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Unprotected SexNCT04043130

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 Child Trends 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
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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. Read more about this study

Who is it for?
Ages 18 to 20 years, women onlyHealthy volunteers can take part
Conditions the study is for
Unprotected Sex, Contraceptive Usage
What is being tested?
Pulse
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,317 participants
Where
1 siteUnited States
Study dates
Nov 2016to Jun 2020
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 the Internet
  • Must speak English
  • 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 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.

Being tested
Pulse
Keywords
Reproductive and Sexual Health Care Utilization
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

    Also called GirlPower

    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.

Study groups in NCT04043130
Study groupRoleWhat they receive
Pulse Treatment AppExperimentalThe 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).
Receives: Behavioral: Pulse
Pulse Control AppActive comparatorThe 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.
Receives: Behavioral: Pulse

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: Baseline (unprotected sex in the past 3 months)

  2. 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)

  3. Unprotected sex, no contraceptive

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

    Measured: 6-months post-baseline (in the past 3 months)

  4. Unprotected sex, no highly effective contraceptive

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

    Measured: Baseline (unprotected sex in the past 3 months)

  5. 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)

  6. Unprotected sex, no highly effective contraceptive

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

    Measured: 6-months post-baseline (in the past 3 months)

Secondary outcomes (2)

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

  2. 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

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

Timeline

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

  1. First posted2 Aug 2019
  2. Study startNov 2016
  3. Primary completionNov 2019
  4. Study completionJun 2020

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04043130
Sponsor's protocol ID
TP2AH000038
Status last verified
Jun 2020
First submitted
1 Mar 2019
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pulse in people with Unprotected Sex and Contraceptive Usage, run by Child Trends 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 16 Jun 2020. 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: Baseline (unprotected sex in the past 3 months)). The study lists 6 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 NCT04043130.

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 16 Jun 2020.

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