Clinical trial NCT00733707: Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
Official title: Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Contraceptive Pill Adherence
Keywords: adherence
oral contraceptive pills
contraception
text messaging
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 82
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average number of missed pills per cycle
timeFrame: 3 months
Secondary outcomes:
measure: Rate of adherence as recorded by the electronic pill-dispensing device versus the rate of adherence as recorded by patient pill diaries
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
Study officials:
affiliation: Planned Parenthood
name: Jane Doe
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.