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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05816083
• Other study ID #: Pro00105369
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Participants eligible for this study include young men who have sex with men (YMSM) and adolescents with substance use disorder (SUD) between the ages of 13 - 25 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

Inclusion Criteria for YMSM are as follows:

• Someone who identifies as a YMSM

• Is aged 13-25

• Have experienced at least one interpersonal traumatic event (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 6 months

Inclusion Criteria for adolescents with SUD are as follows:

• Someone who reports using substances

• Is aged 13-18 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 6 months

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

Related Conditions & MeSH terms

• HIV Infections
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Virtual Reality Tool
Virtual Reality Tool for At-Risk Trauma-Exposed Young People

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 (Session 1) up to Day 14 (Session 3)