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Набор скоро начнётся NCT07631104

Improving the HIV Care Continuum With mHealth Technology

Без фазы С лечением HIV - Human Immunodeficiency Virus HIV Antiretroviral Therapy (ART) Adherence mHealth Application mHealth Intervention

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: MindBodyU Intervention.
Кому может быть актуально
Состояния в реестре: HIV - Human Immunodeficiency Virus, HIV Antiretroviral Therapy (ART) Adherence, mHealth Application, mHealth Intervention. Базовые параметры: 16 лет — 25 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Improving the HIV Care Continuum for Youth in the Deep South Through Mobile Health Technology

Обзор

Youth living with HIV (YLHIV) face barriers to engagement and retention in HIV care, show poor medication adherence, and often fail to achieve and maintain viral suppression. YLHIV in the southern United States have particularly poor care engagement outcomes. South Carolina is one of nine states identified as "key drivers" of the US HIV epidemic, and HIV rates for youth in South Carolina have risen in recent years. Tailored interventions are urgently needed to improve outcomes for this population. One promising approach is to reach YLHIV via mobile Health (mHealth) technology, yet few efforts have sought to tailor mHealth interventions to the needs of YLHIV in the southern US. Thus, the scientific objective of this study is to pilot test a new mHealth intervention, called MindBodyU, designed to increase engagement/retention in care and ART adherence among YLHIV in South Carolina. In this study, investigators will evaluate the feasibility, acceptability, and initial efficacy of the mHealth intervention with a six-month pilot trial with 40 YLHIV in South Carolina.

Подробное описание

In this study, investigators will conduct a brief pilot trial of the MindBodyU intervention--a digital health intervention that is delivered via a smartphone application ('app'). In the study, a total of 40 youth living with HIV (YLHIV) be provided with access to the MindBodyU app. Investigators will collect survey data from youth before youth install the app on their personal phone and again at 12-weeks and 6-months to assess feasibility and acceptability of the intervention, as well as preliminary outcomes (e.g., engagement/retention in care, adherence, viral suppression).

Вмешательства

  • Поведенческое MindBodyU Intervention
    The MindBodyU app is an mHealth intervention that was developed based on input from youth living with HIV, HIV providers, and community-based organizations. The app includes multiple features designed to promote HIV care engagement, medication adherence, and psychosocial wellbeing for youth living with HIV in South Carolina. Users of the app will have the opportunity to create anonymous profiles in which they can access resources related to HIV, behavioral health, sexual health, and other social

Первичные конечные точки

  • Study Retention [Срок оценки: From enrollment to 12-weeks]
  • Acceptability of the MindBodyU Intervention [Срок оценки: From enrollment to 12-weeks]
  • Adherence to Antiretroviral Therapy (ART) [Срок оценки: From enrollment to 12-weeks; follow-up at 6-months]
  • Viral Suppression [Срок оценки: From enrollment to 12-weeks; follow-up at 6-months]
  • HIV Care Engagement [Срок оценки: From enrollment to 12-weeks; follow-up at 6-months]
  • App engagement [Срок оценки: From enrollment to 12-weeks]
  • Perceived Burden of the MindBodyU App [Срок оценки: From enrollment to 12-weeks]
  • Perceived Feasibility of the MindBodyU App [Срок оценки: From enrollment to 12-weeks]
Вторичные конечные точки (5)
  • HIV Stigma [Срок оценки: Enrollment to 12-weeks; 6-month follow-up]
  • Depressive symptoms [Срок оценки: Enrollment to 12-weeks; follow-up at 6-months]
  • Coping Self-Efficacy [Срок оценки: Enrollment to 12-weeks; follow-up at 6-months]
  • Barriers to Mental and Behavioral Health Care [Срок оценки: Enrollment to 12-weeks; follow-up at 6-months]
  • Anxiety symptoms [Срок оценки: Enrollment to 12-weeks; follow-up at 6-months]

Критерии участия

Критерии включения

  • Between the ages of 16 and 25 years
  • Diagnosed with HIV
  • Resident of South Carolina
  • Proficient in English

Критерии исключения

  • Under 16 years of age or over 25 years of age
  • Is not a person living with HIV
  • Is not a resident of South Carolina
  • Is not proficient in English

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of South Carolina — Columbia

Публикации

  • Miller SJ, Weaver KE, Harrison SE. A multi-informant qualitative analysis of desired features for an mHealth tool for youth living with HIV in South Carolina. J Pediatr Psychol. 2024 Sep 1;49(9):616-627. doi: 10.1093/jpepsy/jsae047. PMID 38976587

Идентификаторы

NCT: NCT07631104 · Pro00085794 · 1K01MH118073-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗