Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00051805
Status:
COMPLETED
Last Update Posted:
2007-09-18
First Post:
2003-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Adherence to Anti-HIV Drug Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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': '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', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-17', 'studyFirstSubmitDate': '2003-01-16', 'studyFirstSubmitQcDate': '2003-01-16', 'lastUpdatePostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pill counts for ARV medications'}], 'secondaryOutcomes': [{'measure': 'Viral load'}, {'measure': 'disease progression measures (CD4 count, viral resistance)'}, {'measure': 'self-reported adherence'}, {'measure': 'self-reported psychosocial measures'}]}, 'conditionsModule': {'keywords': ['Patient Compliance', 'Adherence', 'Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Stewart KE,Greene PG,Ross D,Kratt P, Balentine C, Lee P, Wang Y. Sex, drugs, and viral load: Associations in an HIV+ cohort. In: Society of Behavioral Medicine, 27th Annual Meeting & Scientific Sessions; 2006 Mar 23; San Francisco [CA]: Behavioral Medicine Across the Lifespan. Session Abstracts & Program Information Vol. 31, No. suppl. 1, Pages i-I.'}]}, 'descriptionModule': {'briefSummary': 'One of the main causes of treatment failure in HIV infected individuals is lack of adherence to complicated drug regimens. The purpose of this study is to evaluate the effectiveness of a behavioral intervention program designed to improve adherence to anti-HIV drug regimens. Participants in this study will be recruited from the University of Alabama at Birmingham (UAB) Outpatient HIV Clinic.', 'detailedDescription': 'Poor adherence to complicated antiretroviral (ARV) drug regimens is one of the most pressing behavioral problems in the clinical management of HIV infected persons. Recent medical advances have made it possible to maintain tighter control of viral replication, allowing people with HIV to live longer, healthier lives. However, the complexity of ARV drug regimens and drug side effects make medication adherence problematic. Deviations from the prescribed regimen may allow the virus to resume rapid replication and develop drug resistant mutations that could render the prescribed drugs useless. This study will evaluate the efficacy of a 6-month, theory-based behavioral intervention to enhance adherence to antiretroviral treatment regimens. HIV-related attitudes, depressive symptoms, coping strategies, and social support will also be assessed to examine theoretical assumptions regarding the causal relationship between psychosocial constructs and medication adherence.\n\nParticipants in this study will be recruited from UAB Outpatient HIV Clinic patients who are taking ARV medication. Participants will be randomized to a Standard Adherence Promotion Group or an Enhanced Adherence Promotion Group. The Enhanced Adherence Promotion will systematically address specific psychosocial issues associated with medication adherence. Participants will be followed for 6 months, and adherence will be evaluated at monthly study visits. Pill counts, viral loads, self-reported adherence to ARV medication, CD4 count, and genotypic viral resistance will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* HIV infected\n* Receiving services at UAB Outpatient HIV Clinic\n* Taking antiretroviral medication\n* Able to attend monthly assessment meetings at clinic for 6 months\n* Passing score on Mini Mental State Examination'}, 'identificationModule': {'nctId': 'NCT00051805', 'briefTitle': 'Promoting Adherence to Anti-HIV Drug Regimens', 'nctIdAliases': ['NCT00078780'], 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Promoting Adherence to Antiretroviral Regimens', 'orgStudyIdInfo': {'id': '1R01AI045403-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R01AI045403-01A2', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '3R01AI045403-02S1', 'link': 'https://reporter.nih.gov/quickSearch/3R01AI045403-02S1', 'type': 'NIH'}, {'id': '5R01AI045403-03', 'link': 'https://reporter.nih.gov/quickSearch/5R01AI045403-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Promotion of adherence to ARV medications', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Outpatient HIV Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Polly Kratt, PhD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham Outpatient HIV Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}}}}