Completed

NCT Number: NCT01545609

A Trial Assessing the Effectiveness of Text Messages in Improving Continuation of Birth Control

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.

Completed

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Key information

Conditions

Initiation of a Birth Control Method

Age range

15 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mount Sinai Adolescent Health Center

New York, 10128, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text Messaging

Other

Text messages to cell phone with education messages about the specific birth control they are using

Primary outcomes

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 outcomes

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.
Pregnancy

Time frame: at 4 months

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

A Text Message Support System for Effective Continuation of a Birth Control Method in Female Adolescents: 'BC 2U'

Acronym: BC 2U

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Mar 7, 2012
Registry last updated: Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.