The DC Cohort Longitudinal HIV Status Neutral Study
Purpose
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.
Conditions
- HIV
- AIDS
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
Recruiting Locations
Children's National and nearby locations
Washington D.C. 4140963, District of Columbia 4138106 20010
More Details
- NCT ID
- NCT01206920
- Status
- Recruiting
- Sponsor
- George Washington University
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.