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Идёт набор NCT05917210

Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda

Без фазы С лечением Tuberculosis 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: Peer-Navigaton TB-EC Strategy, Usual TB-EC Strategy.
Кому может быть актуально
Состояния в реестре: Tuberculosis, HIV. Базовые параметры: от 18 лет · 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This cluster-randomized trial in Uganda will evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects.

Подробное описание

Study Design

Aim 1. The investigators will conduct a parallel, cluster-randomized, hybrid Type 2, effectiveness-implementation trial at 16 sites in Uganda.

This clinical trials registration focuses on Aim 1.

In addition, we will pursue two additional non-interventional aims to better understand the implementation and outcomes of Aim 1:

Aim 2. Within the Aim 1 study, the investigators will also perform a mediation analysis of social and behavioral factors (i.e., TB knowledge, perceived social support, general self-efficacy, HIV/TB stigma) to identify causal mechanisms of impact.

Aim 3. The investigators will conduct nested quantitaive, qualitative, and mixed methods studies to assess the implementation fidelity and context of the peer-navigation strategy for TB-EC, including the following sub-aims:

1. Surveys of peers and healthcare workers to determine the feasibility, acceptability, and appropriateness of the peer-navigation strategy, 2. Direct observations, document review, interviews with peers, and healthcare worker focus groups to characterize fidelity and adaptation of the peer navigation strategy, 3. Measures of implementation costs, 4. In-depth interviews with peer navigators to characterize their experiences, 5. Focus-group discussions (FGDs) with healthcare workers, and 6. In-depth interviews with people with tuberculosis (PWTB) to characterize their experiences.

Вмешательства

  • Поведенческое Peer-Navigaton TB-EC Strategy
    Participants receive a peer-navigation strategy for TB education and counseling, including individual-level components such as peer navigator support, an illustrated TB-EC booklet with checklist, individualized adherence planning, and behavior-change messaging; and clinic-level components such as task-sharing with peer navigators, workflow restructuring, community of practice meetings, and implementation champions to support delivery.
  • Поведенческое Usual TB-EC Strategy
    Participants receive usual TB education and counseling delivered by healthcare workers, including individual-level components such as TB-HIV education using a flipchart and use of treatment supporters; and clinic-level components such as routine TB-EC delivery by healthcare workers.

Первичные конечные точки

  • Effectiveness: TB Treatment Success [Срок оценки: Up to 12 months after TB treatment initiation]
  • Effectiveness: Antiretroviral Therapy (ART) Retention [Срок оценки: At month 6 after ART initiation (+/- 30 days)]
Вторичные конечные точки (2)
  • Implementation: TB Medication Adherence [Срок оценки: At month 5 after TB treatment initiation, ±30 days]
  • Implementation: ART Adherence [Срок оценки: At month 5 after TB treatment initiation, ±30 days]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Registered as a new, relapse, treatment failure, or previously lost-to-follow-up
  • TB case according to the on-site NTP TB Treatment Register
  • Screened and invited to participate within 30 days of TB treatment initiation

Критерии исключения

  • Diagnosed with possible or confirmed drug-resistant TB
  • Transferring TB care into the clinic from an off-site facility
  • Residing >40 km from the enrolling clinic
  • Lacking mental capacity to provide informed consent

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
Поддерживающая терапия

Центры проведения

Uganda · 1 центр
  • Walimu — Kampala

Идентификаторы

NCT: NCT05917210 · 2000035416 · 1R01HL170926-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗