Clinical Trials Directory

Trials / Completed

CompletedNCT04043130

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,317 (actual)
Sponsor
Child Trends · Academic / Other
Sex
Female
Age
18 Years – 20 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPulseThe 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.

Timeline

Start date
2016-11-01
Primary completion
2019-11-01
Completion
2020-06-01
First posted
2019-08-02
Last updated
2020-06-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04043130. Inclusion in this directory is not an endorsement.