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A Trial Assessing the Effectiveness of Text Messages in Improving Continuation of Birth Control (BC 2U)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01545609
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : December 24, 2013
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:

This study is a randomized controlled trial assessing the effectiveness in a series of educational text messages in improving continuation of a birth control method in comparison to the 'standard counseling', when girls initiate a new method of birth control. Girls aged 15-19 year olds who are attending for a reproductive health visit and who own a working cell phone will be approached and asked if they would like to participate. Following completion of a baseline questionnaire and consultation for initiation of a new birth control method they will be randomized to receive either the intervention or standard counseling.

If randomized to the intervention they will receive 3 messages per week for the initial 3 weeks, 2 messages per week for the following 5 weeks and then one message per week thereafter. Messages will be tailored to the birth control method the participant has initiated. At 4 months all participants will be contacted via telephone and asked to complete a questionnaire regarding continuation of use.

Condition or disease Intervention/treatment Phase
Initiation of a Birth Control Method Other: Text messaging Phase 1

Detailed Description:

Hypothesis. A personalized text messaging program providing trustworthy, reliable information and support to female adolescents initiating a birth control method, will improve adherence and correct use of the method and so reduce unwanted pregnancies.

Methods. Female adolescents aged 15-19 year olds attending Mount Sinai Adolescent Health Center (MSAHC) for initiating a birth control method will be asked if they are interested in participating in the trial.

The Intervention Group. Upon initiation of a birth control method patients will be signed up to the text messaging platform. Via this program they will receive personalized messages regarding their chosen method of birth control. Participants will receive 3 messages during the initial 3 weeks, 2 messages per week in weeks 4-8 and then one message a week thereafter for a period of 12 months. They will be signed up for reminders to take/change their method (as appropriate) and have access to a Healthcare Provider to ask questions via text message that they may have regarding their method. Participants will be reminded (via text message) to attend the clinic for a birth control refill (if necessary) at 3, 6, 9 and 12 months.

The Control Group. Participants randomized in to the control group will have standard care. This is the usual counseling by the Health Care Provider or Health Educator. Patients in the intervention arm will also receive this standard care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Text Message Support System for Effective Continuation of a Birth Control Method in Female Adolescents: 'BC 2U'
Study Start Date : March 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Text messaging
Text messaging
Other: Text messaging
Text messages to cell phone with education messages about the specific birth control they are using

No Intervention: No intervention
No intervention

Primary Outcome Measures :
  1. Continuation of a birth control method [ Time Frame: at 4 months ]
    Birth control continuation will be assessed at 4 months by direct asking of the participant to see if participant has attended for a refill of her birth control method.

Secondary Outcome Measures :
  1. Change in birth control method being used. [ Time Frame: at 4 months ]
    whether subjects continue with the initial method of birth control or discontinue a method at the 4 months.

  2. Pregnancy [ Time Frame: at 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • female
  • Aged 15-19 years old
  • English speaking
  • owner of a working cell phone
  • patient must be wanting to start a birth control method and not have been on a method for preceding 3 months
  • no contra indications to initiating a birth control method

Exclusion Criteria:

  • male
  • younger than 15 years old, older than 19 years old
  • already on a birth control method
  • Not English speaking
  • No working cell phone in possession

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01545609

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United States, New York
Mount Sinai Adolescent Health Center
New York, New York, United States, 10128
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
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Principal Investigator: Jenny Francis, MD Mount Sinai Adolescent Health Center

U.S Teenage Pregnancies, Births, Abortions: National and State Trends and trends by Race and Ethnicity. Guttmacher Institute. January 2010.

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Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT01545609     History of Changes
Other Study ID Numbers: GCO 11-1385
HS#: 11-01558
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by Icahn School of Medicine at Mount Sinai:
Text messaging
birth control