Understanding how chronic stress affects brain and immune function in HIV positive individuals using stimulants
Official title: Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways.
Run by Wake Forest University Health Sciences · NCT06814275 · Data updated 2026-11-12
This study is testing how chronic stress affects the brain and immune system in people with HIV who use stimulants, to see if a new online program can help improve their health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 59 Years |
| Sex | All |
| Enrollment | 189 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | April 29, 2025 |
| Main results expected | May 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT06814275 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are HIV positive individuals aged 18-59 who use stimulants weekly and are currently on antiretroviral therapy.
✕Probably not a fit
Patients with acute brain infections, severe psychiatric disorders, or contraindications for MRI may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research aims to explore the impact of chronic stress on brain and immune system functioning, particularly in individuals who are HIV positive and use stimulants. Participants will undergo a baseline assessment, including psychosocial measures, biospecimen collection, and an MRI brain scan, before being randomized to receive an intervention called ARTEMIS or a waitlist control. The ARTEMIS intervention consists of five individual sessions delivered via Zoom over three months, alongside contingency management for antiretroviral therapy adherence. Follow-up assessments will evaluate changes in neural activity and immune responses as potential mediators of behavioral outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for depression and stimulant use in HIV positive individuals.
How similar studies have gone: Other studies have shown promise in similar interventions targeting mental health and substance use in HIV populations, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Christina S Meade, PhD — Wake Forest University Health Sciences
- Study coordinator: Christina S Meade, PhD
- Email: cmeade@wakehealth.edu
- Phone: 336-716-0695
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.