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

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ClinicalTrials.gov Identifier: NCT03253783
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
Child Trends
Ewald and Wasserman
Meta Media
Information provided by (Responsible Party):
Martinez Garcia, Healthy Teen Network

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.


Condition or disease Intervention/treatment Phase
Unprotected Sex Contraceptive Usage Reproductive and Sexual Health Care Utilization Behavioral: Pulse Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1304 participants
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program
Actual Study Start Date : November 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018



Primary Outcome Measures :
  1. 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)

  2. 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 Outcome Measures :
  1. Reproductive and sexual health care utilization (among full sample) [ Time Frame: 6-weeks post-baseline ]
    Visiting a health care provider for reproductive or sexual health services within the past 6 weeks for the 1st follow-up survey



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Ages Eligible for Study:   18 Years to 20 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253783


Locations
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United States, Maryland
Healthy Teen Network
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Healthy Teen Network
Child Trends
Ewald and Wasserman
Meta Media
Investigators
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Principal Investigator: Genevieve Martinez-Garcia, PhD Healthy Teen Network
Principal Investigator: Jennifer Manlove, PhD Child Trends
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martinez Garcia, Dr. Genevieve Martínez-García, Healthy Teen Network
ClinicalTrials.gov Identifier: NCT03253783    
Other Study ID Numbers: TP2AH000038
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No