Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People (NCT05816083) | Clinical Trial Compass
RecruitingNot Applicable
Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People
United States50 participantsStarted 2025-02-06
Plain-language 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.
Who can participate
Age range
15 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 HIV-positive
Exclusion Criteria for all participants are as follows:
* exhibits psychotic symptoms;
* exhibits significant cognitive disability;
* reports a history of Pervasive Developme…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantity and Frequency of Substance Use
Timeframe: Day 0 (Session 1) up to Day 14 (Session 3)