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Clinical Trials/NCT03253783
NCT03253783
Completed
Not Applicable

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

Healthy Teen Network1 site in 1 country1,304 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unprotected Sex
Sponsor
Healthy Teen Network
Enrollment
1304
Locations
1
Primary Endpoint
Unprotected sex, no contraceptive
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
January 2018
Last Updated
8 years ago
Study Type
Interventional
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martinez Garcia

Dr. Genevieve Martínez-García

Healthy Teen Network

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

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)

Secondary Outcomes

  • Reproductive and sexual health care utilization (among full sample)(6-weeks post-baseline)

Study Sites (1)

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