Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT00720733
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2008-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intervention for (Those) Recently Informed of Seropositive Status (IRISS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2008-07-21', 'studyFirstSubmitQcDate': '2008-07-22', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the efficacy of the Intervention for those Recently Informed of their Seropositive Status (IRISS) for increasing the frequency and intensity of positive affect in men and women newly diagnosed with HIV.', 'timeFrame': 'During the intervention and at 5- 10- and 15-months after diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Effects on outcomes and if increases in positive affect are responsible for improvements; effects of individual facets on affect and outcomes; and, evaluate extent to which personality, se status, race/ethn, & stress level, moderate effects on outcomes.', 'timeFrame': 'At 15 months post diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Mood', 'Emotion', 'Coping', 'Aids', 'Affect', 'Adults', 'Diagnosed'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '28333512', 'type': 'DERIVED', 'citation': 'Moskowitz JT, Carrico AW, Duncan LG, Cohn MA, Cheung EO, Batchelder A, Martinez L, Segawa E, Acree M, Folkman S. Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV. J Consult Clin Psychol. 2017 May;85(5):409-423. doi: 10.1037/ccp0000188. Epub 2017 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'An intervention designed to increase positive affect in a population newly diagnosed with HIV will be effective at improving affect and HIV-related outcomes such as mental and physical health, coping and coping resources.', 'detailedDescription': 'The study is a randomized controlled trial of a 5-session positive affect skills intervention compared to an attention-matched control condition. Participants will be 200 men and women who have tested positive for HIV within the past 12 weeks. Both intervention and control sessions will be approximately one hour long and will be administered one-on-one by trained facilitators. Both groups will have daily home practice over the 5 weeks of the intervention. At the end of the assessment period, participants in the control condition will have the opportunity to attend a ½ day group session that provides a condensed version of the positive affect skills taught in the intervention condition. Participants will complete assessments at four points and CD4 and viral load assays will be run at 3 time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have been informed they were HIV positive within the past 12 weeks\n* speak English or Spanish\n* be 18 years or older\n* have the ability to provide informed consent to be a research participant.\n\nExclusion Criteria:\n\n* inability to provide informed consent, as evidenced by cognitive impairment as assessed by trained interviewers and confirmed by a licensed clinical psychologist\n* active psychosis as assessed by trained interviewers and confirmed by clinical psychologist'}, 'identificationModule': {'nctId': 'NCT00720733', 'acronym': 'IRISS', 'briefTitle': 'Intervention for (Those) Recently Informed of Seropositive Status (IRISS)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Positive Affect Intervention for Those Recently Diagnosed With HIV', 'orgStudyIdInfo': {'id': 'RMH084723A'}, 'secondaryIdInfos': [{'id': '1RO1MHO84723-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Skills Building Group', 'interventionNames': ['Behavioral: Skills-Building Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Personal Interview Group', 'interventionNames': ['Behavioral: Personal Interview Group']}], 'interventions': [{'name': 'Skills-Building Intervention', 'type': 'BEHAVIORAL', 'description': 'A 5-week intervention including 5 weekly sessions covering 8 varied coping skills with daily home practice. The skills are: 1) noting daily positive events; 2) capitalizing on positive events; 3) gratitude; 4) mindfulness; 5) positive reappraisal; 6) focusing on personal strengths; 7) setting and working toward attainable goals; and 8) small acts of kindness. Sessions are 1 hour long and include approximately 30 minutes per day.', 'armGroupLabels': ['1']}, {'name': 'Personal Interview Group', 'type': 'BEHAVIORAL', 'description': 'There are 5 weekly sessions which will be approximately one hour long and will consist of personal interview. The interviews will include both quantitative and qualitative questions. Each session will have a separate theme including: Life 1) History; 2) Health History; 3) Personality; 4) Social Networking; and, 5) Meaning \\& Purpose.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Judith T Moskowitz, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}