Clinical trial NCT01206920: Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: the DC Cohort
Official title: Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: the DC Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
AIDS
Keywords: HIV
AIDS
Co-morbidities
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-09-22
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Following the health of those with HIV throughout the study
timeFrame: duration of cohort
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Kaiser Permanente Mid-Atlantic States
state: District of Columbia
city: Washington
country: United States
facility: Unity Health Care
state: District of Columbia
city: Washington
country: United States
facility: MetroHealth
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: La Clinica Del Pueblo
state: District of Columbia
city: Washington
country: United States
facility: Whitman-Walker Health
state: District of Columbia
city: Washington
country: United States
facility: Children's National Medical Center--Pediatric Clinic
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Washington Health Institute
state: District of Columbia
city: Washington
country: United States
facility: Family and Medical Counseling Service
state: District of Columbia
city: Washington
country: United States
facility: George Washington Medical Faculty Associates
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital--Adult Clinic
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital--Pediatric Clinic
state: District of Columbia
city: Washington
country: United States
facility: Veterans Affairs Medical Center
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Amanda D Castel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: