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NCT Number: NCT01206920

The DC Cohort Longitudinal HIV Status Neutral Study

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Medical Center--Pediatric Clinic, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda D Castel, MD, MPH

CONTACT

[email protected]

202-994-8325

Megan O'Brien, PhD, MPH

CONTACT

[email protected]

202-994-2034

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort

Acronym: DC Cohort

Important dates

Study start
2011
Primary completion
2041
Study completion
2041
First posted
Sep 22, 2010
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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