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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01545609
First received: February 28, 2012
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Initiation of a Birth Control Method
Other: Text messaging
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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'

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Continuation of a birth control method [ Time Frame: at 4 months ] [ Designated as safety issue: No ]
    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:
  • Change in birth control method being used. [ Time Frame: at 4 months ] [ Designated as safety issue: No ]
    whether subjects continue with the initial method of birth control or discontinue a method at the 4 months.

  • Pregnancy [ Time Frame: at 4 months ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545609

Locations
United States, New York
Mount Sinai Adolescent Health Center
New York, New York, United States, 10128
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Jenny Francis, MD Mount Sinai Adolescent Health Center
  More Information

Publications:
Langston AM, Rosario L, Westhoff CL. Structured contraceptive counseling--a randomized controlled trial. Patient Educ Couns. 2010 Dec;81(3):362-7. PubMed PMID: 20869187
Kavanaugh ML, Schwarz EB. Prospective assessment of pregnancy intentions using a single- versus a multi-item measure. Perspect Sex Reprod Health. 2009 Dec;41(4):238-43. PubMed PMID: 20444179
Lim MS, Hocking JS, Aitken CK, Fairley CK, Jordan L, Lewis JA, Hellard ME. Impact of text and email messaging on the sexual health of young people: a randomised controlled trial. J Epidemiol Community Health. 2012 Jan;66(1):69-74. Epub 2011 Mar 17. PubMed PMID: 21415232
U.S Teenage Pregnancies, Births, Abortions: National and State Trends and trends by Race and Ethnicity. Guttmacher Institute. January 2010.
Rose SB, Lawton BA, Brown SA. Uptake and adherence to long-acting reversible contraception post-abortion. Contraception. 2010 Oct;82(4):345-53. Epub 2010 May 26. PubMed PMID: 20851228

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01545609     History of Changes
Other Study ID Numbers: GCO 11-1385, HS#: 11-01558
Study First Received: February 28, 2012
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014