Efficacy Trial of Life Simulation Game to Routinize Adolescent HIV Testing

January 29, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • 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

  • 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
        • Recruiting
        • George Washington University Milken School of Public Health
        • Contact:
          • Amanda D Castel, MD, MPH
          • Phone Number: 202-994-8325
          • Email: acastel@gwu.edu

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

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
Intervention / Treatment
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

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

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

George Washington University

Collaborators

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)

June 24, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID 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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