Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT00241202
Status:
COMPLETED
Last Update Posted:
2008-01-17
First Post:
2005-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of the HIV/AIDS Symptom Management Manual
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 775}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-14', 'studyFirstSubmitDate': '2005-10-13', 'studyFirstSubmitQcDate': '2005-10-14', 'lastUpdatePostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.', 'timeFrame': '1 month and 2 months'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life.', 'timeFrame': '1 month and 2 months'}, {'measure': 'Change in adherence.', 'timeFrame': '1 month and 2 months'}, {'measure': 'Change in symptoms.', 'timeFrame': '1 month and 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['signs and symptoms', 'self care', 'patient compliance', 'quality of life'], 'conditions': ['HIV', 'Acquired Immunodeficiency Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aidsnursingucsf.org', 'label': "Sponsor's website"}]}, 'descriptionModule': {'briefSummary': 'The goals of this research are: 1) To test the efficacy of a self-care symptom management manual by examining whether people who use the manual find it to be useful; 2) To examine symptom and demographic data related to self-care behaviors, symptom control, medication adherence and enhanced quality of life.\n\nThe University of California, San Francisco is the coordinating site for this multi-site international study.', 'detailedDescription': "People living with HIV/AIDS encounter many psychological, physiological, and cognitive symptoms, such as pain, diarrhea, fever, fatigue, depression, and confusion. These symptoms have been found to restrict a person's daily life significantly. Self-management of multiple HIV and medication side effects symptoms and maintaining optimal quality of life have, therefore, become major daily tasks for people living with HIV/AIDS.\n\nThis study is a randomized controlled trial with a two-group repeated measures design to test the efficacy of the symptom management manual. Two groups (experimental and control) will be assessed in a repeated measures design at 3 time points: baseline (time 0), one month (time 1), and two months (time 2). Data will be analyzed using longitudinal mixture modeling.\n\nComparison(s): HIV-positive patients receiving a symptom management manual and orientation to the manual, compared to HIV-positive patients receiving a nutrition manual and orientation to the manual."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed HIV/AIDS\n* Adult (men and women, transgender)\n* Presence of at least one symptom within the past week\n* Consent\n* May or may not be pregnant\n* May or may not be on ART\n* Able to use the manual with or without family support\n\nExclusion Criteria:\n\n* Documented diagnosis of dementia\n* Unable to understand consent procedure as judged by the person getting consent\n* Self-reporting no symptoms within the past week\n* Self-reports having had experience with a self-care Symptom Management Manual'}, 'identificationModule': {'nctId': 'NCT00241202', 'briefTitle': 'The Efficacy of the HIV/AIDS Symptom Management Manual', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Efficacy of the HIV/AIDS Symptom Management Manual', 'orgStudyIdInfo': {'id': 'H642-27289'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Symptom Management Manual', 'type': 'BEHAVIORAL', 'otherNames': ['HIV/AIDS Symptom Management Strategies: A Manual for PLWHA'], 'description': 'Participants receive the Symptom Management Manual, and are shown an example. They are given the Manual to take home with them and use.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "San Francisco Veteran's Affairs Medical Center", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143-0378', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'PositiveHealth Practice', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60649', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Jackson Park Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02116', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Living Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '78550', 'city': 'Harlingen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley AIDS Clinic - Harlingen', 'geoPoint': {'lat': 26.19063, 'lon': -97.6961}}, {'zip': '77009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Thomas Street Health Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Science Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Nairobi', 'country': 'Kenya', 'facility': 'Nazareth Hospital', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}, {'zip': '00936', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'AIDS Clinical Trials Unit', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00693', 'city': 'Vega Baja', 'country': 'Puerto Rico', 'facility': 'Casita de Salud Integral Ramón Vicente, Universidad del Turabo', 'geoPoint': {'lat': 18.44439, 'lon': -66.38767}}, {'zip': '0001', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'PAH ARV Clinic - Tshwane District Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}], 'overallOfficials': [{'name': 'William L. Holzemer, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'University of Puerto Rico', 'class': 'OTHER'}, {'name': 'Aga Khan University', 'class': 'OTHER'}, {'name': 'University of South Africa', 'class': 'OTHER'}, {'name': 'Universidad del Turabo', 'class': 'UNKNOWN'}, {'name': 'Texas A&M University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'William L. Holzemer', 'oldOrganization': 'University of California, San Francisco'}}}}