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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 Trends1 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1日最近更新:
适应症
干预措施

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
1
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

研究组 & 干预措施

Pulse Treatment App

Experimental

The treatment app is a web-based mobile health app designed for Black & Latinx women ages 18-20. Through culturally and age-appropriate content, Pulse provides information on birth control, healthy relationships, sexual health, pregnancy, & utilization of clinical services to encourage users to choose effective birth control, seek reproductive health services, and prevent unplanned pregnancies. Users access Pulse autonomously and on their own terms. The app does not require users to follow a specific sequence of content viewed. Participants randomized to the intervention condition are given access to Pulse and receive Multimedia Messaging Service (MMS) messages related to sexual health several times a week for 6 weeks. Participants receive a baseline survey, 6-week follow-up survey, and 6-month follow-up survey via an electronic survey platform (6-month survey only administered to participants recruited between November 2018-March 2019).

干预措施: Pulse (Behavioral)

Pulse Control App

Active Comparator

The control app, also called Pulse, is a web-based mobile health app designed by the study team for young women ages 18-20. Although Pulse control and Pulse treatment apps look and feel similar aesthetically, they contain different content. Pulse control app provides information on general health topics, such as the importance of sleep, healthy eating, and friendships. Users access Pulse autonomously, on their own terms, and in their own time and place. The app does not require the user to follow a specific sequence of content viewed; however, all users receive a monetary incentive after completing a baseline survey and registering with the app. Control participants also receive MMS messages related to general health for six weeks. Participants receive a baseline survey and a six-week follow-up which are conducted online via an electronic survey platform.

干预措施: Pulse (Behavioral)

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)

Unprotected sex, no contraceptive

时间窗: Baseline (unprotected sex in the past 3 months)

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

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: Baseline (unprotected sex in the past 3 months)

Ever having sexual intercourse without using a hormonal or LARC 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-months post-baseline (in the past 6 months))
  • Reproductive and sexual health care utilization (among full sample)(6-week post-baseline (in the past 6 weeks))

研究者

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

研究点 (1)

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