Efficacy trial for a smartphone game to prevent HIV among young Africans

项目摘要：这项研究的目标是帮助减少艾滋病毒感染率在青年中， 撒哈拉非洲。我们的目标是通过评估交互式智能手机的功效来推进这一目标 一种旨在通过推迟首次性行为和增加艾滋病毒感染率来预防非洲青少年艾滋病毒感染的游戏。 第一次性行为使用避孕套。基于游戏的干预在NIMH资助的随机 肯尼亚可行性研究。干预是由社会行为和教学理论，证据- 基于实践，并在撒哈拉以南非洲的青年性文化独特的形成研究。 Tumaini（在斯瓦希里语中的意思是“未来的希望”）是一款廉价的冒险游戏应用程序， Android智能手机，使用交互式叙事来促进观察学习，认知和行为 排练、解决问题和沉浸。Tumaini旨在通过以下方式提高初次性行为的年龄和避孕套的使用率： 增加关于性健康和艾滋病毒的知识;建立避免和减少风险的技能和相关的 自我效能;挑战艾滋病毒污名化和有害的性别规范和态度;培养未来的方向，目标， 设置和规划;以及促进与成人导师的对话。游戏遵循六个字符（3女孩，3 男孩）与不同的社会人口统计和背景故事，因为他们通过三个游戏的青春期进行 程度.玩家为角色做出决定，并体验这些决定的后果。 人物的生活、健康和未来目标。 该研究将跟踪912名肯尼亚青少年的性别平衡样本，年龄在13-14岁之间， 随机分配到干预或控制游戏45个月， 评估。它将测试艾滋病毒和HSV-2在基线和底线，分析游戏日志文件从手机的 干预武装参与者，并与参与者、他们父母和其他人进行定性研究 持份者 本研究的主要目的是：（1）确定一个基于理论、经验的移动的 基于手机游戏的干预推迟了初次性行为，增加了首次性行为时的安全套使用;（2）确定 基于游戏的干预是否影响行为中介（知识，态度，行为 意图，和相关的自我效能）的早期和无保护的性行为;（3）通过分析结果数据， 移动的电话日志文件，确定哪些游戏组件和理论结构介导的效果。在 此外，我们还有以下次要目标：（SA 1）确定游戏是否减少HSV-2和HIV 感染;（SA 2）进行定性研究，以优化试验实施，监测对内部或 外部有效性，加强干预的变化理论，并告知潜在的传播。 如果被证明有效，拟议的干预措施具有高度可扩展性、低成本和文化上的潜力。 适合撒哈拉以南非洲国家。

Project Summary: The goal of the study is to contribute to reductions in HIV incidence among youth in sub- Saharan Africa. Our objective is to advance that goal by evaluating the efficacy of an interactive smartphone game that is designed to prevent HIV among African adolescents by delaying sexual debut and increasing condom use at first sex. The game-based intervention has shown promise in an NIMH-funded randomized feasibility study in Kenya. The intervention is informed by socio-behavioral and pedagogical theories, evidence- based practice, and unique formative research on youth sexual culture in sub-Saharan Africa. Tumaini (meaning “hope for the future” in Kiswahili) is a choose-your-own-adventure game app for inexpensive Android smartphones that uses interactive narrative to promote observational learning, cognitive and behavioral rehearsal, problem-solving, and immersion. Tumaini is designed to increase age and condom use at first sex by: increasing knowledge about sexual health and HIV; building risk-avoidance and risk-reduction skills and related self-efficacy; challenging HIV stigma and harmful gender norms and attitudes; fostering future orientation, goal- setting, and planning; and promoting dialogue with adult mentors. The game follows six characters (3 girls, 3 boys) with diverse socio-demographics and backstories, as they proceed through adolescence over three game levels. Players make decisions for the characters and experience the consequences of those decisions on characters' lives, health, and future goals. The study will follow a gender-balanced sample of 912 Kenyan adolescents, aged 13-14 at enrolment, and randomly assigned to the intervention or to a control game for 45 months with 4-monthly behavioral assessments. It will test for HIV and HSV-2 at baseline and endline, analyze game log files from the phones of intervention arm participants, and conduct qualitative research with participants, their parents and other stakeholders. The proposed project has the following aims: (1) Determine if a theory-based, empirically grounded mobile phone game-based intervention delays sexual debut and increases condom use at first sex; (2) Determine whether the game-based intervention influences behavioral mediators (knowledge, attitudes, behavioral intentions, and related self-efficacy) of early and unprotected sex; (3) Through analysis of outcome data and the mobile phone log files, determine which game components and theoretical constructs mediated effects. In addition, we have the following secondary aims: (SA1) Determine whether the game reduces HSV-2 and HIV infection; (SA2) Conduct qualitative research to optimize trial implementation, monitor threats to internal or external validity, strengthen the intervention's theory of change, and inform potential dissemination. If proven efficacious, the proposed intervention has the potential to be highly scalable, low cost, and culturally adaptable to individual sub-Saharan countries.