A Trial Assessing the Effectiveness of Text Messages in Improving Continuation of Birth Control (BC 2U)
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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. Another questionnaire will be asked at 12 months.
| 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' |
- Continuation of a birth control method [ Time Frame: at 3 months ] [ Designated as safety issue: No ]Birth control continuation will be assessed at 3, 6, 9, and 12 months by direct asking of the participant as well as access to electronic medical records to see if participant has attended for a refill of her birth control method.
- Continuation of a birth control method [ Time Frame: at 6 months ] [ Designated as safety issue: No ]Birth control continuation will be assessed at 3, 6, 9, and 12 months by direct asking of the participant as well as access to electronic medical records to see if participant has attended for a refill of her birth control method.
- Continuation of a birth control method [ Time Frame: at 9 months ] [ Designated as safety issue: No ]Birth control continuation will be assessed at 3, 6, 9, and 12 months by direct asking of the participant as well as access to electronic medical records to see if participant has attended for a refill of her birth control method.
- Continuation of a birth control method [ Time Frame: at 12 months ] [ Designated as safety issue: No ]Birth control continuation will be assessed at 3, 6, 9, and 12 months by direct asking of the participant as well as access to electronic medical records to see if participant has attended for a refill of her birth control method.
- Change in birth control method being used. [ Time Frame: at 3 months ] [ Designated as safety issue: No ]whether subjects continue with the initial method of birth control or discontinue a method at the 3, 6, 9 & 12 month time intervals.
- Change in birth control method being used. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]whether subjects continue with the initial method of birth control or discontinue a method at the 3, 6, 9 & 12 month time intervals.
- Change in birth control method being used. [ Time Frame: at 9 months ] [ Designated as safety issue: No ]whether subjects continue with the initial method of birth control or discontinue a method at the 3, 6, 9 & 12 month time intervals.
- Change in birth control method being used. [ Time Frame: at 12 months ] [ Designated as safety issue: No ]whether subjects continue with the initial method of birth control or discontinue a method at the 3, 6, 9 & 12 month time intervals.
- Pregnancy [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
- Pregnancy [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- Pregnancy [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
- Pregnancy [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated 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 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 |
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| Contact: Katherine Malbon, MD | 212-731-7639 | katherine.malbon@mountsinai.org |
| United States, New York | |
| Mount Sinai Adolescent Health Center | Recruiting |
| New York, New York, United States, 10128 | |
| Contact: Katherine Malbon, MD 212-731-7639 katherine.malbon@mountsinai.org | |
| Principal Investigator: Katherine Malbon, MD | |
| Sub-Investigator: Jenny Francis, MD | |
| Principal Investigator: | Katherine Malbon, MD | Mount Sinai Adolescent Health Center |
More Information
Publications:
| 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: | November 5, 2012 |
| 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 June 13, 2013