ClinicalTrials.gg
Active, not recruitingNCT05816083Updated Oct 20, 2026

Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People

An interventional study of Virtual Reality Tool in Substance Use Disorders and HIV Infections, sponsored by Medical University of South Carolina. Active, not recruiting at 1 site in United States. Open to participants aged 15 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Updated Oct 20, 2026Now Active, not recruitingStudy documents posted+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
15 Years to 30 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 48 studies in Substance-Related Disorders by Medical University of South Carolina — 7 open to participants now, 10 under way, none of them phase 3. Substance-Related Disorders · Medical University of South Carolina.

Planned enrollment
33rd of 47
50 · median 81
Started
2025
with 3 others
No phase
24 of 48
6 open now
Registered
40th of 48
by date

Among the 48 studies in Substance-Related Disorders by Medical University of South Carolina, this one is the 33rd largest by planned enrollment of the 47 interventional ones, is one of 4 that started in 2025, is one of 24 with no phase, and was the 40th registered.

By phase

48 studies; the count open now beside each. This study's row is marked.

No phasethis study24 · 6 open
Phase 213 · 1 open
Phase 1/25 · 0 open
Phase 13 · 0 open
Phase 42 · 0 open
Observational1 · 0 open

By the year they started

First in 1992; this study’s year is marked. 4 started in 2025.

Size and results

Median enrollment 81 across the 47 interventional studies, 24 across the 1 observational. Of the 37 that completed or were terminated, 18 (49%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 48 studies in Substance-Related Disorders by Medical University of South Carolina, or all of them as a file.
02

Study summary

This is a multi-phased study, funded through a National Institute on Drug Abuse (NIDA) K24 grant that aims to ultimately refine a virtual reality tool through qualitative and quantitative research targeting HIV and substance abuse risk behavior among at-risk young people who have experienced psychosocial trauma. Participants eligible for this study include young men who have sex with men (YMSM)/individuals who are romantically/physically attracted to men and adolescents with substance use disorder (SUD) between the ages of 15 - 30 and have experienced at least one traumatic event in their lifetime. Frontline healthcare workers who work within these populations are eligible for the study as well.

Read the detailed description

YMSM and adolescents with SUD participants will complete 3 study sessions. During session 1, informed consent and baseline measures are administered. Approximately one week later, during session 2, participants use and assess the virtual reality tool. Approximately one week later, during session 3, baseline assessments are re-administered.

03

Conditions studied

  • Substance Use Disorders
  • HIV Infections

Keywords

  • substance use disorders
  • alcohol use
  • substance use
  • HIV infections
  • HIV risk
  • virtual reality
04

Who can participate

Ages eligible
15 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for YMSM are as follows:

  • Someone who identifies as a YMSM or identifies as someone with romantic or physical attraction to individuals who identify as men
  • Is aged 15-30 years
  • Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)
  • Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months
  • Live in the Charleston, SC/Tri-county area

Inclusion Criteria for adolescents with SUD are as follows:

  • Someone who reports using substances in the past year (for participants ages 15-17) or the past 6 months (for participants ages 18-30)
  • Is aged 15-30 years
  • Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)
  • Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months
  • Live in the Charleston, SC/Tri-county area

Inclusion Criteria for front line healthcare workers are as follows:

  • works directly with adolescents who have experienced ITE and/or
  • works directly with adolescents or young adults with SUD and/or
  • works directly with YMSM and/or
  • works directly with and/or adolescent or young adults who are -positive

Exclusion Criteria for all participants are as follows:

  • exhibits psychotic symptoms;
  • exhibits significant cognitive disability;
  • reports a history of Pervasive Developmental Disorder;
  • has active suicidal or homicidal ideations
  • self-reports high levels of motion sickness
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Virtual Reality

    All participants will receive the same intervention

    Behavioral: Virtual Reality Tool

Interventions

  • BehavioralVirtual Reality Tool

    Virtual Reality Tool for At-Risk Trauma-Exposed Young People

06

What researchers measure

Primary outcomes

  1. Quantity and Frequency of Substance Use

    The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in substance use. Higher numbers of substance use are indicative of greater substance use.

    Time frame: Day 0 (Session 1) up to Day 14 (Session 3)

07

Study locations

1 site
  • National Crime Victims Research and Treatment Center
    Charleston, South Carolina 29425, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 20, 2026
Primary completion
Dec 31, 2026→Aug 28, 2026 (actual)
Oct 20, 2026
Documents
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Recruiting→Active, not recruiting
    Documents Informed consent form ↗ posted
    Primary completion Dec 31, 2026→Aug 28, 2026 (now actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05816083
Responsible party
Carla Kmett Danielson (Professor-Faculty, Medical University of South Carolina) — Principal investigator
First posted
Apr 18, 2023
Start date
Feb 6, 2025
Primary completion
Aug 28, 2026
Completion
Feb 28, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Danielson
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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