The DC Cohort Longitudinal HIV Status Neutral Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HIV, AIDS. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort
Overview
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.
Primary outcome measures
- viral suppression among persons with HIV [Time frame: 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 [Time frame: through study completion, an average of 5 years from enrollment to the end of study follow up period]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 14 centers
- Kaiser Permanente Mid-Atlantic States — Washington D.C.
- Unity Health Care — Washington D.C.
- Georgetown University — Washington D.C.
- La Clinica Del Pueblo — Washington D.C.
- Whitman-Walker Health — Washington D.C.
- Children's National Medical Center--Pediatric Clinic — Washington D.C.
- Washington Hospital Center — Washington D.C.
- Washington Health Institute — Washington D.C.
- … and 6 more centers
Identifiers
NCT: NCT01206920 · 071029 · R24AI152598