Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT02191527
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2013-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013587', 'term': 'Syphilis'}], 'ancestors': [{'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Before and after intervention study design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1673}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2013-08-15', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.', 'timeFrame': 'Within 1 month', 'description': 'Number of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women'}], 'secondaryOutcomes': [{'measure': 'Proportion of women at first ANC visit tested and treated for syphilis', 'timeFrame': 'Within 1 month', 'description': 'Number of women at first ANC tested and treated for syphilis divided by the number of women attending first ANC visit'}, {'measure': 'The proportion of pregnant women tested and treated for anemia', 'timeFrame': 'Within 1 month', 'description': 'Number of pregnant women test and treated for anemia divided by the number of pregnant women'}, {'measure': 'Number of HIV infections in infants averted', 'timeFrame': '1-3 months of age', 'description': 'Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PMTCT', 'HIV', 'Syphilis', 'Anemia during pregnancy', 'Point of care diagnostics'], 'conditions': ['HIV', 'Syphilis', 'Anemia During Pregnancy']}, 'descriptionModule': {'briefSummary': 'The general goal of the proposed study is to evaluate the cost-effectiveness of POC technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting performed within MCH services to improve maternal and infant health.\n\nA prospective, quasi-experimental study will be done in Cabo Delgado province, where health facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and infant health will be measured.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First antenatal care visit\n* Able to provide informed consent and signed consent form\n* Minimum 18 years of age\n* Diagnosed HIV positive at antenatal care visit\n* Living in the catchment area of the health facility\n\nExclusion Criteria:\n\n* Age \\<18 years\n* No consent form signed\n* Being on ART at time of first antenatal care visit'}, 'identificationModule': {'nctId': 'NCT02191527', 'briefTitle': 'Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique', 'organization': {'class': 'OTHER', 'fullName': 'Elizabeth Glaser Pediatric AIDS Foundation'}, 'officialTitle': 'Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services and Their Impact on Mother and Child Health Outcomes in Cabo Delgado Province, Mozambique', 'orgStudyIdInfo': {'id': 'EGPAF-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Point of Care Testing', 'description': 'The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.', 'interventionNames': ['Device: PIMA® for quantitative analysis of CD4-count', 'Device: Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin', 'Device: SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis']}, {'type': 'NO_INTERVENTION', 'label': 'Laboratory Testing - Standard of care', 'description': 'Samples sent to the laboratory for analysis, (standard of care)'}], 'interventions': [{'name': 'PIMA® for quantitative analysis of CD4-count', 'type': 'DEVICE', 'armGroupLabels': ['Point of Care Testing']}, {'name': 'Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin', 'type': 'DEVICE', 'armGroupLabels': ['Point of Care Testing']}, {'name': 'SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis', 'type': 'DEVICE', 'armGroupLabels': ['Point of Care Testing']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Caroline DeSchacht, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation'}, {'name': 'Ilesh V Jani, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Saúde, Mozambique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Glaser Pediatric AIDS Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Mozambique', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}