[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"social-determinants-of-health-sdoh\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:social-determinants-of-health-sdoh":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,71,119,160,182,210,237,267],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100583120","using-clinical-decision-support-to-provide-social-risk-informed-care-for-opioid-use-disorder-in-the-emergency-department-100583120",false,"NCT06872190","Using Clinical Decision Support to Provide Social Risk-Informed Care for Opioid Use Disorder in the Emergency Department","Inclusion criteria:\n\n* All University of California, San Francisco ED providers (residents, attendings, advanced practice providers) who have used either CDSv1 or CDSv2 will be eligible to participate in surveys and interviews regarding feasibility and acceptability.\n* English-speaking patients ≥18 years of age presenting to the UCSF ED with opioid use disorder who receive medication treatment (as a result of CDSv1 or CDSv2) will be eligible to participate.\n\nExclusion criteria:\n\n\\- Participants will be excluded if:\n\n* they have a medical or psychiatric condition requiring hospitalization at the index ED visit,\n* are actively suicidal, are cognitively impaired,\n* present from an extended care facility, or\n* require opioids for a pain condition.","ALL","18 Years",{"count":18,"type":19},300,"ESTIMATED","INTERVENTIONAL",[22],"NA","The overarching goal of this proposal is to integrate patient social risk information into an existing electronic health record (EHR)-based clinical decision support (CDS) tool (CDSv1) to facilitate emergency department (ED)-initiated, social risk-informed opioid use disorder (OUD) medication treatment and ultimately improve treatment adherence and follow up. The investigators will evaluate the feasibility and acceptability of the social care-enhanced CDS tool, CDSv2, (compared to CDSv1) at a single study site (UCSF) as an intervention to increase medication treatment adherence and follow up for adult ED patients experiencing opioid use disorder using a mixed-methods, before-after approach.",[25,26],"Opioid Use Disorder","Social Determinants of Health (SDOH)",[28,29,30],"social risk-informed care","clinical decision support","opioid use disorder","RECRUITING","2026-06-26",{"date":34,"type":35},"2026-06-29","ACTUAL",{"date":37,"type":35},"2025-04-20",{"date":39,"type":19},"2027-07",{"name":41,"class":42},"University of California, San Francisco","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100582880","re-engineered-discharge-for-diabetes-care-transitions-100582880","NCT06869057","Re-Engineered Discharge for Diabetes Care Transitions","Re-Engineered Discharge for Diabetes Care Transitions: Screening and Addressing Social Determinants of Health Needs at Hospital Discharge","REDDCAT2","Inclusion Criteria:\n\n* adult aged 18 years or older\n* diagnosed with type 2 diabetes\n* hospitalized at Univ of Massachusetts-affiliated hospital\n* endorsed at least 1 unmet social need via screening survey\n\nExclusion Criteria:\n\n* pregnancy\n* discharge to short or long-term nursing facility or hospital\n* medical contraindication\n* cognitive impairment\n* unable to provide informed consent",{"count":53,"type":19},412,[22],"The goal of this project is to test a novel bedside SDOH screening intervention coupled with post-discharge navigation for hospitalized patients with a diabetes diagnosis to reduce unmet social needs, compared to usual care.",[57,26,58],"Diabetes Mellitus Type 2","Hospital Readmission",[60,61,62],"diabetes","social determinants of health","hospital readmission",{"date":64,"type":35},"2026-06-30",{"date":66,"type":35},"2026-06-08",{"date":68,"type":19},"2029-05-30",{"name":70,"class":42},"University of Massachusetts, Worcester",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":79,"minAge":16,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":20,"phases":82,"briefSummary":83,"conditions":84,"keywords":106,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":43},"100586442","personalized-care-for-prenatal-stress-reduction--prevention-of-preterm-birth-ptb-disparities-100586442","NCT06915428","Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities","Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) A Randomized Controlled Trial (RCT) of Personalized Care for Prenatal Stress Reduction and Preterm Birth Disparities Prevention","PTBCARE+","Inclusion Criteria:\n\n1. Viable, singleton pregnancy, 8+0 to 19+6 weeks, dated by last menstrual period ± ultrasound using standard obstetric criteria per American College of Obstetricians and Gynecologists.\n\n   Gestational age at first ultrasound by last menstrual period (LMP) \u002F Ultrasound method \u002F Measurement agreement with LMP required • Up to 8 weeks 6 days \u002F crown rump length \u002F ± 5 days\n   * 9 weeks 0 days to 13 weeks 6 days \u002F crown rump length \u002F ± 7 days\n   * 14 weeks 0 days to 15 weeks 6 days \u002F standard fetal biometry \u002F ± 7 days\n   * 16 weeks 0 days to 19 weeks 6 days \u002F standard fetal biometry \u002F ± 10 days\n   * Gestational dating \u002F fetal viability must be confirmed by ultrasound prior to enrollment \u002F randomization.\n   * Ultrasound report must include documentation of normal fetal heart rate of ≥ 120 beats per minute, or subsequent medical record documentation of auscultation of fetal heart rate ≥ 120 beats per minute.\n   * Viability must be confirmed \u002F re-confirmed within 7 days of randomization.\n\n   If initial consent occurs early in pregnancy and V1\u002Frandomization occur later, viability must be reconfirmed to ensure ongoing eligibility prior to initiating V1 activities (including surveys) and proceeding with randomization.\n2. No signs or symptoms of, or clinical diagnosis of, evolving miscarriage, active preterm labor, preterm prelabor rupture of membranes at the time of enrollment.\n\n   * Cervical dilation at the time of enrollment is an exclusion criterion. However, cervical evaluation and digital cervical exam is not required prior to enrollment.\n\n     (3a) High a priori risk for medically indicated preterm birth - must meet at least one of the following 3 criteria (maternal medical history, prior pregnancy history, or moderate risk factor history)\n   * miPTB criteria #1: Maternal Medical History - any one of the following:\n\n     o Known chronic hypertension requiring medications in the 3 months prior to conception or prior to 22 weeks gestation.\n\n     o At least 2 blood pressure readings 6 hours apart, \\\u003C20 weeks gestation, with systolic ≥ 130 mmHg or diastolic ≥ 80 mmHg \\*regardless of need for medication or formal diagnosis of hypertension in chart\\*\n\n     o Pre-gestational diabetes mellitus.\n     * Diabetes diagnosed \\\u003C20 weeks gestation.\n     * Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:\n\n       \\*biopsy proven chronic renal disease history; and\u002For\n\n       \\*serum creatinine ≥ 1.1 mg\u002FdL at any time during pregnancy prior to enrollment, in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis); and\u002For\n\n       \\*chronic proteinuria, defined as baseline urine protein:creatinine ratio ≥ 0.30 mg\u002FdL or 24 hour total urine protein ≥ 300 mg in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis)\n\n       \\*Systemic Lupus Erythematosus\n       * Antiphospholipid Antibody Syndrome\n   * miPTB criteria #2: Prior pregnancy history - any ONE of the following: o Previous pregnancy complicated by preeclampsia or hypertensive disorders of pregnancy at any gestational age, in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Previous history of stillbirth ≥ 16+0 weeks in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy. The stillbirth etiology must not have been attributed to physical trauma (e.g., domestic violence, motor vehicle accident) or illicit drug use (e.g., cocaine use leading to abruption and stillbirth).\n   * miPTB criteria #3: Any two or more of the following moderate risk factors: o Nulliparity, defined as no prior pregnancy to reach at least 20 weeks gestation note that this is the traditional \u002F classic definition of 'nulliparous' and that there is overlap between nulliparity as defined this way and 'preterm birth' due to cervical insufficiency, which allows for deliveries in the 16-19 week gestational age range to be considered as 'preterm births'\n\n     o Obesity: current or pre-pregnancy body mass index ≥30 kg\u002Fm\\^2\n\n     o Family history: first degree relative with a history of preeclampsia\n\n     o Advanced maternal age: maternal age ≥ 35 years at estimated date of confinement\n\n     o Prior adverse obstetric history - one or more of the following:\n\n     \\- history of low birth weight or small for gestational age baby in a singleton gestation, defined as weight \\\u003C10% for gestational age and fetal sex; the fetus must not have had major structural anomalies or aneuploidy.\n\n     \\- history of adverse pregnancy outcome in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Long interpregnancy interval: ≥ 10 year (3650 day) pregnancy interval, defined as the time (in days) between the date of delivery of the last pregnancy to reach ≥ 20 weeks gestation and the first day of the last menstrual period for the current pregnancy.\n\n     o Black or African-American race (as a proxy for underlying racism) - self-reported. Participants who self-identify as being of more than one racial group will be considered to be of Black race for the purposes of this criterion if one of the racial groups is Black or African-American.\n     * Low socioeconomic status, defined as one or more of the following: housing or food insecurity noted in chart within the last year, self-pay or Medicaid insurance, less than high school education\n\nand\u002For\n\n(3b) High a priori risk for spontaneous preterm birth - must meet at least one of the following 2 criteria (prior pregnancy history or current pregnancy course)\n\n* sPTB criteria #1: Prior pregnancy history\n\n  * EITHER a history of a delivery of a singleton, non-anomalous baby between 16+0 and 34+6 weeks gestation or delivery of a twin, non-anomalous pregnancy between 160 \u002F7and 276 \u002F7 weeks gestation due to spontaneous preterm labor, preterm premature rupture of membranes, cervical insufficiency, or placental abruption - Chart documentation of prior preterm birth, the gestational age of the prior preterm birth (referred to as the 'qualifying delivery') should be determined. If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the greater of the two will be used assuming that neither is the 'source document' (i.e. an ultrasound report with a due date, a c-section report, a delivery note, etc).\n\nUse the following table as a validation of the previous delivery. For example, if the infant was male and weighed more than 2763 grams (6 pounds, 1.5 ounces) then the patient would be ineligible based on history of a preterm birth criteria. This table should only be used to determine whether the qualifying delivery is most likely to be preterm less than 35 weeks gestation when the gestational age CANNOT be verified\u002Fcalculated by review of the medical records or is not available in the medical records.\n\nGestational age 90th percentile - boys 90th percentile - girls 33 weeks \\> 2488g 5 lbs 7.8 oz \\> 2116g 4 lbs 10.6 oz 34 weeks \\> 2763g 6 lbs 1.5 oz \\> 2379g 5 lbs 3.9 oz 35 weeks \\> 3084g 6 lbs 12.8 oz \\> 2661g 5 lbs 13.9 oz\n\n* Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \\\u003C25mm between 16+0 and 23+6 weeks gestation or cervical dilation ≥ 0.5cm requiring cervical cerclage placement prior to 24+0 weeks gestation, even if delivery ultimately occurred ≥ 35 weeks gestation or at term.\n\n  • sPTB criteria #2: Current pregnancy course\n* Asymptomatic cervical shortening \\\u003C25mm in the current pregnancy, diagnosed by transvaginal ultrasound that is performed ≥14+0 weeks gestation, per Registered Diagnostic Medical Sonographer(RDMS) certified Sonographer or physician with transvaginal ultrasound training program (or similar) qualifications\n* Cervical cerclage in situ in the current pregnancy due to concern for risk of preterm birth, at the discretion of the primary obstetric provider\n\n  (4) Ability to provide written, informed consent in English or Spanish\n\n  (5) Planned prenatal care at the University of North Carolina at Chapel Hill obstetrics clinics and planned delivery at the University of North Carolina Women's Hospital (Chapel Hill, NC).\n\nExclusion Criteria:\n\n1. Participation in another intervention based clinical trial during pregnancy that is deemed, at the discretion of the investigative team for the current study or the other concurrent study, to conflict with this research and\u002For confound the study results.\n\n   o There are some concurrent studies, even those designed to test an intervention, which may be compatible with the current study; this will be reviewed by the investigative leadership team on a case-by-case basis.\n2. Previous participation in the PTBCARE+ program in another pregnancy, with randomization to the PTBCARE+ (active intervention) group.\n3. Current, ongoing, illicit drug use ≥ 12 weeks gestation.\n\n   * Use of tobacco and\u002For marijuana products is not an exclusion.\n   * Receiving treatment for opioid use disorder with methadone, suboxone, or similar in an approved treatment program is not an exclusion.\n4. History of radical trachelectomy\n5. Planned voluntary termination of pregnancy.\n6. Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:\n\n   * Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment\n   * Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment\n   * Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment\n7. Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system\n\n   1. Mild renal abnormalities, clubfoot, isolated cleft lip\u002Fpalate, etc. in the fetus are not a reason for exclusion.\n   2. Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion.\n   3. If a major congenital anomaly is diagnosed \\*after\\* enrollment, the patient will continue to participate in the study, however, the investigators will plan to analyze the study results with and without these individuals included.\n8. Positive aneuploidy screening test (traditional biochemical assay, e.g., quad screen - risk of aneuploidy of 1:25 or higher or cell free deoxynucleic acid (DNA) test result that is screen positive for trisomy 13, trisomy 18, trisomy 21, or sex chromosome abnormality) in the absence of definitive fetal karyotype evaluation.\n\n   * Definitive fetal karyotype evaluation can only be obtained through direct testing of the tissue from the conceptus - by chorionic villus sampling or amniocentesis during pregnancy.\n   * The term \"suspected aneuploidy\" is commonly used in the medical record but this is not a diagnosis and by itself is not informative and not an exclusion criteria.\n9. Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.\n\n   * Note that a cystic hygroma remains an exclusion criterion regardless of subsequent diagnostic testing results because fetuses with this history carry an elevated risk of major congenital heart disease.\n   * Fetal echocardiogram is most accurately performed at 22-24 weeks gestation, which is later than the enrollment gestational age window.\n10. Polyhydramnios at or prior to enrollment.\n\n    o Polyhydramnios is defined as a maximum vertical pocket ≥ 8.0 cm, given that polyhydramnios \\\u003C22 weeks has a high likelihood of being associated with congenital anomalies\u002Faneuploidy and\u002For preterm birth due to preterm prelabor rupture of membranes.\n11. For potential participants who meet eligibility criteria ONLY due to prior spontaneous or medically indicated preterm birth: if the prior preterm birth was in a pregnancy complicated by twins, confirmed fetal aneuploidy, or major congenital fetal anomalies in the absence of another pregnancy meeting inclusion criteria they are not eligible.\n12. Known HIV positive with viral load greater than 1,000 copies\u002FmL or cluster of differentiation 4 (CD4) count less than 350\u002Fmm\\^3\n13. Unwillingness to undergo randomization.","FEMALE",{"count":81,"type":19},1228,[22],"The goal of this clinical trial is to learn if a personalized prenatal support program \\[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \\& Beyond, (PTBCARE+)\\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\\[s\\] it aims to answer are:\n\n* Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?\n* Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?\n* Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term?\n\nResearchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term.\n\nParticipants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care.\n\nAll participants will be asked to:\n\n* complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device.\n* complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit.\n\nPeople who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as:\n\n* a stress reduction toolkit;\n* access to an online website that can also be downloaded as a smart phone app;\n* the option to receive an electronic massage while in clinic, and more.\n* additional support gifts provided at routine clinical appointments\n\nPeople who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.",[85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,26,101,102,103,104,105],"Preterm Birth Complication","Preterm Birth","Preterm Birth Recurrence","Preeclampsia","Preeclampsia (PE)","Hypertensive Disorders of Pregnancy","Support Program","Stress","Resilience, Psychological","Empowerment, Patient","Emotional Stress","Pregnancy","Pregnancy Complications","Pregnancy Induced Hypertension","Neonates and Preterm Infants","Cervical Insufficiency","Cervical Shortening","Disparities in Pregnancy Complications","Disparities","Prenatal Care","Care Coordination",[77,107,108,109],"pregnancy-related disparities","patient support program","enhanced prenatal care","NOT_YET_RECRUITING","2026-06-25",{"date":34,"type":35},{"date":114,"type":19},"2026-08-01",{"date":116,"type":19},"2029-01",{"name":118,"class":42},"University of North Carolina, Chapel Hill",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":20,"phases":129,"briefSummary":130,"conditions":131,"keywords":138,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":43},"100576849","pathways-to-perinatal-mental-health-equity-100576849","NCT06790641","Pathways to Perinatal Mental Health Equity","Pathways","Inclusion Criteria for perinatal care setting team members:\n\n* Be employed by a participating perinatal care setting in a clinical role (including as an obstetrician-gynecologist, midwife, nurse practitioner, a nurse, a navigator, or administrative staff member who implemented the respective intervention during the study period).\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English\n\nInclusion Criteria for peer mentors:\n\n* Have completed PSI training to be a peer mentor\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English\n\nInclusion Criteria for perinatal individuals:\n\n* Have received perinatal care at a study partnering perinatal care setting during the study period\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English or Spanish\n\nExclusion Criteria:\n\nAn individual who does not meet the inclusion criteria listed above will be excluded from participation in this study. There are no additional exclusion criteria.","70 Years",{"count":128,"type":19},1270,[22],"Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, \"Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?\" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.",[132,133,26,134,135,136,137],"Perinatal Anxiety","Perinatal Depression","Peer Support","Obstetric Care","Substance Use Disorder (SUD)","Perinatal Depression, Substance Use",[139,140,141,142,143,144,145,146,147,148,149,150,151],"implementation strategies","obstetric care","perinatal mental health","perinatal anxiety","perinatal depression","perinatal mood disorders","qualitative study","focus groups","mixed methods","perinatal care","peer mentors","peer support","healthcare-community partnership","2026-04-14",{"date":154,"type":35},"2026-04-20",{"date":156,"type":35},"2025-12-05",{"date":158,"type":19},"2030-10-01",{"name":70,"class":42},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":166,"sex":15,"minAge":16,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":20,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":43},"100586259","the-development-implementation-and-evaluation-of-a-social-engagement-support-system-100586259","NCT06913049","The Development, Implementation, and Evaluation of a Social Engagement Support System","Inclusion Criteria:\n\n* Members of partner health plan aged 18-64\n\nExclusion Criteria:\n\n\\-",true,"64 Years",{"count":169,"type":19},249660,[22],"The goal of this clinical trial is to determine if artificial intelligence and machine learning (AI\u002FML) models can help address social needs in Medicaid enrollees. The main questions it aims to answer are:\n\nCan AI\u002FML models accurately identify social needs from administrative healthcare data?\n\nCan AI\u002FML models accurately predict which people will engage with social supports?\n\nResearchers will compare individuals who live in different regions to see if AI\u002FML models perform better than the status quo.",[26],"2026-04-01",{"date":175,"type":35},"2026-04-07",{"date":177,"type":19},"2026-06",{"date":179,"type":19},"2029-04",{"name":181,"class":42},"University of Maryland, Baltimore County",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":79,"minAge":4,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":20,"phases":192,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100627264","rhode-island-community-based-maternal-support-services-100627264","NCT07446374","Rhode Island Community-based Maternal Support Services","Rhode Island Community-based Maternal Support Services (RI COMSS) Bundle for Advancing Perinatal Health Equity","RICOMSS","Inclusion Criteria:\n\n* All birthing people receiving perinatal care (prenatal, postpartum) at Women and Infants Hospital (WIH) and its affiliated clinics\n\nExclusion Criteria:\n\n* Anyone not meeting the above criteria",{"count":191,"type":19},3000,[22],"The purpose of this project is to improve perinatal health outcomes in Rhode Island by bringing together the hospital, community health workers (CHWs), doulas, and community-based organizations to build a service delivery model that addresses care coordination and social determinants of health (SDOH) as a part of a concerted effort towards achieving equitable perinatal health outcomes. Over 4 years, the hospital-led project team will implement the community-based maternal support services (COMSS) bundle in 6 affiliated clinics, including care coordination, doula care, and referrals and linkages to community-based organizations that address key SDOH (food, housing, transportation). Maternal and infant health outcomes will be compared pre and post program implementation.\n\nThe central hypothesis is that COMSS will reduce adverse maternal and infant outcomes and associated racial disparities.",[195,26,196,96],"Perinatal Outcomes","Health Disparity, Minority and Vulnerable Populations",[198,61,199],"pregnancy","perinatal outcomes","2026-03-02",{"date":202,"type":35},"2026-03-03",{"date":204,"type":35},"2025-05-19",{"date":206,"type":19},"2028-12",{"name":208,"class":42},"Women and Infants Hospital of Rhode Island",7,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":20,"phases":220,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":43},"100553014","phase-2-an-integrated-intervention-using-a-pill-ingestible-sensor-system-100553014","NCT06480578","An Integrated Intervention Using a Pill Ingestible Sensor System","An Integrated Intervention Using a Pill Ingestible Sensor System to Trigger Actions on Multifaceted Social and Behavioral Determinants of Health Among PLWH","Sensor-SBDOH","Inclusion Criteria:\n\n1. HIV-infected individuals in HIV care\n2. Greater than 17 years of age\n3. Demonstrated ability to take co-encapsulated ARVs at the time of screening\n4. Able to provide informed consent\n5. Receiving ART with sub-optimal adherence estimated by patient (self-reports \\\u003C 90% adherence over last 28 days) or treating clinician \\[e.g., based on gaps in treatment (e.g. missed appointments) or viral load elevations within 6 months\\], or at high risk for sub-optimal adherence, or with known challenges with SBDOH (e.g. unstable housing, substance use disorder, and poverty\n6. Currently receiving antiretroviral treatment that includes one of the following:\n\n   * TDF\u002FFTC (Truvada)\n   * TAF\u002FFTC (Descovy)\n   * EFV\u002FFTC\u002FTDF (Atripla)\n   * ABC\u002F3TC (Epzicom)\n   * DTG\u002FABC\u002F3TC (Triumeq)\n   * RPV\u002FTAF\u002FFTC (Odefsey)\n   * EVG\u002Fc\u002FFTC\u002FTAF (Genvoya)\n   * BIC\u002FFTC\u002FTAF (Biktarvy)\n7. For participants of reproductive potential, negative serum or urine pregnancy test with a sensitivity of ≤25 mIU\u002FmL at screening. This will be repeated again at study entry.\n\nNOTE: Participants are considered to be NOT of reproductive potential if:\n\n1. participants have had amenorrhea for at least 12 consecutive months prior to study entry (i.e., who have had no menses within 12 months prior to study entry), and have a documented FSH \\>40 IU\u002FmL; OR\n2. an FSH level is not available, but participants have had 24 consecutive months of amenorrhea (in the absence of medications known to induce amenorrhea); OR\n3. participants report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation\u002Fhysteroscopic tubal occlusion).\n\nExclusion Criteria:\n\n1. Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior\n2. Pregnancy (Evaluated during the screening visit through a pregnancy test.)",{"count":219,"type":19},110,[221],"PHASE2","This study integrates technology-based adherence measures with alerts for social and behavioral determinants of health (SBDOH) to improve HIV treatment outcomes. It involves 110 adult patients from a Los Angeles County HIV clinic, focusing on those at risk for poor adherence. Participants will be randomized into intervention or usual care groups, with endpoints including intervention acceptability, SBDOH interventions, adherence to ART, viral load, and high-risk sexual activity. The study aims to assess the effectiveness of the integrated intervention in improving adherence, virologic outcomes, and reducing high-risk behavior among PLWH.",[224,225,26],"HIV\u002FAIDS","Medication Adherence",[224,225,227],"SDOH","2026-02-11",{"date":230,"type":35},"2026-02-13",{"date":232,"type":35},"2024-12-19",{"date":234,"type":19},"2027-07-01",{"name":236,"class":42},"University of California, Los Angeles",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":166,"sex":15,"minAge":244,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":20,"phases":248,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":43},"100572348","philly-ceal--decide-adaptation-100572348","NCT06732102","Philly CEAL- DECIDE+ Adaptation","PhillyCEAL: Addressing Disparities in Chronic Disease Self-management Through an Enhanced Community Health Worker Program","Inclusion Criteria:\n\n* Reside in Philadelphia\n* Be between 35 and 75 years of age (inclusive)\n* Self-report having been told by a healthcare provider that they have one or more of the following CVD-related chronic conditions:\n\n  1. Pre-diabetes\n  2. Diabetes\n  3. Hypertension\n  4. Hyperlipidemia\u002F high cholesterol)\n  5. BMI \\>=30.\n* Have completed an initial visit with a CEO CHW\n* Have one or more unmet social needs identified in the CEO Intake Form in the following areas:\n\n  1. Housing Stability,\n  2. Food security,\n  3. Transportation to medical appointments and\u002For work,\n  4. Employment,\n  5. Household utilities,\n  6. Healthcare access,\n  7. Health literacy, and\n  8. Social support.\n* Willing to consent to participate in the CEAL study regular access to a mobile device to qualify for enrollment.\n\nExclusion Criteria:\n\n* Does not reside in Philadelphia\n* Not between 35 and 75 years of age (inclusive)\n* Does not self-report having been told by a healthcare provider that they have one or more of the following CVD-related chronic conditions:\n\n  1. Pre-diabetes\n  2. Diabetes\n  3. Hypertension\n  4. Hyperlipidemia\u002F high cholesterol)\n  5. BMI \\>=30.\n* Has not completed an initial visit with a CEO CHW\n* Does not have one or more unmet social needs identified in the CEO Intake Form in the following areas:\n\n  1. Housing Stability,\n  2. Food security,\n  3. Transportation to medical appointments and\u002For work, employment,\n  4. Household utilities,\n  5. Healthcare access,\n  6. Health literacy, and\n  7. Social support.\n* Unwilling to consent to participate in the CEAL study regular access to a mobile device to qualify for enrollment.","35 Years","75 Years",{"count":247,"type":19},500,[22],"Cardiovascular disease (CVD) disproportionately affects racial\u002Fethnic minorities and underserved populations in Philadelphia. This study aims to evaluate the effectiveness of an enhanced community health worker (CHW) program that combines the evidence-based DECIDE self-management intervention with structured CHW consultations to improve CVD self-management skills and address social needs. Using a Type 1 Hybrid Effectiveness-Implementation Design, we will recruit 500 Philadelphia residents aged 35-75 with CVD risk factors and unmet social needs. Participants will be offered the DECIDE+ intervention (9 bi-weekly group sessions plus alternating CHW consultations) or continue with standard CHW services. The primary outcome is CVD self-management skills measured by the Self-care of Chronic Illness Inventory Maintenance scale. Secondary outcomes include health behaviors and resolution of social needs. Implementation outcomes will assess CHW experiences, community advisory council impact, and factors influencing participation. Propensity score methods will be used to compare changes in outcomes between DECIDE+ participants and those receiving standard CHW services. Mediation analyses will examine pathways through problem-solving skills, self-efficacy, and social needs resolution. Mixed methods will evaluate implementation outcomes. This study will provide evidence on the effectiveness of integrating an evidence-based self-management program with CHW services to address both clinical and social needs.\n\nThis study has the potential to generate important and impactful findings that can advance health equity and the science of effective community health worker programs. By rigorously evaluating the real-world implementation of a city-wide CHW-delivered chronic disease self-management program that also addresses collaborative approaches and support to addressing social needs, our findings can provide a roadmap for other communities looking to implement evidence-based interventions to reduce health disparities. Demonstrating improved CVD self-management behaviors and reduced social needs among Philadelphia residents receiving the DECIDE+ intervention would provide compelling evidence for the synergistic benefit of these services, and to sustain and scale up this model.\n\nOBJECTIVES: We propose both effectiveness and implementation questions to guide our work:\n\nEffectiveness of CHW Engagement:\n\n1. Is the DECIDE intervention with CHW consultations (DECIDE+) effective in improving CVD self-management skills compared to the standard and limited CHW engagement?\n\n   1. Do DECIDE+ sessions improve CVD self-management skills by strengthening problem solving and self-efficacy?\n   2. Does participation in CHW consultations improve CVD self-management skills by meeting social needs?\n\n   Implementation Questions:\n2. What key sociodemographic and psychosocial factors influence client participation in the study?\n3. How do CHWs perceive the impact of facilitator training on their a.) knowledge, attitudes and practices in supporting clients b.) personal health management, and c.) job satisfaction?\n4. How does the CAC facilitate resource mobilization to enhance access to services that address social needs in Philadelphia's communities?",[103,251,252,26],"Community Health Workers","Cardiovascular Diseases",[254,255,256,257],"Community Health Worker","Chronic Disease Management","Cardiovascular Health","Unmet social needs","2025-09-29",{"date":260,"type":35},"2025-10-01",{"date":262,"type":35},"2025-04-14",{"date":264,"type":19},"2028-03-31",{"name":266,"class":42},"University of Pennsylvania",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":166,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":20,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":43},"100606354","the-e-sincere-study-100606354","NCT07174466","The e-SINCERE Study","Enhanced Digital Access to Bridge Social Needs and Reduce Health Disparities: The e-SINCERE Study","e-SINCERE","Inclusion Criteria:\n\n* Community Advisory Board Members\n\nHealth system, governmental, and community service stakeholders\n\nAble to understand English\n\nAdult (\\> 18 years)\n\n\\- General screening population:\n\nAny patient who completes the SINCERE screener.\n\nAble to understand or read English or Spanish.\n\n\\- Survey study inclusion criteria:\n\nAny patient who completes the SINCERE screener who has connected with 211 for service outreach\n\nAble to understand or read English or Spanish.\n\nAdult (\\> 18 years)\n\nExclusion Criteria:\n\n* Those unable to communicate verbally in English or Spanish\n* Those living in nursing facilities, or those who are not otherwise responsible for self-care",{"count":276,"type":19},600,[22],"The e-SINCERE study will evaluate whether providing stable cell phones and digital navigation assistance helps patients overcome ICT barriers and connect more successfully with community services. The study will begin with patients in the UHealth ED, with additional sites added in the future, and will involve working with community service providers and policy leaders to refine and implement the intervention. Findings from this study may guide the development of future programs and policies to improve access to services for patients facing economic and technological barriers.",[26,280,281],"Digital Health Literacy","Health Services Utilization","2025-09-12",{"date":284,"type":35},"2025-09-16",{"date":286,"type":35},"2025-08-08",{"date":288,"type":19},"2029-08-31",{"name":290,"class":42},"Andrea Wallace"]