NCT03253783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

August 11, 2017

Last Update Submit

January 18, 2018

Conditions

Unprotected SexContraceptive UsageReproductive and Sexual Health Care Utilization

Outcome Measures

Primary Outcomes (2)

  • 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 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)

Secondary Outcomes (1)

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

    6-weeks post-baseline

Interventions

PulseBEHAVIORAL

Eligibility Criteria

Age18 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (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 to the Internet
  • Must speak English or Spanish
  • Must live in the United States or a U.S. territory

You may not qualify if:

  • Currently pregnant or trying to get pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Teen Network

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

  • 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: 32779730DERIVED

MeSH Terms

Conditions

Unsafe SexContraception Behavior

Interventions

Pulse

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorReproductive Behavior

Intervention Hierarchy (Ancestors)

HemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Genevieve Martinez-Garcia, PhD

    Healthy Teen Network

    PRINCIPAL INVESTIGATOR

  • Jennifer Manlove, PhD

    Child Trends

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
PREVENTION
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Genevieve Martínez-García

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 18, 2017

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)