AIDS, HIV
Conditions
Keywords
HIV, AIDS, Co-morbidities
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.
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.
Interventions
None listed
Sponsors
George Washington University
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| viral suppression among persons with HIV | 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 | 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 |
Countries
United States
Contacts
CONTACTAmanda D Castel, MD, MPH
CONTACTMegan O'Brien, PhD, MPH
PRINCIPAL_INVESTIGATORAmanda D Castel, MD, MPH
George Washington University
Outcome results
None listed