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RecruitingNCT01206920DC CohortUpdated Feb 2, 2026

The DC Cohort Longitudinal HIV Status Neutral Study

An observational study in HIV and AIDS, sponsored by George Washington University. Recruiting at 14 sites in United States. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by George Washington University · Observational

From the registry’s dates

  • Started Jan 2011; still recruiting 15 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19,000
Sex
All
01

Study 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.

Read the detailed description

All major community and academic clinics treating persons with HIV in the District of Columbia (DC) are included in the "DC Cohort", with consideration to be given subsequently to the inclusion of large private physician practices. Recruitment of persons at higher risk for acquiring HIV will occur in selected clinics based on the numbers of persons estimated to be receiving HIV preventive services at those clinics. 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 quarter 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.

02

Conditions studied

  • HIV
  • AIDS

Keywords

  • HIV
  • AIDS
  • Co-morbidities
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's planned enrollment of 19,000 is above the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Study participants will include men, women and children receiving HIV prevention, care or treatment services at major publicly-funded, government and academic medical centers in the District of Columbia.

Eligibility criteria

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. viral suppression among persons with HIV

    The study will assess rates of viral suppression (defined as an HIV RNA test less than 200 copies/ml) from enrollment to 10 years post enrollment.

    Time frame: through study completion, an average of 10 years from enrollment to the end of study follow up

  2. clinical outcomes persons at higher risk for acquiring HIV

    Persons who are receiving HIV preventive services will be followed longitudinally to assess time to HIV positivity from baseline to 5 years post enrollment

    Time frame: through study completion, an average of 5 years from enrollment to the end of study follow up period

07

Study locations

14 of 14 sites recruiting
  • Kaiser Permanente Mid-Atlantic States
    Washington D.C., District of Columbia 20002, United States
    Recruiting
  • Unity Health Care
    Washington D.C., District of Columbia 20003, United States
    Recruiting
  • Georgetown University
    Washington D.C., District of Columbia 20007, United States
    Recruiting
  • La Clinica Del Pueblo
    Washington D.C., District of Columbia 20009, United States
    Recruiting
  • Whitman-Walker Health
    Washington D.C., District of Columbia 20009, United States
    Recruiting
  • Children's National Medical Center--Pediatric Clinic
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • Washington Health Institute
    Washington D.C., District of Columbia 20017, United States
    • Jose Bordon, MD, PhD · Contact · jbordon@dc-whi.org · 202-525-5175
    • Jose Bordon, MD, PhD · Principal investigator
    Recruiting
  • Family and Medical Counseling Service
    Washington D.C., District of Columbia 20020, United States
    Recruiting
  • George Washington Medical Faculty Associates
    Washington D.C., District of Columbia 20037, United States
    Recruiting
  • Howard University Hospital--Adult Clinic
    Washington D.C., District of Columbia 20060, United States
    Recruiting
  • Howard University Hospital--Pediatric Clinic
    Washington D.C., District of Columbia 20060, United States
    Recruiting
  • Veterans Affairs Medical Center
    Washington D.C., District of Columbia 20422, United States
    Recruiting
  • Us Helping Us, People into Living, Inc.
    Washington D.C., District of Columbia, United States
    Recruiting
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01206920
Lead sponsor
George Washington University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Amanda D. Castel (PI, George Washington University) — Principal investigator
First posted
Sep 22, 2010
Start date
Jan 2011
Primary completion
Jan 2041 (estimated)
Completion
Jan 2041 (estimated)
Last update
Feb 2, 2026

Study contacts

Amanda D Castel, MD, MPH
Contact
acastel@gwu.edu
202-994-8325
Megan O'Brien, PhD, MPH
Contact
megan.obrien1@gwu.edu
202-994-2034
Amanda D Castel, MD, MPH
principal investigator · George Washington University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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