Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Neural Functional Connectivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ARTEMIS
Participants in this arm will receive the ARTEMIS intervention immediately following randomization.
干预措施: ARTEMIS (Behavioral)
ARTEMIS
Participants in this arm will receive the ARTEMIS intervention immediately following randomization.
干预措施: Contingency management for Antiretroviral (ARV) adherence (Behavioral)
Waitlist Control (WLC)
Participants in the WLC arm will be offered the ARTEMIS intervention after the final (6-month) follow-up.
干预措施: Contingency management for Antiretroviral (ARV) adherence (Behavioral)
结局指标
主要结局
Neural Functional Connectivity
时间窗: Month 3
Functional connectivity (FC) will be derived from the the resting-state functional MRI data. Using a theory-driven, seed-based approach, the 4D time series \[average blood oxygenation level dependent (BOLD) signal across voxels\] will be extracted from a priori seeds in the reward network (i.e., nucleus accumbens, subgenual anterior cingulate cortex, medial orbitofrontal cortex). Normalized Z-scores will be calculated for FC between regions of interest. These analyses will control for baseline FC.
Neural Activation
时间窗: Month 3
The Monetary Incentive Delay Task will be used to probe neural activation to reward processing, using an event-level design. Blood oxygenation level dependent (BOLD) activation will be modeled as a canonical hemodynamic response function specified at stimulus onset. Event epochs that are time locked to the onset of each trial will be extracted from the overall time series. Random-effects general linear model will be used to calculate statistical parametric maps reflecting the probability that a voxel is activated as a function of the experimental task. The primary analysis will focus on nucleus accumbens and ventromedial prefrontal cortex activity as regions of interest (ROI). Mean beta values will be averaged across all voxels in each ROI. These analyses will control for baseline activation levels.
次要结局
- Change in Frequency of Stimulant Use(3 and 6 month follow-ups)
- Depression Scores(3 and 6 month follow-ups)
- CTRA Leukocyte Signaling(Baseline, Month 3, Month 6)
- Change in Peripheral Inflammation(3 and 6 month follow-ups)