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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Virtual Reality Receives: Behavioral: Virtual Reality |
| 2 | Experimental | Health Promotion Receives: Behavioral: Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent-reported self-efficacy for HIV prevention behaviors
Measured: 3 months
Secondary outcomes (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.
- First posted14 Jan 2015 (estimated)
- Study startMay 2010
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliciting Affect in Teens in a Virtual World (Project AVATAR)
- ClinicalTrials.gov ID
- NCT02338063
- Acronym / sponsor ID
- 0079-10
- Conditions
- HIV Infections
- Keywords
- Adolescent Risk Behavior, Emotion Regulation, Health Promotion, Intervention, Mental Health
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2010
- Primary completion
- Jan 2016 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether immersive virtual reality technology is an effective intervention tool for HIV Prevention with adolescents.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Virtual RealityVirtual Reality |
| 2 | Experimental | Behavioral: Health PromotionHealth Promotion |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 7th \& 8th graders at participating public schools.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAlso: IVRE intervention4-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. | Behavioural | 1 |
| Health Promotion4-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. | Behavioural | 2 |
Primary outcome
Adolescent-reported self-efficacy for HIV prevention behaviors
Time frame: 3 months
1 secondary outcome
Adolescent-reported condom use self-efficacy
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.