Clinical trial NCT06814275: Project neuroARTEMIS
Official title: Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stimulant Use
Human Immunodeficiency Virus (HIV)
Depression
Keywords: HIV
Stimulant use
substance abuse
chronic stress
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Florida International University
name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-02-07
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will utilize two treatment arms in which participants are randomized using a 2:1 allocation. Arm A will receive the ARTEMIS intervention immediately following their baseline visit. Arm B will be considered a wait-list control, being offered the ARTEMIS intervention after a 6-month delay.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Neural Functional Connectivity
timeFrame: Month 3
measure: Neural Activation
timeFrame: Month 3
Secondary outcomes:
measure: Change in Frequency of Stimulant Use
timeFrame: 3 and 6 month follow-ups
measure: Depression Scores
timeFrame: 3 and 6 month follow-ups
measure: CTRA Leukocyte Signaling
timeFrame: Baseline, Month 3, Month 6
measure: Change in Peripheral Inflammation
timeFrame: 3 and 6 month follow-ups
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christina S Meade, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida International University
name: Adam W Carrico, PhD
role: PRINCIPAL_INVESTIGATOR
References: