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

NCT03253783 — Not applicable, Completed, 1304 participants, Healthy Teen Network

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RegistryNCT03253783
StatusCompleted
PhaseNot applicable
Study typeInterventional; masking: none, prevention
Enrollment1304 (Actual)
SponsorHealthy Teen Network (Other); collaborators: Child Trends, Ewald and Wasserman, Meta Media
ConditionsUnprotected Sex, Contraceptive Usage, Reproductive and Sexual Health Care Utilization
InterventionsPulse (Behavioral)
Datesstart 2016-11-01, primary completion 2017-12-01, completion 2018-01-01, first posted 2017-08-18, last updated 2018-01-23
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Unprotected Sex All trials for Contraceptive Usage All trials of Pulse

-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.

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+Arms and interventions

  • Pulse (Behavioral)

+Outcome measures

Primary outcomes

  • Unprotected sex, no contraceptive [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 [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]: Visiting a health care provider for reproductive or sexual health services within the past 6 weeks for the 1st follow-up survey

+Eligibility

Sex: Female, ages: 18 Years to 20 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Healthy Teen NetworkBaltimore, MarylandUnited States

+Publications

  • Results publication: 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. PMID 32779730

+Investigators