Efficacy Trial of Life Simulation Game to Routinize Adolescent HIV Testing

August 12, 2025 updated by: George Washington University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Amanda D Castel, MD,MPH
  • Phone Number: 202-994-8325
  • Email: acastel@gwu.edu

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20052
        • George Washington University Milken School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mobile Game
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.
Other: Mobile Game
An enhanced life-simulation prototype of a playable interactive game to increase HIV testing.
Active Comparator: Mobile Application
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.
Other: Mobile Application
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HIV testing
Time Frame: prior 6 months
Self-reported HIV testing in the past 6 months
prior 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intent to test for HIV
Time Frame: baseline, 1, 3, 6 months
Intent to test will be assessed using a validated 6-point Likert scale
baseline, 1, 3, 6 months
HIV knowledge
Time Frame: baseline, 1, 3, 6 months
18-item scale
baseline, 1, 3, 6 months
HIV risk perception and behaviors
Time Frame: baseline, 1, 3, 6 months
8-item scale and perceived likelihood of getting infected (0-100%)
baseline, 1, 3, 6 months
Knowledge of PrEP
Time Frame: baseline, 1, 3, 6 months
Has participant heard of PrEP at specified time period
baseline, 1, 3, 6 months
CDC risk estimator scores
Time Frame: baseline, 1, 3, 6 months
baseline, 1, 3, 6 months
Frequency of game use
Time Frame: 1, 3, 6 months
1, 3, 6 months
PrEP screening
Time Frame: baseline, 1, 3, 6 months
ever been screened for PrEP eligibility
baseline, 1, 3, 6 months
PrEP use/uptake
Time Frame: baseline, 1, 3, 6 months
been prescribed/taken PrEP
baseline, 1, 3, 6 months
PrEP locator use
Time Frame: baseline, 1, 3, 6 months
Number of linkages to PrEP locator
baseline, 1, 3, 6 months
Duration of game use
Time Frame: 1, 3, 6 months
1, 3, 6 months
Reasons for continued or discontinued use of game
Time Frame: 1, 3, 6 months
1, 3, 6 months
HIV locator use
Time Frame: baseline, 1, 3, 6 months
Number of linkage to HIV testing locator
baseline, 1, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
George Washington University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Media Rez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCR191708

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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