Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort (DC Cohort)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by George Washington University
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01206920
First received: September 21, 2010
Last updated: February 18, 2016
Last verified: February 2016
  Purpose
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.

Condition
HIV
AIDS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Following the health of those with HIV throughout the study [ Time Frame: duration of cohort ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: January 2011
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patient is receiving care for HIV at one or more of the twelve participating clinics in the DC Cohort.
  • Patient is either age 18 years or older, or seeks HIV care independently and is able to understand and sign informed consent.
  • Patient is a minor who is consented by a parent or legal guardian.

Exclusion Criteria:

  • Patient is unable or refuses to provide informed consent.
  • Minor children ages 12 through 17 who are unaware of their HIV status
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206920

Contacts
Contact: Amanda D Castel, MD, MPH 202-994-8325 acastel@gwu.edu
Contact: Lindsey P Happ, MPH 202-994-3340 lpowers@gwu.edu

Locations
United States, District of Columbia
Children's National Medical Center--Adolescent Clinic Recruiting
Washington, District of Columbia, United States, 20010
MetroHealth Recruiting
Washington, District of Columbia, United States, 20005
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
La Clinica Del Pueblo Recruiting
Washington, District of Columbia, United States, 20009
Whitman-Walker Health Recruiting
Washington, District of Columbia, United States, 20009
Veterans Affairs Medical Center Recruiting
Washington, District of Columbia, United States, 20422
Children's National Medical Center--Pediatric Clinic Recruiting
Washington, District of Columbia, United States, 20010
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Family and Medical Counseling Service Recruiting
Washington, District of Columbia, United States, 20020
George Washington Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Howard University Hospital--Adult Clinic Recruiting
Washington, District of Columbia, United States, 20060
Howard University Hospital--Pediatric Clinic Recruiting
Washington, District of Columbia, United States, 20060
Unity Health Care Recruiting
Washington, District of Columbia, United States, 20003
Sponsors and Collaborators
George Washington University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Amanda D Castel, MD, MPH George Washington University
  More Information

Additional Information:
Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01206920     History of Changes
Other Study ID Numbers: 071029  3U01AI069503-03S2 
Study First Received: September 21, 2010
Last Updated: February 18, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
HIV
AIDS
Co-morbidities

ClinicalTrials.gov processed this record on April 27, 2016