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

NCT ID: NCT04043130

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2317 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-06-30

Brief 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

Unprotected Sex; Contraceptive Usage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Pulse

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Pulse

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

GirlPower

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Healthy Teen Network

OTHER

Sponsor Role: collaborator

Ewald and Wasserman

UNKNOWN

Sponsor Role: collaborator

MetaMedia Training International, Inc.

INDUSTRY

Sponsor Role: collaborator

Child Trends

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Healthy Teen Network

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

TP2AH000038

Identifier Type: -

Identifier Source: org_study_id