An Interactive Video Game for HIV Prevention in Early Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 2
- 主要终点
- Delay in the initiation of sexual activity
研究概览
简要总结
The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens.
详细描述
The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens. The investigators are using proven components of HIV prevention interventions, social cognitive theory, self-efficacy, prospect theory, message framing, and video gaming principles to develop and evaluate this interactive HIV prevention video game. In Phase 1 of this project, the investigators have been working with Schell Games of Pittsburgh, PA, Digitalmill of Portland, ME, and the Farnam Neighborhood House in New Haven, CT to develop our interactive video game with the input from our experts and focus groups and interviews with adolescents. Phase 1 has been a developmental iterative process in which the investigators have been building the software for the game for the purposes of targeting HIV prevention in our population of interest: young minority adolescents. Following development of the video game, the investigators will move to Phase 2 in which the investigators will enroll 330 minority adolescents who are attendees at one of several after-school programs in the greater New Haven area and assign them to play either the experimental game or a control game. In the experimental game, the player will be presented with a series of "risk challenges" thereby helping them to develop sex, drug and alcohol negotiation and refusal skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 11-14 years
- •Able to provide assent/parental/guardian consent
- •Agree to participate in a computer-based videogame (willing to sit at a computer for 75 minutes twice weekly to play the game)
- •English-speaking
排除标准
- •Not between the ages of 11-14 years
- •Not able to provide assent/parental/guardian consent
- •Not willing to sit at a computer for 75 minutes twice weekly to play the game
- •Non-English speaking
结局指标
主要结局
Delay in the initiation of sexual activity
时间窗: 24 months
The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.
次要结局
- Knowledge about HIV/AIDS risk behaviors and transmission(24 months)
- Level of social competency in using negotiating and refusal skills in the virtual environment(24 months)
- Level of self-efficacy regarding negotiation around initiation of sexual activity(24 months)
- Drug and alcohol use behaviors(24 months)
- Level of self-efficacy in negotiating situations involving offers of drugs and alcohol(24 months)
- Overall risk-taking behaviors(24 months)
研究者
Lynn E. Fiellin
Associate Professor
Yale University