The DC Cohort Longitudinal HIV Status Neutral Study

George Washington University (GW)

Status

Enrolling

Conditions

AIDS

HIV

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT01206920

071029

R24AI152598 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

19,000 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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