Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort
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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 |
| Estimated Enrollment: | 15000 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
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.
Each participant will be prospectively followed in the DC Cohort database from the visit in which consent was given. Select retrospective clinical data prior to the consent date will also be included in the DC Cohort database including HIV diagnosis date; AIDS diagnosis date; nadir CD4; and ARV exposures and resistance documented as of that date.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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| Contact: Amanda D Castel, MD, MPH | 202-994-8325 | acastel@gwu.edu |
| Contact: Mariah M Marshall, MHS | 202-994-4752 | mariahm@gwu.edu |
| United States, District of Columbia | |
| Whitman-Walker Clinic | Recruiting |
| Washington, District of Columbia, United States, 20009 | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Veterans Affairs Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20422 | |
| Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Children's National Medical Center--Pediatric Clinic | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Children's National Medical Center--Burgess Clinic | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| George Washington University Medical Faculty Associates | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Unity Health Care | Not yet recruiting |
| Washington, District of Columbia, United States, 20003 | |
| Howard University | Not yet recruiting |
| Washington, District of Columbia, United States, 20060 | |
| Family and Medical Counseling Services | Recruiting |
| Washington, District of Columbia, United States, 20020 | |
| Carl Vogel Center | Not yet recruiting |
| Washington, District of Columbia, United States, 20005 | |
| La Clinica Del Pueblo | Not yet recruiting |
| Washington, District of Columbia, United States, 20009 | |
| Principal Investigator: | Alan E Greenberg, MD, MPH | George Washington University |
More Information
Additional Information:
No publications provided
| 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 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by George Washington University:
|
HIV AIDS Co-morbidities |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013