Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders

Study Overview
=================
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.

Official Title
-----------------
Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders

Conditions
-----------------
Oral Contraceptive Pill Adherence

Intervention / Treatment
-----------------
* Behavioral: Text messaging reminders


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Text messaging reminders | Behavioral: Text messaging reminders<br>* 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.<br>|
| No Intervention: 2<br>No text messaging reminder | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of missed pills per cycle |  | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adherence, oral contraceptive pills, contraception, text messaging