Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-10 @ 8:48 PM
Study NCT ID:
NCT01892228
Status:
UNKNOWN
Last Update Posted:
2015-05-12
First Post:
2013-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Immediate HIV Treatment in Guangxi, China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-11-30', 'releaseDate': '2015-10-27'}], 'estimatedResultsFirstSubmitDate': '2015-10-27'}}, '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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2013-05-18', 'studyFirstSubmitQcDate': '2013-06-30', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '12 months', 'description': 'HIV-related mortality rates of participants who are newly diagnosed during the study period Numerator: Number of all-cause deaths during the study period Denominator: Number of HIV infected patients followed during the study period.'}, {'measure': 'ART treatment coverage', 'timeFrame': '12 months', 'description': 'Percentage of newly diagnosed HIV-infected participants who receive ART Numerator: Number of patients who are diagnosed with HIV and initiate ART during the study period Denominator: Number of newly reported HIV cases during the study period'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '36 months', 'description': 'mortality rates of participants who are newly diagnosed during the study period Numerator: Number of all-cause deaths during the study period Denominator: Number of HIV infected patients followed during the study period.'}, {'measure': 'ART treatment coverage', 'timeFrame': '36 months', 'description': 'Percentage of newly diagnosed HIV-infected participants who receive ART Numerator: Number of patients who are diagnosed with HIV and initiate ART during the study period Denominator: Number of newly reported HIV cases during the study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antiretroviral therapy', 'education', 'mortality'], 'conditions': ['HIV', 'Acquired Immunodeficiency Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to measure the effectiveness of a pilot program in Guangxi, China to decrease mortality related to HIV.\n\nThe study\'s proposed mechanism of decreasing mortality rates is to shorten the time between initial HIV screening and ART implementation to within two weeks.\n\nThe study population consists of participants who received an initial HIV infection diagnosis within the study period. Medical institutions will provide "one-stop services" by following detailed guidelines regarding reporting of positive HIV antibody screenings, further testing procedures, and treatment referrals in accordance with a pre-determined timetable. In addition, additional strategies focusing on policy development, medical personnel training, and a broad general public education campaign will be implemented.\n\nMain assessment measures are HIV-related mortality rates, treatment coverage, or other health outcomes.', 'detailedDescription': 'The aim of the study is to measure the effectiveness of a pilot program in Guangxi, China to decrease mortality related to HIV/AIDS. In past years, Guangxi has experienced a relatively high rate of late HIV diagnoses, which has contributed to a significant proportion of HIV-related deaths occurring in the same year of initial diagnosis. The study\'s proposed mechanism of decreasing mortality rates is to shorten the time between initial HIV screening and ART implementation to within two weeks.\n\nTwo pilot sites were selected based on past core assessment indicators. The study population consists of participants who received an initial HIV infection diagnosis within the study period. Medical institutions will provide "one-stop services" by following detailed guidelines regarding reporting of positive HIV antibody screenings, further testing procedures, and treatment referrals in accordance with a pre-determined timetable. In addition, additional strategies focusing on policy development, medical personnel training, and a broad general public education campaign will be implemented.\n\nThe study will be performed from July,2012 to July,2015. Main assessment measures are HIV-related mortality rates, treatment coverage, or other health outcomes.\n\n1. HIV-related mortality rates of participants who are newly diagnosed during the study period Numerator: Number of all-cause deaths during the study period Denominator: Number of HIV infected patients followed during the study period.\n2. Percentage of newly diagnosed HIV-infected participants who receive ART Numerator: Number of patients who are diagnosed with HIV and initiate ART during the study period Denominator: Number of newly reported HIV cases during the study period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New diagnosis of HIV infection as defined by having positive HIV antibody screening results between July 1, 2012 and July 1, 2015 OR\n* Having a current residential address inside of pilot site limits\n\nExclusion criteria:\n\n* Current residing outside of the borders of the designated study sites'}, 'identificationModule': {'nctId': 'NCT01892228', 'briefTitle': 'Pilot Study of Immediate HIV Treatment in Guangxi, China', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Center for AIDS/STD Control and Prevention, China CDC'}, 'officialTitle': 'Pilot Study of Immediate HIV Treatment by Means of "One-stop Service" in Hospital in Guangxi, China', 'orgStudyIdInfo': {'id': 'Treat-All HIV Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Two counties: Zhongshan and Pubei', 'description': 'Immediate post-screening treatment education for HIV-positive participants residing in the Zhongshan and Pubei pilot sites in the "Treat-All" HIV Pilot Program', 'interventionNames': ['Behavioral: Immediate post-screening treatment education']}], 'interventions': [{'name': 'Immediate post-screening treatment education', 'type': 'BEHAVIORAL', 'description': 'immediate treatment education after screening to decrease time from initial HIV screening to treatment implementation', 'armGroupLabels': ['Two counties: Zhongshan and Pubei']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xiaojiang', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Pubei Center for Disease Control', 'geoPoint': {'lat': 22.27296, 'lon': 109.55184}}, {'city': 'Zhongshan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Zhongshan Center for Disease Control', 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}], 'centralContacts': [{'name': 'Zunyou Wu, PhD', 'role': 'CONTACT', 'email': 'wuzunyou@chinaaids.cn', 'phone': '+86-10-5890-0901'}], 'overallOfficials': [{'name': 'Zunyou Wu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Center for AIDS/STD Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for AIDS/STD Control and Prevention, China CDC', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Guangxi Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, {'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-10-27', 'type': 'RELEASE'}, {'date': '2015-11-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'National Center for AIDS/STD Control and Prevention, China CDC'}}}}