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Идёт набор NCT07706634

Care Disengagement Prevention in PLWH in Indonesia

Без фазы С лечением HIV Indonesia Engagement in HIV Care Stigma

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: Stigma reduction.
Кому может быть актуально
Состояния в реестре: HIV, Indonesia, Engagement in HIV Care, Stigma. 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
Индонезия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Care Disengagement Prevention in Treatment Naive Indonesians Living With HIV

Обзор

This study is being done because the investigators want to learn about how stigma and culture in Indonesia affects how much contact people living with HIV have with the healthcare system and also how it might affect their health status.

Подробное описание

This project focuses on an innovative evidence-based stigma-reduction intervention that addresses HIV care engagement, which is key for reducing HIV transmission. This work is directly relevant to the U.S., including the Ending the HIV Epidemic (EHE) initiative, as stigma remains a key barrier to care engagement across variable populations. U.S. communities, including faith-based populations, need to strengthen retention across the HIV care continuum to reduce HIV transmission and eventually eradicate HIV infection from the U.S. However, there is a dearth of information related to strategies to reduce HIV stigma among Muslims who are living with HIV in the U.S., who are both widely distributed and in concentrations that make studies impossible to carry out over short time frames. As the world's largest Muslim-majority country, accounting for 13% of the global Muslim population, Indonesia provides a critical context for developing culturally grounded stigma-reduction interventions to improve HIV treatment engagement. In Asia, the population size of people living with HIV (PLH) in Indonesia is second only to that in India and China. According to recent estimates from UNAIDS, while there were an estimated 540,000 PLH in Indonesia in 2022, only 179,659 (33.27%) were reportedly on antiretroviral therapy (ART), 36,821 (6.82%) were regularly tested for viral load, and 33,395 (6.18%) achieved viral suppression. The majority of Indonesian PLHs are lost across the HIV care continuum, even after the government's Strategic Use of Antiretroviral Therapy program launched in 2013. The reasons for this failure to retain PLH in care include insufficient knowledge and limited accessibility and affordability of care, but the most prominent barrier is the fear of stigma. Stigma not only deters PLH from seeking care but also strains patient-provider relationships. Indeed, stigma is considered the greatest barrier to ending HIV in Indonesia whose cultural meanings surrounding HIV are rooted in the local "religious-familial" complex. The scientific premise is that HIV stigma remains rampant in Indonesia, where Islamic doctrine is prominent, with severe negative impacts on treatment engagement. This study addresses the critical need to increase treatment engagement among PLH and retain them in care by addressing the stigma surrounding HIV. Study aims are to adapt an evidence-based stigma reduction intervention and to test the feasibility, acceptability, and preliminary efficacy of the adapted intervention for stigma reduction and care engagement in a Muslim-dominant population. This study will provide transferable insights to inform stigma-reduction strategies and improve HIV care engagement in the U.S. context. The project's key innovations are culturally grounded modules informed by Islamic teachings on justice, compassion, and mindful prayer, while employing a nurse-led, low-intensity, four-session intervention model designed for scalability in resource-poor settings in the U.S. The project findings will advance the understanding of stigma reduction tools used to prevent leakage from the HIV care continuum and ultimately help protect the health of Americans.

Вмешательства

  • Поведенческое Stigma reduction
    The study intervention was adapted for stigma reduction and care engagement in a Muslim-dominant population.

Первичные конечные точки

  • Change in Perceived Stigma Score From Baseline to End of Intervention [Срок оценки: Baseline to 26 weeks]
  • Change in Adherence From Baseline to End of Intervention [Срок оценки: Baseline to 26 weeks]
  • Level of Healthcare Engagement From Baseline to End of Intervention as Measured by Missed or Delayed Clinic Visits [Срок оценки: Baseline to 26 weeks]
  • Changes in Patient Activation from Baseline to End of Intervention [Срок оценки: Baseline to 26 weeks]
  • Change in Internal Stigma Score From Baseline to End of Intervention [Срок оценки: Baseline to 26 weeks]

Критерии участия

Критерии включения

  • Living with HIV
  • Able to give informed consent
  • Able to attend study visits

Критерии исключения

  • Condition that prevents full participation in the study such as neurological disease, major depression or cardiovascular disease
  • Unable to communicate

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

Индонезия · 1 центр
  • University of Indonesia Hospital — Depok

Идентификаторы

NCT: NCT07706634 · IRB-25-1193 · 1R01TW013110

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗