PRIORITIES REGARDING HEALTHCARE DECISIONS WHILE AVOIDING EXTREME RESPONSE AND SOCIAL DESIRABILITY BIASES. IN THIS STUDY, WE PROPOSE DEVELOPING AND FIELDING A BEST-WORST SCALING SURVEY TO IDENTIFY AND PRIORITIZE THE CHARACTERISTICS OF OBESITY THAT PARENTS CARE MOST ABOUT. WE CAN THEREFORE WEED OUT LOWER PRIORITY ISSUES THAT WOULD NOT INFLUENCE A DECISION FROM HEALTH COMMUNICATION MESSAGING. WE HYPOTHESIZE THAT FOCUSING RISK COMMUNICATION ON THE SPECIFIC OBESITY-RELATED ISSUES THAT ARE IMPORTANT TO PARENTS MAY CATALYZE MORE PARENTS OF CHILDREN WITH OBESITY TO ENGAGE IN BEHAVIOR CHANGE TO ADDRESS THEIR CHILD’S WEIGHT STATUS AND WHEN INDICATED, TO ENGAGE IN CHILDHOOD OBESITY TREATMENT PROGRAMS.

IMPROVING PRIMARY CARE TO PREVENT CHILDHOOD OBESITY

SEXUAL ORIENTATION-RELATED DISPARITIES IN UNINTENDED PREGNANCIES BY STATE-LEVEL POLICY AND STRUCTURAL CONTEXTS - PROJECT SUMMARY/ABSTRACT SEXUAL MINORITY WOMEN (SMW; E.G., THOSE WITH SAME-SEX PARTNERS OR ATTRACTIONS, OR IDENTIFY AS LESBIAN, GAY, OR BISEXUAL) ARE SUBJECTED TO STIGMA AND DISCRIMINATION. THEY ALSO DISPROPORTIONATELY EXPERIENCE POVERTY, SEXUAL VIOLENCE, AND LIMITED ACCESS TO HIGH-QUALITY REPRODUCTIVE HEALTHCARE (INCLUDING FAMILY PLANNING SERVICES). AS A RESULT, SMW MAY HAVE HIGHER RATES OF UNINTENDED PREGNANCIES THAN THEIR HETEROSEXUAL PEERS. PARTICULAR SUB- GROUPS OF SMW MAY SUFFER FROM GREATER DISPARITIES. FIRST, SMW WHO ARE RACIAL/ETHNIC MINORITIES MAY EXPERI- ENCE GREATER DISPARITIES THAN WHITE SMW DUE TO THEIR MULTIPLE MARGINALIZATION. SECOND, SMW WHO LIVE IN STATES WITH RESTRICTIVE POLICIES—INCLUDING THOSE RELATED TO REPRODUCTIVE HEALTH (E.G., ABORTION/CONTRACEPTION) OR DISCRIMI- NATION (REFLECTIVE OF SEXISM/HETEROSEXISM)—MAY EXPERIENCE GREATER DISPARITIES DUE TO HAVING LESS ACCESS TO REPRODUCTIVE HEALTHCARE AND GREATER EXPOSURE TO DISCRIMINATION. FURTHERMORE, AS ACCESS TO ABORTION IS RE- STRICTED, ESPECIALLY POST-DOBBS, MORE UNINTENDED PREGNANCIES WILL BE CARRIED TO TERM, AND THUS, INCREASING RISK FOR ADVERSE PERINATAL OUTCOMES. HOWEVER, WE DO NOT KNOW THE EXTENT TO WHICH STATE-LEVEL REPRODUCTIVE HEALTH AND DISCRIMINATORY POLICIES IMPACT SMW, PARTICULARLY THOSE WHO ARE RACIAL/ETHNIC MINORITIES. THIS PROJECT WILL USE LONGITUDINAL DATA FROM THE GROWING UP TODAY STUDY (N=15,044) AND NURSES’ HEALTH STUDY 3 (N>51,094, OPEN COHORT) TO INVESTIGATE THE SEXUAL ORIENTATION-RELATED DISPARITIES IN UNINTENDED PREGNANCIES AND RESULTING ADVERSE PERINATAL OUTCOMES (AIM 1) AND QUANTIFY THE INTERSECTIONAL DISPARITIES IN THESE OUTCOMES AMONG THOSE DOUBLY MINORITIZED BY SEXUAL ORIENTATION AND RACE/ETHNICITY (AIM 2). I WILL ALSO DETERMINE THE EXTENT TO WHICH STATE-LEVEL REPRODUCTIVE HEALTH (ABORTION/CONTRACEPTION) AND DISCRIMINATORY (SEXIST/HETEROSEXIST) POLICIES MODIFY THESE DIS- PARITIES, AND THE EXTENT TO WHICH INDIVIDUAL-LEVEL EXPERIENCES OF VIOLENCE AND DISCRIMINATION AMELIORATE OR EXAC- ERBATE POLICY IMPACTS (AIM 3). THIS WORK IS TIMELY AS REPRODUCTIVE HEALTH POLICIES HAVE BECOME MORE POLARIZED SINCE THE DOBBS DECISION, AND DISCRIMINATORY POLICIES IMPACTING SMW HAVE DRAMATICALLY INCREASED. THIS WORK IS ALSO INNOVATIVE BECAUSE THE GEOGRAPHIC SPREAD OF PARTICIPANTS AND ~30 YEARS OF ONGOING FOLLOW-UP WILL ALLOW ME TO EXAMINE IMPACTS OF POLICY CHANGES OVER A LONG TIME PERIOD, HOW CHANGES IN SEXUAL ORIENTATION IDENTITY IMPACTS CHANGES IN DISPARITIES, AND HOW MOVING TO MORE OR LESS RESTRICTIVE STATES IMPACTS UNINTENDED PREGNAN- CIES AMONG SMW. THIS AWARD ALIGNS WITH NICHD’S SCIENTIFIC PRIORITY TO UNDERSTAND THE IMPACTS OF REPRODUCTIVE HEALTH POLICY CHANGES IN AN NIH HEALTH DISPARITIES POPULATION, SMW. I WILL OBTAIN ADVANCED TRAINING IN INTERSEC- TIONALITY AND POLICY SURVEILLANCE METHODS. THIS TRAINING AND RESEARCH WILL BE CRITICAL FOR HELPING ME BUILD AN INDE- PENDENT CAREER IN QUANTIFYING HOW POLICIES AND STRUCTURES AFFECT REPRODUCTIVE HEALTH OUTCOMES AND REPRODUCTIVE AGENCY. THE PROPOSED RESEARCH IS AN ESSENTIAL NEXT STEP TOWARDS (1) IDENTIFYING PARTICULAR HARMFUL POLICIES FOR POLICY CHANGE, (2) ELUCIDATING THE MECHANISMS BY WHICH STATE POLICIES AFFECT UNINTENDED PREGNANCIES AND THEIR OUTCOMES AMONG SMW, AND (3) LAYING THE FOUNDATION FOR SIMILAR RESEARCH IN OTHER STIGMATIZED POPULATIONS.

STRATEGIES FOR GROUP A STREPTOCOCCAL PREVENTION

IMPACT OF UNIVERSAL DECOLONIZATION ON ICU OUTBREAKS, A SECONDARY ANALYSIS OF THE REDUCE MRSA TRIAL

IDENTIFYING TREATMENT-RESISTANT DEPRESSION IN AUTOMATED DATABASES

SATSCAN: SPATIAL SCAN STATISTIC SURVEILLANCE SOFTWARE