Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT02744404
Status:
COMPLETED
Last Update Posted:
2018-07-27
First Post:
2016-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point of Care Early Infant Diagnosis Patient Impact Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1752}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2016-04-15', 'studyFirstSubmitQcDate': '2016-04-15', 'lastUpdatePostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ART initiation retention', 'timeFrame': '6-9 months', 'description': 'Proportion of HIV-positive infants initiated on anti-retroviral therapy'}], 'secondaryOutcomes': [{'measure': 'Test turnaround time', 'timeFrame': '6-9 months', 'description': 'Number of days from testing to result being received by the health care facility'}, {'measure': 'Tests received', 'timeFrame': '6-9 months', 'description': 'Proportion of tests received by the health care facility'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be mother-infant pairs from the general population attending the seven clinics for routine HIV-related, PMTCT and post-natal care services. Study subjects will be infants from mother-infant pairs presenting consecutively to the clinic for EID testing per the national EID guidelines during the study period.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Younger than 12 months of age\n* Clinical or other indication for an EID test (screen or confirmation), such as birth to an HIV-positive mother\n\nExclusion Criteria:\n\n* Older than 12 months of age\n* Serious medical conditions which would make testing dangerous for the infant, or disrupt the accuracy of normal laboratory analysis and its interpretation\n* Already initiated ART'}, 'identificationModule': {'nctId': 'NCT02744404', 'briefTitle': 'Point of Care Early Infant Diagnosis Patient Impact Study', 'organization': {'class': 'OTHER', 'fullName': 'Clinton Health Access Initiative Inc.'}, 'officialTitle': 'Evaluation of the Clinical Impact of Point-of-Care HIV Early Infant Diagnostic Technologies', 'orgStudyIdInfo': {'id': 'Malawi POC EID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'POC EID', 'description': 'Point of Care Early Infant Diagnosis qualitative technologies (Alere q) will be implemented. Sample collection and testing will happen in the same location within the health care facility.', 'interventionNames': ['Device: POC EID']}, {'label': 'Laboratory-based testing', 'description': 'Conventional laboratory-based testing using the Abbott m2000 technology will continue to be used per standard of care in Malawi. Dried blood spot samples will be collected at health care facilities and transported within the national network to centralized laboratories for testing.'}], 'interventions': [{'name': 'POC EID', 'type': 'DEVICE', 'armGroupLabels': ['POC EID']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Kamuzu Central Hospital', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'city': 'Liwonde', 'country': 'Malawi', 'facility': 'Machinga District Hospital', 'geoPoint': {'lat': -15.06665, 'lon': 35.22543}}, {'city': 'Mzuzu', 'country': 'Malawi', 'facility': 'Mzuzu Central Hospital', 'geoPoint': {'lat': -11.46556, 'lon': 34.02071}}, {'city': 'Nsanama', 'country': 'Malawi', 'facility': 'Nsanama Health Center', 'geoPoint': {'lat': -14.96667, 'lon': 35.51667}}, {'city': 'Ntaja', 'country': 'Malawi', 'facility': 'Ntaja Health Center', 'geoPoint': {'lat': -15.40641, 'lon': 34.52207}}, {'city': 'Ntcheu', 'country': 'Malawi', 'facility': 'Ntcheu District Hospital', 'geoPoint': {'lat': -14.82027, 'lon': 34.63586}}, {'city': 'Phalombe', 'country': 'Malawi', 'facility': 'Migowi Health Center', 'geoPoint': {'lat': -15.80635, 'lon': 35.65067}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinton Health Access Initiative Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Malawi', 'class': 'OTHER_GOV'}, {'name': 'UNICEF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}