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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01206920
Other study ID # 071029
Secondary ID 3U01AI069503-03S
Status Recruiting
Phase
First received
Last updated
Start date January 2011
Est. completion date January 2041

Study information

Verified date October 2023
Source George Washington University
Contact Amanda D Castel, MD, MPH
Phone 202-994-8325
Email acastel@gwu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15000
Est. completion date January 2041
Est. primary completion date January 2041
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's National Medical Center--Pediatric Clinic Washington District of Columbia
United States Family and Medical Counseling Service Washington District of Columbia
United States George Washington Medical Faculty Associates Washington District of Columbia
United States Georgetown University Washington District of Columbia
United States Howard University Hospital--Adult Clinic Washington District of Columbia
United States Howard University Hospital--Pediatric Clinic Washington District of Columbia
United States Kaiser Permanente Mid-Atlantic States Washington District of Columbia
United States La Clinica Del Pueblo Washington District of Columbia
United States MetroHealth Washington District of Columbia
United States Unity Health Care Washington District of Columbia
United States Veterans Affairs Medical Center Washington District of Columbia
United States Washington Health Institute Washington District of Columbia
United States Washington Hospital Center Washington District of Columbia
United States Whitman-Walker Health Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
George Washington University National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Following the health of those with HIV throughout the study duration of cohort
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