Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-28 @ 5:14 AM
Study NCT ID:
NCT06179732
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2023-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C560613', 'term': 'transfluthrin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Neither the deliverers of the intervention nor the outcome assessors are blinded to the group allocations.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'entomological outcome: vector density', 'timeFrame': '7 months', 'description': 'the relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies'}, {'measure': 'epidemiological outcome: malaria incidence', 'timeFrame': '7 months', 'description': 'Malaria incidence will be estimated as the total number of malaria episodes per person over the course of the trial.'}], 'secondaryOutcomes': [{'measure': 'feasibility, acceptance and uptake of Mesh', 'timeFrame': '7 months', 'description': 'To measure community and household acceptance and uptake of Mesh, a questionnaire will be conducted with the Mesh-receiving households.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['malaria', 'cluster randomised trial', 'children', 'vector borne diseases', 'Nigeria', 'Internally Displaced People camps'], 'conditions': ['Malaria', 'Childhood ALL', 'Vector Borne Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial.\n\nBy conducting the research in challenging camp settings in the north of Nigeria, the MENTOR Initiative aims to determine whether Mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Shelters with 1 or more children from 6-10 years old\n* Shelters with an adult/head of the household\n\nExclusion Criteria:\n\n* Shelters without children from 6-10 years old'}, 'identificationModule': {'nctId': 'NCT06179732', 'briefTitle': 'Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities', 'organization': {'class': 'OTHER', 'fullName': 'The Mentor Initiative'}, 'officialTitle': 'Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities:A Cluster Randomised Trial', 'orgStudyIdInfo': {'id': 'USDA01YEM - Nigeria'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home).\n2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age'}, {'type': 'EXPERIMENTAL', 'label': 'Mesh', 'description': '1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home).\n2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age\n3. Mesh product distributed to households', 'interventionNames': ['Combination Product: Mesh - spatial repellent impregnated with transfluthrin (2500mg)', 'Behavioral: Information and Education Campaigns (IEC)', 'Diagnostic Test: test and treat malaria cases']}], 'interventions': [{'name': 'Mesh - spatial repellent impregnated with transfluthrin (2500mg)', 'type': 'COMBINATION_PRODUCT', 'description': 'Mesh is one of the first spatial repellent tools to provide long-lasting protection to users, with predicted efficacy of 6-months. The active ingredient of Mesh is transfluthrin, a fast-acting volatile pyrethroid with low persistency, which can act either by killing or via sublethal toxicity that causes deviation (repellency) in host attraction, reducing host-contact and risk of infectious bites. The chemical passively releases into the air and interacts with vector odour receptors causing irritation. The design of Mesh is simple with a transfluthrin-infused sheet protected by plastic mesh and encased in a plastic frame.\n\nMesh will be distributed to the intervention arm only.', 'armGroupLabels': ['Mesh']}, {'name': 'Information and Education Campaigns (IEC)', 'type': 'BEHAVIORAL', 'description': 'IEC campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home) using leaflets and word of mouth. IEC will be conducted in both arms.', 'armGroupLabels': ['Mesh']}, {'name': 'test and treat malaria cases', 'type': 'DIAGNOSTIC_TEST', 'description': 'All children in the cohort (both arms) will be tested by rapid diagnostic testing (RDT) monthly. If any children test positive, they will be treated with a course of 3-day artemisinin combination therapy (ACT) according to standard protocol and local guidelines. All children in the cohort will receive ACT to provide clearance of any malaria parasites during the baseline of the study.', 'armGroupLabels': ['Mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RH16 1PG', 'city': 'Haywards Heath', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': 'Sara Estecha Querol', 'geoPoint': {'lat': 50.99769, 'lon': -0.10313}}], 'overallOfficials': [{'name': 'Richard Allan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Mentor Initiative'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Mentor Initiative', 'class': 'OTHER'}, 'collaborators': [{'name': 'Liverpool School of Tropical Medicine', 'class': 'OTHER'}, {'name': 'University of Maiduguri', 'class': 'OTHER'}, {'name': 'US government', 'class': 'UNKNOWN'}, {'name': 'SCJohnson', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}