Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-21 @ 1:03 PM
Study NCT ID:
NCT00661258
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2008-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
China Antiretroviral Treatment Adherence for Life
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lsabin@bu.edu', 'phone': '617-414-1272', 'title': 'Dr. Lora Sabin', 'organization': 'Boston University Center for Global Health and Development'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year of data collection', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': "The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.", 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for "enhanced counseling" with a doctor. This counseling was based on the patient\'s self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output.', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change in CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data."}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for'}], 'classes': [{'categories': [{'measurements': [{'value': '90.0', 'spread': '171.6', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '152.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6, Month 12', 'description': 'Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Adherence, as Measured by Electronic Drug Monitors (EDM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data."}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for'}], 'classes': [{'title': 'Mean adherence in Month 12', 'categories': [{'measurements': [{'value': '96.5', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '84.5', 'spread': '21.0', 'groupId': 'OG001'}]}]}, {'title': 'Mean adherence in intervention period (Months 7-12', 'categories': [{'measurements': [{'value': '96.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '84.1', 'spread': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12 (last month of 6-month intervention period) and 6-month post-intervention period', 'description': "We used the electronic drug monitors (EDM) adherence metric that was found to be most strongly associated with viral suppression (HIV RNA \\<400 copies/ml) in analysis of the pre-intervention data, EDM 'proportion taken within dose time' (see Gill et al, 2009). This measure estimated monthly adherence as the proportion of prescribed doses taken on time, e.g., within 1 hour of scheduled dose time (\\[number of doses taken ±1 hour of dose time\\] / \\[total number of prescribed doses\\]).", 'unitOfMeasure': 'percentage of doses taken on time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 68 subjects randomized at 6 months, 64 completed the full 12 months of data collection, 31 in Intervention Arm and 33 in Comparison Arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': "The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data."}, {'id': 'FG001', 'title': 'Control', 'description': 'The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for "enhanced counseling" with a doctor. This counseling was based on the patient\'s self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'caught by police and in detox center', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "A total of 80 patients were recruited at the Dali 2nd People's Hospital, in Dali, Yunnan Province, from June to November 2006 in the 6-month pre-intervention period. A total of 68 patients completed this passive phase and were randomized to intervention vs. control arm."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': "The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data."}, {'id': 'BG001', 'title': 'Control', 'description': 'The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for "enhanced counseling" with a doctor. This counseling was based on the patient\'s self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '35.1', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '35.6', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2008-04-11', 'resultsFirstSubmitDate': '2013-04-19', 'studyFirstSubmitQcDate': '2008-04-15', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-11', 'studyFirstPostDateStruct': {'date': '2008-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Adherence, as Measured by Electronic Drug Monitors (EDM)', 'timeFrame': 'Month 12 (last month of 6-month intervention period) and 6-month post-intervention period', 'description': "We used the electronic drug monitors (EDM) adherence metric that was found to be most strongly associated with viral suppression (HIV RNA \\<400 copies/ml) in analysis of the pre-intervention data, EDM 'proportion taken within dose time' (see Gill et al, 2009). This measure estimated monthly adherence as the proportion of prescribed doses taken on time, e.g., within 1 hour of scheduled dose time (\\[number of doses taken ±1 hour of dose time\\] / \\[total number of prescribed doses\\])."}], 'secondaryOutcomes': [{'measure': 'Change in CD4 Count', 'timeFrame': 'Month 6, Month 12', 'description': 'Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV antiretroviral treatment adherence intervention China', 'adherence to antiretroviral treatment', 'treatment experienced'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This study focuses on collecting and analyzing quantitative data related to adherence to antiretroviral treatment from patients in Dali, China, over a one-year time-frame and generating preliminary data on an intervention designed to improve adherence to antiretroviral treatment among the study population.', 'detailedDescription': 'This study is a continuation of "Adherence for Life (AFL): Phase I: Exploratory Research" (H-25203), which focused on collecting and analyzing qualitative data on adherence to antiretroviral treatment (ART) among HIV-positive patients in Dali, Yunnan Province, China. Like Phase I, the AFL Pilot Study (Phases II and III) will be a collaborative effort between US researchers based in Boston, MA and Chinese researchers based in Beijing and Dali. The current study, Phases II and III, will focus on collecting and analyzing qualitative and quantitative data related to adherence to ART over a one-year time-frame and generating preliminary data on an intervention designed to improve adherence to ART among the study population. The questionnaires used in these phases of the study will draw on the results of Phase I as well as standardized instruments adapted to the Chinese context. The specific aims of the study are as follows: (1) To determine the best surrogate measure of ART adherence among the study population; (2) To determine ART adherence rates in this population; (3) To analyze the relationship between adherence factors and measured adherence rates; and (4) To generate preliminary effectiveness data on an intervention that makes use of electronic drug monitors (EDM) to improve ART adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are 18 years of age or older, currently on antiretroviral treatment or about to begin it, live in the study catchment area, and are willing to provide informed consent.\n\nExclusion Criteria:\n\n* Persons below the age of 18 years, persons who are not currently on or about to start antiretroviral treatment, persons who live outside the study catchment area, or person not willing to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT00661258', 'acronym': 'AFL', 'briefTitle': 'China Antiretroviral Treatment Adherence for Life', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Antiretroviral Treatment Adherence for Life Pilot Study: Phases II and III', 'orgStudyIdInfo': {'id': 'H-25495'}, 'secondaryIdInfos': [{'id': 'GHS-A-00-03-00030-00', 'type': 'OTHER_GRANT', 'domain': 'GHS-A-00-03-00030-00'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "The intervention group patients were given their electronic drug monitoring feedback data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.", 'interventionNames': ['Behavioral: Electronic drug monitoring feedback data']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison', 'description': 'The comparison group patients were not given the data from the electronic data monitoring feedback data. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for "enhanced counseling" with a doctor. This counseling was based on the patient\'s self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output.'}], 'interventions': [{'name': 'Electronic drug monitoring feedback data', 'type': 'BEHAVIORAL', 'description': 'All patients were given electronic drug monitors that can monitor pill-taking behavior. In the intervention arm, patients and their attending doctors were given the electronic drug monitoring data on pill bottle openings at each monthly visit for use in adherence counseling sessions. Control arm patients were not given their electronic drug monitoring feedback data and their counseling sessions were based on self-reported adherence, as per standard of care in Dali.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dali', 'state': 'Yunnan', 'country': 'China', 'facility': "Dali Second People's Hospital", 'geoPoint': {'lat': 25.58474, 'lon': 100.21229}}], 'overallOfficials': [{'name': 'Lora L Sabin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for International Health and Development, Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, {'name': "Second People's Hospital, Dali", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lora Sabin', 'investigatorAffiliation': 'Boston University'}}}}