Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06814275

Conditions

Stimulant Use

Human Immunodeficiency Virus (HIV)

Depression

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Interventions

ARTEMIS

Contingency management for Antiretroviral (ARV) adherence

Study Details

Brief summary:

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.

Conditions

Stimulant Use

Human Immunodeficiency Virus (HIV)

Depression

Study ID

NCT06814275

Start date

Apr 29, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

189 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ARTEMIS

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

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.

Primary outcome measure

  • Neural Functional Connectivity [ Time Frame: Month 3 ]
  • Neural Activation [ Time Frame: Month 3 ]

Central Contacts and Locations

Central contacts

Christina S Meade, PhD

336-716-0695cmeade@wakehealth.edu

Sheri L Towe, PhD

336-716-4331stowe@wakehealth.edu

Locations

Wake Forest University School of Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27101

Contacts

Christina S Meade, PhD

336-716-0695cmeade@wakehealth.edu

Sheri L Towe, PhD

336-716-4331stowe@wakehealth.edu

Principal Investigator:

Christina S Meade, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • HIV
  • Stimulant use
  • substance abuse
  • chronic stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-09-03.