VR Mindfulness for People With HIV and Substance Use

NCT07088289 | Not Yet Recruiting

• 2 other identifiers: 2025-949R21DA061682
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to explore whether a virtual reality (VR) mindfulness app is acceptable, appropriate, and feasible for supporting people with HIV and substance use problems. Participants will:

• Use a VR headset with a mindfulness app at home;
• Complete three online surveys over three months;
• Take part in an individual interview or focus group to share their experiences.

Conditions

HIV; Substance Use (Drugs, Alcohol)

Outcome Measures

Primary Outcomes (3)

• Intervention acceptability as measured by the Acceptability of Intervention Measure

  The Acceptability of Intervention Measure is a 4-item scale that assesses the extent to which participants find the intervention agreeable or satisfactory. Items are rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). Scores are averaged to create a total score, with higher scores indicating greater perceived acceptability of the intervention. Example items include: "I like \[intervention\]" and "\[intervention\] meets my approval."

  One-month follow-up

• Intervention appropriateness as measured by the Intervention Appropriateness Measure

  The Intervention Appropriateness Measure is a 4-item scale designed to assess how suitable or relevant the intervention is for the target population. Each item is rated from 1 (Completely disagree) to 5 (Completely agree), and a total score is calculated by averaging responses. Higher scores reflect a stronger belief that the intervention is appropriate for the individual's needs or situation. Example items include: "\[intervention\] seems like a good match" and "\[intervention\] seems suitable."

  One-month follow up

• Intervention feasibility as measured by the Feasibility of Intervention Measure

  The Feasibility of Intervention Measure includes 4 items that measure how practical and doable the intervention seems from the participant's perspective. Participants respond on a 5-point scale from 1 (Completely disagree) to 5 (Completely agree), with higher average scores indicating greater perceived feasibility. Example items include: "\[intervention\] seems implementable" and "\[intervention\] seems easy to use."

  One-month follow up

Secondary Outcomes (1)

• Intervention engagement as measured by VR mindfulness app use frequency

  From enrollment to the end at 12 weeks.

Study Arms (1)

VR mindfulness

EXPERIMENTAL

Participants in this arm will receive a virtual reality (VR) mindfulness intervention named TRIPP. TRIPP is a commercially available VR mindfulness app designed to promote relaxation, focus, and emotional well-being through immersive, guided experiences. The app combines visual and auditory stimulation, breathwork, meditation, and interactive elements to help users reduce stress and improve mood.

Behavioral: TRIPP

Interventions

TRIPP BEHAVIORAL

In this study, participants will use TRIPP with a VR headset at home, engaging in short mindfulness sessions 3+ times per week for 4-12 weeks.

VR mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to speak, read, and write in English
• Aged 18 years or older
• Diagnosed with HIV
• Currently prescribed ART therapy
• Reporting moderate to high risk related to alcohol, opioids, nicotine, cannabis, or stimulant use (score of 4 or higher on the Alcohol, Smoking, and Substance Involvement Screening Test - ASSIST). Participants may also use other substances, but the primary risk must fall within these categories, as these have the strongest research support for mindfulness-based interventions.
• Having stable housing that allow using VR safely
• Willing to provide contact information for at least one person whom the study team can reach if the participant becomes unreachable after repeated attempts

You may not qualify if:

• Living in institutionalized settings or unsheltered
• Terminal illness with a life expectancy of less than 6 months
• Planning to move out of the area in the next eight weeks
• Engaging in regular mindfulness practice outside of TRIPP
• Experiencing fear of closed spaces or unable to tolerate wearing a VR headset (verified during orientation session)
• Having visual or auditory impairments or severe physical disabilities that hinder VR use, history of seizures, severe cognitive impairment, severe motion sickness, severe unmanaged psychiatric symptoms, or currently pregnant
• Participants without home internet access will not be excluded and will be provided either funding for internet service or VR headsets preloaded with TRIPP sessions for offline use.

Sponsors & Collaborators

• Tulane University: lead

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Audrey Hang Hai, PhD

CONTACT

504-247-1457; ahai@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share