Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT04999267
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2021-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Increasing Vaccine Uptake Among Adolescents in the Rural South
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000088823', 'term': 'Vaccination Hesitancy'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chip.walter@duke.edu', 'phone': '919 620 5346', 'title': 'Chip Walter', 'organization': 'Duke University - Duke Human Vaccine Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants are school districts, therefore no adverse events were collected.', 'description': 'Participants are school districts, therefore no adverse events were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'INVEST Intervention', 'description': 'INVEST: The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in the Percentage of Adolescents Who Ever Received at Least One Dose of HPV Vaccination in the Intervention Group After the Intervention Implementation Compared With Before Intervention Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2868', 'groupId': 'OG000'}]}, {'units': 'School District', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVEST Intervention', 'description': 'INVEST: The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pre-intervention vs. Post-intervention analysis'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 9 months', 'description': 'HPV vaccination status (received at least one versus no doses) of middle schoolers (by district) will be obtained from official vaccination records before and after intervention implementation.', 'unitOfMeasure': 'percentage of adolescents', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'School District', 'denomUnitsSelected': 'School District'}, {'type': 'SECONDARY', 'title': 'Difference in Percentage of Adolescents Who Have Completed the HPV Vaccination Series (2 Doses Depending on Age at Vaccination Initiation) in the Intervention Group After Implementation Compared With Before Intervention Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2868', 'groupId': 'OG000'}]}, {'units': 'School District', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVEST Intervention', 'description': 'INVEST: The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pre-intervention vs. Post-intervention analysis'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 9 months', 'description': 'HPV vaccination status (received at least one versus no doses) of middle schoolers (by district) will be obtained from official vaccination records before and after intervention implementation.', 'unitOfMeasure': 'percentage of adolescents', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'School District', 'denomUnitsSelected': 'School District'}, {'type': 'SECONDARY', 'title': 'Fidelity of Intervention Across Intervention Schools', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}, {'units': 'School District', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVEST Intervention', 'description': 'INVEST: The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '76.1', 'upperLimit': '98.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'Score items (0-100%) from a study specific checklist (Fidelity Checklist) will be completed by school nurses from intervention schools with a high score (100%) indicating more adherence to the study intervention and 0% indicating the worse score and less adherence to the study intervention', 'unitOfMeasure': 'Percent', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'School District', 'denomUnitsSelected': 'School District', 'populationDescription': 'School nurses from intervention schools.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'INVEST Intervention School Districts', 'description': 'INVEST: The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2868'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2868'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'School District', 'preAssignmentDetails': 'School nurses from intervention schools were not considered enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'INVEST Intervention', 'description': 'INVEST: The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources.'}], 'measures': [{'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Race and Ethnicity Not Collected', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'The participants are school districts; baseline characteristics data were not collected.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-29', 'size': 282621, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-29T11:30', 'hasProtocol': True}, {'date': '2021-12-22', 'size': 199007, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-09-01T12:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2021-08-05', 'resultsFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-10-15', 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the Percentage of Adolescents Who Ever Received at Least One Dose of HPV Vaccination in the Intervention Group After the Intervention Implementation Compared With Before Intervention Implementation', 'timeFrame': 'Baseline, 9 months', 'description': 'HPV vaccination status (received at least one versus no doses) of middle schoolers (by district) will be obtained from official vaccination records before and after intervention implementation.'}], 'secondaryOutcomes': [{'measure': 'Difference in Percentage of Adolescents Who Have Completed the HPV Vaccination Series (2 Doses Depending on Age at Vaccination Initiation) in the Intervention Group After Implementation Compared With Before Intervention Implementation', 'timeFrame': 'Baseline, 9 months', 'description': 'HPV vaccination status (received at least one versus no doses) of middle schoolers (by district) will be obtained from official vaccination records before and after intervention implementation.'}, {'measure': 'Fidelity of Intervention Across Intervention Schools', 'timeFrame': '9 months', 'description': 'Score items (0-100%) from a study specific checklist (Fidelity Checklist) will be completed by school nurses from intervention schools with a high score (100%) indicating more adherence to the study intervention and 0% indicating the worse score and less adherence to the study intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human papillomavirus (HPV)', 'Adolescent', 'School based intervention', 'Vaccine', 'HPV vaccine'], 'conditions': ['Vaccine Hesitancy']}, 'descriptionModule': {'briefSummary': 'The benefits of adolescent vaccines are well known for preventing meningococcal infection and human papillomavirus (HPV)-related pre-cancerous lesions. Yet, many adolescents in the United States (US) remain under-vaccinated, with vaccination rates among rural adolescents significantly lower than among their urban peers. In addition, there are urban-rural disparities in the coverage of HPV vaccine, particularly in Southern states like North and South Carolina, which currently fall below the Healthy People 2020 goal of ≥80% coverage. The goal of the proposed study is to evaluate the feasibility and preliminary efficacy of a school-based intervention for increasing vaccine uptake among adolescents in rural North and South Carolina.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Any public middle school in Cherokee County, South Carolina or Rockingham County, North Carolina school districts'}, 'identificationModule': {'nctId': 'NCT04999267', 'acronym': 'INVEST', 'briefTitle': 'Increasing Vaccine Uptake Among Adolescents in the Rural South', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Tailored School-based Intervention to INcrease VaccinE Uptake Among adoleScenTs (INVEST) in the Rural South', 'orgStudyIdInfo': {'id': 'Pro00101137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INVEST Intervention School Districts', 'interventionNames': ['Other: INVEST']}], 'interventions': [{'name': 'INVEST', 'type': 'OTHER', 'description': 'The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources.', 'armGroupLabels': ['INVEST Intervention School Districts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29340', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Emmanuel Walter, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of South Carolina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}