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临床试验/NCT03253783
NCT03253783已完成不适用

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

Healthy Teen Network2 个研究点 分布在 1 个国家目标入组 1,304 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
入组人数
1,304
试验地点
2
主要终点
Unprotected sex, no contraceptive

研究概览

简要总结

This study uses 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 is comprised of women with the following characteristics at study enrollment: aged 18-20, not pregnant or trying to become pregnant, has daily access to a smartphone, currently living in the United States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to enroll up to 1,300 participants over a one-year enrollment period using social media, including Facebook, Instagram, and Twitter.

Users access 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 will receive a monetary incentive after registering with the apps. Youth randomized to the intervention condition are given access to Pulse indefinitely and receive daily text messages related to sexual health for 6 weeks. Control participants are directed to a free general health/fitness web-based mobile application, also called Pulse, and receive 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 receive a baseline survey and a 6-week follow-up survey. Participants will also receive incentives once they complete the baseline and post-intervention survey. Both surveys are conducted online via an electronic survey platform. This study is being 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
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 to the Internet
  • Must speak English or Spanish
  • 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-week post-baseline (in the past 6 weeks)

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

Unprotected sex, no highly effective contraceptive

时间窗: 6-week post-baseline (in the past 6 weeks)

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-weeks post-baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martinez Garcia

Dr. Genevieve Martínez-García

Healthy Teen Network

研究点 (2)

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