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

NCT ID: NCT01206920

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2041-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 outpatients with Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) in Washington, DC.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All major community and academic clinics treating HIV-infected persons in the District of Columbia (DC) will initially be included in the development of a city-wide "DC Cohort" of HIV-infected persons in care, with consideration to be given subsequently to the inclusion of large private physician practices. 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 six months 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV AIDS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amanda D. Castel

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amanda D Castel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaiser Permanente Mid-Atlantic States

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

Site Status RECRUITING

Unity Health Care

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

Site Status RECRUITING

MetroHealth

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

Site Status RECRUITING

Georgetown University

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

Site Status RECRUITING

La Clinica Del Pueblo

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

Site Status RECRUITING

Whitman-Walker Health

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

Site Status RECRUITING

Children's National Medical Center--Pediatric Clinic

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

Site Status RECRUITING

Washington Hospital Center

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

Site Status RECRUITING

Washington Health Institute

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

Site Status RECRUITING

Family and Medical Counseling Service

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

Site Status RECRUITING

George Washington Medical Faculty Associates

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

Site Status RECRUITING

Howard University Hospital--Adult Clinic

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

Site Status RECRUITING

Howard University Hospital--Pediatric Clinic

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

Site Status RECRUITING

Veterans Affairs Medical Center

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

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amanda D Castel, MD, MPH

Role: CONTACT

202-994-8325

Anne K Monroe, MD, MSPH

Role: CONTACT

202-994-0251

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Michael A Horberg, MD

Role: primary

301-816-6302

Gebeyehu Teferi, MD

Role: primary

Duane Taylor

Role: primary

Princy Kumar, MD

Role: primary

Ricardo Fernandez, MD

Role: primary

Stephen Abbott, MD

Role: primary

Natella Rakhmanina, MD

Role: primary

Adam Klein, MD

Role: primary

Jose Bordon, MD, PhD

Role: primary

202-525-5175

Jose Bordon, MD, PhD

Role: backup

Rita Aidoo, MD

Role: primary

Jose Lucar, MD

Role: primary

Jhansi Gajjala, MD

Role: primary

Sohail Rana, MD

Role: primary

Debra Benator, MD

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3U01AI069503-03S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

071029

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Biology of HIV Transmission
NCT00001092 COMPLETED
HIV and Cardiovascular Risk
NCT00465426 COMPLETED
HIV Patients Cohort
NCT02203006 ACTIVE_NOT_RECRUITING NA
Fecal Microbiota Transplantation in HIV
NCT02256592 COMPLETED PHASE1