Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 6:50 AM
Study NCT ID:
NCT05293392
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving COVID-19 Vaccine Uptake Among Black and Latino Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000088823', 'term': 'Vaccination Hesitancy'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000072758', 'term': 'Vaccination Refusal'}, {'id': 'D016312', 'term': 'Treatment Refusal'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thaoly.phan@nemours.org', 'phone': '302-331-7342', 'title': 'Thao-Ly Phan, MD, MPH', 'organization': "Nemours Children's Health"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention', 'description': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention: This is a multi-component intervention to increase COVID-19 vaccine uptake among youth that was co-created with community partners and refined with qualitative feedback from Black and Latino youth and parents. The intervention consists of culturally-tailored educational materials to increase awareness about the COVID-19 vaccine, culturally-sensitive communication strategies employed by pediatric primary care providers and community health workers, and strategies to facilitate and standardize access to the COVID-19 vaccine in the primary care clinic.', 'otherNumAtRisk': 2244, 'deathsNumAtRisk': 2244, 'otherNumAffected': 0, 'seriousNumAtRisk': 2244, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.', 'otherNumAtRisk': 3548, 'deathsNumAtRisk': 3548, 'otherNumAffected': 0, 'seriousNumAtRisk': 3548, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'COVID-19 Vaccination Rate for Eligible Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2221', 'groupId': 'OG000'}, {'value': '3529', 'groupId': 'OG001'}]}, {'units': 'Primary care clinic', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention', 'description': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention: This is a multi-component intervention to increase COVID-19 vaccine uptake among youth that was co-created with community partners and refined with qualitative feedback from Black and Latino youth and parents. The intervention consists of culturally-tailored educational materials to increase awareness about the COVID-19 vaccine, culturally-sensitive communication strategies employed by pediatric primary care providers and community health workers, and strategies to facilitate and standardize access to the COVID-19 vaccine in the primary care clinic.'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.'}], 'classes': [{'title': 'Phase 1: Community-Tailored Handouts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}, {'units': 'Primary care clinic', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '33.5', 'groupId': 'OG001'}]}]}, {'title': 'Phase 2: Videos Featuring Local Families', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}, {'units': 'Primary care clinic', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}]}]}, {'title': 'Phase 3: Family-Centered Communication at Primary Care Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}]}, {'units': 'Primary care clinic', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '19.4', 'groupId': 'OG001'}]}]}, {'title': 'Phase 4: Community Health Worker Outreach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1230', 'groupId': 'OG000'}, {'value': '2019', 'groupId': 'OG001'}]}, {'units': 'Primary care clinic', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'Percent of patients who received a COVID-19 vaccine among all children who were eligible for and had not yet been vaccinated for the COVID-19 vaccine during the time of their visit to one of the four participating primary care clinics.', 'unitOfMeasure': 'Percent of participants vaccinated', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary care clinic', 'denomUnitsSelected': 'Primary care clinic', 'populationDescription': 'The multi-component intervention was introduced in phases at the two intervention clinics to understand the effect of each component of COVID-19 vaccination. Individual participants were counted if they had a clinic visit during a particular phase of the trial at either of the 2 intervention clinics or two standard care clinic. Because of this, the number analyzed for each phase is different from one another and different from the number analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention', 'description': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention: This is a multi-component intervention to increase COVID-19 vaccine uptake among youth that was co-created with community partners and refined with qualitative feedback from Black and Latino youth and parents. The intervention consists of culturally-tailored educational materials to increase awareness about the COVID-19 vaccine, culturally-sensitive communication strategies employed by pediatric primary care providers and community health workers, and strategies to facilitate and standardize access to the COVID-19 vaccine in the primary care clinic.'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.'}], 'periods': [{'title': 'Phase 1: Community-Tailored Handouts', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '268'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '406'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '268'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '406'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Phase 2: Videos Featuring Local Families', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '281'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '476'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '281'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '476'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Phase 3: Family-Centered Communication', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '442'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '628'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '442'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '628'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Phase 4:Community Health Worker Outreach', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1230'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '2019'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1230'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '2019'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Primary care clinic', 'recruitmentDetails': 'Four primary care clinics were recruited to participate in the pilot cluster randomized clinical trial. Primary care clinics were randomized 1:1 to receive the intervention or not, with stratification by geographic region (Northern and Southern Delaware). Because of the cluster randomized nature of the trial and collection of data routinely collected in the electronic health record, a waiver of consent was approved.', 'preAssignmentDetails': 'Patients were counted as participants if they were eligible for but had not received the COVID-19 vaccine at the time of a visit to one of the participating clinics. Because individual patients were counted at the time of their clinic visit and the intervention was implemented in phases, participation differed from phase to phase. While the intervention was delivered to both patient (child) and their parent, only data about the patient (child) was collected from the electronic health record.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2221', 'groupId': 'BG000'}, {'value': '3529', 'groupId': 'BG001'}, {'value': '5750', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention', 'description': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention: This is a multi-component intervention to increase COVID-19 vaccine uptake among youth that was co-created with community partners and refined with qualitative feedback from Black and Latino youth and parents. The intervention consists of culturally-tailored educational materials to increase awareness about the COVID-19 vaccine, culturally-sensitive communication strategies employed by pediatric primary care providers and community health workers, and strategies to facilitate and standardize access to the COVID-19 vaccine in the primary care clinic.'}, {'id': 'BG001', 'title': 'Standard Care', 'description': 'Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '5-11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2221', 'groupId': 'BG000'}, {'value': '3529', 'groupId': 'BG001'}, {'value': '5750', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1268', 'groupId': 'BG000'}, {'value': '1985', 'groupId': 'BG001'}, {'value': '3253', 'groupId': 'BG002'}]}]}, {'title': '12-17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2221', 'groupId': 'BG000'}, {'value': '3529', 'groupId': 'BG001'}, {'value': '5750', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '953', 'groupId': 'BG000'}, {'value': '1544', 'groupId': 'BG001'}, {'value': '2497', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2221', 'groupId': 'BG000'}, {'value': '3529', 'groupId': 'BG001'}, {'value': '5750', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1049', 'groupId': 'BG000'}, {'value': '1736', 'groupId': 'BG001'}, {'value': '2785', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1171', 'groupId': 'BG000'}, {'value': '1793', 'groupId': 'BG001'}, {'value': '2964', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2221', 'groupId': 'BG000'}, {'value': '3529', 'groupId': 'BG001'}, {'value': '5750', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic', 'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '511', 'groupId': 'BG001'}, {'value': '991', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '627', 'groupId': 'BG000'}, {'value': '1177', 'groupId': 'BG001'}, {'value': '1804', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic White', 'measurements': [{'value': '923', 'groupId': 'BG000'}, {'value': '1481', 'groupId': 'BG001'}, {'value': '2404', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic Other', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2221', 'groupId': 'BG000'}, {'value': '3529', 'groupId': 'BG001'}, {'value': '5750', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2221', 'groupId': 'BG000'}, {'value': '3529', 'groupId': 'BG001'}, {'value': '5750', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'COVID-19 vaccination rate in participating clinics in the month prior to trial', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '659', 'groupId': 'BG000'}, {'value': '1174', 'groupId': 'BG001'}, {'value': '1833', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'BG000'}, {'value': '34.8', 'groupId': 'BG001'}, {'value': '33.4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Because this was a cluster randomized controlled trial, we analyzed each participating clinic's COVID-19 vaccination rate in the month prior to the start of the clinical trial to establish a baseline COVID-19 vaccination rate for the groups. In particular, we report the percent of participants vaccinated against COVID-19 at each clinic.", 'unitOfMeasure': 'Percent of participants vaccinated', 'populationDescription': 'The number of participants represents the number of patients who had a visit to one of the participating primary care clinics (2 in each arm) and were eligible for but had not yet received the COVID-19 vaccine.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-06', 'size': 349347, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-30T14:00', 'hasProtocol': True}, {'date': '2021-06-07', 'size': 411114, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-30T14:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5792}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2022-03-22', 'resultsFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-31', 'studyFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 Vaccination Rate for Eligible Children', 'timeFrame': '4 months', 'description': 'Percent of patients who received a COVID-19 vaccine among all children who were eligible for and had not yet been vaccinated for the COVID-19 vaccine during the time of their visit to one of the four participating primary care clinics.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthcare disparities', 'Vaccine hesitancy'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Black and Latino youth may be less likely to get the COVID-19 vaccine than White youth. In this study we will work with community members to come up with ways to help Black and Latino families learn more about the COVID-19 vaccine and get the COVID-19 vaccine. We will test these ideas out in pediatric primary care clinics. This study will help us make sure that all youth have an equal chance of getting the COVID-19 vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Youth 0-21 years of age and their caregiver\n* Receiving care at one of four Nemours primary care practices selected for this study\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05293392', 'briefTitle': 'Improving COVID-19 Vaccine Uptake Among Black and Latino Youth', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Health System"}, 'officialTitle': 'Improving Pediatric COVID-19 Vaccine Awareness, Access, and Accountability in Underrepresented Communities', 'orgStudyIdInfo': {'id': 'U54GM104941-09S1', 'link': 'https://reporter.nih.gov/quickSearch/U54GM104941-09S1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U54GM104941-09S1', 'link': 'https://reporter.nih.gov/quickSearch/U54GM104941-09S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention', 'interventionNames': ['Behavioral: Culturally-Tailored COVID-19 Vaccine Uptake Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'interventionNames': ['Behavioral: Standard Care']}], 'interventions': [{'name': 'Culturally-Tailored COVID-19 Vaccine Uptake Intervention', 'type': 'BEHAVIORAL', 'description': 'This is a multi-component intervention to increase COVID-19 vaccine uptake among youth that was co-created with community partners and refined with qualitative feedback from Black and Latino youth and parents. The intervention consists of culturally-tailored educational materials to increase awareness about the COVID-19 vaccine, culturally-sensitive communication strategies employed by pediatric primary care providers and community health workers, and strategies to facilitate and standardize access to the COVID-19 vaccine in the primary care clinic.', 'armGroupLabels': ['Culturally-Tailored COVID-19 Vaccine Uptake Intervention']}, {'name': 'Standard Care', 'type': 'BEHAVIORAL', 'description': 'Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': "Nemours Children's Hospital, Delaware", 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}], 'overallOfficials': [{'name': 'Thao-Ly T Phan-Vo, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nemours Children's Health"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Health System", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, {'name': 'University of Delaware', 'class': 'OTHER'}, {'name': 'ChristianaCare', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics; Research Scientist', 'investigatorFullName': 'Thao-Ly Phan', 'investigatorAffiliation': "Nemours Children's Health System"}}}}