Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-01 @ 5:01 PM
Study NCT ID:
NCT01140633
Status:
COMPLETED
Last Update Posted:
2013-09-02
First Post:
2010-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma samples with HIV viral DNA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-30', 'studyFirstSubmitDate': '2010-06-07', 'studyFirstSubmitQcDate': '2010-06-08', 'lastUpdatePostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of adherence', 'timeFrame': 'Monthly adherence levels will be determined over the six-month study period.', 'description': 'Distribution of adherence based on wireless adherence monitoring devices and interactive voice response (IVR) or short message service (SMS) self report by caregivers of HIV-infected children under ten years old in Mbarara, Uganda.'}], 'secondaryOutcomes': [{'measure': 'Feasibility and acceptability of wireless adherence measures', 'timeFrame': 'Assessments will be made a the one-month time point.', 'description': 'Quantitive rating and qualitative description of the feasibility and acceptability of wireless adherence measures'}, {'measure': 'Model of adherence behavior', 'timeFrame': 'Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period.', 'description': 'Qualitative data will be used to explore a theoretical model of adherence behavior among young children in a rural African setting'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV/AIDS', 'pediatric', 'wireless adherence monitoring', 'HIV Infections'], 'conditions': ['HIV-infection/Aids']}, 'descriptionModule': {'briefSummary': "Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Real-time objective adherence monitoring could redirect efforts from a reactive response to the proactive prevention of treatment failure. Because adherence is so closely associated with viral suppression, accurate adherence monitoring could also strategically limit viral monitoring only to those patients at a defined risk for viral rebound.\n\nThis observational study is assessing a wireless adherence monitoring device and mobile phone-based adherence data collection among caregivers of children under the age of ten years in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility and acceptability of these measures, as well as circumstances of adherence lapses and other individual and cultural factors affecting adherence. The qualitative data will be used to explore models of adherence behavior, which will likely include the child-caregiver dynamic, the child's mental and physical health, and social support mechanism.", 'detailedDescription': 'See above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'young children receiving HIV antiretroviral therapy in a rural African setting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 1 to 10 years\n* HIV-infected, meeting Ugandan criteria for antiretroviral therapy\n* living within 30 km of Mbarara, Uganda\n\nExclusion Criteria:\n\n* lack of mobile-phone reception'}, 'identificationModule': {'nctId': 'NCT01140633', 'briefTitle': 'Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda', 'orgStudyIdInfo': {'id': '2009-P-001062'}, 'secondaryIdInfos': [{'id': 'K23MH087228', 'link': 'https://reporter.nih.gov/quickSearch/K23MH087228', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mbarara', 'country': 'Uganda', 'facility': 'Mbarara University Teaching Hospital', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'overallOfficials': [{'name': 'Jessica E Haberer, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Mbarara University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant in Medicine', 'investigatorFullName': 'Jessica Haberer, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}