Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19,000
- 试验地点
- 14
- 主要终点
- viral suppression among persons with HIV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
viral suppression among persons with HIV
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Amanda D. Castel
PI
George Washington University