AzTrials
AzTrials

Unprotected SexNCT03253783

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

A study testing Pulse in people with Unprotected Sex and Contraceptive Usage, run by Healthy Teen Network at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 20 years, women onlyHealthy volunteers can take part
What is being tested?
Pulse
How many people
1,304 participants
Where
1 siteUnited States
Study dates
Nov 2016to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 20 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Currently pregnant or trying to get pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Healthy Teen Network

    Baltimore, Maryland, 21202

Other trials in United States

About this study

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.

Being tested
Pulse
Medical subject headings
Unsafe Sex, Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PulseBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unprotected sex, no contraceptive

    Ever having sexual intercourse without using any method of contraception (among full sample)

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

  2. Unprotected sex, no highly effective contraceptive

    Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)

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

Secondary outcomes (1)

  1. 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

    Measured: 6-weeks post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2017
  2. Study startNov 2016
  3. Primary completionDec 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Masking
None (open label)
Enrolment
1,304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03253783
Sponsor's protocol ID
TP2AH000038
Status last verified
Jan 2018
First submitted
11 Aug 2017
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32779730

Questions about this trial

What is this clinical trial studying?

A study testing Pulse in people with Unprotected Sex and Contraceptive Usage, run by Healthy Teen Network at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unprotected sex, no contraceptive (time frame: 6-week post-baseline (in the past 6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03253783, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in