NCT01206920

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19,000

participants targeted

Target at P75+ for all trials

Timeline
177mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jan 2011Jan 2041

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
30 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2041

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2041

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

30 years

First QC Date

September 21, 2010

Last Update Submit

January 29, 2026

Conditions

Keywords

HIVAIDSCo-morbidities

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

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

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient is unable or refuses to provide informed consent.
  • Minor children ages 12 through 17 who are unaware of their HIV status
  • 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)
  • bacterial STI (GC, chlamydia, syphilis) tests at 2 or more different encounters
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

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

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

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Amanda D Castel, MD, MPH

    George Washington University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda D Castel, MD, MPH

CONTACT

Megan O'Brien, PhD, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

January 1, 2011

Primary Completion (Estimated)

January 1, 2041

Study Completion (Estimated)

January 1, 2041

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations