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 — BEHAVIORALThe 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 — BEHAVIORALAll 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: ARTEMISParticipants 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
- Christina S Meade, PhD336-716-0695
- Sheri L Towe, PhD336-716-4331
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27101 | Christina S Meade, PhD (PRINCIPAL_INVESTIGATOR) |
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