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

NCT04043130 | Completed

• 1 other identifier: TP2AH000038
• Study Type: interventional
• Target: 2,317
• Locations: 1 country
• Sites: 1

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.

Conditions

Unprotected Sex; Contraceptive Usage

Keywords

Reproductive and Sexual Health Care Utilization

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• Reproductive and sexual health care utilization (among full sample)

  6-week post-baseline (in the past 6 weeks)

• Reproductive and sexual health care utilization (among full sample)

  6-months post-baseline (in the past 6 months)

Study Arms (2)

Pulse Treatment App

EXPERIMENTAL

The treatment app is a web-based mobile health app designed for Black \& Latinx women ages 18-20. Through culturally and age-appropriate content, Pulse provides information on birth control, healthy relationships, sexual health, pregnancy, \& utilization of clinical services to encourage users to choose effective birth control, seek reproductive health services, and prevent unplanned pregnancies. Users access Pulse autonomously and on their own terms. The app does not require users to follow a specific sequence of content viewed. Participants randomized to the intervention condition are given access to Pulse and receive Multimedia Messaging Service (MMS) messages related to sexual health several times a week for 6 weeks. Participants receive a baseline survey, 6-week follow-up survey, and 6-month follow-up survey via an electronic survey platform (6-month survey only administered to participants recruited between November 2018-March 2019).

Behavioral: Pulse

Pulse Control App

ACTIVE COMPARATOR

The control app, also called Pulse, is a web-based mobile health app designed by the study team for young women ages 18-20. Although Pulse control and Pulse treatment apps look and feel similar aesthetically, they contain different content. Pulse control app provides information on general health topics, such as the importance of sleep, healthy eating, and friendships. Users access Pulse autonomously, on their own terms, and in their own time and place. The app does not require the user to follow a specific sequence of content viewed; however, all users receive a monetary incentive after completing a baseline survey and registering with the app. Control participants also receive MMS messages related to general health for six weeks. Participants receive a baseline survey and a six-week follow-up which are conducted online via an electronic survey platform.

Behavioral: Pulse

Interventions

Pulse BEHAVIORAL

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.

Also known as: GirlPower

Pulse Control App; Pulse Treatment App

Eligibility Criteria

• Age: 18 Years - 20 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Currently pregnant or trying to get pregnant

Sponsors & Collaborators

• Child Trends: lead
• Healthy Teen Network: collaborator
• Ewald and Wasserman: collaborator
• MetaMedia Training International, Inc.: collaborator

Study Sites (1)

Healthy Teen Network

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Unsafe Sex; Contraception Behavior

Interventions

Pulse

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Reproductive Behavior

Intervention Hierarchy (Ancestors)

Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: August 2, 2019
• Study Start: November 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)