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

This study uses 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 is comprised of women with the following characteristics at study enrollment: aged 18-20, not pregnant or trying to become pregnant, has daily access to a smartphone, currently living in the United States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to enroll up to 1,300 participants over a one-year enrollment period using social media, including Facebook, Instagram, and Twitter.

Users access 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 will receive a monetary incentive after registering with the apps. Youth randomized to the intervention condition are given access to Pulse indefinitely and receive daily text messages related to sexual health for 6 weeks. Control participants are directed to a free general health/fitness web-based mobile application, also called Pulse, and receive 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 receive a baseline survey and a 6-week follow-up survey. Participants will also receive incentives once they complete the baseline and post-intervention survey. Both surveys are conducted online via an electronic survey platform. This study is being 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; Reproductive and Sexual Health Care Utilization
• Intervention / Treatment: Behavioral: Pulse

• Study Type: Interventional
• Enrollment (Actual): 1304
• 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 to the Internet
• Must speak English or Spanish
• 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
• Masking: NONE

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)

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-weeks post-baseline

Collaborators and Investigators

• Sponsor: Healthy Teen Network
• Collaborators: Child Trends; Ewald and Wasserman; Meta Media
• Investigators: Principal Investigator: Genevieve Martinez-Garcia, PhD, Healthy Teen Network

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (ACTUAL): August 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• 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