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Идёт набор NCT07559266

BEYOND Study: Improving HIV Treatment and Well-Being Among Young MSM in Vietnam

Наблюдательное HIV Infections Mental Health Medication Adherence

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: NO interventions listed.
Кому может быть актуально
Состояния в реестре: HIV Infections, Mental Health, Medication Adherence. Базовые параметры: 18 лет — 24 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Вьетнам
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

BEYOND Study: Bridging Equity, Youth, And Optimal Nurture for HIV Dynamics - Enhancing Treatment and Well-Being Among Young MSM Living With HIV in Vietnam

Обзор

The BEYOND Study aims to evaluate HIV treatment outcomes and well-being among young men who have sex with men (YMSM) living with HIV in Ho Chi Minh City, Vietnam. Despite progress in HIV services, YMSM continue to experience disparities in engagement in care, antiretroviral therapy (ART) adherence, and viral suppression, influenced by individual, social, and structural factors including stigma and limited access to person-centered care. This prospective cohort study will enroll 300 YMSM living with HIV from four clinical sites, including public, private, and community-based clinics. Participants will be followed for 12 months, with data collection at baseline, 6 months, and 12 months. The study will assess key outcomes including viral suppression, ART adherence, retention in care, mental health, and quality of life. In addition, in-depth interviews will be conducted with a subset of 20-30 participants to explore experiences with HIV care and barriers and facilitators to engagement. The study will also examine the implementation and perceived impact of person-centered care and one-stop-shop service models across different healthcare settings. Findings from this study will inform strategies to improve HIV treatment outcomes and support the development of integrated, patient-centered approaches to care for YMSM living with HIV in Vietnam and similar settings.

Вмешательства

  • Другое NO interventions listed
    NO interventions listed

Первичные конечные точки

  • Viral Suppression Rate at 6 Months (HIV RNA <200 copies/mL) [Срок оценки: 6 months after enrollment]
  • Viral Suppression Rate at 12 Months (HIV RNA <200 copies/mL) [Срок оценки: 12 months after enrollment]
Вторичные конечные точки (6)
  • ART Adherence (≥95% of Prescribed Doses, 30-Day Recall) [Срок оценки: 6 months and 12 months after enrollment]
  • Depressive Symptoms (Center for Epidemiologic Studies Depression Scale-Revised [CESD-R] Total Score) [Срок оценки: Baseline, 6 months, and 12 months]
  • Experience of Person-Centered HIV Care (Qualitative Assessment via In-Depth Interviews) [Срок оценки: At a single time point during the 12 month follow up]
  • Overall Depression Severity and Impairment (Overall Depression Severity and Impairment Scale [ODSIS] Total Score) [Срок оценки: Baseline, 6 months, and 12 months]
  • Anxiety Severity and Impairment (Overall Anxiety Severity and Impairment Scale [OASIS] Total Score) [Срок оценки: Baseline, 6 months, and 12 months]
  • Perceived Social Support (Multidimensional Scale of Perceived Social Support [MSPSS] Mean Score) [Срок оценки: Baseline, 6 months, and 12 months]

Критерии участия

Критерии включения

  • Aged 18 to 24 years
  • Self-identified as male and reporting sex with men in the past 12 months
  • Confirmed HIV diagnosis according to Vietnam Ministry of Health (MOH) national HIV testing guidelines
  • Currently receiving antiretroviral therapy (ART) at one of the participating study clinics
  • Residing in Ho Chi Minh City or nearby areas and able to attend study visits at participating clinics
  • Able to understand and communicate in Vietnamese
  • Willing and able to provide informed consent and participate in study procedures

Критерии исключения

  • Younger than 18 years or older than 24 years
  • Not currently receiving ART or receiving ART from a non-participating clinic
  • Severe cognitive impairment or mental health condition that, in the judgment of the research team, would interfere with the ability to provide informed consent or participation
  • Currently enrolled in another clinical or behavioral study that may interfere with this study
  • Unwilling or unable to provide informed consent or comply with study procedures

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Вьетнам · 1 центр
  • GoVap, MaiKhoi, Galant, Xomchieu — Ho Chi Minh City

Идентификаторы

NCT: NCT07559266 · CARMAH · IN-US-380-7737

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗