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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04917575
Other study ID # NCR191708
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 24, 2021
Est. completion date September 2024

Study information

Verified date January 2024
Source George Washington University
Contact Amanda D Castel, MD,MPH
Phone 202-994-8325
Email acastel@gwu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Mobile Game
An enhanced life-simulation prototype of a playable interactive game to increase HIV testing.
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.

Locations

Country Name City State
United States George Washington University Milken School of Public Health Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
George Washington University Media Rez

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary HIV testing Self-reported HIV testing in the past 6 months prior 6 months
Secondary Intent to test for HIV Intent to test will be assessed using a validated 6-point Likert scale baseline, 1, 3, 6 months
Secondary HIV knowledge 18-item scale baseline, 1, 3, 6 months
Secondary HIV risk perception and behaviors 8-item scale and perceived likelihood of getting infected (0-100%) baseline, 1, 3, 6 months
Secondary Knowledge of PrEP Has participant heard of PrEP at specified time period baseline, 1, 3, 6 months
Secondary CDC risk estimator scores baseline, 1, 3, 6 months
Secondary Frequency of game use 1, 3, 6 months
Secondary PrEP screening ever been screened for PrEP eligibility baseline, 1, 3, 6 months
Secondary PrEP use/uptake been prescribed/taken PrEP baseline, 1, 3, 6 months
Secondary PrEP locator use Number of linkages to PrEP locator baseline, 1, 3, 6 months
Secondary Duration of game use 1, 3, 6 months
Secondary Reasons for continued or discontinued use of game 1, 3, 6 months
Secondary HIV locator use Number of linkage to HIV testing locator baseline, 1, 3, 6 months
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