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Completed

NCT Number: NCT04043130

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

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.

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Key information

Age range

18 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Healthy Teen Network

Baltimore, Maryland, 21202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Currently pregnant or trying to get pregnant

Treatment and study plan

Pulse

Behavioral

The intervention provides participants access to Pulse, a web-based mobile health app designed for Black and Latinx women ages 18-20. Participants can access the app autonomously and on their own schedule. The app for the experimental arm, the Pulse treatment app, provides information on birth control, healthy relationships, sexual health and physiology, pregnancy, and utilization of clinical services. The app for the comparator arm, the Pulse control app, provides information on general health topics, such as the importance of sleep, healthy eating, and friendships. Participants receive MMS messages that reinforce app content and remind them to visit the app.

Other names: GirlPower

Primary outcomes

  1. Unprotected sex, no contraceptive

    Time frame: Baseline (unprotected sex in the past 3 months)

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

  2. Unprotected sex, no contraceptive

    Time frame: 6-week post-baseline (in the past 6 weeks)

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

  3. Unprotected sex, no contraceptive

    Time frame: 6-months post-baseline (in the past 3 months)

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

  4. Unprotected sex, no highly effective contraceptive

    Time frame: Baseline (unprotected sex in the past 3 months)

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

  5. Unprotected sex, no highly effective contraceptive

    Time frame: 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)

  6. Unprotected sex, no highly effective contraceptive

    Time frame: 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)

Secondary outcomes

  1. Reproductive and sexual health care utilization (among full sample)

    Time frame: 6-week post-baseline (in the past 6 weeks)

    Visiting a health care provider for reproductive or sexual health services within the past 6 weeks for the 1st follow-up survey

  2. Reproductive and sexual health care utilization (among full sample)

    Time frame: 6-months post-baseline (in the past 6 months)

    Visiting a health care provider for reproductive or sexual health services within the past 6 months for the 1st follow up survey

Sponsors and collaborators

Lead sponsor

Child Trends

Other

Collaborators

  • Ewald and Wasserman
  • Healthy Teen Network
  • MetaMedia Training International, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Aug 2, 2019
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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