Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
Study NCT ID:
NCT04102592
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2019-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Getting Malaria "Off the Back" of Women and Children in Western Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to control (25) or intervention group (25)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reported change in frequency of use of lesu', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Self-reported, includes discontinuation of use'}], 'secondaryOutcomes': [{'measure': 'Incidence of symptomatic malaria episodes among children', 'timeFrame': '12 weeks', 'description': 'As defined by typical symptoms including fever, malaise, and convulsions.'}, {'measure': 'Incidence of P. falciparum malaria parasitemia among children', 'timeFrame': '12 weeks', 'description': 'As determined by quantitative PCR'}, {'measure': 'Change in mosquito salivary antigen response among children', 'timeFrame': 'Baseline, 12 weeks'}, {'measure': 'Change in mosquito salivary antigen response among mothers', 'timeFrame': 'Baseline, 12 weeks'}, {'measure': 'Changes in hemoglobin levels among children', 'timeFrame': 'Baseline, 12 weeks'}, {'measure': 'Changes in hemoglobin levels among mothers', 'timeFrame': 'Baseline, 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malaria', 'P. Falciparum', 'Permethrin', 'Rapid diagnostic test'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '35197060', 'type': 'DERIVED', 'citation': 'Boyce RM, Muhindo E, Baguma E, Muhindo R, Shem B, Francois R, Hawke S, Shook-Sa BE, Ntaro M, Nalusaji A, Nyehangane D, Reyes R, Juliano JJ, Siedner MJ, Staedke SG, Mulogo EM. Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda. Malar J. 2022 Feb 23;21(1):63. doi: 10.1186/s12936-022-04086-w.'}]}, 'descriptionModule': {'briefSummary': 'This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of P. falciparum malaria among infants in a rural area of western Uganda. Participants will be recruited from four villages immediately adjacent to the Bugoye Level III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of western Uganda.\n\nThe purpose of the study is to assess the feasibility and tolerability of using insecticide-treated lesus to reduce the incidence of P. falciparum malaria infection among infants.', 'detailedDescription': 'This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of P. falciparum malaria among infants in a rural area of western Uganda. Participants will be recruited from four villages immediately adjacent to the Bugoye Level III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of western Uganda.\n\nThe first phase will consist of a series of focus group sessions with mothers of young children and their male partners to gain further insight into lesu use, to include location of purchase and frequency of washing, as well as exploring initial perceptions of insecticide-treated clothing and inform the protocols for the open-label study.\n\nThe second phase will consist of a prospective, open-label study. Twenty-five (25) mothers and their young children will be provided with insecticide-treated lesus and twenty-five (25) controls who will be provided untreated lesus. After an initial visit, bi-weekly follow up, including finger-prick blood collections will continue for a period of twelve (12) weeks.\n\nCollected blood spots will be transported to Epicentre for real-time PCR to identify sub-microscopic parasitemia and to the French Research Institute for Development (https://en.ird.fr) in Marseille, France for quantification of the mosquito salivary antigen (gSG6-P1 peptide). Remaining samples will be stored for future analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women (age greater or equal to 18 years) with a healthy child between the ages of 6 months to 18 months from one of four eligible villages\n\nExclusion Criteria:\n\n* Mother or child with HIV (and thus taking cotrimoxazole prophylaxis)'}, 'identificationModule': {'nctId': 'NCT04102592', 'briefTitle': 'Getting Malaria "Off the Back" of Women and Children in Western Uganda', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'IGHID 11829 - Getting Malaria "Off the Back" of Women and Children in Western Uganda', 'orgStudyIdInfo': {'id': '18-1819'}, 'secondaryIdInfos': [{'id': 'IGHID 11829', 'type': 'OTHER', 'domain': 'University of North Carolina at Chapel Hill'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Participants in this arm receive Lesu (baby wrap) treated with 0.5% permethrin', 'interventionNames': ['Other: Permethrin-treated Lesu (baby wrap)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in this arm receive Lesu (baby wrap) soaked with water only to mimic re-treatment and mask allotment', 'interventionNames': ['Other: Untreated Lesu (baby wrap)']}], 'interventions': [{'name': 'Permethrin-treated Lesu (baby wrap)', 'type': 'OTHER', 'description': '0.5% permethrin application', 'armGroupLabels': ['Intervention Group']}, {'name': 'Untreated Lesu (baby wrap)', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'Matching untreated lesu', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bugoye', 'state': 'Kasese', 'country': 'Uganda', 'facility': 'Bugoye Level III Health Centre', 'geoPoint': {'lat': 1.16667, 'lon': 32.33333}}], 'overallOfficials': [{'name': 'Ross Boyce, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '9 to 36 months following publication', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conservation, Food, and Health Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}