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HIV InfectionsPhase 1/2NCT02338063

Eliciting Affect in Teens in a Virtual World (Project AVATAR)

A Phase 1/2 study testing Virtual Reality and Health Promotion in people with HIV Infections, run by Rhode Island Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 12 to 16 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Virtual Reality and Health Promotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteUnited States
Study dates
May 2010to Jan 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rhode Island Hospital

    Providence, Rhode Island, 02903

Other trials in United States

About this study

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

Read the detailed description

The project will examine the use of immersive virtual reality technology as an intervention tool for HIV Prevention with adolescents. Adolescents are at risk for contracting HIV while affect dysregulation is common among adolescents. Research has demonstrated connections between poor affect management abilities and risky sexual behavior among adolescents. This research suggests that the ability to regulate one's emotions is key to avoiding risk behaviors and that adolescents are at greater risk for poor affect management skills. Fortunately, these skills can be taught via teaching and modeling, making them an excellent target for intervention, which has previously been approached through role-playing. Immersive virtual reality offers many advantages over group based role-plays, used in HIV prevention interventions for adolescents, in its ability to simulate real-world environments and enhance the impact of HIV prevention interventions. Immersive virtual reality is a promising technology for giving teens the opportunity to experientially practice using effective affect regulation skills in a highly realistic, context specific virtual environment. Additional benefits of this technology will likely be increased engagement and retention in HIV prevention interventions among young adolescents. The overall aims of Phase I and Phase II of this project are to develop, refine, and evaluate virtual reality environments for adolescents targeting affect management. In Phase I, the research team developed and refined an immersive virtual environment that elicited affect in a high-risk situation. The final immersive virtual reality environments (completed in Phase II) can be used by health promotion interventionists in conjunction with an HIV prevention intervention manual as a means to elicit affect and provide adolescents with a "real world" environment in which to practice emotion regulation skills related to substance use and HIV prevention. These aims will be achieved through the collaboration of researchers at Rhode Island Hospital/Brown and Virtually Better, Inc. a small business that specializes in creating immersive virtual reality environments for treatment, education, and training purposes. This tool will represent a significant advance in the way in which affect regulation skills are practiced and honed, currently achieved via role plays or imaginal exposure, by increasing the salience of cues used to elicit affect, thus making it highly marketable to interventionists, schools, and mental health clinicians.

Conditions
HIV Infections
Being tested
Virtual Reality, Health Promotion
Keywords
Adolescent Risk Behavior, Emotion Regulation, Health Promotion, Intervention, Mental Health
Medical subject headings
HIV Infections, Emotional Regulation, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityBehavioural

    Also called IVRE intervention

    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.

  • Health PromotionBehavioural

    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.

Study groups in NCT02338063
Study groupRoleWhat they receive
1ExperimentalVirtual Reality
Receives: Behavioral: Virtual Reality
2ExperimentalHealth Promotion
Receives: Behavioral: Health Promotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adolescent-reported self-efficacy for HIV prevention behaviors

    Measured: 3 months

Secondary outcomes (1)
  1. Adolescent-reported condom use self-efficacy

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2015 (estimated)
  2. Study startMay 2010
  3. Primary completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02338063
Sponsor's protocol ID
0079-10
Other IDs
5R42MH087322-03
Status last verified
Apr 2016
First submitted
9 Jan 2015
Last updated
6 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Virtual Reality and Health Promotion in people with HIV Infections, run by Rhode Island Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adolescent-reported self-efficacy for HIV prevention behaviors (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.

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