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

Sponsor
George Washington University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01206920
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
10,000
Enrollment
15
Locations
130
Duration (Months)
666.7
Patients Per Site
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    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
    Study Start Date :
    Jan 1, 2011
    Anticipated Primary Completion Date :
    Nov 1, 2021
    Anticipated Study Completion Date :
    Nov 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Following the health of those with HIV throughout the study [duration of cohort]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Washington District of Columbia United States 20002
    2 Unity Health Care Washington District of Columbia United States 20003
    3 MetroHealth Washington District of Columbia United States 20005
    4 Georgetown University Washington District of Columbia United States 20007
    5 La Clinica Del Pueblo Washington District of Columbia United States 20009
    6 Whitman-Walker Health Washington District of Columbia United States 20009
    7 Children's National Medical Center--Adolescent Clinic Washington District of Columbia United States 20010
    8 Children's National Medical Center--Pediatric Clinic Washington District of Columbia United States 20010
    9 Washington Hospital Center Washington District of Columbia United States 20010
    10 Providence Hospital Washington District of Columbia United States 20017
    11 Family and Medical Counseling Service Washington District of Columbia United States 20020
    12 George Washington Medical Faculty Associates Washington District of Columbia United States 20037
    13 Howard University Hospital--Adult Clinic Washington District of Columbia United States 20060
    14 Howard University Hospital--Pediatric Clinic Washington District of Columbia United States 20060
    15 Veterans Affairs Medical Center Washington District of Columbia United States 20422

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    George Washington University
    ClinicalTrials.gov Identifier:
    NCT01206920
    Other Study ID Numbers:
    • 071029
    • 3U01AI069503-03S2
    First Posted:
    Sep 22, 2010
    Last Update Posted:
    Mar 8, 2019
    Last Verified:
    Mar 1, 2019
    Keywords provided by George Washington University
    HIV
    AIDS
    Co-morbidities

    Study Results

    No Results Posted as of Mar 8, 2019