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Набор скоро начнётся NCT06580184

Theoretically Informed Behavioral Intervention

Без фазы С лечением HIV CVD Metabolic Disease

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: LEARN 2 Platform.
Кому может быть актуально
Состояния в реестре: HIV, CVD, Metabolic Disease. Базовые параметры: от 18 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
США
Следующий шаг
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Официальное название

Theoretically Informed Behavioral Intervention to Prevent HIV-related Comorbidities

Обзор

The goal of this waitlist control clinical trial is to learn if the tailored LEARN 2 platform can prevent HIV-related comorbidities with shared risk factors in men ages 18 and older living with HIV. The main question\[s\] are: 1. Can the virtual environment improve quality of life among these participants? 2. Does the LEARN 2 platform effectively serve as prevention education for HIV comorbidity shared risk factors? Researchers will compare participants receiving the LEARN2 virtual environment intervention to those in a waitlist control group to see if the intervention leads to improvements in quality of life and reductions in risk factors. Participants will be asked to: 1. Engage with the virtual environment weekly. 2. Participate in virtual live health educator sessions. 3. Complete daily assessments of personal health behaviors through Ecological Momentary Assessment.

Подробное описание

The goal of this waitlist control clinical trial is to determine the efficacy of the tailored LEARN 2 platform in preventing HIV-related comorbidities characterized by shared risk factors. The principal questions this study aims to address are:

1. Can engagement with the virtual environment enhance the quality of life for participants? 2. Is the LEARN 2 platform effective in providing prevention education of shared risk factors associated with HIV comorbidities?

To evaluate these objectives, the investigators will conduct comparisons between participants allocated to the LEARN 2 virtual environment intervention and those assigned to a waitlist control group. This design will facilitate the assessment of whether participation in the LEARN 2 intervention correlates with significant improvements in quality of life metrics (behavioral and psychosocial) and a reduction in associated health risk factors.

Participants will be instructed to:

1. Engage with the virtual environment on a weekly basis, exploring tailored health content designed to address their specific needs. 2. Attend virtual live sessions with health educators, where they will receive real-time education on health issues relevant to their condition and associated lifestyle factors using the American Heart Association's Life's Essential 8 as a behavioral prevention framework. 3. Complete daily assessments of their personal health behaviors using Ecological Momentary Assessment (EMA), capturing real-time data on behavioral trends that may influence their health outcomes.

This systematic approach aims to generate comprehensive data on the impact of the LEARN 2 intervention on both quality of life and the modulation of health-related behaviors among these at-risk populations.

Вмешательства

  • Поведенческое LEARN 2 Platform
    The LEARN 2 Platform will provide tailored prevention education of HIV-comorbidities with shared risk factors. Participants will navigate LEARN 2 and access targeted health content.

Первичные конечные точки

  • Quality of Life scale [Срок оценки: Baseline, 3 and 6 months]
Вторичные конечные точки (9)
  • Diet [Срок оценки: Months 1, 3, and 5]
  • Physical Activity [Срок оценки: Months 1, 3, and 5]
  • Sleep Quality [Срок оценки: Months 1, 3, and 5]
  • Health Care Utilization [Срок оценки: Months 1, 3, and 5]
  • Physical Relationship Health [Срок оценки: Months 1, 3, and 5]
  • Smoking [Срок оценки: Months 1, 3, and 5]
  • Social Support [Срок оценки: Months 1, 3, and 5]
  • Coping [Срок оценки: Months 1, 3, and 5]
  • Social Cohesion [Срок оценки: Months 1, 3, and 5]

Критерии участия

Критерии включения

Self-identify as:

  • living with HIV
  • English speaking
  • Access to a device compatible with LEARN 2

Критерии исключения

\- medical history of serious complications such as heart attack, stroke, cognitive impairment, or cancer.

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
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Yale University — Orange

Публикации

  • Ramos SR, Reynolds H, Johnson C, Melkus G, Kershaw T, Thayer JF, Vorderstrasse A. Perceptions of HIV-Related Comorbidities and Usability of a Virtual Environment for Cardiovascular Disease Prevention Education in Sexual Minority Men With HIV: Formative Phases of a Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Aug 22;26:e57351. doi: 10.2196/57351. PMID 38924481

Идентификаторы

NCT: NCT06580184 · 2000033508 · R01MD019956

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗