Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT00554567
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2007-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization of HIV Clinical Services in Rural India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082922', 'term': 'HIV Testing'}], 'ancestors': [{'id': 'D008828', 'term': 'Microbiological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2007-11-05', 'studyFirstSubmitQcDate': '2007-11-05', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Utilization of HIV Testing', 'timeFrame': 'Annual'}], 'secondaryOutcomes': [{'measure': 'Proportion with Sexually Transmitted Infection History', 'timeFrame': 'Annual'}, {'measure': 'Proportion with Behavioral HIV risk history', 'timeFrame': 'Annual'}, {'measure': 'WHO Clinical Stage at time of HIV diagnosis', 'timeFrame': 'Quarterly'}, {'measure': 'WHO Clinical Stage at first clinical care visit', 'timeFrame': 'Quarterly'}, {'measure': 'Birth outcomes for HIV-infected pregnant women', 'timeFrame': 'Quarterly'}, {'measure': 'Awareness of HIV Testing Services', 'timeFrame': 'Annual'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV/AIDS', 'Voluntary Counseling and Testing', 'Rural India', 'HIV Care', 'Health Services Research'], 'conditions': ['HIV Infections', 'Sexually Transmitted Infections']}, 'referencesModule': {'references': [{'pmid': '18340657', 'type': 'RESULT', 'citation': 'Sinha G, Dyalchand A, Khale M, Kulkarni G, Vasudevan S, Bollinger RC. Low utilization of HIV testing during pregnancy: What are the barriers to HIV testing for women in rural India? J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):248-52.'}, {'pmid': '18462015', 'type': 'RESULT', 'citation': 'Celentano DD. Is HIV screening in the labor and delivery unit feasible and acceptable in low-income settings? PLoS Med. 2008 May 6;5(5):e107. doi: 10.1371/journal.pmed.0050107.'}]}, 'descriptionModule': {'briefSummary': 'This community-based clinical trial based in two districts of rural Maharashtra, India compares utilization of an intervention model of "fully-decentralized," or rural primary clinic-based, HIV testing and care services, with a control model of the Indian government\'s partially-decentralized HIV services, offering rural referral clinic testing and urban-based HIV care.', 'detailedDescription': 'India has one of the highest estimated number of HIV cases globally. Sixty percent of its HIV cases occur in rural residents, yet there is no system of HIV testing or care services for them. Preliminary studies have identified very low HIV testing utilization among men and recently pregnant women in rural Maharashtra, even though these are, by government policy, high-priority target groups for rural HIV testing, diagnosis, and prevention.\n\nThis study will compare two models of rural HIV testing and care services in two districts of Maharashtra, India. The "Control" model is the Indian government\'s current strategy of "partially decentralized" rural-based HIV testing services at a secondary-level Community Health Center clinic, which serves a village group population of 30,000. HIV care including antiretroviral therapy is provided a the rural district headquarters in the district urban center. The "Intervention" model is a novel model of "fully decentralized" rural-based HIV testing which will be offered at the Community Health Center, two Primary Health Centers, and eight village-level sub-center clinics, and HIV care offered at a rural-based clinic.\n\nThe primary outcomes of this trial are to assess and compare utilization rates for these two types of HIV services models among rural adult men age 18-49 and pregnant women age 18 and older. Additionally, the secondary outcomes include comparing HIV clinical and behavioral risk characteristics of services utilizers in each model, and characteristics of utilizers versus non-utilizers between and within each model. Clinical care outcomes include WHO Clinical stage at time of HIV diagnosis and at first clinical care visit, and birth outcomes for HIV-infected pregnant women.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Male Age 18 - 49 or Pregnant Female age 18 and older\n* Capacity to give written informed consent\n\nExclusion Criteria:\n\n* Refusal, or Physical or Mental incapacity to give written informed consent'}, 'identificationModule': {'nctId': 'NCT00554567', 'briefTitle': 'Utilization of HIV Clinical Services in Rural India', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Health Management, Pachod, India'}, 'officialTitle': 'Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India', 'orgStudyIdInfo': {'id': 'VCTUtilizationStudy2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Fully Decentralized HIV Testing and Care Services', 'interventionNames': ['Behavioral: HIV Testing and Care Services']}], 'interventions': [{'name': 'HIV Testing and Care Services', 'type': 'BEHAVIORAL', 'description': 'Fully-decentralized HIV Voluntary Counseling and Testing and referral for care', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '431 121', 'city': 'Pachod, Aurangabad District', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Institute of Health Management, Pachod (IHMP)', 'geoPoint': {'lat': 20.61869, 'lon': 77.82973}}], 'overallOfficials': [{'name': 'Ashok Dyalchand, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Health Management, Pachod (IHMP), Maharashtra, India'}, {'name': 'Gita Sinha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University School of Medicine, Baltimore, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Health Management, Pachod, India', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Gita Sinha, MD MPH', 'oldOrganization': 'Johns Hopkins University School of Medicine'}}}}