Меню
Идёт набор NCT01206920

The DC Cohort Longitudinal HIV Status Neutral Study

— Наблюдательное HIV AIDS

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: HIV, AIDS. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Development of a City-Wide Cohort of HIV-Infected Persons in Care in the District of Columbia: The DC Cohort

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • viral suppression among persons with HIV [Срок оценки: 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 [Срок оценки: through study completion, an average of 5 years from enrollment to the end of study follow up period]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 14 центров
  • 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.
  • … и ещё 6 центров

Идентификаторы

NCT: NCT01206920 · 071029 · R24AI152598

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗