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

Contraceptive Usage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043130
• Other study ID #: TP2AH000038
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: June 2020

Study information

• Verified date: June 2020
• Source: Child Trends
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2317
• Est. completion date: June 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Usage
• Unprotected Sex

Intervention

Behavioral:
• Pulse
The intervention provides participants access to Pulse, a web-based mobile health app designed for Black and Latinx women ages 18-20. Participants can access the app autonomously and on their own schedule. The app for the experimental arm, the Pulse treatment app, provides information on birth control, healthy relationships, sexual health and physiology, pregnancy, and utilization of clinical services. The app for the comparator arm, the Pulse control app, provides information on general health topics, such as the importance of sleep, healthy eating, and friendships. Participants receive MMS messages that reinforce app content and remind them to visit the app.

Locations

Country	Name	City	State
United States	Healthy Teen Network	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Child Trends	Ewald and Wasserman, Healthy Teen Network, MetaMedia Training International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unprotected sex, no contraceptive	Ever having sexual intercourse without using any method of contraception (among full sample)	Baseline (unprotected sex in the past 3 months)
Primary	Unprotected sex, no contraceptive	Ever having sexual intercourse without using any method of contraception (among full sample)	6-week post-baseline (in the past 6 weeks)
Primary	Unprotected sex, no contraceptive	Ever having sexual intercourse without using any method of contraception (among full sample)	6-months post-baseline (in the past 3 months)
Primary	Unprotected sex, no highly effective contraceptive	Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)	Baseline (unprotected sex in the past 3 months)
Primary	Unprotected sex, no highly effective contraceptive	Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)	6-week post-baseline (in the past 6 weeks)
Primary	Unprotected sex, no highly effective contraceptive	Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)	6-months post-baseline (in the past 3 months)
Secondary	Reproductive and sexual health care utilization (among full sample)	Visiting a health care provider for reproductive or sexual health services within the past 6 weeks for the 1st follow-up survey	6-week post-baseline (in the past 6 weeks)
Secondary	Reproductive and sexual health care utilization (among full sample)	Visiting a health care provider for reproductive or sexual health services within the past 6 months for the 1st follow up survey	6-months post-baseline (in the past 6 months)