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Идёт набор NCT06814275

Project neuroARTEMIS

Без фазы С лечением Stimulant Use Human Immunodeficiency Virus (HIV) Depression

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: ARTEMIS, Contingency management for Antiretroviral (ARV) adherence.
Кому может быть актуально
Состояния в реестре: Stimulant Use, Human Immunodeficiency Virus (HIV), Depression. Базовые параметры: 18 лет — 59 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

Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways.

Обзор

The purpose of this research is to understand how chronic stress affects the way our brain and immune systems function, and in turn how this affects the way people feel, think, and behave. By learning more about how these processes work, the hope is to be able to develop better treatments to help with problems like depression and substance use. This study is intended for individuals that are HIV positive, currently taking prescription antiretroviral medications, and use stimulants. Through this intervention, the aim is to determine if this positive affect intervention can lead to reductions in stimulant use and depressed mood.

Подробное описание

Participants who meet initial eligibility criteria will complete a baseline assessment that includes psychosocial and behavioral measures, biospecimen collection, and an MRI brain scan. Participants will then be randomized to either: 1) ARTEMIS; or 2) a waitlist control (WLC) condition. ARTEMIS participants will receive 5 sessions delivered individually over Zoom across 3 months. All participants (including WLC) will receive contingency management (CM) for antiretroviral therapy (ART) adherence to support sustained viral suppression over the active phase of the trial. During the intent-to-treat period, assessments at 3- and 6-month follow-ups will characterize changes in neural activity (assessed via fMRI) and conserved transcriptional response to adversity (CTRA) leukocyte signaling (assessed via RNA sequencing) as plausible mediators of behavioral outcomes following ARTEMIS. WLC participants will be offered the ARTEMIS intervention after a 6-month delay.

Вмешательства

  • Поведенческое ARTEMIS
    The ARTEMIS intervention includes 5 sessions delivered individually over Zoom across 3 months. The intervention teaches 9 positive affect skills: noting and capitalizing on positive events, gratitude journaling, formal and informal mindfulness, positive reappraisal and problem solving coping skills training, focusing on personal strengths, setting achievable goals, and small acts of kindness. Each session consists of a didactic portion with in vivo skills practice, and participants are asked to
  • Поведенческое Contingency management for Antiretroviral (ARV) adherence
    All participants will received the contingency management (CM) intervention to support ARV adherence. They will use the Spotlight by Scene Health platform, a HIPAA-compliant mHealth application for directly observed therapy, to upload videos of ART adherence. The app records and uploads time-stamped videos of medication doses, which staff verify asynchronously. Participants will be paid for each verified dose and receive a weekly bonus if they complete 6 doses.

Первичные конечные точки

  • Neural Functional Connectivity [Срок оценки: Month 3]
  • Neural Activation [Срок оценки: Month 3]
Вторичные конечные точки (4)
  • Change in Frequency of Stimulant Use [Срок оценки: 3 and 6 month follow-ups]
  • Depression Scores [Срок оценки: 3 and 6 month follow-ups]
  • CTRA Leukocyte Signaling [Срок оценки: Baseline, Month 3, Month 6]
  • Change in Peripheral Inflammation [Срок оценки: 3 and 6 month follow-ups]

Критерии участия

Критерии включения

  • 18-59 years old
  • Weekly use of stimulants reported in the past month or a score of 4 or more on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
  • Confirmed HIV diagnosis
  • Current receipt of daily oral antiretroviral therapy (ART) medication
  • English fluency/literacy

Критерии исключения

  • Acute brain infection (e.g., neurosyphilis, toxoplasmosis)
  • Acutely symptomatic bipolar I or psychotic disorder
  • Prescription for immunomodulatory medications or other immunotherapy
  • Any MRI contraindications
  • If applicable, on antidepressant medication regimen for at least 2 months

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
Лечение

Центры проведения

США · 1 центр
  • Wake Forest University School of Medicine — Winston-Salem

Идентификаторы

NCT: NCT06814275 · IRB00117907 · 1R01DA061952-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗