[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Johns Hopkins Bloomberg School of Public Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":638},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,49,74,97,117,147,177,199,221,245,267,286,312,335,373,396,421,440,470,494,515,543,563,583,614],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100054206","phase-3-co-administration-of-calcium-and-multiple-micronutrient-supplements-for-maternal-and-newborn-hemoglobin-and-iron-status-100054206",false,"NCT06568315","Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status","Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status: A Randomized Non-inferiority Trial in Burkina Faso and Pakistan","CaMMS","Inclusion Criteria:\n\n* Burkina Faso: married or unmarried pregnant women aged ≥15 years\n* Pakistan: married pregnant women ≥18 years\n* Willing to receive all antenatal care at a study clinic\n* Willing to stop iron folic acid supplementation to receive the study intervention\n* Hb ≥70 g\u002FL\n* 6\\\u003C20 weeks of gestation based on fetal ultrasound\n\nExclusion Criteria:\n\n* Burkina Faso: \\\u003C15 years or unmarried pregnant women \\\u003C18 years without consent from parent \u002F guardian\n* Pakistan: pregnant women \\\u003C18 years.\n* Unwilling to receive antenatal care at a study clinic\n* Unwilling to stop iron folic acid supplementation to receive the study intervention\n* Hemoglobin \\\u003C 70 g\u002FL\n* \\\u003C6 weeks of gestation or ≥20 weeks of gestation\n* Non-viable or extrauterine pregnancy\n* Any contraindications to study supplements",true,"FEMALE","15 Years",{"count":22,"type":23},3200,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","The World Health Organization (WHO) currently recommends the pregnant women receive iron-containing supplements and, in settings where calcium intake is low, calcium supplements. Supplements are to be taken at two separate times of the day as calcium may interfere with iron absorption. The goal of this clinical trial is to learn whether taking daily calcium supplements and iron-containing multiple micronutrient supplements together, at the same time, has any negative impact on the hemoglobin or iron status of pregnant women or the woman's infants. Participants will be randomly assigned and counseled to either take the supplements together every morning or to take the multiple micronutrient supplement in the morning and the calcium supplement in the evening. Participants will visit the antenatal clinic monthly and be asked to provide a blood sample in early, mid, and late pregnancy. Researchers will also take blood samples from infants at the time of birth.",[29],"Anemia, Iron Deficiency",[31,32,33,34,35],"calcium","iron","supplementation","anemia","pregnancy","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2025-08-25",{"date":44,"type":23},"2026-08",{"name":46,"class":47},"Johns Hopkins Bloomberg School of Public Health","OTHER",2,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":18,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100580318","implementation-of-multiple-micronutrient-supplementation-mms-for-pregnant-women-in-uganda-100580318","NCT06835738","Implementation of Multiple Micronutrient Supplementation (MMS) for Pregnant Women in Uganda","Inclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1)\n\n* ≤24 weeks of amenorrhea\u002Fgestation as verified by health professionals\n* Attending first ANC visit at government or PNFP health facilities.\n* Accepted to take MMS at first ANC visit\n\nExclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1)\n\n* Pregnant women with pre-existing hematological conditions such as sickle cell anemia, thalassemia, hemochromatosis.\n* Pregnant women planning to relocate outside the study district during the study period.\n\nInclusion Criteria for Pregnant women \u002F Women that have recently delivered (single contact) (sample 2)\n\n* Currently pregnant woman or a woman who is not more than 8 weeks postpartum.\n* Received MMS at an ANC visit at least 3 months ago or more.\n* Attended at least any 2 monthly ANC visits.\n* Attending\u002Fattended ANC at government or private-not-for-profit health facility.\n\nExclusion Criteria for Pregnant women \u002F Women that have recently delivered (single contact) (sample 2)\n\n* Enrolled in study population 1.\n* Women who are more than 8 weeks postpartum.\n\nInclusion Criteria for ANC providers having ANC health education\u002Fcounseling with pregnant woman(en) observed (sample 3)\n\n• Healthcare providers that are currently providing ANC health education (group) or ANC individual counseling at government or PNFP health facilities.\n\nExclusion Criteria for ANC providers having ANC health education\u002Fcounseling with pregnant woman(en) observed (sample 3) • Healthcare providers that are currently providing ANC health education (group) or ANC individual counseling to a woman(en) that have not provided written informed consent to have the ANC session observed.\n\nInclusion Criteria for Influential family members (male partners \\& mothers\u002Fmothers-in law) (sample 4)\n\n* Spouse or partner of a pregnant woman or woman with a child less than 8 weeks old who is receiving\u002F has received ANC services in one of the 8 study districts.\n* Mother or mother-in-law of a pregnant woman or woman with a child less than 8 weeks old who is receiving\u002F has received ANC services in one of the 8 study districts.\n\nExclusion Criteria for Influential family members (male partners \\& mothers\u002Fmothers-in law) (sample 4) • None\n\nInclusion Criteria for Healthcare Providers- including facility in-charge, ANC providers, Health Assistants, staff in-charge of records, and stores manager (sample 5)\n\n* Health workers who provide ANC services (e.g., midwives\u002Fnurse, medical\u002F clinical officers, health assistants, and nutrition focal person) at government or private-not-for-profit facilities in one of the 8 study districts.\n* Health facility staff (e.g., Facility In-charge, Maternity In-charge, Pharmacy\u002FStores In-charge) at government or private-not-for-profit facilities in one of the 8 study districts.\n\nExclusion Criteria for Healthcare Providers- including facility in-charge, ANC providers, Health Assistants, staff in-charge of records, and stores manager (sample 5)\n\n• None\n\nInclusion Criteria for Community Health Workers (VHTs) and Mentor Mothers (sample 6) • Voluntary Health Team (VHT), Mentor Mothers, or Para-socials attached to at least one of the study facilities.\n\nExclusion Criteria for Community Health Workers (VHTs) and Mentor Mothers (sample 6) • None\n\nInclusion Criteria for National, regional, and district-level stakeholders (sample 7)\n\n* National, regional, or district-level decision-makers working in nutrition, maternal, newborn and child health, district health educator or pharmaceutical roles associated with the antenatal care system in Uganda.\n* Implementing partners involved in direct implementation of MMS within the 8 study districts\n\nExclusion Criteria for National, regional, and district-level stakeholders (sample 7)\n\n• None\n\nInclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8)\n\n* Woman who has been pregnant or delivered within the study period.\n* Household is within one of the 4 selected districts.\n\nExclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8)\n\n• Women who moved to the district after delivery.","ALL","0 Years","80 Years",{"count":59,"type":23},4077,[61],"NA","The objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Uganda national health system context to support improved maternal nutrition and birth outcomes. Formative research has been conducted to design the implementation strategies that will be tested in this second phase of the study. The objectives are to:\n\n* Describe the implementation of the MMS intervention (which consists of MMS product, a social behavior change communication (SBCC) strategy, capacity building, MMS supply chain support, monitoring, and evaluation) and explore acceptability, feasibility, fidelity, coverage, and potential for sustainability.\n* Determine the effect of dispensing MMS in different bottle counts on MMS adherence and ANC attendance among pregnant women.\n* Determine the cost and budget impact of MMS intervention implementation integrated in the Ugandan ANC service delivery system",[64],"Nutrient Deficiency","2026-06-29",{"date":67,"type":40},"2026-07-01",{"date":69,"type":40},"2025-06-18",{"date":71,"type":23},"2026-12-31",{"name":46,"class":47},1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":18,"sex":55,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":24,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":73},"100639319","adaptive-mobile-interventions-to-reduce-cancer-risk-behaviors-100639319","NCT07585357","Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors","Inclusion Criteria:\n\n* live in the U.S.;\n* are between 18 and 40 years of age;\n* own a smartphone with iOS and Android operating system and GPS capabilities;\n* are carrying smartphone every day;\n* are willing to participate in the study for 44 days and give the research team access to the phone GPS data;\n* have smoked ≥100 cigarettes in the participant's life and currently smoke at least 3 cigarettes per day on 5 or more days of the week;\n* are planning to quit smoking within the next 30 days.\n\nExclusion Criteria:\n\n* None","18 Years","40 Years",{"count":83,"type":23},7,[61],"Tobacco use remains the leading cause of preventable death, causing over 400,000 annual deaths in the United States alone. Smartphone-based interventions, particularly those leveraging real-time adaptive messaging, represent a promising yet underutilized approach to delivering personalized tobacco and cannabis treatment. The investigator's ongoing NCI funded micro-randomized trial (MRT; R01 CA246590) has shown initial feasibility in reducing smoking urges through situationally tailored cognitive-behavioral therapy (CBT) and mindfulness-based acceptance and commitment-based therapy (ACT) messages triggered by real-time contextual data (e.g., geolocation, momentary stress). To advance from a static MRT framework to a dynamic, data-driven just-in-time adaptive intervention (JITAI), this project aims to develop, test, and refine a reinforcement learning (RL) algorithm that can continuously adapt to user needs in real-time, enhancing treatment outcomes for various tobacco and cannabis products.\n\nTo ensure optimal usability and engagement, the investigators will conduct user-centered testing with the developed RL-based intervention delivery in one cohort (N=7) over 45 days. This will include usability assessment via the System Usability Scale, analysis of app interaction metrics, and semi-structured interviews to gather feedback for refining message content, timing, and design.",[87],"Smoking Cessation","NOT_YET_RECRUITING","2026-06-23",{"date":91,"type":40},"2026-06-25",{"date":93,"type":23},"2026-07",{"date":95,"type":23},"2026-09",{"name":46,"class":47},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":55,"minAge":80,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":24,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":73},"100503503","testing-the-impact-of-smartphone-based-messaging-to-support-young-adult-smoking-cessation-100503503","NCT05836103","Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation","Inclusion Criteria:\n\n1. live in the U.S.\n2. read English;\n3. are between 18 and 30 years of age;\n4. own an iPhone or Android smartphone;\n5. have smoked ≥100 cigarettes in their lives and currently smoke at least 3 cigarettes per day on 5 or more days of the week;\n6. are planning to quit smoking within the next 30 days.\n\nExclusion Criteria:\n\n* None","30 Years",{"count":105,"type":23},160,[61],"Clinical practice guidelines for smoking cessation emphasize cognitive behavioral therapy (CBT) to help patients develop coping strategies for urges. Mindfulness or Acceptance and Commitment Therapy (ACT) offer a different approach, which teaches smokers psychological flexibility through accepting negative experiences. While there is evidence for the efficacy of both CBT and Mindfulness\u002FACT smoking cessation interventions, it is unclear if these approaches are efficacious when implemented in real-time and with young adults. The overall goal of this proposal is to evaluate the efficacy of CBT and Mindfulness\u002FACT messages for young adults targeted at specific high-risk situations for smoking.",[109],"Tobacco Cigarette Smoking",{"date":111,"type":40},"2026-06-26",{"date":113,"type":40},"2024-10-22",{"date":115,"type":23},"2026-11-30",{"name":46,"class":47},{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":18,"sex":19,"minAge":80,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":24,"phases":127,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":73},"100642577","betterinfo-on-womens-prep-choices-and-outcomes-in-malawi-100642577","NCT07579754","BetterInfo on Women's PrEP Choices and Outcomes in Malawi","BetterInfo Tracing Approach to Evaluate HIV PrEP Choices and Use Over Time Among Women in Blantyre, Malawi","Inclusion Criteria:\n\nThe population for this research includes women aged 18 years or older at risk of HIV who initiated injectable or oral PrEP at one of the 20 Blantyre sites supported through PathToScale. PathToScale supports various types of facilities including public health clinics, drop-in centers for prioritized populations (DICs), and private hospitals\u002Fclinics.\n\nThose eligible for sampling are as follows:\n\n* Adult women ≥18 years; and\n* Initiated PrEP (injectable or oral) at the implementing facilities and lost to follow up within prior 2 years prior to sampling; and\n* Lost-to-follow-up (missed their PrEP visit by ≥3 months and for whom outcomes are unknown); and\n* Has a registered phone number for contact\n\nThose eligible for tracing are as follows:\n\n* Women sampled per eligibility criteria above; and\n* Women who have indicated permission for in-person follow-up\n\nHealth Care Providers, Implementing Partners, Ministry of Health (MOH) Stakeholers\n\n* providers and implementing partners from PathtoScale, and Ministry of Health stakeholders will be consented to participate in in-depth-interviews\n\nExclusion Criteria:\n\nThose excluded from sampling or tracing include:\n\n* Women who have an EMR record of a documented case of discontinuation of PrEP in consultation with a provider; or\n* Women who are known to have died; or\n* Women who have EMR documented transfers out of PathToScale supported facilities; or\n* Women refusing follow-up via phone on their ScanForm; or\n* Women refusing follow-up in person (during phone tracing); or\n* Women who do not speak Chichewa or English; or\n* Men (excluded from client interviews only)","110 Years",{"count":126,"type":23},384,[61],"The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.",[130,131],"Long-acting Injectable Cabotegravir for PrEP","Oral Pre-Exposure Prophylaxis (PrEP)",[133,134,135,136,137,138],"Implementation Science","Long-acting injectable cabotegravir for PrEP","Oral pre-exposure prophylaxis (PrEP)","HIV","pre-exposure prophylaxis (PrEP)","Lost-to-follow up (LTFU)","2026-06-12",{"date":141,"type":40},"2026-06-15",{"date":143,"type":23},"2026-06",{"date":145,"type":23},"2029-04",{"name":46,"class":47},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":18,"sex":19,"minAge":80,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":163,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":73},"100524377","developmental-impacts-of-microplastics-exposure-in-early-life-100524377","NCT06107933","Developmental Impacts of Microplastics Exposure in Early Life","Developmental Impacts of MicroPLastics Exposure in Early Life","DIMPLE","Inclusion Criteria:\n\n* All gender expressions\n* Mothers at 1 or 3 months postpartum (± 2 weeks)\n* Intent to exclusively breastfeed for ≥ 6 months\n* Nulliparous and singleton births\n* Receiving only breast milk from the mother, with no formula supplementation\n\nExclusion Criteria:\n\n* Physical, mental, or cognitive disability that prevents participation; current incarceration\n* Chronic conditions in mother and\u002For infant (e.g., heart disease, cancer, autoimmune disease, diabetes, intestinal bowel syndrome\u002Fdisease), conditions diagnosed for the first time during pregnancy (e.g. gestational diabetes), neurological conditions in mother and\u002For infant (e.g. epilepsy, seizures), psychological conditions in mother and\u002For infant (e.g. bipolar disorder), or neurological\u002Fpsychological conditions diagnosed in mother during or immediately after pregnancy (e.g. postpartum depression)\n* Previously diagnosed with any major illness (e.g., intrauterine growth restriction, birth asphyxia, cancer) or eating disorder or previous gastric band surgery\n* Maternal antibiotic use during pregnancy or the postpartum period. Infant antibiotic use at any time during life or taking medications that could affect plastic exposure or the microbiome, such as medications administered via a plastic syringe.\n* Use of any breast pump except the Silicon Breast Pump for the 14 days prior to the clinical visit.\n* PHQ9 score greater than or equal to 10 indicating clinically relevant symptoms of moderate or worse depression\n* Infants who are intersex\n* Smoking, drug use (including marijuana use), or alcohol abuse",{"count":156,"type":23},40,"OBSERVATIONAL","The goal of this observational study is to characterize and evaluate micro- and nano-plastic (MNP) exposures among mothers and infants in mother-infant dyads 1 or 3 months postpartum living in Baltimore, Maryland. The main questions it aims to answer are:\n\n* What MNPs are present in breastmilk and maternal blood samples and in their infants stool sample?\n* Are there associations between amount of maternal MNPs in breast milk and mass of MNP particles in infant stool?\n* Which environmental and lifestyle factors are most predictive of maternal MNP burden?\n* Is infant exposure to MNPs associated with birth weight and postnatal growth trajectories?\n\nParticipants will:\n\n* Complete several questionnaires assessing medical histories, lifestyle factors, environmental exposures, eating behaviors, etc.\n* Provide biological specimens including: maternal blood, stool, and breastmilk; infant stool\n* Clinical visit to have anthropometric measures documented including maternal height and weight, infant weight, length, and skin-fold thickness",[160,161,162],"Infant Development","Breast Feeding","Environmental Exposure",[164,165,166,167,168],"microplastic","breastmilk","infant microplastic exposure","gut microbiome","fecal metabolome","2026-06-05",{"date":171,"type":40},"2026-06-09",{"date":173,"type":40},"2023-10-01",{"date":175,"type":23},"2027-01-01",{"name":46,"class":47},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":55,"minAge":184,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":24,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":73},"100496397","adaptation-and-evaluation-of-bright-horizons-100496397","NCT05743699","Adaptation and Evaluation of Bright Horizons","Adaptation and Evaluation of Bright Horizons: An Evidence Based Intervention for Prevention of Binge Drinking and Drug Use","Inclusion Criteria:\n\n* Aged 10-24\n* Confirmed binge alcohol use event reported to the surveillance system within 90 days\n* Self identify as Native American\n* Reside on or near the Fort Apache Indian Reservation\n* Have parental or legal guardian consent\u002Fprovide youth assent\n\nExclusion Criteria:\n\n* Unstable and severe medical, psychiatric or drug use problems that necessitates inpatient treatment\n* Acute suicidal or homicidal ideation requiring immediate intervention\n* Recent and severe stressful life events such as physical or sexual abuse, or violent crime victimization that requires specific and high intensity interventions or out of home placement\n* Doesn't speak English\n* Severally visually impaired","10 Years","24 Years",{"count":187,"type":23},100,[61],"This study will test if a program called 'Bright Horizons' is effective at reducing binge substance use among adolescents.\n\nBright Horizons is a culturally adapted intervention developed and tested through a partnership between The White Mountain Apache Tribe and Johns Hopkins University. Bright Horizons is a brief intervention that teaches emotion regulation, coping skills, and problem solving. The intervention also uses goal setting to reduce alcohol and other substance use and to connect to individuals with treatment.",[191,192],"Alcohol Abuse","Substance Use",{"date":171,"type":40},{"date":195,"type":40},"2025-07-17",{"date":197,"type":23},"2027-01-31",{"name":46,"class":47},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":18,"sex":55,"minAge":80,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":24,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":73},"100506035","systems-science-approaches-to-improve-access-to-healthier-foods-the-fresh-trial-100506035","NCT05869149","Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial","FRESH","Inclusion Criteria:\n\n* Adult (18-75 years)\n* Regular restaurant customer (e.g., visits the specified restaurant at least 1x\u002Fweek)\n* Live in a household of at least 2 persons (criterion intended to provide a more stable sample, and to reduce loss to follow-up)\n* Current resident of study neighborhood\n\nExclusion Criteria:\n\n* Anticipate moving out of Baltimore or District of Columbia metropolitan area in the next 18 months\n* Pregnant (due to changes in diet, weight and body composition)","75 Years",{"count":208,"type":23},756,[61],"Working with independently owned restaurants, a common source of calorie-rich, nutrient-poor foods in predominantly minority, low-income urban neighborhoods, has the potential to improve dietary quality, and contribute to cancer prevention. This study uses systems science approaches to improve access to healthier foods in independently owned restaurants by: 1) testing the effects of a novel intervention called FRESH (Focus on Restaurant Engagement to Strengthen Health) on dietary quality, health indicators and other outcomes in African American and Latin communities, and 2) developing a system dynamics model to allow stakeholders to virtually test FRESH strategies in their own communities. The resulting restaurant intervention simulation model offers potential cost savings from avoided trial-and-error testing, and will support community-based cancer prevention.",[212],"Healthy Eating Index","2026-05-26",{"date":215,"type":40},"2026-05-27",{"date":217,"type":40},"2023-06-01",{"date":219,"type":23},"2026-10-31",{"name":46,"class":47},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":18,"sex":55,"minAge":80,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":24,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":73},"100463910","a-setting-focus-overdose-prevention-intervention-100463910","NCT05320835","A Setting Focus Overdose Prevention Intervention","A Geospatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland","Oasis","Inclusion Criteria:\n\n* Current drug user (opioid use in the prior two weeks)\n\nExclusion Criteria:\n\n* Any mental or physical health impairment that impedes ability to participate",{"count":230,"type":23},285,[61],"A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).",[234,235,236],"HIV Infections","HCV","Drug Overdose","2026-05-19",{"date":239,"type":40},"2026-05-22",{"date":241,"type":40},"2022-04-30",{"date":243,"type":23},"2027-05-30",{"name":46,"class":47},{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":252,"minAge":80,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":24,"phases":254,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":264,"leadSponsor":266,"locationsCount":48},"100559103","the-hastiin-bidziil-strong-man-intervention-100559103","NCT06559774","The Hastiin Bidziil (Strong Man) Intervention","The Hastiin Bidziil (Strong Man) Intervention: A Study to Measure the Effectiveness of a Secondary Prevention Program Aimed at Reducing Substance Use Among Adult Native Men","Inclusion Criteria:\n\n* Self-identify as American Indian\n* Self-identify as a man\n* Age 18 years or older at time of enrollment\n* Screen positive for lifetime use of alcohol and\u002For drugs, except for tobacco use only\n* Reside within \\~60 miles of a study community (Fort Defiance, AZ; Chinle, AZ)\n\nExclusion Criteria:\n\n* Any condition that would affect successful participation (e.g., planned move)\n* Profound disability that limits the ability to participate in assessments or interventions\n* Participated in the preliminary phase of this study to adapt CETA for this project","MALE",{"count":105,"type":23},[61],"The Hastiin Bidziil (Strong man) Intervention study is part of a larger project called, Community-Driven Indigenous Research, Cultural Strengths \\& Leadership to Advance Equity in Substance Use Outcomes (CIRCLE) Center of Excellence. CIRCLE aims to address drug use related health problems in collaboration with diverse Indigenous communities. This study is a randomized controlled trial study to measure the effectiveness of a secondary prevention program, called Hastiin Bidziil (Strong Man), aimed at reducing substance use among Native American Indian (AI) men ages 18 years and older",[192],[258,259],"Young Men","Common Elements Treatment Approach (CETA)","2026-05-12",{"date":262,"type":40},"2026-05-14",{"date":69,"type":40},{"date":265,"type":23},"2028-06",{"name":46,"class":47},{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":18,"sex":55,"minAge":4,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":24,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":285,"locationsCount":73},"100553158","improving-vaccine-acceptance-through-ehr-integrated-patient--and-provider-facing-decision-support-100553158","NCT06482450","Improving Vaccine Acceptance Through EHR Integrated Patient- and Provider-Facing Decision Support","Inclusion Criteria:\n\n* Patient has an upcoming appointment in 2 business days at Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic.\n* A valid mobile phone number or e-mail address is available in the EHR as of 2 business days prior to the appointment date.\n\nPhase 1: COVID-19 Vaccine only:\n\n* Due for a COVID-19 vaccine based on Epic Systems© COVID-19 vaccine health maintenance topic.\n\nPhase 2: All Vaccines:\n\n* Due for any vaccines based on Epic Systems© implementation using health maintenance topics of the Centers for Disease Control CDS for Immunization (CDSi) specifications.\n\nExclusion Criteria:\n\n* None",{"count":274,"type":23},1200,[61],"The goal of this project is to establish the technical feasibility of a scalable, integrated platform to improve patient informed decision-making and increase vaccine uptake and to evaluate the effectiveness of the integrated platform to improve vaccine uptake.",[278,279],"Vaccine Hesitancy","Vaccine Refusal","2026-05-11",{"date":262,"type":40},{"date":283,"type":40},"2025-06-11",{"date":93,"type":23},{"name":46,"class":47},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":55,"minAge":80,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":24,"phases":297,"briefSummary":298,"conditions":299,"keywords":303,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},"100628176","phase-3-efficacy-of-integrating-next-generation-sequencing-for-treatment-of-surgical-site-infection-after-fracture-fixation-100628176","NCT07458230","Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:","Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation: A Multicenter Randomized Control Trial","NGS","Inclusion Criteria:\n\n* Age 18-84 years\n* History of extremity fracture proximal to the metatarsals and carpal bones treated with any type of internal fixation. Note that both healed and unhealed fractures are eligible.\n* Deep infection requiring surgery after fracture fixation as determined by either of the following:\n\nFRI confirmatory criteria CDC criteria (without the timeframe). This includes the possibility of culture negative infection but determined to be infection by treatment team.\n\n* Plan for treatment includes antibiotic therapy prescribed by Infectious Disease provider(s), regardless of SOCHB culture or NGS results.\n\nExclusion Criteria:\n\n* Spine fractures\n* High risk of amputation based on the initial managing physician opinion\n* Incarcerated\u002Finstitutionalized\n* Patient is too sick to have surgery, i.e., medical co-morbidities which preclude treatment with a general anesthetic\n* Prior history of chronic infection at the surgical site\n* Pathological fractures from a neoplastic process\n* History of Paget's Disease\n* Unavailable for the planned 12 months of follow-up (e.g., planned follow-up at a location other than one of the study sites)\n* Extremity fracture occurred more than 2 years prior to the hospital admission for the presenting infection","84 Years",{"count":296,"type":23},250,[26],"The study focuses on the serious problem of infections and wound-healing issues that can happen after high-energy bone fractures. These complications are common and can affect between 10% and 60% of patients, especially those with severe injuries. When a fracture is repaired with surgery and an infection develops afterward, patients often face long recovery times, more pain, and sometimes multiple surgeries. In the worst cases, the infection can lead to permanent disability or even amputation. The current standard test used in hospitals, called a culture, often misses certain bacteria, which can make treatment less effective. Because of this, the study aims to find out whether adding a newer test called Next Generation Sequencing (NGS) can help doctors identify infections more accurately and improve patient outcomes.\n\nThe main goal of the study is to see whether using NGS along with standard hospital cultures reduces the number of treatment failures compared to using standard cultures alone. Treatment failure means the infection does not get better and the patient must return to the operating room. The study also wants to learn whether NGS helps doctors make better antibiotic choices and avoid unnecessary or ineffective treatments. Another goal is to understand which NGS results are most helpful when doctors decide to change a patient's antibiotics. By learning this, researchers hope to create a model that explains how NGS information influences treatment decisions.\n\nTo join the study, patients must be between 18 and 84 years old and have a deep infection after a fracture was repaired with internal fixation, such as plates, screws, or rods. Patients must also meet infection criteria from either the Fracture-Related Infection (FRI) guidelines or the CDC's infection criteria. A total of 250 patients will be randomly placed into one of two groups: one group will receive treatment guided by both NGS and standard cultures, while the other group will receive treatment based only on standard cultures. Researchers will then compare how often treatment fails in each group.\n\nTreatment failure includes several possible outcomes. The most important is an unplanned return to the operating room because the infection did not improve. Other types of failure include new superficial infections that do not require surgery, bones that fail to heal properly (called nonunion), amputation, and complications caused by antibiotics. Patients will return for follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after joining the study so researchers can track the patient's progress and monitor for any problems.\n\nRight now, the failure rate for treating these infections using standard hospital cultures is about 30%, which is considered unacceptably high. The researchers believe that adding NGS will help lower this number because NGS can detect more types of bacteria, including ones that are hard to grow in a lab. With better information, doctors can choose antibiotics that are more likely to work the first time, which may reduce the need for additional surgeries and improve healing. This could be especially important for military service members, who often suffer high-energy injuries and face a greater risk of long-term complications if treatment fails.\n\nNGS is already available, covered by Medicare, and fast enough to be useful in real-time medical decisions. If this study shows that NGS improves treatment outcomes, hospitals could begin using it widely and quickly. The researchers hope that this approach will lead to fewer infections, better antibiotic use, faster recovery, and improved long-term function for patients.",[300,301,302],"Next Generation Sequencing (NGS)","Surgical Site Infection (SSI)","Fracture Fixation",[300],"2026-05-07",{"date":306,"type":40},"2026-05-08",{"date":67,"type":23},{"date":309,"type":23},"2028-10-01",{"name":46,"class":47},18,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":18,"sex":55,"minAge":320,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":24,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":48},"100548823","addressing-health-disparities-in-normal-pressure-hydrocephalus-nph-in-maryland-100548823","NCT06426004","Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland","Community Interventions to Address Health Disparities in the Care of Normal Pressure Hydrocephalus (NPH) in Maryland","NPH","Inclusion Criteria:\n\n* People over 65 years old who have completed the Annual Wellness Survey (AWV) survey\n* have a clinical profile in the Hopkins Epic data sets\n* live in Maryland\n\nExclusion Criteria:\n\n* People under 65 years old will be excluded if they have not completed the AWV survey\n* do not live in Maryland\n\nCommunity Health Worker (CHW) Inclusion Criteria:\n\n* certified Community Health Workers from Maryland\n* completed accredited training by the Maryland Department of Health\n\nPrimary Care Physician inclusion criteria:\n\n* must have patients in Johns Hopkins University AWV","65 Years",{"count":322,"type":23},660,[61],"The study aims to estimate Normal Pressure Hydrocephalus (NPH) prevalence and evaluate health equity gaps in Baltimore and Maryland based on zip codes and race, with a focus on the Black community. Interventions will include educational elements about NPH and three layers targeting patients, Primary Care Providers, and community health workers to enhance care access. Short-term outcomes will measure referrals to specialists, while long-term outcomes will assess healthcare utilization. The study aims to identify and reduce racial disparities in NPH care access, informing intervention strategies for NPH and other surgical areas.",[326,327],"Normal Pressure Hydrocephalus","Hakim Syndrome","2026-05-01",{"date":304,"type":40},{"date":331,"type":23},"2027-08-01",{"date":333,"type":23},"2032-03-30",{"name":46,"class":47},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":24,"phases":345,"briefSummary":346,"conditions":347,"keywords":353,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":370,"leadSponsor":372,"locationsCount":4},"100635484","phase-3-periodontal-disease-and-small-vulnerable-newborns-in-rural-nepal-a-community-based-trial-100635484","NCT07553286","Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial","Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Randomized Trial","Inclusion Criteria:\n\n* Married women of reproductive age (15-35 years).\n* Living in the study area who are pregnant and consent to participate.\n\nExclusion Criteria:\n\n* Currently pregnant women.\n* Women who are sterilized or use long-acting contraceptive methods or are divorced or widowed.\n* Women identified as pregnant ≥12 gestational weeks based upon date of last menstrual period.","35 Years",{"count":344,"type":23},2280,[26],"Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and\u002For low birth weight. Infants who have at least one of these outcomes, known as small vulnerable newborns (SVN)), are at increased risk of early death and poor infant growth and development. Rigorous, high-quality randomized trials are needed to evaluate whether improving the periodontal health of pregnant women can reduce the risk of adverse pregnancy outcomes in areas like South Asia, where these outcomes are common and neonatal mortality remains high. This study is a community-based, randomized controlled trial (n=2,280) to evaluate a package of oral health interventions delivered to pregnant women in the first trimester until delivery on the incidence of SVNs in rural Sarlahi District, Nepal. The intervention package will include a daily antiseptic oral rinse and intensive oral hygiene education and instruction. Both intervention and control groups will be provided a manual toothbrush and toothpaste. The investigators will determine intervention effects on incidence of SVNs and individual outcomes of preterm birth, small-for-gestational age, and low birth weight. In a biospecimen sub-study (n=200), the investigators will collect venous blood, gingival crevicular fluid, and plaque in early and late pregnancy to explore relationships between subgingival inflammation, systemic inflammation, and SVN types and other adverse pregnancy outcomes. If efficacious, a low-cost package of oral health interventions - including an antiseptic oral rinse, intensive oral hygiene education and instruction, and provision of a manual toothbrush and toothpaste - could improve maternal and newborn outcomes at this critical time of growth and development.",[348,349,350,351,352],"Preterm Birth","Low Birth Weight","Small Vulnerable Newborn","Small-for-gestational Age","Periodontal Disease",[354,355,356,357,358,359,360,361,362,363,364,365,366],"Nepal","Oral health","Small Vulnerable Newborns","Preterm birth","Periodontal disease","Low birth weight","Small-for-gestational age","Pregnancy","Antenatal care","Dental health","Gingivitis","Antiseptic oral rinse","Oral hygiene","2026-04-27",{"date":328,"type":40},{"date":67,"type":23},{"date":371,"type":23},"2028-12-31",{"name":46,"class":47},{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":18,"sex":55,"minAge":80,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":24,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":73},"100610436","improving-information-sharing-between-family-caregivers-and-home-care-aides-100610436","NCT07227558","Improving Information Sharing Between Family Caregivers and Home Care Aides","Improving Information Sharing Between Family Caregivers and Home Care Aides Caring for Persons Living With ADRD","Inclusion Criteria:\n\n1. Home care agency aide:\n\n   * English speaking,\n   * home care aides, personal care aides, or personal care aides, providing services to older adults with ADRD.\n2. Family or unpaid caregiver eligible for the study if:\n\n   * 18 years and older\n   * English speaking\n   * hear well enough to communicate by telephone\n   * identify themselves as the primary family member or unpaid (friend\u002Fcompanion) caregiver\n\nExclusion Criteria:\n\n1. Home care aides are ineligible if:\n\n   * non-English speaking\n   * certified nursing assistants, nursing assistant, home health aides, or medication technicians.\n2. Family\u002Funpaid caregivers ineligible if:\n\n   * less than 18 years old\n   * non-English speaking\n   * do not hear well enough to communicate by telephone\n   * two or more incorrect answers or not being able to respond to a validated 6-item telephone screening instrument\n   * are not identified as the person's primary caregiver, or are paid for services.",{"count":187,"type":23},[61],"This study will assess the feasibility and acceptability of delivering a home care role and preference guide to up to 50 family caregivers and home care aides of persons living with disability for the purpose of identifying roles between family caregivers and home care aides.",[384],"Shared Care",[384,386,387],"Family Caregiving","Paid Caregiving","2026-04-22",{"date":390,"type":40},"2026-04-23",{"date":392,"type":40},"2026-04-14",{"date":394,"type":23},"2027-08-31",{"name":46,"class":47},{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":55,"minAge":403,"maxAge":404,"enrollmentInfo":405,"targetDuration":4,"studyType":24,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":4},"100562249","phase-3-nitazoxanide-for-treatment-of-cryptosporidium-in-children-100562249","NCT06600711","Nitazoxanide for Treatment of Cryptosporidium in Children","Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh","Inclusion Criteria:\n\n* tests positive for Cryptosporidium by stool point-of-care test, with or without active diarrhea\n* family plans on remaining in the area for next 6 months\n\nExclusion Criteria:\n\n* history of hypersensitivity to nitazoxanide.\n* taking warfarin. Tizoxanide, the metabolite of nitazoxanide is highly bound to plasma proteins and may compete with binding sites of other highly plasma bound drugs with narrow therapeutic indices, including warfarin.\n* history of renal insufficiency or a baseline serum creatinine = 40 µmol\u002FL. Renal clearance of the drug has not been studied.\n* history of hepatic dysfunction or serum aspartate aminotransferase (AST) ;\n* 50 U\u002FL, serum alanine transaminase (ATL) ;\n* 50 U\u002FL, or serum bilirubin ;\n* 23 µmol\u002FL. Hepatic clearance of the drug has not been studied.","6 Months","12 Months",{"count":406,"type":23},480,[26],"The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months. The main questions it aims to answer are:\n\n* Does NTZ treatment of diarrheal Cryptosporidium infection lower the number of days of diarrhea?\n* Does NTZ treatment of diarrheal and non-diarrheal Cryptosporidium infection lower the number of days that parasites can be found in the stool?\n\nResearchers will compare NTZ to a placebo (a look-alike substance that contains no drug) to see if NTZ works to treat Cryptosporidium.\n\nParticipants will:\n\n* Take NTZ or placebo for 3 days\n* Receive regular visits from field research assistants\n* Provide blood and urine samples",[410],"Cryptosporidiosis",[412],"Nitazoxanide","2026-04-16",{"date":415,"type":40},"2026-04-17",{"date":417,"type":23},"2026-06-30",{"date":419,"type":23},"2030-05",{"name":46,"class":47},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":55,"minAge":403,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":48},"100082288","chronic-kidney-disease-in-children-prospective-cohort-study-ckid-100082288","NCT00327860","Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)","CKiD","Inclusion Criteria:\n\n* Age between 1 and 16 years (before 17th birthday) for Cohorts 1 and 2; age between 6 months and 16 years (before 17th birthday) for Cohort 3; age between 16 to 22 years (before 23rd birthday) for Cohort 4\n* Estimated (based on SCr) Schwartz GFR between 30 and 90 ml\u002Fmin\\|1.73m2 for Cohort 1 OR an estimated GFR between 45 and 90 ml\u002Fmin\\|1.73m2 based on the updated Schwartz formula for Cohort 2; an estimated GFR ≤60 based on the CKiD Under 25 estimating equation (U25eGFR) OR KRT experience (dialysis or transplant) for Cohort 4\n* Willingness and ability to provide informed consent and assent\n* For Cohort 3, children with non-glomerular diagnosis and duration of kidney disease less than 5 years will be enrolled.\n\nExclusion Criteria:\n\n* Solid organ (other than kidney), bone marrow or stem cell transplantation\n* Cancer diagnosis and receiving treatment or within 12 months post completion of treatment\n* Ongoing monitoring for cardiotoxic effects of prior chemotherapy or targeted cancer therapies (e.g., anthracyclines, trastuzumab)\n* HIV infection with detectable viral load despite current antiretroviral therapy\n* Current pregnancy or pregnancy within past twelve months\n* Inability to complete major data collection procedures\n* Not fluent in English or Spanish\n* Plans to move out of area of any participating CKiD site (families can be transferred to another CKiD site if the family moves)\n* Existing moderate to severe congenital structural heart disease\n* Genetic syndromes involving the central nervous system (e.g., Downs syndrome)\n* History of severe to profound intellectual disability (i.e., Intelligence Quotient (IQ)\\\u003C40, significant impairment in adaptive function and\u002For inability to independently execute self-care skills)\n* For cohort 3, children who are expected to receive renal replacement therapy within 6 months of date of enrollment will not be recruited","22 Years",{"count":430,"type":23},1300,"The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Heart, Lung and Blood Institute (NHLBI) funded a cooperative agreement including two Clinical Coordinating Centers (at Children's Hospital of Philadelphia and at Children's Mercy Hospital in Kansas City), a central biochemistry laboratory (at the University of Minnesota) and a Data Coordinating Center (at Johns Hopkins School of Public Health) to conduct a prospective epidemiological study of children with chronic kidney disease (CKD).",[433],"Chronic Kidney Disease",{"date":415,"type":40},{"date":436,"type":40},"2003-10",{"date":438,"type":23},"2028-07",{"name":46,"class":47},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":18,"sex":55,"minAge":4,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":24,"phases":449,"briefSummary":450,"conditions":451,"keywords":454,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":469,"locationsCount":73},"100554417","testing-a-scalable-model-of-the-cholera-hospital-based-intervention-for-7-days-chobi7-100554417","NCT06498817","Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)","CHoBI7","Inclusion Criteria:\n\n* Diarrhea patients presenting with three or more loose stools over a 24h period\n* Having no running water inside of the patient's home\n* Plan to reside in current residence for the next 3 months\n* Have a child \\\u003C5 years in the patient's household\n* Have a working mobile phone in the household\n\nExclusion Criteria:\n\n* No one will be excluded because of age, sex, religion, or sexual preference",{"count":448,"type":23},1600,[61],"The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections, diarrheal disease, and stunting among young children in intervention households, and had significant sustained impacts on handwashing with soap behaviors and improved water quality 12 months post intervention. Therefore, the investigators next step in the transition to scale is to: (1) To tailor the CHoBI7 program for delivery in rural health facilities and market test the CHoBI7 Program to determine the feasibility of providing a modified water, sanitation, and hygiene (WASH) package with only a soapy water bottle and chlorine tablets in both urban and rural settings through formative research and engagement of key stakeholders (Formative Research Phase); and (2) To evaluate the effectiveness of delivering the CHoBI7 program in district hospitals and sub-district health complexes in rural areas in terms of increases in WASH behaviors and decreases in diarrheal disease by conducting a randomized controlled trial (RCT) (Intervention Implementation and Evaluation Phase).",[452,453],"Diarrhea Infectious","Cholera",[455,456,457,458,459,460,461,462],"randomized controlled trial","Bangladesh","cholera","diarrheal diseases","water, sanitation, and hygiene","healthcare facilities","mobile health","child health","2026-04-10",{"date":465,"type":40},"2026-04-15",{"date":467,"type":40},"2024-08-19",{"date":71,"type":23},{"name":46,"class":47},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":19,"minAge":477,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":24,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":493},"100503502","family-spirit-strengths-100503502","NCT05836090","Family Spirit Strengths","FSS","Inclusion Criteria:\n\n* Self-identify as female; and\n* Pregnant or be a primary caregiver of a child that is 24 months or younger; and\n* 14 years or older at time of enrollment; and\n* Report a family history of high-risk substance use and\u002For report high-risk levels of personal substance use; and\n* Have elevated symptoms of depression and\u002For anxiety and\u002For risk of substance use disorder; and\n* Be part of the service population of one of the participating sites.\n\nExclusion Criteria:\n\n* Profound disability that limits the ability to participate in assessments or interventions; and\n* Unlikely to be residing in or near the research service area for the next 6 months.","14 Years",{"count":479,"type":23},188,[61],"This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.",[483,484,192,485],"Depressive Symptoms","Anxiety Disorders and Symptoms","Mental Health Issue",{"date":487,"type":40},"2026-04-13",{"date":489,"type":40},"2023-04-20",{"date":491,"type":23},"2028-06-30",{"name":46,"class":47},3,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":18,"sex":55,"minAge":80,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":24,"phases":503,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":73},"100598714","phase-2-giiigoshimong-sitting-with-your-first-family-100598714","NCT07075081","Gii'Igoshimong: Sitting With Your First Family","The Protective Role of Ceremony Against Substance Use for American Indian Adults","Inclusion Criteria:\n\n* Are 18 years of age or older,\n* Self-identify as Ojibwe\u002FAnishinaabe\u002FChippewa,\n* Self-report using any kind of substances in the past 30 days,\n* Have no history of head injury with loss of consciousness,\n* Do not have a seizure disorder,\n* Do not currently have Type 2 Diabetes,\n* Are not currently pregnant\n\nExclusion Criteria:\n\n* Younger than18 years of age\n* Does not Self-identify as Ojibwe\u002FAnishinaabe\u002FChippewa,\n* Does not self-report using any kind of substances in the past 30 days,\n* Has history of head injury with loss of consciousness,\n* Has Type 2 Diabetes,\n* Has a seizure disorder,\n* Currently pregnant",{"count":502,"type":23},300,[504],"PHASE2","The goal of this randomized wait-list control study is to understand the relationship between ceremony and substance use (SU), SU risk (e.g., SU severity, depressive symptoms) and protective factors (e.g., spirituality, community support). The main questions it aims to answer are:\n\n* Will adults enrolled in Gii'igoshimong show improved SU outcomes compared to those in control groups?\n* Will self-relevant processing networks activated during stimulus engagement increase from pre- to post- engagement in ceremony and at 6-month follow-up?\n\nResearchers will compare adults that complete Gii'igoshimong with those that do not complete Gii'igoshimong to see if health outcomes are different.\n\nAfter completing baseline assessments, participants will be randomized to complete Gii'igoshimong now (intervention) or after the participants have completed the 1 month and 6-month post assessments (waitlist control). All participants (intervention and waitlist control) within a cohort will complete 1 month and 6 month post assessments at the same time.",[192,485],"2026-03-30",{"date":509,"type":40},"2026-03-31",{"date":511,"type":40},"2025-09-09",{"date":513,"type":23},"2029-05-31",{"name":46,"class":47},{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":55,"minAge":523,"maxAge":524,"enrollmentInfo":525,"targetDuration":527,"studyType":157,"phases":4,"briefSummary":528,"conditions":529,"keywords":532,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":542},"100514653","gpcrc-pediatric-gastroparesis-registry-2-100514653","NCT05981300","GpCRC Pediatric Gastroparesis Registry 2","GpCRC Pediatric Gastroparesis Registry 2: Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric, Adolescent, and Young Adult Participants With Symptoms of Gastroparesis","PGpR2","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form and assent, as age appropriate.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* 8 to 25 years of age at the time of enrollment\n* Symptoms of Gp of at least 12 weeks duration: constellation of some combination of:\n\nnausea, vomiting, early satiety, postprandial fullness; symptoms sometimes may be accompanied by upper abdominal pain\n\n* Have undergone a gastric emptying scintigraphic study of solids using 4-hour Egg Beaters protocol (or equivalent generic liquid egg white meal) within the last 12 months who fall into one of the two categories:\n* Delayed gastric emptying-defined as an abnormal 2-hour (\\>60% retention) and\u002For 4- hour (\\>10% retention) result based on a 4-hour scintigraphic gastric emptying study\n* Gastric emptying that is not delayed but who have symptoms of Gp (designated in this study as GLS) or have previously participated in the Pediatric Gastroparesis Registry (PGpR) study\n* An etiology of either diabetic or idiopathic Gp or GLS\n\nExclusion Criteria:\n\n* Inability to comply with or complete the scintigraphic gastric emptying test (including allergy to eggs)\n* Pregnancy\n* Autism spectrum disorder, significant developmental delay, psychosis (because of inability to complete questionnaires)\n* Use of narcotic analgesics greater than three days per week.\n* Presence of conditions associated with GI mucosal disease (e.g., inflammatory bowel disease, known eosinophilic gastroenteritis or eosinophilic esophagitis, gastric ulcer, peptic ulcer, celiac disease)\n* Presence of any other condition that could case delayed gastric emptying\n* Gastrointestinal construction confirmed by upper endoscopy (EGD), upper gastrointestinal series (UGI), or abdominal CT\n* Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory\u002Finfectious legions\n* Acute or chronic renal failure (abnormal creatinine for age) and \u002For on hemodialysis or peritoneal dialysis\n* Acute liver failure\n* Advanced liver disease (features of portal hypertension)\n* Clinically significant congenital heart disease (i.e., vaginal injury during cardiac repair)\n* History of esophageal, gastric or bowel surgery.\n* Metabolic disease including mitochondrial disease and inborn errors of metabolism\n* Chronic lung disease (including cystic fibrosis)\n* A serious chronic medical condition (e.g., inflammatory bowel disease)\n* Use of medications that can affect motility during the gastric emptying study\n* Any other condition, which in the option of the investigator, could explain the symptoms or could interfere with study requirements.","8 Years","25 Years",{"count":526,"type":23},216,"3 Years","The objective of the Pediatric Gastroparesis Registry 2 is to create a national prospective registry of children, adolescents, and young adults with gastroparesis and gastroparesis-like syndrome (symptoms of gastroparesis but normal gastric emptying).",[530,531],"Gastroparesis","Gastroparesis-like Syndrome",[533,534],"Functional Disorder of Gastrointestinal Tract","Gastro-Intestinal Disorder",{"date":536,"type":40},"2026-04-03",{"date":538,"type":40},"2024-12-18",{"date":540,"type":23},"2027-04-30",{"name":46,"class":47},6,{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":55,"minAge":80,"maxAge":551,"enrollmentInfo":552,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":562,"locationsCount":542},"100504322","gastroparesis-registry-4-100504322","NCT05846802","Gastroparesis Registry 4","Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia","GpR4","Inclusion Criteria:\n\n* Age at least 18 years at initial screening visit\n* Symptoms of Gp and\u002For FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.\n* Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 9 months\n* Negative upper endoscopy or upper radiographic GI series within 5 years of registration\n\nExclusion Criteria:\n\n* Use of narcotic analgesics greater than three days per week\n* Presence of other conditions that could explain the patient's symptoms such as:\n* Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT\n* Active inflammatory bowel disease\n* Known eosinophilic gastroenteritis or eosinophilic esophagitis\n* Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory\u002Finfectious lesions\n* Acute or chronic renal failure (serum creatinine \\>3 mg\u002FdL) and\u002For on hemodialysis or peritoneal dialysis\n* Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)\n* Pancreatic disorder if present on pancreatic imaging or pancreatic function testing\n* Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)\n* Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements\n* Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.\n* Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)\n* Inability to obtain informed consent","85 Years",{"count":296,"type":23},"The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.",[530,555,556,557,533,534],"Gastroparesis Nondiabetic","Gastroparesis Due to Diabetes Mellitus Type I","Gastroparesis Due to Diabetes Mellitus Type II",{"date":536,"type":40},{"date":560,"type":40},"2024-09-20",{"date":540,"type":23},{"name":46,"class":47},{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":18,"sex":55,"minAge":80,"maxAge":551,"enrollmentInfo":570,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":572,"conditions":573,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":582},"100413256","pyloric-sphincter-abnormalities-in-patients-with-gastroparesis-symptoms-100413256","NCT04661215","Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms","PSAGS","Inclusion Criteria FOR SYMPTOMATIC PARTICIPANTS:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, aged 18-85\n4. Symptoms of gastroparesis, either diabetic or idiopathic etiology\n5. Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0\n6. Individual will have had a prior 4-hour gastric emptying scintigraphy test performed for clinical evaluation within the last 6 months. This gastric emptying test would be done for clinical evaluation and is not part of the research study. From these participants with gastroparesis symptoms, we will include those with delayed gastric emptying as well as those with normal gastric emptying.\n7. Participant must not initiate any new treatments until completion of the study procedures.\n8. Willingness to:\n\n   1. Stop histamine 2 antagonists, prokinetics (e.g., metoclopramide, erythromycin, domperidone, prucalopride), narcotics, anticholinergics, constipation medications (over the counter laxatives, isotonic polyethylene glycol (PEG) electrolyte preparations (e.g. MiraLax), prescription laxatives (e.g. lubiprostone), proton pump inhibitors, cannabinoids, and cannabidiol (CBD) for 3 days prior to each visit;\n   2. Abstain from food and water after midnight (at least for 8 hours) before the start of each visit until after the visit.\n\nINCLUSION CRITERIA FOR CONTROL PARTICIPANTS\n\n1. Provision of signed and dated informed consent form\n2. Male or female, aged 18 or older\n3. Undergoing an upper endoscopy for their clinical evaluation of diarrhea, GI bleed, or iron-deficiency anemia, or evaluation for bariatric surgery.\n4. Do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) of PAGI-SYM questionnaire.\n\nEXCLUSION CRITERIA:\n\n1. Prior gut lumen surgery on the esophagus or the stomach, including Nissen fundoplication.\n2. Prior surgery on the pylorus (G-POEM, surgical pyloroplasty, surgical pyloromyotomy)\n3. Known history of achalasia or esophageal stricture\n4. Known history of physiological or mechanical GI obstruction\n5. Abnormalities seen on a prior upper endoscopy placing patient at increased risk:\n\n   * Ulcer of the esophagus, stomach, or duodenum\n   * Esophageal varices\n6. Individuals at risk for prolonging the endoscopy procedure: severe chronic pulmonary disease, severe food retention in the stomach on endoscopy.\n7. Presence of significant gastric or duodenal pathology that could be expected to cause dysmotility (e.g. significant inflammation, infiltrate disorders etc)\n8. Individuals with a history of other chronic disease potentially causative of gastrointestinal symptom\n9. Acute or chronic renal insufficiency\n10. Current eating disorders\n11. Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures.\n12. Individuals with contraindications for endoscopy, including bleeding abnormalities\n13. Allergy to eggs preventing sedation with propofol and\u002For gastric emptying test\n14. Significant dysphagia\n15. Prior inflammatory bowel disease, Crohn's\n16. History of any esophageal\u002Fgastric\u002Fpyloric injection of botulinum toxin\n17. Patients on daily opioid use or \\>3 day\u002Fweek use\n18. Use of glucagon-like peptide 1 (GLP1) receptor agonists or Sodium-Glucose Transport Protein 2 (SGLT2); Gastric inhibitory polypeptide (GIP)- glucagon-like peptide (GLP) combo",{"count":571,"type":23},150,"The overall objective of this study is to determine if there are pyloric sphincter abnormalities in patients with gastroparesis symptoms and determine how prevalent these abnormalities are using tests to assess the pyloric sphincter - endoluminal functional luminal imaging probe (Endoflip™), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetry™ System.",[530,574,575],"Idiopathic Gastric Motility Disorder","Diabetic Gastroparesis",{"date":536,"type":40},{"date":578,"type":40},"2026-01-13",{"date":580,"type":23},"2027-04-15",{"name":46,"class":47},5,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":55,"minAge":403,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":24,"phases":593,"briefSummary":594,"conditions":595,"keywords":598,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":613},"100626268","phase-2-the-impact-of-shigellosis-and-recommended-treatment-in-children-100626268","NCT07433426","The Impact of Shigellosis and Recommended Treatment in Children","TrtNDSD","Inclusion Criteria:\n\n* Patients \\>6 and ≤59 months of age seeking care in the study hospitals\n* Patients residing within the study catchment area\n* Present with watery diarrhea and positive for Shigella by RLDT\n* Willing to be available for sample and data collection during the follow up visits\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant's parent\u002Fguardian to give written informed consent or comply with study protocol\n* Diarrhea started more than 96 hours before enrollment\n* Antibiotics related to shigellosis treatment (including the investigational drug azithromycin) taken in the past 5 days\n* More than 2 doses of antidiarrheal drugs taken in the past 24 hours\n* History of allergy to Azithromycin\n* Presence of visible blood in stool\n* Children with severe acute malnutrition (below -3z scores of the median WHO growth standards).\n* History of congenital heart diseases, known gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease, inherited or acquired immune system deficiency rendering the patient immunocompromised, including chronic\u002Flong-term steroid treatment or other immunosuppressive treatment\n* Fever over 39°C (102°F) with other complications that require antibiotic treatment\n* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study","59 Months",{"count":592,"type":23},700,[504],"The purpose of this study is to evaluate whether antibiotic treatment of non-dysentery Shigella associated watery diarrhea (NDSD) cases improves clinical outcomes and growth in children.\n\nChildren with NDSD seeking care for diarrhea at the study hospitals in Bangladesh and Zambia will be enrolled and randomized to receive Azithromycin or placebo (a look-alike substance that contains no drug). Enrolled children will be followed for three months with household visits.\n\nThe investigators will determine whether antibiotic treatment of NDSD reduces the duration of diarrhea and time to microbiological cure (shedding of Shigella in stool), and whether it improves growth in children compared with the placebo group.",[452,596,597],"Shigella","Growth & Development",[599,600,601,602,603,604,605],"shigella","children","randomized clinical trial","weight for age","growth outcomes","Azithromycin","Diarrhea","2026-03-27",{"date":507,"type":40},{"date":609,"type":40},"2026-03-18",{"date":611,"type":23},"2030-08",{"name":46,"class":47},4,{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":19,"minAge":80,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":24,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":73},"100570116","a-multi-level-trauma-informed-approach-to-increase-hiv-pre-exposure-prophylaxis-initiation-among-black-women-100570116","NCT06703060","A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women","Trauma-Informed HIV Prevention for Black Women in Baltimore","MATCH","Inclusion Criteria:\n\n* self-identified Black cisgender woman;\n* self-reported HIV-negative status, and\n* ≥18 years.\n* reports unprotected vaginal or anal sex in the past 6 months with a male sexual partner,\n* have at least one substantial HIV risk factor in the past 6 months according to the 2021 Centers for Disease Control (CDC) PrEP Eligibility Guidelines (i.e., HIV-positive sexual partner, recent bacterial Sexually Transmitted Disease (STD), 2+ sex partners, history of inconsistent or no condom use, commercial sex work, and residing in high HIV prevalence area or network), and\n* never taken PrEP\n\nExclusion Criteria:\n\n* non-English speaking and\n* currently living with HIV",{"count":502,"type":23},[61],"U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.",[626,627,628,629],"HIV Prevention","PrEP","Women","Intimate Partner Violence (IPV)","2026-03-19",{"date":632,"type":40},"2026-03-23",{"date":634,"type":40},"2025-02-28",{"date":636,"type":23},"2028-02",{"name":46,"class":47},""]