Actively Recruiting

Phase Not Applicable
Age: 18Years - 59Years
All Genders
ID06814275

Project ARTEMIS: A Mechanistic Clinical Trial of Neuroimmune Pathways

Led by Wake Forest University Health Sciences · Updated on 2025-09-11

189

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

F

Florida International University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand how chronic stress impacts brain and immune system functions, and how these changes affect emotions, thinking, and behavior. The study focuses on individuals who are HIV positive, currently taking antiretroviral medications, and use stimulants. By studying these processes, researchers hope to develop better treatments for issues like depression and substance use. Participants who qualify will undergo a baseline assessment including behavioral surveys, biospecimen collection, and an MRI brain scan. Then, they will be randomly assigned to either the ARTEMIS intervention group or a waitlist control group. The ARTEMIS group receives five individual sessions over Zoom in three months teaching nine positive affect skills. All participants will receive contingency management to support adherence to their antiretroviral therapy throughout the active trial phase. Those in the waitlist control group will have the option to receive ARTEMIS after six months. Throughout the study, participants will have follow-ups at three and six months to evaluate changes in brain function via fMRI and immune signaling through RNA sequencing. Researchers will also measure stimulant use frequency, depression scores, and peripheral inflammation. Adherence to medication is monitored with a mobile app that records videos of dosing. The total participation time includes baseline, intervention, follow-ups, and possible delayed intervention for the control group, lasting up to six months or longer.

CONDITIONS

Brief Title

Project neuroARTEMIS

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 59 years
  • Weekly stimulant use in the past month or a score of 4 or more on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
  • Confirmed HIV diagnosis
  • Currently taking daily oral antiretroviral therapy (ART) medication
  • Able to speak and read English
Not Eligible

You will not qualify if you...

  • Acute brain infection (e.g., neurosyphilis, toxoplasmosis)
  • Acutely symptomatic bipolar I or psychotic disorder
  • Taking immunomodulatory medications or other immunotherapy
  • Any contraindications for MRI scanning
  • Currently on an antidepressant medication regimen for at least 2 months, if applicable

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for baseline assessment including psychosocial and behavioral measures, biospecimen collection, and an MRI brain scan

Outpatient Treatment

Duration - 3 months

Participants randomized to the ARTEMIS group receive 5 individual behavioral therapy sessions delivered over Zoom across 3 months teaching positive affect skills. All participants use a mobile health app to support antiretroviral therapy adherence with video uploads and incentives.

5 therapy sessions delivered individually over Zoom and ongoing use of the adherence app with weekly monitoring

Follow-up

Duration - 3 months

Participants complete follow-up assessments at 3 and 6 months to evaluate changes in neural activity, immune signaling, and behavioral outcomes.

2 follow-up visits (at Month 3 and Month 6) including fMRI scans and blood sample collection

Trial Site Locations

Total: 1 location

1

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States, 27101

Actively Recruiting

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Research Team

C

Christina S Meade, PhD

S

Sheri L Towe, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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