NCT02338063

Brief Summary

The purpose of this study is to determine whether immersive virtual reality technology is an effective intervention tool for HIV Prevention with adolescents.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2010

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

5.7 years

First QC Date

January 9, 2015

Last Update Submit

April 5, 2016

Conditions

HIV Infections

Keywords

Adolescent Risk BehaviorEmotion RegulationHealth PromotionInterventionMental Health

Outcome Measures

Primary Outcomes (1)

  • Adolescent-reported self-efficacy for HIV prevention behaviors

    3 months

Secondary Outcomes (1)

  • Adolescent-reported condom use self-efficacy

    3 months

Study Arms (2)

1

EXPERIMENTAL

Virtual Reality

Behavioral: Virtual Reality

2

EXPERIMENTAL

Health Promotion

Behavioral: Health Promotion

Interventions

Virtual RealityBEHAVIORAL

4-session group intervention including affect management training as well as sexual health skills training to prevent the transmission of HIV. Group will practice skills using 3-D goggles for some activities.

Also known as: IVRE intervention
1
Health PromotionBEHAVIORAL

4-session group intervention including affect management training as well as sexual health skills training to prevent the transmission of HIV. Group will practice skills using traditional role-plays for some activities.

2

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- 7th \& 8th graders at participating public schools.

You may not qualify if:

  • Adolescent is illiterate.
  • Adolescent has parent/guardian who does not speak English.
  • Adolescents has high risk of motion sickness.
  • For Phase II only, previous participation in Project Trac or Phase I.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

HIV InfectionsEmotional RegulationPsychological Well-Being

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSelf-ControlSocial BehaviorBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 14, 2015

Study Start

May 1, 2010

Primary Completion

January 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(1)