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.

Study Overview

• Status: Completed
• Conditions: Contraceptive Usage; Unprotected Sex
• Intervention / Treatment: Behavioral: Pulse

• Study Type: Interventional
• Enrollment (Actual): 2317
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Healthy Teen Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 20 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulse Treatment App; 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).	Behavioral: Pulse; 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
Active Comparator: Pulse Control App; 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.	Behavioral: Pulse; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unprotected sex, no contraceptive	Ever having sexual intercourse without using any method of contraception (among full sample)	6-week post-baseline (in the past 6 weeks)
Unprotected sex, no highly effective contraceptive	Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)	6-week post-baseline (in the past 6 weeks)
Unprotected sex, no contraceptive	Ever having sexual intercourse without using any method of contraception (among full sample)	Baseline (unprotected sex in the past 3 months)
Unprotected sex, no contraceptive	Ever having sexual intercourse without using any method of contraception (among full sample)	6-months post-baseline (in the past 3 months)
Unprotected sex, no highly effective contraceptive	Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)	Baseline (unprotected sex in the past 3 months)
Unprotected sex, no highly effective contraceptive	Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)	6-months post-baseline (in the past 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproductive and sexual health care utilization (among full sample)	Visiting a health care provider for reproductive or sexual health services within the past 6 weeks for the 1st follow-up survey	6-week post-baseline (in the past 6 weeks)
Reproductive and sexual health care utilization (among full sample)	Visiting a health care provider for reproductive or sexual health services within the past 6 months for the 1st follow up survey	6-months post-baseline (in the past 6 months)

Collaborators and Investigators

• Sponsor: Child Trends
• Collaborators: Healthy Teen Network; Ewald and Wasserman; MetaMedia Training International, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Reproductive and Sexual Health Care Utilization
• Other Study ID Numbers: TP2AH000038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No