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NCT04043130 · ClinicalTrials.gov registry record · NA
The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program
A NA study of Contraceptive Usage and Unprotected Sex, sponsored by Child Trends.
- Completed
- Registry status
- NA
- Development phase
- 2,317
- Enrollment target
- 1
- Study location
NCT04043130: Completed NA study of Contraceptive Usage and Unprotected Sex, sponsored by Child Trends.
NCT04043130 is a NA study of Contraceptive Usage and Unprotected Sex that has completed, run by Child Trends. The registered enrollment target is 2,317 participants, above the 418-participant average among 11 other Contraceptive Usage trials with a reported enrollment target (454% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04043130, a NA study of Contraceptive Usage and Unprotected Sex, has completed, sponsored by Child Trends.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,317 participants
- Enrollment target
- 1
- Study location
Study 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 s
Primary Outcome
Ever having sexual intercourse without using any method of contraception (among full sample)
Conditions Studied
Interventions
- BEHAVIORAL Pulse
Study Locations (1)
Maryland
- Healthy Teen Network - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,317 participants |
| Start Date | 2016-11 |
| Est. Completion | 2020-06 |
| Phase | NA |
What the finished NCT04043130 record still lists
NCT04043130 is an interventional study that assigns participants to a tested intervention. Its 2,317 participants enrollment target places it among the larger protocols in the corpus, above the 418-participant average among 11 other Contraceptive Usage trials with a reported enrollment target (454% higher).
The record links to 2 conditions, with Contraceptive Usage appearing as the primary indexed condition, and to 1 intervention - of which Pulse is the first listed.
NCT04043130 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04043130 about?
NCT04043130 is a clinical study titled "The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program". 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 incr...
What is the current status of trial NCT04043130?
This trial is currently completed. It is a NA study. The enrollment target is 2,317 participants. The study started on 2016-11. Estimated completion is 2020-06.
What conditions does trial NCT04043130 study?
This clinical trial studies the following conditions: Contraceptive Usage, Unprotected Sex.
What interventions are being tested in trial NCT04043130?
The interventions under investigation include: Pulse (BEHAVIORAL).
Who is sponsoring clinical trial NCT04043130?
This trial is sponsored by Child Trends, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04043130 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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