Substance Use DisordersNCT05816083
Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People
A study testing Virtual Reality Tool in people with Substance Use Disorders and HIV Infections, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, HIV Infections
- What is being tested?
- Virtual Reality Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 28 Feb 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
- Someone who reports using substances in the past year (for participants ages 15-17) or the past 6 months (for participants ages 18-30)
Show all 15Show fewer
- 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 HIV-positive
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Crime Victims Research and Treatment Center
Charleston, South Carolina, 29425
About this study
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.
- Conditions
- Substance Use Disorders, HIV Infections
- Being tested
- Virtual Reality Tool
- Keywords
- substance use disorders, alcohol use, substance use, HIV infections, HIV risk, virtual reality
- Medical subject headings
- Substance-Related Disorders, HIV Infections, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ToolBehavioural
Virtual Reality Tool for At-Risk Trauma-Exposed Young People
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | All participants will receive the same intervention Receives: Behavioral: Virtual Reality Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (Session 1) up to Day 14 (Session 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start6 Feb 2025
- Primary completion28 Aug 2026
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Kmett Danielson, Medical University of South Carolina
- Investigators
- Danielson, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816083
- Sponsor's protocol ID
- Pro00105369
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People
- ClinicalTrials.gov ID
- NCT05816083
- Acronym / sponsor ID
- Pro00105369
- Conditions
- Substance Use Disorders, HIV Infections
- Keywords
- substance use disorders, alcohol use, substance use, HIV infections, HIV risk, virtual reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Apr 2023 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual Reality ToolAll participants will receive the same intervention |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Virtual Reality ToolVirtual Reality Tool for At-Risk Trauma-Exposed Young People | Behavioural | Virtual Reality |
Primary outcome
Quantity and Frequency of Substance Use
Time frame: Day 0 (Session 1) up to Day 14 (Session 3)
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.
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 20 Oct 2026.
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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. This study is not recruiting at the moment.
Danielson principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Tool in people with Substance Use Disorders and HIV Infections, run by Medical University of South Carolina at 1 site in United States.
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 15 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity and Frequency of Substance Use (time frame: Day 0 (Session 1) up to Day 14 (Session 3)). 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 20 Oct 2026.