Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-06 @ 3:33 PM
Study NCT ID:
NCT00870792
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D055118', 'term': 'Medication Adherence'}], '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'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antiretroviral medication adherence as assessed by electronic pill cap monitoring.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Self-reported medication adherence', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'antiretroviral therapy', 'medication adherence', 'Treatment Experienced'], 'conditions': ['HIV Infection', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '17577653', 'type': 'BACKGROUND', 'citation': 'Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.'}, {'pmid': '18503620', 'type': 'BACKGROUND', 'citation': 'Vranceanu AM, Safren S, Cowan J, Ring D. The development of the negative pain thoughts questionnaire. Pain Pract. 2008 Sep-Oct;8(5):337-41. doi: 10.1111/j.1533-2500.2008.00213.x. Epub 2008 May 23.'}]}, 'descriptionModule': {'briefSummary': "We hypothesized that providing physicians treating with HIV disease, at the time of a routine outpatient visit, with a detailed report describing patients' adherence with HIV antiretroviral medications, would improve the quality of the physician-patient interaction, and also patients' subsequent adherence."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* on ART\n* willing to use MEMS cap\n* speaks and reads English\n* detectable viral loads\n\nExclusion Criteria:\n\n* uses a pill box'}, 'identificationModule': {'nctId': 'NCT00870792', 'acronym': 'MAP', 'briefTitle': 'Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals', 'orgStudyIdInfo': {'id': 'ibwadhrct88$'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Received report', 'interventionNames': ['Behavioral: Adherence report']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Routine care', 'description': 'Patients receive usual, routine, care.', 'interventionNames': ['Behavioral: Adherence report']}], 'interventions': [{'name': 'Adherence report', 'type': 'BEHAVIORAL', 'description': 'During the intervention phase, the data collected at the study visit were summarized in a 3-page report that was given to the provider before each intervention visit. The report included data on self-reported adherence, MEMS adherence, reminder use, beliefs about ART, reasons for missed doses, alcohol and drug use, and depression.', 'armGroupLabels': ['Received report', 'Routine care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ira B. Wilson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Ira B. Wilson, MD, MSc', 'oldOrganization': 'Tufte Medical Center'}}}}