Evaluation of the SafeSpace App Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Child Trends
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Penile-vaginal sex without a condom or a more effective method of contraception
研究概览
简要总结
The goal of this study is to evaluate the impact of SafeSpace Sexual Health App, an innovative sexual health promotion program focused on reducing sexual risk factors and promoting sexual and reproductive health and wellbeing among young people assigned female or intersex at birth, particularly Black and/or Latine youth, LGBTQ+ youth, youth in states with high teen birth rates and youth who live in rural communities. This study utilizes a two-arm randomized control trial design to measure impacts of receiving the SafeSpace Sexual Health program compared to receiving a similar-length control app program, SafeSpace General Health that focuses on general health.
The investigators will ask participants to:
- Keep the SafeSpace app downloaded to their device and visit the app regularly over the course of 10 weeks.
- Provide contact information.
- Receive and open app push notifications for 10 weeks (up to 3 per week).
- Complete 3 online surveys over a year: baseline, short-term follow-up (10 weeks after baseline), and long-term follow up (9 months after short-term follow-up).
- Receive occasional text messages from the study team.
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
- 14 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must be assigned female or intersex at birth
- •Participants must be youth in the U.S. (14-18 years old)
- •Participants must have daily access to an iPhone
排除标准
- •Participants must not be currently pregnant or currently trying to become pregnant
- •Other Criteria:
- •The study's priority/preference population is for Black and/or Latine youth, LGBTQ+ youth, youth from geographic areas with high teen birth rates, and youth living in rural areas.
结局指标
主要结局
Penile-vaginal sex without a condom or a more effective method of contraception
时间窗: Past 3 months at baseline; past 9 months at long-term follow-up
Yes = Had penile-vaginal sex without using pill, shot, patch, ring, IUD, implant, or condom every time; No = Did not have penile-vaginal sex OR always used pill, shot, patch, ring, IUD, implant, or condom during penile-vaginal sex
次要结局
- Penile-vaginal sex or anal sex without a condom every time(Past 3 months at baseline; past 9 months at long-term follow-up)
- Number of Sexual and Reproductive Health topics discussed with a trusted adult in the past 3 months.(Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up)
- Utilization of sexual health services(Has received SRH services in the past 12 months or has an appointment scheduled in the next 3 months at baseline; Received SRH services in the past 9 months or has an appointment scheduled in the next 3 months at long-term follow-up.)
- Sexual agency during every recent sexual experience or no recent sexual experiences(Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up)