Project neuroARTEMIS

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06814275
Status
Recruiting

Conditions

  • Depression
  • Human Immunodeficiency Virus (HIV)
  • Stimulant Use

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • ARTEMIS — BEHAVIORAL
    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.
  • Contingency management for Antiretroviral (ARV) adherence — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 29, 2025
Status verified
Sep 2025
Primary completion
May 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
189 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ARTEMIS
    Participants in this arm will receive the ARTEMIS intervention immediately following randomization.
  • Other: Waitlist Control (WLC)
    Participants in the WLC arm will be offered the ARTEMIS intervention after the final (6-month) follow-up.

Primary Outcome Measure

Neural Functional Connectivity [ Time Frame: Month 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University School of MedicineWinston-SalemNorth Carolina27101
Christina S Meade, PhD
336-716-0695
Sheri L Towe, PhD
336-716-4331
Christina S Meade, PhD (PRINCIPAL_INVESTIGATOR)

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