Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01206920
Status:
RECRUITING
Last Update Posted:
2024-10-26
First Post:
2010-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: the DC Cohort
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2041-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2010-09-21', 'studyFirstSubmitQcDate': '2010-09-21', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2041-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Following the health of those with HIV throughout the study', 'timeFrame': 'duration of cohort'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'AIDS', 'Co-morbidities'], 'conditions': ['HIV', 'AIDS']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://go.gwu.edu/dccohort', 'label': 'DC Cohort Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of the DC Cohort is to establish a clinic-based city-wide longitudinal cohort that will describe clinical outcomes, and improve the quality of care for outpatients with Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) in Washington, DC.', 'detailedDescription': 'All major community and academic clinics treating HIV-infected persons in the District of Columbia (DC) will initially be included in the development of a city-wide "DC Cohort" of HIV-infected persons in care, with consideration to be given subsequently to the inclusion of large private physician practices. Socio-demographics, risk factors, treatments, diagnoses, labs and procedures documented in outpatient medical record systems will be included in the DC Cohort database. Routine reports will be generated every six months for sites comparing their participants\' socio-demographics, clinical status, treatments, and outcomes to all other data in the DC Cohort database, and other comparisons specifically requested by sites. All sites will be provided analytic support in research areas of interest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will include men, women and children receiving HIV/AIDS care at major publicly-funded, government and academic medical centers in the District of Columbia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is receiving care for HIV at one or more of the twelve participating clinics in the DC Cohort.\n* Patient is either age 18 years or older, or seeks HIV care independently and is able to understand and sign informed consent.\n* Patient is a minor who is consented by a parent or legal guardian.\n\nExclusion Criteria:\n\n* Patient is unable or refuses to provide informed consent.\n* Minor children ages 12 through 17 who are unaware of their HIV status'}, 'identificationModule': {'nctId': 'NCT01206920', 'acronym': 'DC Cohort', 'briefTitle': 'Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: the DC Cohort', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: the DC Cohort', 'orgStudyIdInfo': {'id': '071029'}, 'secondaryIdInfos': [{'id': '3U01AI069503-03S2', 'link': 'https://reporter.nih.gov/quickSearch/3U01AI069503-03S2', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20002', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael A Horberg, MD', 'role': 'CONTACT', 'email': 'Michael.Horberg@kp.org', 'phone': '301-816-6302'}], 'facility': 'Kaiser Permanente Mid-Atlantic States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20003', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gebeyehu Teferi, MD', 'role': 'CONTACT', 'email': 'GTeferi@unityhealthcare.org'}], 'facility': 'Unity Health Care', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20005', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Duane Taylor', 'role': 'CONTACT', 'email': 'dtaylor@metrohealthdc.org'}], 'facility': 'MetroHealth', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Princy Kumar, MD', 'role': 'CONTACT', 'email': 'Princy.N.Kumar@gunet.georgetown.edu'}], 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ricardo Fernandez, MD', 'role': 'CONTACT', 'email': 'rfernandez@lcdp.org'}], 'facility': 'La Clinica Del Pueblo', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephen Abbott, MD', 'role': 'CONTACT', 'email': 'sabbott@whitman-walker.org'}], 'facility': 'Whitman-Walker Health', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natella Rakhmanina, MD', 'role': 'CONTACT', 'email': 'NRakhman@childrensnational.org'}], 'facility': "Children's National Medical Center--Pediatric Clinic", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adam Klein, MD', 'role': 'CONTACT', 'email': 'Adam.J.Klein@medstar.net'}], 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20017', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jose Bordon, MD, PhD', 'role': 'CONTACT', 'email': 'jbordon@dc-whi.org', 'phone': '202-525-5175'}, {'name': 'Jose Bordon, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Washington Health Institute', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20020', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rita Aidoo, MD', 'role': 'CONTACT', 'email': 'raidoo@fmcsinc.org'}], 'facility': 'Family and Medical Counseling Service', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jose Lucar, MD', 'role': 'CONTACT', 'email': 'jlucar@mfa.gwu.edu'}], 'facility': 'George Washington Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jhansi Gajjala, MD', 'role': 'CONTACT', 'email': 'jhansi.gajjala@howard.edu'}], 'facility': 'Howard University Hospital--Adult Clinic', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sohail Rana, MD', 'role': 'CONTACT', 'email': 'srana@howard.edu'}], 'facility': 'Howard University Hospital--Pediatric Clinic', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debra Benator, MD', 'role': 'CONTACT', 'email': 'Debra.Benator@va.gov'}], 'facility': 'Veterans Affairs Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Amanda D Castel, MD, MPH', 'role': 'CONTACT', 'email': 'acastel@gwu.edu', 'phone': '202-994-8325'}, {'name': 'Anne K Monroe, MD, MSPH', 'role': 'CONTACT', 'email': 'amonroe@gwu.edu', 'phone': '202-994-0251'}], 'overallOfficials': [{'name': 'Amanda D Castel, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Amanda D. Castel', 'investigatorAffiliation': 'George Washington University'}}}}