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

Not Applicable

Recruiting

• Conditions: HIV Infections; Substance Use Disorders
• Interventions: Behavioral: Virtual Reality Tool

• Registration Number: NCT05816083
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-18
• Study Start: 2025-02-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Virtual Reality Tool	All participants will receive the same intervention

Primary Outcome Measures

Name	Time	Method
Quantity and Frequency of Substance Use	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.

Trial Locations

Locations (1)

National Crime Victims Research and Treatment Center; 🇺🇸 Charleston, South Carolina, United States