Clinical trial NCT04043130: 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
Keywords: Reproductive and Sexual Health Care Utilization
Lead sponsor: Child Trends
Sponsor class: OTHER
Collaborators: name: Healthy Teen Network
name: Ewald and Wasserman
name: MetaMedia Training International, Inc.
First posted: 2019-08-02
Enrollment: 2317
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study used 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 was comprised of 2,317 women aged 18-20 who, at enrollment, were not pregnant or trying to become pregnant, had daily access to a smartphone, were currently living in the United States or a U.S. territory, and spoke English. Most of the sample (86%) identified as Black and/or Latinx. The evaluation team enrolled participants over a two and a half year enrollment period using social media, including Facebook and Instagram.

Users accessed 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 received a monetary incentive after registering with the app. Young women randomized to the intervention condition were given access to Pulse indefinitely and received daily text messages related to sexual health for 6 weeks. Control participants were directed to a free general health/fitness web-based mobile application, also called Pulse, and received 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 received a baseline survey, a 6-week follow-up survey, and a 6-month follow-up survey (the 6-month follow-up survey was only administered to participants recruited between November 2018 and March 2019). Participants also received incentives for completing the baseline and post-intervention surveys. Both surveys were conducted online via an electronic survey platform. This study was 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 the Internet
* Must speak English
* 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: Baseline (unprotected sex in the past 3 months)
measure: Unprotected sex, no contraceptive
timeFrame: 6-week post-baseline (in the past 6 weeks)
measure: Unprotected sex, no contraceptive
timeFrame: 6-months post-baseline (in the past 3 months)
measure: Unprotected sex, no highly effective contraceptive
timeFrame: Baseline (unprotected sex in the past 3 months)
measure: Unprotected sex, no highly effective contraceptive
timeFrame: 6-week post-baseline (in the past 6 weeks)
measure: Unprotected sex, no highly effective contraceptive
timeFrame: 6-months post-baseline (in the past 3 months)
Secondary outcomes:
measure: Reproductive and sexual health care utilization (among full sample)
timeFrame: 6-week post-baseline (in the past 6 weeks)
measure: Reproductive and sexual health care utilization (among full sample)
timeFrame: 6-months post-baseline (in the past 6 months)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Healthy Teen Network
state: Maryland
Study officials:
References: