Understanding how chronic stress affects brain and immune function in HIV positive individuals using stimulants
Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 189 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06814275 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are HIV positive individuals aged 18-59 who use stimulants weekly and are currently on antiretroviral therapy.
Not a fit: Patients with acute brain infections, severe psychiatric disorders, or contraindications for MRI may not benefit from this study.
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 performed: Other studies have shown promise in similar interventions targeting mental health and substance use in HIV populations, suggesting potential for success.
Eligibility criteria
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 this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.