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Набор по приглашению NCT06183723

Optimizing Care for Challenging People Living With HIV

Без фазы С лечением Adherence, Medication HIV Infections Social Media

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: Combination of social-behavior model and eHealth.
Кому может быть актуально
Состояния в реестре: Adherence, Medication, HIV Infections, Social Media. 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
Тайвань
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

Feasible Program of Sustainable Medical Care for People Living With HIV Who Are Difficult to Treat or Marginalized in Taiwan

Обзор

Conduct an intervention combining social and behavioral health models with digital health technologies to improve their adherence to their medication schedules. The success of the intervention is assessed by comparing adherence rates before and after its implementation to see if there's a notable enhancement in how well patients follow their antiretroviral therapy.

Подробное описание

This is an intervention strategy for HIV-infected individuals based on their viral load measurements and medication adherence rates, measured by the proportion of days covered (PDC) for the past 365 days. A specific PDC threshold identifies individuals with less than 90% viral suppression at under 200 copies/mL. An intervention approach integrating social and behavioral models with electronic health (eHealth) technology is implemented for cases with a PDC below this threshold. The intervention aims to enhance the patient's adherence to their medication regimen. The effectiveness of this intervention is evaluated by comparing indicators before and after its application to determine if there are significant improvements in the participants' compliance with their antiretroviral therapy.

Вмешательства

  • Другое Combination of social-behavior model and eHealth
    The study examines how an intervention combining the social-behavior model and eHealth can improve medication adherence among individuals who struggle to follow their medical regimens. The platform offers multiple features including health education, medication reminders, online consultations, chat rooms, news, and Q\&A services. The intervention and follow-up are based on a 28-day month. The first intervention period runs from the first to the third month post-enrollment, with the introduction

Первичные конечные точки

  • Change in HIV Viral Load from Baseline to 1st and 2nd Follow-Up [Срок оценки: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment]
  • Change in CD4 Count from Baseline to 1st and 2nd Follow-Up [Срок оценки: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment]
  • Change in Quality of Life Score (WHOQOL-BREF Taiwan Version) from Baseline to 1st and 2nd Follow-Up [Срок оценки: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment]
  • Change in HIV symptoms index (HIV-SI) in score from Baseline to 1st and 2nd Follow-Up [Срок оценки: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment]
  • Change in Self-Reported Antiretroviral Therapy (ART) Medication Adherence from Baseline to 1st and 2nd Follow-Up [Срок оценки: At baseline, 84th (+-14) day after enrollment, and 168th (+-14) day after enrollment]
Вторичные конечные точки (1)
  • Change in Proportion of Days Covered (PDC) over the Past 180 Days from Baseline to 1st and 2nd Follow-Up [Срок оценки: At baseline and 168th (+-14) day after enrollment]

Критерии участия

Критерии включения

1\. PLWH with adherence below the specific proportion of days covered (PDC), which is defined as the specific level that corresponds to 90% at viral suppression (< 200 copies/mL).

Критерии исключения

  • Under 18 years of age.
  • Illiterate.
  • Non-consenting individuals.
  • Less than 365 days from the initial use of antiretroviral drugs to the assessment for inclusion in the study.
  • Inability to obtain complete medication records for the 365 days prior to inclusion.
  • Lack of a smart phone.
  • No willingness to return for follow-up at the participating hospital.

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
Другое

Центры проведения

Тайвань · 1 центр
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City

Идентификаторы

NCT: NCT06183723 · KMUHIRB-SV(I)-20230081

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗