A Trial Assessing the Effectiveness of Text Messages in Improving Continuation of Birth Control (BC 2U)
A Text Message Support System for Effective Continuation of a Birth Control Method in Female Adolescents: 'BC 2U'
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10128
- Mount Sinai Adolescent Health Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：介入なし
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実験的：Text messaging
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Text messages to cell phone with education messages about the specific birth control they are using
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Continuation of a birth control method
時間枠：at 4 months
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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.
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at 4 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in birth control method being used.
時間枠：at 4 months
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whether subjects continue with the initial method of birth control or discontinue a method at the 4 months.
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at 4 months
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Pregnancy
時間枠：at 4 months
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at 4 months
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協力者と研究者
捜査官
- 主任研究者：Jenny Francis, MD、Mount Sinai Adolescent Health Center
出版物と役立つリンク
一般刊行物
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