HIVNCT07088289
VR Mindfulness for People With HIV and Substance Use
A study testing TRIPP in people with HIV and Substance Use (Drugs, Alcohol), run by Tulane University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Substance Use (Drugs, Alcohol)
- What is being tested?
- TRIPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Virtual Reality Mindfulness Intervention for Supporting 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.
- Conditions
- HIV, Substance Use (Drugs, Alcohol)
- Being tested
- TRIPP
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIPPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: TRIPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: 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."
Measured: One-month follow up
Secondary outcomes (1)
Intervention engagement as measured by VR mindfulness app use frequency
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.
Measured: From enrollment to the end at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Audrey Hang Hai, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088289
- Sponsor's protocol ID
- 2025-949
- Other IDs
- R21DA061682
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Mindfulness Intervention for Supporting People With HIV and Substance Use
- ClinicalTrials.gov ID
- NCT07088289
- Acronym / sponsor ID
- 2025-949
- Conditions
- HIV, Substance Use (Drugs, Alcohol)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR mindfulness | Experimental | Behavioral: TRIPPParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIPPIn 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. | Behavioural | VR mindfulness |
Primary outcome
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."
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."
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."
1 secondary outcome
Intervention engagement as measured by VR mindfulness app use frequency
Time frame: From enrollment to the end at 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey Hang Hai, PhD principal investigator
University of Texas at Austin
Questions about this trial
What is this clinical trial studying?
A study testing TRIPP in people with HIV and Substance Use (Drugs, Alcohol), run by Tulane University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Hang Hai, PhD ((504)862-3497, ahai@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention acceptability as measured by the Acceptability of Intervention Measure (time frame: One-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.