Clinical trial NCT05816083: Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People
Official title: Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
HIV Infections
Keywords: substance use disorders
alcohol use
substance use
HIV infections
HIV risk
virtual reality
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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 HIV-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

Primary outcomes:
measure: Quantity and Frequency of Substance Use
timeFrame: Day 0 (Session 1) up to Day 14 (Session 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: National Crime Victims Research and Treatment Center
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Danielson
role: PRINCIPAL_INVESTIGATOR
References: