Castel Amanda D, Wilbourn Brittany, Trexler Connie, D'Angelo Lawrence D, Greenberg Daniel
Department of Epidemiology, Milken Institute School of Public Health, George Washington University, Washington, DC, United States.
Adolescent Clinical Research, Children's National Hospital, Washington, DC, United States.
JMIR Res Protoc. 2021 Jun 24;10(6):e29792. doi: 10.2196/29792.
Two strategies of the US Ending the HIV Epidemic 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 (AYAs) who are disproportionately affected by HIV, particularly if they identify as Black and/or lesbian, gay, bisexual, transgender, queer or questioning, and others (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 AYAs aged 13-24 years in Washington, DC.
This mixed methods study aims to determine the acceptability of an interactive, enhanced life-simulation game prototype among AYAs, conduct a pilot test of the gaming intervention among a small cohort of AYAs to ensure game usability and acceptability, and evaluate the efficacy of the game in a randomized controlled study with AYAs at risk for HIV in Washington, DC.
This research protocol will be conducted in 3 phases. A formative phase will involve surveys and focus groups (n=64) with AYAs living in the DC area. These focus groups will allow researchers to understand youth preferences for game enhancement. 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 randomized controlled study among 300 AYAs 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 e-surveys. At 6 months, a subset of intervention participants (n=25) will participate in in-depth exit interviews regarding their experience being in the study.
Institutional review board approval was received on February 5, 2020. This project is currently recruiting participants for the formative phase.
This interactive life-simulation intervention aims to increase HIV testing and PrEP access among AYAs in the DC area. In this intervention, 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 AYAs, 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.
ClinicalTrials.gov NCT04917575; https://clinicaltrials.gov/ct2/show/NCT04917575.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/29792.
美国“终结艾滋病流行”倡议的两项策略是通过广泛检测实现感染的早期诊断，以及使用暴露前预防（PrEP）预防新感染。这些策略对受艾滋病影响尤为严重的青少年和年轻人（AYA）来说尤为重要，特别是那些自我认同为黑人及/或女同性恋、男同性恋、双性恋、跨性别者、酷儿或疑问者以及其他群体（LGBTQ+）的人。本研究将开发并测试一款交互式生活模拟游戏，玩家可以在其中模拟现实生活行为并获得自身的艾滋病风险概况，以改善华盛顿特区13至24岁青少年和年轻人的艾滋病检测及PrEP获取情况。
这项混合方法研究旨在确定一款交互式增强生活模拟游戏原型在青少年和年轻人中的可接受性，在一小群青少年和年轻人中对游戏干预进行试点测试，以确保游戏的可用性和可接受性，并在一项针对华盛顿特区有艾滋病风险的青少年和年轻人的随机对照研究中评估该游戏的效果。
本研究方案将分三个阶段进行。形成性阶段将包括对居住在华盛顿特区地区的青少年和年轻人进行调查和焦点小组访谈（n = 64）。这些焦点小组将使研究人员了解青少年对游戏增强功能的偏好。第二阶段将包括对游戏干预进行试点测试（n = 10）。该试点测试将使研究人员能够根据形成性结果修改游戏，并与目标最终用户测试计划的招募和数据收集策略。第三阶段将包括对300名青少年和年轻人进行随机对照研究，以检验与基于应用程序的艾滋病教育材料相比，生活模拟游戏在改变艾滋病检测、知识、风险行为和PrEP获取方面的效果。从入组时起，参与者将有3个月无限制访问生活模拟游戏或教育应用程序中的任意一个。研究评估将在入组时以及入组后1个月、3个月和6个月通过电子调查进行。在6个月时，一部分干预参与者（n = 25）将参加关于他们参与研究经历的深入退出访谈。
2020年2月5日获得了机构审查委员会的批准。该项目目前正在为形成性阶段招募参与者。
这种交互式生活模拟干预旨在增加华盛顿特区地区青少年和年轻人的艾滋病检测及PrEP获取情况。在这种干预中，玩家可以模拟现实生活行为并获得自身的艾滋病风险概况，以促进艾滋病检测和寻求PrEP。这样的干预有很大潜力提高青少年和年轻人对艾滋病和PrEP的认识，增强与艾滋病检测和PrEP使用相关的动机和自我效能，并减少常常阻碍参与艾滋病预防服务的个人和结构性障碍。
ClinicalTrials.gov NCT04917575；https://clinicaltrials.gov/ct2/show/NCT04917575。
国际注册报告识别码（IRRID）：PRR1-10.2196/29792。
