Recruiting

Observational Study

Sponsor:

George Washington University

Code:

NCT01206920

Conditions

HIV

AIDS

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

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 patients diagnosed with Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) or at higher risk for acquiring HIV and receiving care in Washington, DC.

Conditions

HIV

AIDS

Study ID

NCT01206920

Start date

Jan, 2011

Status verified date

Jan, 2026

Completion date

Jan, 2041

Anticipated

Primary completion date

Jan, 2041

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Treatment Cohort 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.

Treatment Cohort Exclusion Criteria:

  • Patient is unable or refuses to provide informed consent.
  • Minor children ages 12 through 17 who are unaware of their HIV status

Prevention Cohort Inclusion Criteria:

Persons receiving any antiretroviral prescription without evidence of HIV or Hepatitis B infection

  • PrEP (e.g., TDF/FTC, Descovy, Apretude)
  • Combination ART indicative of nPEP in an HIV-uninfected person
  • Persons receiving an antiretroviral prescription indicative of DoxyPEP Doxycycline 200mg PO taken within 72 hrs of unprotected sexual encounter (or variations thereof where clearly not prescribed as a treatment course)
  • Test positive for ≥1 bacterial STI (positive gonorrhea (GC/NG) or chlamydia (CT) test or positive syphilis test requiring treatment within one year)

  • 2 bacterial STI (GC, chlamydia, syphilis) tests at 2 or more different encounters
  • 2 HIV tests at 2 or more different encounters
  • Patient requesting PrEP at their clinical visit
  • Patient requesting nPEP at their clinical visit
  • People who identify as injecting drugs

Patients with a Z29.81 Encounter for HIV pre-exposure prophylaxis

Study Design

Enrollment

19000 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment Cohort

These are individuals who are diagnosed with HIV and receiving care at a participating DC Cohort clinical site.

Prevention Cohort

These are individuals who are receiving HIV preventive services at a participating DC Cohort site.

Primary outcome measure

  • viral suppression among persons with HIV [ Time Frame: through study completion, an average of 10 years from enrollment to the end of study follow up ]
  • clinical outcomes persons at higher risk for acquiring HIV [ Time Frame: through study completion, an average of 5 years from enrollment to the end of study follow up period ]

Central Contacts and Locations

Central contacts

Amanda D Castel, MD, MPH

202-994-8325acastel@gwu.edu

Megan O'Brien, PhD, MPH

202-994-2034megan.obrien1@gwu.edu

Locations

Kaiser Permanente Mid-Atlantic States

Recruiting

Washington D.C., District of Columbia, United States, 20002

Contacts

Michael A Horberg, MD

301-816-6302Michael.Horberg@kp.org

Unity Health Care

Recruiting

Washington D.C., District of Columbia, United States, 20003

Contacts

Gebeyehu Teferi, MD

GTeferi@unityhealthcare.org

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Princy Kumar, MD

Princy.N.Kumar@gunet.georgetown.edu

La Clinica Del Pueblo

Recruiting

Washington D.C., District of Columbia, United States, 20009

Contacts

Amina Chaudhry, MD

AChaudhry@lcdp.org

Whitman-Walker Health

Recruiting

Washington D.C., District of Columbia, United States, 20009

Contacts

Stephen Abbott, MD

sabbott@whitman-walker.org

Children's National Medical Center--Pediatric Clinic

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Natella Rakhmanina, MD

NRakhman@childrensnational.org

Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Adam Klein, MD

Adam.J.Klein@medstar.net

Washington Health Institute

Recruiting

Washington D.C., District of Columbia, United States, 20017

Contacts

Jose Bordon, MD, PhD

202-525-5175jbordon@dc-whi.org

Principal Investigator:

Jose Bordon, MD, PhD

Family and Medical Counseling Service

Recruiting

Washington D.C., District of Columbia, United States, 20020

Contacts

Angela Wood

afulwood@fmcsinc.org

George Washington Medical Faculty Associates

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Maria Elena Ruiz, MD

mruiz@mfa.gwu.edu

Howard University Hospital--Adult Clinic

Recruiting

Washington D.C., District of Columbia, United States, 20060

Contacts

Jhansi Gajjala, MD

jhansi.gajjala@howard.edu

Howard University Hospital--Pediatric Clinic

Recruiting

Washington D.C., District of Columbia, United States, 20060

Contacts

Sohail Rana, MD

srana@howard.edu

Veterans Affairs Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20422

Contacts

Rachel Denyer, MD

Rachel.Denyer@va.gov

Us Helping Us, People into Living, Inc.

Recruiting

Washington D.C., District of Columbia, United States

Contacts

DeMarc Hickson, PhD

dhickson@uhupil.org

More Information

Sponsor

George Washington University

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • HIV
  • AIDS
  • Co-morbidities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Washington University on 2026-02-02.