Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-25 @ 7:18 AM
Study NCT ID:
NCT03049332
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2017-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self- and Family-management Intervention in HIV+ Chinese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The same group of individuals will be measured pre and post intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2017-02-07', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retention rates', 'timeFrame': '6 months', 'description': 'the percentage of self- and family-management intervention sessions attended by both HIV+ women and one family member'}, {'measure': 'compliance with data collection procedures', 'timeFrame': '6 months', 'description': 'includes attending counseling sessions and completing questionnaires'}, {'measure': 'acceptability', 'timeFrame': '6 months', 'description': 'including reports of burden related to the study and/or intervention procedures measured by intervention session logs and exit interview'}, {'measure': 'feelings of safety', 'timeFrame': '6 months', 'description': 'family members and study participants feelings of safety related to participating in this project measured by intervention session logs and exit interview'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of Life'], 'conditions': ['Hiv']}, 'referencesModule': {'references': [{'pmid': '35705934', 'type': 'DERIVED', 'citation': 'Chen WT, Shiu C, Zhang L, Zhao H. Care engagement with healthcare providers and symptom management self-efficacy in women living with HIV in China: secondary analysis of an intervention study. BMC Public Health. 2022 Jun 15;22(1):1195. doi: 10.1186/s12889-022-13573-3.'}]}, 'descriptionModule': {'briefSummary': 'This project is to develop a culturally sensitive and feasible self- and family-management intervention that will assist HIV+ Chinese women and their families to manage the illness and improve quality of life and clinical outcomes.', 'detailedDescription': 'The study will be conducted in 3 phases.\n\nPhase 1: The PI conducted a secondary qualitative analysis of in-depth interviews to further illuminate the sociocultural and family context of HIV+ Chinese women. The data were obtained from three previous projects conducted in China from 2005 to 2011.\n\nPhase 2: The PI developed and adapted a theory-driven, culturally sensitive and feasible intervention to improve the quality of life and clinical outcomes of HIV+ Chinese women and their families.\n\nPhase 3: The PI conducted a feasibility, compliance, and acceptability study for a self- and family-management intervention with HIV+ women and of their family members.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for HIV+ women.\n\n* be at least 18 years of age,\n* be able to give informed consent for the study and to cognitively participate,\n* be receiving clinical care at Ditan Hospital and SPHCC,\n* have been diagnosed with HIV within the past 12 months,\n* have disclosed their status to at least one family member and willing to invite that family member to the intervention,\n* be well enough to attend counseling sessions at the hospital, and\n* be able to attend follow-up visits at the hospital.\n\nInclusion criteria for family members.\n\n* be 18 years of age,\n* be able to give informed consent for the study and to cognitively participate,\n* have a female family member who is HIV+, and is currently receiving clinical care at Ditan Hospital and SPHCC,\n* be a family member who are taking care of the female HIV+ family member,\n* be well enough to attend counseling sessions at the hospital, and\n* be able to attend follow-up visits at the hospital.\n\nExclusion Criteria:\n\nExclusion criteria for HIV+ women\n\n* history of an affective illness such as depression or bipolar disease,\n* are under age 18, or\n* are unwilling or unable to bring a family member to participate in the study.\n\nExclusion criteria for family members.\n\n* have a history of an affective illness such as depression or bipolar disease,\n* are under age 18,\n* or are unwilling or unable to come with their HIV+ family member to participate the study.'}, 'identificationModule': {'nctId': 'NCT03049332', 'briefTitle': 'Self- and Family-management Intervention in HIV+ Chinese Women', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Self- and Family-management Intervention in HIV+ Chinese Women', 'orgStudyIdInfo': {'id': '1207010522'}, 'secondaryIdInfos': [{'id': 'K23NR014107-02', 'link': 'https://reporter.nih.gov/quickSearch/K23NR014107-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All participants', 'description': 'HIV+ Chinese women in China and a family member will be recruited for the pilot testing of the intervention.', 'interventionNames': ['Behavioral: self- and family-management intervention sessions']}], 'interventions': [{'name': 'self- and family-management intervention sessions', 'type': 'BEHAVIORAL', 'description': 'The self- and family management intervention will have six elements: (a) biofeedback for relaxation; (b) family support; (c) coping skills; (d) anxiety, stress, and depression management; (e) cognitive-behavioral management skills; and (f) psycho-educational classes.', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Ditan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Public Health Clinical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Weiti Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University School of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Public Health Clinical Center', 'class': 'OTHER_GOV'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}