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NCT06814275NARecruiting

Project neuroARTEMIS

Wake Forest University Health Sciences

Start Date

4/29/2025

Completion Date

12/31/2028

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

Age Range: 18 years to 59 years

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

Interventions

BEHAVIORAL

ARTEMIS

BEHAVIORAL

Contingency management for Antiretroviral (ARV) adherence

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Conditions

Stimulant UseHuman Immunodeficiency Virus (HIV)Depression

Locations

Wake Forest University School of Medicine

Winston-Salem, North Carolina 27101

United States