Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).
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 navigation effectiveness.
- Кому может быть актуально
- Состояния в реестре: Hiv. Базовые параметры: 12 лет — 19 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
- ЮАР
- 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 is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (ART) on viral suppression and retention in care among adolescents living with HIV and receiving care in South Africa.
Подробное описание
This study aims to deploy peer-navigated support (psychosocial support, HIV education, appointment reminders, adherence support, sexual and reproductive health, and healthcare navigation) to facilitate viral suppression and retention in care as adolescents living with HIV transition into adult care. The study population includes adolescents from South Africa aged 12 to less than 19 years, living with HIV, aware of their HIV status and receiving ART for at least six months.
In Stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18-24 months in two 6-month steps across 12 clinics will be evaluated. In addition, during Stage 1, user and key stakeholder preferences will be evaluated for the uptake and use of long-acting injectable ART, perform a costing and economic analysis and a program evaluation of the public health impact of the intervention. In Stage 2, an individually-randomised trial will be nested in a subset of clinics to evaluate long-acting injectable ART in adolescents with HIV.
The study procedures include a peer navigation intervention in Stage 1, alongside a user and key stakeholder preferences evaluation for the uptake and use of long-acting injectable ART and a cost and economic evaluation.
The study duration is two years (about 5-7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 12 months to assess the sustainability of the intervention. The nested individually-randomised trial of long-acting ART will be conducted during the second 18-month period.
Вмешательства
- Поведенческое Peer navigation effectiveness
To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.
Первичные конечные точки
- Peer navigation - viral suppression (effectiveness) [Срок оценки: 18 months]
- Peer navigation - retention in care (effectiveness) [Срок оценки: 18 months]
Вторичные конечные точки (7)
- Peer navigation - viral suppression (sustainability) [Срок оценки: 36 months]
- Peer navigation - retention (sustainability) [Срок оценки: 36 months]
- long-acting injectable ART - acceptability [Срок оценки: 36 months]
- Economic evaluation analysis of providing LAI [Срок оценки: 36 months]
- Economic evaluation analysis of providing peer navigation [Срок оценки: 36 months]
- Cost-effectiveness analyses of providing LAI [Срок оценки: 36 months]
- Cost-effectiveness analyses of providing peer navigation [Срок оценки: 36 months]
Критерии участия
Критерии включения
- Aged between 12 - <19, at enrolment
- Living with HIV
- Aware of their HIV status
- Receiving ART for at least six months
- Able to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
- Willing and able to consent to study activities
- Willing and able to get parental consent for study activities
- (Stage 1, objective 2 only) Age ≥ 18 years and Caregiver of an adolescent with HIV
- (Stage 1, objective 2 only) Age ≥ 18 years and provides clinical services or is a policy maker involved in adolescents with HIV
Критерии исключения
- Inability to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
- Severe mental or physical illness preventing participation in informed consent activities.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
ЮАР · 12 центров
- Charlotte Maxeke Hospital — Johannesburg
- Rahima Moosa Mother and Child Hospital — Johannesburg
- Kgabo CHC — Pretoria
- KT Motubatse CHC — Pretoria
- Soshanguve Block JJ — Pretoria
- Soshanguve Block TT — Pretoria
- Cato Manor CHC — Durban
- KwaMashu CHC — Durban
- … и ещё 4 центра
Идентификаторы
NCT: NCT06721078 · A0005-6490/2023 · 1UG1MD019435-01