Project neuroARTEMIS
Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways.
2 other identifiers
interventional
189
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 7, 2025
CompletedStudy Start
First participant enrolled
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
September 11, 2025
September 1, 2025
3.1 years
February 3, 2025
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neural Functional Connectivity
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.
Month 3
Neural Activation
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.
Month 3
Secondary Outcomes (4)
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
Study Arms (2)
ARTEMIS
ACTIVE COMPARATORParticipants in this arm will receive the ARTEMIS intervention immediately following randomization.
Waitlist Control (WLC)
OTHERParticipants in the WLC arm will be offered the ARTEMIS intervention after the final (6-month) follow-up.
Interventions
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 complete daily home practice of the skills between sessions.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- Florida International Universitycollaborator
- National Institutes of Health (NIH)collaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina S Meade, PhD
Wake Forest University Health Sciences
- PRINCIPAL INVESTIGATOR
Adam W Carrico, PhD
Florida International University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2025
First Posted
February 7, 2025
Study Start
April 29, 2025
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- The investigators will lock the data until the primary analyses are completed and accepted for publication, after which the investigators will make the data as widely available as possible. Data and supporting documentation will be prepared for deposit in the appropriate repositories in Years 4-5 of the project, with deposit occurring in the final quarter of Year 5 (Q4 2029).
- Access Criteria
- All data for all research subjects will be preserved and deposited in designated NIH-supported repositories for sharing broadly with the scientific community. Anyone with access to these repositories will have access to the deidentified data from this project.
All individual-level phenotypic, clinical, genomic, and neuroimaging data for all research subjects will be preserved and deposited in designated NIH-supported repositories for sharing broadly with the scientific community (described below). While identifiers will be collected, all data will be de-identified prior to deposit into any repository. Shared data will include raw and processed files for genomic and neuroimaging data. Recruitment progress and final results will be documented at ClinicalTrials.gov. The sources of data include clinical interviewing, computerized questionnaires, neuropsychological testing, biological sampling (blood and urine), MRI neuroimaging, and medical record review. The final dataset from this project will also include data on demographic factors (including biological variables) and clinical variables such as HIV disease characteristics.