HIVDC CohortNCT01206920
The DC Cohort Longitudinal HIV Status Neutral Study
An observational study of HIV and AIDS, run by George Washington University at 14 sites in United States.
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 patients diagnosed with Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) or at higher risk for acquiring HIV and receiving care in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- How many people
- 19,000 participants
- Where
- 14 sitesUnited States
- Study dates
- Jan 2011to Jan 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Kaiser Permanente Mid-Atlantic States
Washington D.C., District of Columbia, 20002
Michael A Horberg, MD, 301-816-6302, Michael.Horberg@kp.org
- Recruiting
Unity Health Care
Washington D.C., District of Columbia, 20003
Gebeyehu Teferi, MD, GTeferi@unityhealthcare.org
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
Princy Kumar, MD, Princy.N.Kumar@gunet.georgetown.edu
- Recruiting
La Clinica Del Pueblo
Washington D.C., District of Columbia, 20009
Amina Chaudhry, MD, AChaudhry@lcdp.org
- Recruiting
Whitman-Walker Health
Washington D.C., District of Columbia, 20009
Stephen Abbott, MD, sabbott@whitman-walker.org
- Recruiting
Children's National Medical Center--Pediatric Clinic
Washington D.C., District of Columbia, 20010
Natella Rakhmanina, MD, NRakhman@childrensnational.org
- Recruiting
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Adam Klein, MD, Adam.J.Klein@medstar.net
- Recruiting
Washington Health Institute
Washington D.C., District of Columbia, 20017
Jose Bordon, MD, PhD, 202-525-5175, jbordon@dc-whi.org
Jose Bordon, MD, PhD
- Recruiting
Family and Medical Counseling Service
Washington D.C., District of Columbia, 20020
Angela Wood, afulwood@fmcsinc.org
- Recruiting
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Maria Elena Ruiz, MD, mruiz@mfa.gwu.edu
- Recruiting
Howard University Hospital--Adult Clinic
Washington D.C., District of Columbia, 20060
Jhansi Gajjala, MD, jhansi.gajjala@howard.edu
- Recruiting
Howard University Hospital--Pediatric Clinic
Washington D.C., District of Columbia, 20060
Sohail Rana, MD, srana@howard.edu
- Recruiting
Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422
Rachel Denyer, MD, Rachel.Denyer@va.gov
- Recruiting
Us Helping Us, People into Living, Inc.
Washington D.C., District of Columbia
DeMarc Hickson, PhD, dhickson@uhupil.org
About this study
Official title: Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort
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.
- Keywords
- HIV, AIDS, Co-morbidities
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Persons who are receiving HIV preventive services will be followed longitudinally to assess time to HIV positivity from baseline to 5 years post enrollment
Measured: through study completion, an average of 5 years from enrollment to the end of study follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2041 (estimated)
- Study completionJan 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda D. Castel, George Washington University
- Investigators
- Amanda D Castel, MD, MPH, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206920
- Sponsor's protocol ID
- 071029
- Other IDs
- R24AI152598
- Acronym
- DC Cohort
- Status last verified
- Jan 2026
- First submitted
- 21 Sep 2010
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort
- ClinicalTrials.gov ID
- NCT01206920
- Acronym / sponsor ID
- DC Cohort / 071029
- Keywords
- HIV, AIDS, Co-morbidities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 19,000 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2011 (actual)
- Primary completion
- Jan 2041 (estimated)
- Study completion
- Jan 2041 (estimated)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- DC Cohort WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda D Castel, MD, MPH principal investigator
George Washington University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and AIDS, run by George Washington University at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda D Castel, MD, MPH (202-994-8325, acastel@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.