Clinical trial NCT01545609: A Trial Assessing the Effectiveness of Text Messages in Improving Continuation of Birth Control
Official title: A Text Message Support System for Effective Continuation of a Birth Control Method in Female Adolescents: 'BC 2U'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Initiation of a Birth Control Method
Keywords: Text messaging
birth control
adolescents
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 220
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Continuation of a birth control method
timeFrame: at 4 months
Secondary outcomes:
measure: Change in birth control method being used.
timeFrame: at 4 months
measure: Pregnancy
timeFrame: at 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Adolescent Health Center
state: New York
Study officials:
affiliation: Mount Sinai Adolescent Health Center
name: Jenny Francis, MD
role: PRINCIPAL_INVESTIGATOR
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