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NCT Number: NCT07088289

VR Mindfulness for People With HIV and Substance Use

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.

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Key information

Conditions

HIV Chemically-Induced Disorders Mental Disorders Substance Use (Drugs, Alcohol) Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Intervention acceptability as measured by the Acceptability of Intervention Measure

    Time frame: One-month follow-up

    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."

  2. Intervention appropriateness as measured by the Intervention Appropriateness Measure

    Time frame: One-month follow up

    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."

  3. Intervention feasibility as measured by the Feasibility of Intervention Measure

    Time frame: One-month follow up

    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."

Secondary outcomes

  1. Intervention engagement as measured by VR mindfulness app use frequency

    Time frame: From enrollment to the end at 12 weeks.

    Engagement with the intervention will be measured by the frequency of VR mindfulness app use, as recorded by the TRIPP app. The system captures the number of times participants launch and complete mindfulness sessions during the study period. Higher session counts reflect greater engagement with the intervention. There is no maximum score, and a higher number of sessions indicates more frequent use of the app.

Study contacts

Contact information is provided by the study sponsor or research team.

Audrey Hang Hai, PhD

CONTACT

[email protected]

504-247-1457

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Official study title

Virtual Reality Mindfulness Intervention for Supporting People With HIV and Substance Use

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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