Project neuroARTEMIS for HIV, Stimulant Use, and Depression

This study, Project neuroARTEMIS, aims to understand how stress affects the brain and immune system in people living with HIV who also use stimulants and experience depression. Researchers hope to find better ways to treat depression and stimulant use. You might be eligible if you are 18-59 years old, have HIV, take daily antiretroviral therapy (ART) medication, use stimulants weekly, and speak English. The study tests an intervention called ARTEMIS, which teaches positive coping skills, and also provides contingency management (CM) to help with ART adherence. Success will be measured by changes in brain activity and connectivity after 3 months. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 189 participants. Participants will be randomly assigned to either receive the ARTEMIS intervention or be in a waitlist control group.
What's involved
Participants will complete a baseline assessment including surveys, biological samples, and an MRI brain scan. Those in the ARTEMIS group will have 5 Zoom sessions over 3 months. All participants will use a mobile app to upload videos for ART adherence.
Compensation
Not stated in the trial record.
Follow-up
Participants will have follow-up assessments at 3 and 6 months after the start of the study. Waitlist control participants will be offered the ARTEMIS intervention after a 6-month delay.

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NCT06814275

Project neuroARTEMIS

Recruiting
NAAges 18–59InterventionalTreatment
Wake Forest University Health Sciences
~189 participants
Updated 2025-09-11 on ClinicalTrials.gov
What's tested:ARTEMISContingency management for Antiretroviral (ARV) adherence

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neural Functional Connectivity
Measured over Month 3
+1 more outcome measured
Stimulant Use
Human Immunodeficiency Virus (HIV)
Depression
1 sites across 1 states
North Carolina1
  • Christina S Meade, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
  • Adam W Carrico, PhD · PRINCIPAL_INVESTIGATOR · Florida International University

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Neural Functional ConnectivityMonth 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 ActivationMonth 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.