Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders

NCT00733707 | Completed

• 1 other identifier: Grant-806
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Contraceptive Pill Adherence

Keywords

adherence; oral contraceptive pills; contraception; text messaging

Outcome Measures

Primary Outcomes (1)

• Average number of missed pills per cycle

  3 months

Secondary Outcomes (1)

• Rate of adherence as recorded by the electronic pill-dispensing device versus the rate of adherence as recorded by patient pill diaries

  3 months

Study Arms (2)

1

EXPERIMENTAL

Text messaging reminders

Behavioral: Text messaging reminders

2

NO INTERVENTION

No text messaging reminder

Interventions

Text messaging reminders BEHAVIORAL

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.

1

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead

Study Sites (1)

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Hou MY, Hurwitz S, Kavanagh E, Fortin J, Goldberg AB. Using daily text-message reminders to improve adherence with oral contraceptives: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):633-640. doi: 10.1097/AOG.0b013e3181eb6b0f.

  PMID: 20733446 DERIVED

Study Officials

• Jane Doe

  Planned Parenthood

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

US (1)