Targeted Video Messaging About Emergency Contraception

July 15, 2019 updated by: Planned Parenthood League of Massachusetts

Targeted Video Messaging About Emergency Contraception Via a Social Media Platform

This research study will assess the real-world effectiveness of Facebook advertising as a strategy to reach women of reproductive age who are at risk of unintended pregnancy with a brief educational intervention about emergency contraception (EC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research study will assess the real-world effectiveness of Facebook advertising as a strategy to reach women of reproductive age who are at risk of unintended pregnancy with a brief educational intervention about emergency contraception (EC). The investigators will assess whether a video or website link has superior reach, engagement, and return on investment (measured as cost per click) through a Facebook ad campaign. The investigators will also ensure that both modalities of consumer engagement (website and video) are efficacious at ensuring adequate and improved knowledge of emergency contraception through a laboratory-environment trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • PPLM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women
  • 18 to 29 years old
  • Living or seeking care in or around Boston, MA
  • Able to participate in an in-person visit at Planned Parenthood League of Massachusetts (PPLM) Boston Health Center
  • English fluency
  • Have at least one social media account (i.e. Facebook, Instagram, Twitter, Pinterest, YouTube, Snapchat)
  • Endorse using social media at least once a week

Exclusion Criteria:

  • PPLM staff
  • Currently or ever employed in the reproductive health field
  • Currently using long-acting reversible contraception (LARC)
  • History of permanent sterilization (by participant or sexual partner)
  • Previous participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Website about emergency contraception
Subjects are randomly assigned to view an existing website about emergency contraception. The website contains information about the three methods of emergency contraception: the copper IUD, ulipristal pill, and levonorgestrel pill. It includes information about their relative effectiveness and where to access emergency contraception.
Other: Emergency contraception website
Existing website with factual information about emergency contraception
Other: Video about emergency contraception
Subjects are randomly assigned to view an existing video about emergency contraception. The video is two minutes in length and contains information about the three methods of emergency contraception: the copper IUD, ulipristal pill, and levonorgestrel pill. It includes information about their relative effectiveness and where to access emergency contraception.
Other: Emergency contraception video
Existing video with factual information about emergency contraception

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Emergency contraception knowledge (binary)
Time Frame: Immediately after intervention
This outcome is a binary outcome that reflects a participant's ability to correctly identify an emergency contraceptive method, when to use it, and how to access it
Immediately after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Copper IUD as emergency contraception knowledge
Time Frame: Immediately after intervention
This outcome is a binary outcomes that reflects a participant's ability to correctly identify the copper IUD as emergency contraception, when to use it, and how to access it.
Immediately after intervention
Levonorgestrel pill as emergency contraception knowledge
Time Frame: Immediately after intervention
This outcome is a binary outcomes that reflects a participant's ability to correctly identify the levonorgestrel pill as emergency contraception, when to use it, and how to access it.
Immediately after intervention
Ulipristal pill as emergency contraception knowledge
Time Frame: Immediately after intervention
This outcome is a binary outcomes that reflects a participant's ability to correctly identify the ulipristal pill as emergency contraception, when to use it, and how to access it.
Immediately after intervention
Emergency contraception knowledge (continuous)
Time Frame: Immediately after intervention
This outcome reflects the participant's overall knowledge of emergency contraception after the website or video intervention, as measured by the proportion of questions they get correct on the survey
Immediately after intervention
Change in emergency contraception knowledge pre- and post-intervention
Time Frame: Immediately before and immediately after intervention
This outcome reflects the participant's change in knowledge of emergency contraception before and after the website or video intervention, as measured by the proportion of questions they get correct on the survey.
Immediately before and immediately after intervention
Likelihood of using emergency contraception pre- and post-intervention
Time Frame: Immediately before and immediately after intervention
This outcome reflects the participant's likelihood of using emergency contraception both before and after the intervention, as measured on a 6 point likert scale (I would definitely use it, Very likely, Somewhat likely, Somewhat unlikely, Very unlikely, I definitely would NOT use it)
Immediately before and immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Planned Parenthood League of Massachusetts

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Principal Investigator, MD, Planned Parenthood League of Massachusetts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018P001764

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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