HivNCT04917575
Efficacy Trial of Life Simulation Game to Routinize Adolescent HIV Testing
A study testing Mobile Game and Mobile Application in people with Hiv, run by George Washington University at 1 site in United States.
Trial summary
This study will aim to assess the acceptability, usability and efficacy of using state-of-the-art video game technology to increase HIV testing among adolescents and young adults (AYA) ages 13-24. AYA often lack awareness of their personal risk of contracting HIV and where to go for testing and care. Read more about this study
- Who is it for?
- Ages 13 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Mobile Game and Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to 31 Oct 2024
- Phase
- Interventional
- 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 13 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 13-24
- self-reported HIV negative or unknown status
- self-reported ever sexually active
- resident of the DC metropolitan region which includes the District of Columbia, Maryland and Virginia for at least the next 6 months
- Is able to provide informed consent or assent
- able to complete all study procedures in English
- has own mobile phones and be willing to use them for the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Milken School of Public Health
Washington D.C., District of Columbia, 20052
About this study
This study will aim to assess the acceptability, usability and efficacy of using state-of-the-art video game technology to increase HIV testing among adolescents and young adults (AYA) ages 13-24. AYA often lack awareness of their personal risk of contracting HIV and where to go for testing and care. This lack of awareness has contributed to poor uptake of HIV testing among AYA despite engagement in high risk behaviors. The goal of this project is to harness this strong motivation to play games to increase HIV testing. Previous games for behavior change have yielded early success for increasing target behaviors among their sample populations, yet research on increasing HIV testing among AYA through gaming has been limited. This intervention builds on prior formative work and is designed to offer AYA personally-tailored risk messages and supports their accessibility to HIV testing and prevention services through an innovative gaming approach that is sharable over social media with in-game rewards for sharing the game with peers. The specific aim of this study is to determine the efficacy of a life-simulation game in changing HIV testing, knowledge, and risk behaviors among AYA at risk for HIV.
- Conditions
- Hiv
- Being tested
- Mobile Game, Mobile Application
- Keywords
- HIV prevention, HIV testing, mHealth, Pre-exposure prophylaxis (PrEP), adolescents, interactive technology
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile GameOther
An enhanced life-simulation prototype of a playable interactive game to increase HIV testing.
Mobile ApplicationOther
A mobile application that will include basic information on HIV basics (e.g., routes of transmission, data on the epidemiology of HIV among youth), prevention information, and information on HIV testing and PrEP, as well as a link to the HIV risk estimator, and HIV testing and PrEP locators.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Game | Experimental | An enhanced life-simulation prototype of a playable interactive game to increase HIV testing, risk assessment tool, and HIV and pre-exposure prophylaxis (PrEP) locators embedded within the game. Receives: Other: Mobile Game |
| Mobile Application | Active comparator | A mobile application that will include basic information on HIV basics (e.g., routes of transmission, data on the epidemiology of HIV among youth), prevention information on HIV testing and PrEP, as well as a link to the HIV risk estimator, and HIV testing and PrEP locators. Receives: Other: Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV testing
Self-reported HIV testing in the past 6 months
Measured: prior 6 months
Secondary outcomes (12)
Intent to test for HIV
Intent to test will be assessed using a validated 6-point Likert scale
Measured: baseline, 1, 3, 6 months
HIV knowledge
18-item scale
Measured: baseline, 1, 3, 6 months
HIV risk perception and behaviors
8-item scale and perceived likelihood of getting infected (0-100%)
Measured: baseline, 1, 3, 6 months
Knowledge of PrEP
Has participant heard of PrEP at specified time period
Measured: baseline, 1, 3, 6 months
CDC risk estimator scores
Measured: baseline, 1, 3, 6 months
Frequency of game use
Measured: 1, 3, 6 months
PrEP screening
ever been screened for PrEP eligibility
Measured: baseline, 1, 3, 6 months
PrEP use/uptake
been prescribed/taken PrEP
Measured: baseline, 1, 3, 6 months
PrEP locator use
Number of linkages to PrEP locator
Measured: baseline, 1, 3, 6 months
Duration of game use
Measured: 1, 3, 6 months
Reasons for continued or discontinued use of game
Measured: 1, 3, 6 months
HIV locator use
Number of linkage to HIV testing locator
Measured: baseline, 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start24 Jun 2021
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Media Rez
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917575
- Sponsor's protocol ID
- NCR191708
- Status last verified
- Aug 2025
- First submitted
- 20 May 2021
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Castel AD, Wilbourn B, Trexler C, D'Angelo LD, Greenberg D. A Digital Gaming Intervention to Improve HIV Testing for Adolescents and Young Adults: Protocol for Development and a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 Jun 24;10(6):e29792. doi: 10.2196/29792.
PubMed 34185022
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Trial of Life Simulation Game to Routinize Adolescent HIV Testing
- ClinicalTrials.gov ID
- NCT04917575
- Acronym / sponsor ID
- NCR191708
- Conditions
- Hiv
- Keywords
- HIV prevention, HIV testing, mHealth, Pre-exposure prophylaxis (PrEP), adolescents, interactive technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Media Rez
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 8 Jun 2021 (actual)
- 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.
This study will aim to assess the acceptability, usability and efficacy of using state-of-the-art video game technology to increase HIV testing among adolescents and young adults (AYA) ages 13-24. AYA often lack awareness of their personal risk of contracting HIV and where to go for testing and care. This lack of awareness has contributed to poor uptake of HIV testing among AYA despite engagement in high risk behaviors. The goal of this project is to harness this strong motivation to play games to increase HIV testing. Previous games for behavior change have yielded early success for increasing target behaviors among their sample populations, yet research on increasing HIV testing among AYA through gaming has been limited. This intervention builds on prior formative work and is designed to offer AYA personally-tailored risk messages and supports their accessibility to HIV testing and prevention services through an innovative gaming approach that is sharable over social media with in-game rewards for sharing the game with peers. The specific aim of this study is to determine the efficacy of a life-simulation game in changing HIV testing, knowledge, and risk behaviors among AYA at risk for HIV.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Game | Experimental | Other: Mobile GameAn enhanced life-simulation prototype of a playable interactive game to increase HIV testing, risk assessment tool, and HIV and pre-exposure prophylaxis (PrEP) locators embedded within the game. |
| Mobile Application | Active comparator | Other: Mobile ApplicationA mobile application that will include basic information on HIV basics (e.g., routes of transmission, data on the epidemiology of HIV among youth), prevention information on HIV testing and PrEP, as well as a link to the HIV risk estimator, and HIV testing and PrEP locators. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- age 13-24
- self-reported HIV negative or unknown status
- self-reported ever sexually active
- resident of the DC metropolitan region which includes the District of Columbia, Maryland and Virginia for at least the next 6 months
- Is able to provide informed consent or assent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mobile GameAn enhanced life-simulation prototype of a playable interactive game to increase HIV testing. | Other | Mobile Game |
| Mobile ApplicationA mobile application that will include basic information on HIV basics (e.g., routes of transmission, data on the epidemiology of HIV among youth), prevention information, and information on HIV testing and PrEP, as well as a link to the HIV risk estimator, and HIV testing and PrEP locators. | Other | Mobile Application |
Primary outcome
HIV testing
Time frame: prior 6 months
Self-reported HIV testing in the past 6 months
12 secondary outcomes
Intent to test for HIV
Time frame: baseline, 1, 3, 6 months
HIV knowledge
Time frame: baseline, 1, 3, 6 months
HIV risk perception and behaviors
Time frame: baseline, 1, 3, 6 months
Knowledge of PrEP
Time frame: baseline, 1, 3, 6 months
CDC risk estimator scores
Time frame: baseline, 1, 3, 6 months
Frequency of game use
Time frame: 1, 3, 6 months
PrEP screening
Time frame: baseline, 1, 3, 6 months
PrEP use/uptake
Time frame: baseline, 1, 3, 6 months
PrEP locator use
Time frame: baseline, 1, 3, 6 months
Duration of game use
Time frame: 1, 3, 6 months
Reasons for continued or discontinued use of game
Time frame: 1, 3, 6 months
HIV locator use
Time frame: baseline, 1, 3, 6 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 13 Aug 2025.
- Background: PubMed 34185022Castel AD, Wilbourn B, Trexler C, D'Angelo LD, Greenberg D. A Digital Gaming Intervention to Improve HIV Testing for Adolescents and Young Adults: Protocol for Development and a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 Jun 24;10(6):e29792. doi: 10.2196/29792.
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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 study testing Mobile Game and Mobile Application in people with Hiv, run by George Washington University 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 7 inclusion and 0 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 13 Aug 2025. 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.
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?
HIV testing (time frame: prior 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917575, which also lists 1 linked publication.
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 13 Aug 2025.