Clinical trial NCT03253783: The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program
Official title: The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unprotected Sex
Contraceptive Usage
Reproductive and Sexual Health Care Utilization
Lead sponsor: Healthy Teen Network
Sponsor class: OTHER
Collaborators: name: Child Trends
name: Ewald and Wasserman
name: Meta Media
First posted: 2017-08-18
Enrollment: 1304
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Unprotected sex, no contraceptive
timeFrame: 6-week post-baseline (in the past 6 weeks)
measure: Unprotected sex, no highly effective contraceptive
timeFrame: 6-week post-baseline (in the past 6 weeks)
Secondary outcomes:
measure: Reproductive and sexual health care utilization (among full sample)
timeFrame: 6-weeks post-baseline
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Healthy Teen Network
state: Maryland
Study officials:
affiliation: Healthy Teen Network
name: Genevieve Martinez-Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Child Trends
name: Jennifer Manlove, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.