A Digital Gaming Intervention to Improve HIV Testing for Adolescents and Young Adults: Protocol for Intervention Refinement and Randomized Controlled Trial (Preprint)

BACKGROUND Two strategies of the U.S. Ending the HIV Epidemic (EHE) initiative are early diagnosis of infections via widespread testing and prevention of new infections using pre-exposure prophylaxis (PrEP). These strategies are particularly important for adolescents and young adults (AYA) who are disproportionately impacted by HIV, particularly if they identify as Black and/or LGBTQ+. This study will develop and test an interactive life-simulation game in which players can enact real-life behaviors and receive their HIV risk profile to improve HIV testing and PrEP access among AYA ages 13-24 in Washington, DC. OBJECTIVE The goals of this mixed-methods study are to (1) determine the acceptability of an interactive enhanced life-simulation game prototype among AYA, (2) conduct a pilot test of the gaming intervention among a small cohort of AYA to ensure game usability and acceptability, and (3) evaluate the efficacy of an interactive life-simulation game in a randomized controlled study (RCT) with AYA at risk for HIV in Washington, DC. METHODS This research protocol will be conducted in three phases. A formative phase will involve surveys and focus groups (n=64) with AYA living in the DC area. These focus groups will allow researchers to understand youth preferences for game enhancements. The second phase will consist of a pilot test (n=10) of the gaming intervention. This pilot test will allow researchers to modify the game based on formative results and test the planned recruitment and data collection strategy with intended end-users. The third phase will consist of a RCT among 300 AYA to examine the efficacy of the life-simulation game compared with app-based HIV educational materials on HIV and PrEP in changing HIV testing, knowledge, risk behaviors, and PrEP access. Participants will have unlimited access to either the life-simulation game or the educational app for 3 months from the time of enrollment. Study assessments will occur at enrollment and at 1-, 3-, and 6-months post-enrollment via electronic surveys. At 6 months, a subset of intervention participants (n=25) will participate in-depth “exit” interviews regarding their experience being in the study. RESULTS Institutional review board approval was received on February 5, 2020. This project is currently recruiting participants for the formative phase. CONCLUSIONS This interactive life-simulation intervention aims to increase HIV testing and PrEP access among AYA in the DC area. This intervention uses social interactions in which players can enact real-life behaviors and receive their HIV risk profile to promote HIV testing and PrEP seeking. Such an intervention has great potential to improve knowledge of HIV and PrEP among AYA, increase motivation and self-efficacy related to HIV testing and PrEP use, and decrease individual and structural barriers that often preclude engagement in HIV prevention services.

A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial

Background In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP’s safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence. Objective The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior. Methods This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60). Results Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing. Conclusions This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings. Trial Registration ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr International Registered Report Identifier (IRRID) DERR1-10.2196/18640

A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial (Preprint)

BACKGROUND In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP’s safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence. OBJECTIVE The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior. METHODS This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60). RESULTS Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing. CONCLUSIONS This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings. CLINICALTRIAL ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18640