Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders

March 16, 2016 updated by: Planned Parenthood League of Massachusetts

The purpose of this study is to determine whether there is increased oral contraceptive pill (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared to women who do not receive reminders. The investigators hypothesize that women who receive daily text messaging reminders to take their OCP will have increased pill adherence compared to women who do not receive reminders.

The investigators also hope to determine whether there is a difference in OCP adherence as measured by electronic monitoring device and wireless real-time data collection versus traditional patient pill diaries. The investigators hypothesize that electronic monitoring device and wireless real-time data collection will demonstrate lower adherence compared to traditional patient pill diaries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • 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
        • Planned Parenthood League of Massachusetts

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

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Using oral contraceptive pills (OCPs) for less than 1 month, or plan to initiate OCP use at their current visit
  • Be willing to use OCPs that are on formulary for the duration of the study
  • Having a personal mobile phone with text messaging capabilities
  • Proficiency in English or Spanish
  • Agreeing to surveys regarding demographics, pill adherence behavior and its influences
  • If younger than 18, must be accompanied by a parent or legal guardian who can provide informed consent for research participation

Exclusion Criteria:

  • Electing OCPs solely for non-contraceptive benefits only
  • Interest in pregnancy within the next 12 months
  • Inability to give informed consent
  • Planning to move from the local area before study completion, and is unable to return for follow-up and return the electronic pill bottle
  • Planning travel outside the cell phone networks of United States or Canada
  • Being in a situation where receiving text messages to take a birth control pill may endanger the safety of the subject

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Text messaging reminders
Behavioral: Text messaging reminders
Subjects in this arm will receive daily text message reminders once per day at the same time each day. Messages will remind the subject to take their oral contraceptive pill.
No Intervention: 2
No text messaging reminder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average number of missed pills per cycle
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of adherence as recorded by the electronic pill-dispensing device versus the rate of adherence as recorded by patient pill diaries
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Planned Parenthood League of Massachusetts

Investigators

  • Principal Investigator: Jane Doe, Planned Parenthood

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Grant-806

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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