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临床试验/NCT04043130
NCT04043130已完成不适用

The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program

Child Trends2 个研究点 分布在 1 个国家目标入组 2,317 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Child Trends
入组人数
2,317
试验地点
2
主要终点
Unprotected sex, no contraceptive

研究概览

简要总结

This study used a randomized controlled design to evaluate the efficacy of a new mobile app, Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based mobile health application that can be accessed through mobile smartphones and computers. Pulse was designed to increase highly effective birth control use and reproductive and sexual health care utilization, and ultimately decrease teen pregnancy. The sample was comprised of 2,317 women aged 18-20 who, at enrollment, were not pregnant or trying to become pregnant, had daily access to a smartphone, were currently living in the United States or a U.S. territory, and spoke English. Most of the sample (86%) identified as Black and/or Latinx. The evaluation team enrolled participants over a two and a half year enrollment period using social media, including Facebook and Instagram.

Users accessed Pulse autonomously, on their own terms, and in their own time and place. The app consists of 6 sections and includes 3 hours of unique content. It does not require the user to follow a specific sequence of content viewed; however, all users received a monetary incentive after registering with the app. Young women randomized to the intervention condition were given access to Pulse indefinitely and received daily text messages related to sexual health for 6 weeks. Control participants were directed to a free general health/fitness web-based mobile application, also called Pulse, and received text messages related to general health for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain different content. Participants in both the intervention and comparison groups received a baseline survey, a 6-week follow-up survey, and a 6-month follow-up survey (the 6-month follow-up survey was only administered to participants recruited between November 2018 and March 2019). Participants also received incentives for completing the baseline and post-intervention surveys. Both surveys were conducted online via an electronic survey platform. This study was conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.

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
18 Years 至 20 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gender: Female
  • Age Limit: 18-20
  • Must have daily access to a smartphone that receives text messages and can access the Internet
  • Must speak English
  • Must live in the United States or a U.S. territory

排除标准

  • Currently pregnant or trying to get pregnant

结局指标

主要结局

Unprotected sex, no contraceptive

时间窗: 6-months post-baseline (in the past 3 months)

Ever having sexual intercourse without using any method of contraception (among full sample)

Unprotected sex, no highly effective contraceptive

时间窗: 6-months post-baseline (in the past 3 months)

Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)

次要结局

  • Reproductive and sexual health care utilization (among full sample)(6-months post-baseline (in the past 6 months))

研究者

发起方
Child Trends
申办方类型
Other
责任方
Sponsor

研究点 (2)

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