NCT05816083

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Feb 2025Jul 2026

First Submitted

Initial submission to the registry

February 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1.8 years until next milestone

Study Start

First participant enrolled

February 6, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

February 23, 2023

Last Update Submit

April 7, 2026

Conditions

HIV InfectionsSubstance Use Disorders

Keywords

substance use disordersalcohol usesubstance useHIV infectionsHIV riskvirtual reality

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Virtual Reality

EXPERIMENTAL

All participants will receive the same intervention

Behavioral: Virtual Reality Tool

Interventions

Virtual Reality ToolBEHAVIORAL

Virtual Reality Tool for At-Risk Trauma-Exposed Young People

Virtual Reality

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Crime Victims Research and Treatment Center

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersHIV InfectionsAlcohol Drinking

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDrinking BehaviorBehavior

Study Officials

  • Danielson

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charli Kirby, BA

CONTACT

(843) 408-6140kirbych@musc.edu

Carla Danielson, PhD

CONTACT

danielso@musc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

April 18, 2023

Study Start

February 6, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(1)