RecruitingNot ApplicableNCT06814275

Project neuroARTEMIS

Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways.

Sponsor

Wake Forest University Health Sciences

Enrollment

189 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Depression Stimulant Use Human Immunodeficiency Virus (HIV)

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.

Eligibility

Min Age: 18 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how stimulant drug use (such as cocaine or methamphetamine) affects the brains of people living with HIV. Many people with HIV who use stimulants develop thinking and memory problems — this study uses brain scans (MRI) to look at brain structure and function, and tracks changes over time, in hopes of identifying better treatment approaches. **You may be eligible if...** - You are between 18 and 59 years old - You have a confirmed HIV diagnosis - You are currently taking daily antiretroviral (HIV) medication - You have used stimulants in the past month, or scored 4 or higher on a substance use screening test - You are fluent in English **You may NOT be eligible if...** - You have an active brain infection (such as neurosyphilis or toxoplasmosis) - You have an acute episode of bipolar I disorder or psychosis - You have metal implants or other conditions preventing MRI - You are on immunotherapy medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALARTEMIS

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.

BEHAVIORALContingency management for Antiretroviral (ARV) adherence

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.