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Идёт набор NCT06126913

HeadStART: Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV

Без фазы С лечением HIV Infections Hiv

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
В протоколе указаны: Community Antiretroviral Therapy.
Кому может быть актуально
Состояния в реестре: HIV Infections, Hiv. 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
Uganda
Следующий шаг
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Официальное название

Achieving HIV Viral Suppression in Refugee Settlements in Uganda With Head StART: A Cluster Randomized Trial Evaluating the Effectiveness of Community ART Delivery for People Newly Diagnosed With HIV

Обзор

This is a cluster randomized controlled trial at 12 health centers in refugee settlements in Uganda aiming to evaluate effectiveness of expansion of community antiretroviral therapy (ART) delivery to people newly diagnosed with HIV in achieving HIV viral suppression.

Подробное описание

Community antiretroviral therapy (ART) delivery is a differentiated care model that fosters social support and reduces time and transportation barriers yielding improved engagement in HIV care. In Uganda, to participate in community ART delivery, clients must be "stable" in care (\> 1 year on ART and viral load \< 1,000 copies/mL). Therefore, persons newly diagnosed with HIV are not eligible for community ART delivery. Community ART delivery may benefit persons newly diagnosed with HIV in refugee settlements by bolstering social support and by bringing ART closer to individuals living in these expansive rural settlements. The primary objective of this research is to evaluate the effectiveness of expanding community ART delivery to clients newly diagnosed with HIV.

Вмешательства

  • Другое Community Antiretroviral Therapy
    Newly diagnosed individuals (diagnosed in the prior 6 months) at intervention sites will be offered community ART delivery on a rolling basis during the enrollment window, initiating individuals into groups as close to their date of diagnosis as possible. Newly enrolled individuals will join existing community ART delivery groups, or when a new group is needed based on group size or geographic location, a new group will be formed.

Первичные конечные точки

  • HIV viral suppression at 12 months [Срок оценки: 12 months (+/- 2 months)]
Вторичные конечные точки (2)
  • HIV viral suppression at 6 months [Срок оценки: 6 months (+/- 2 months)]
  • Antiretroviral therapy adherence among those virally unsuppressed at 12 months [Срок оценки: 12 months (+/- 2 months)]

Критерии участия

Критерии включения

  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Adult ≥18 years of age or mature minors or emancipated minor. Mature minors are defined as individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection. Emancipated minors are defined as individuals below the age of majority (18 years) who are pregnant, married, have a child, or are self-sufficient.
  • Tested HIV positive in the past 6 months and not already known to be HIV positive.
  • Able to communicate in one of the following 5 study languages: Kiswahili, Runyankore, Kinyarwanda, Somali, or English.

Inclusion criteria for data abstraction only:

  • Adult ≥18 years of age or mature minors or emancipated minor.
  • Tested HIV positive in the past 6 months and not already known to be HIV positive.

Критерии исключения

  • Pregnant and breastfeeding women.
  • Clients deemed by the clinician(s) unfit for community-based care secondary to medical need.
  • Concurrently enrolled in another biomedical clinical trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Uganda · 1 центр
  • Infectious Diseases Institute, Makerere University — Kampala

Публикации

  • Klabbers RE, Mugyenyi A, Nsubuga R, Asaba G, Faustin Z, Kiragga A, Drown L, Mujugira A, Mugambi M, Sharma M, Drain P, Middleton NA, Sveum EM, Lewis S, Muwonge TR, O'Laughlin KN. Protocol for Head StART: A hybrid type II cluster randomized controlled trial evaluating community ART delivery for people newly diagnosed with HIV in refugee settlements in Uganda. PLoS One. 2026 Feb 27;21(2):e0340916. do PMID 41758805

Идентификаторы

NCT: NCT06126913 · STUDY00016473 · R01MH130216

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗