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Not yet recruiting NCT07088289

VR Mindfulness for People With HIV and Substance Use

No phase Interventional HIV Substance Use (Drugs, Alcohol)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRIPP.
Who it may be relevant to
Registry conditions: HIV, Substance Use (Drugs, Alcohol). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral TRIPP
    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 outcome measures

  • Intervention acceptability as measured by the Acceptability of Intervention Measure [Time frame: One-month follow-up]
  • Intervention appropriateness as measured by the Intervention Appropriateness Measure [Time frame: One-month follow up]
  • Intervention feasibility as measured by the Feasibility of Intervention Measure [Time frame: One-month follow up]
Secondary outcome measures (1)
  • Intervention engagement as measured by VR mindfulness app use frequency [Time frame: From enrollment to the end at 12 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07088289 · 2025-949 · R21DA061682

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗