Initiation of a Birth Control MethodPhase 1BC 2UNCT01545609
A Trial Assessing the Effectiveness of Text Messages in Improving Continuation of Birth Control
A Phase 1 study testing Text messaging in people with Initiation of a Birth Control Method, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Initiation of a Birth Control Method
- What is being tested?
- Text messaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Adolescent Health Center
New York, New York, 10128
About this study
Official title: 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.
Read the 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.
- Conditions
- Initiation of a Birth Control Method
- Being tested
- Text messaging
- Keywords
- Text messaging, birth control, adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messagingOther
Text messages to cell phone with education messages about the specific birth control they are using
| Study group | Role | What they receive |
|---|---|---|
| Text messaging | Experimental | Text messaging Receives: Other: Text messaging |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation of a birth control method
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.
Measured: at 4 months
Secondary outcomes (2)
Change in birth control method being used.
whether subjects continue with the initial method of birth control or discontinue a method at the 4 months.
Measured: at 4 months
Pregnancy
Measured: at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Initiation of a Birth Control MethodStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenny Francis, MD, Principal investigator, Mount Sinai Adolescent Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545609
- Sponsor's protocol ID
- GCO 11-1385
- Other IDs
- HS#: 11-01558
- Acronym
- BC 2U
- Status last verified
- Dec 2013
- First submitted
- 28 Feb 2012
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gilliam M, Knight S, McCarthy M Jr. Success with oral contraceptives: a pilot study. Contraception. 2004 May;69(5):413-8. doi: 10.1016/j.contraception.2003.12.006.
PubMed 15105065Woods JL, Shew ML, Tu W, Ofner S, Ott MA, Fortenberry JD. Patterns of oral contraceptive pill-taking and condom use among adolescent contraceptive pill users. J Adolesc Health. 2006 Sep;39(3):381-7. doi: 10.1016/j.jadohealth.2005.12.014. Epub 2006 Jul 10.
PubMed 16919800Moos MK, Bartholomew NE, Lohr KN. Counseling in the clinical setting to prevent unintended pregnancy: an evidence-based research agenda. Contraception. 2003 Feb;67(2):115-32. doi: 10.1016/s0010-7824(02)00472-9.
PubMed 12586322Bruckner H, Martin A, Bearman PS. Ambivalence and pregnancy: adolescents' attitudes, contraceptive use and pregnancy. Perspect Sex Reprod Health. 2004 Nov-Dec;36(6):248-57. doi: 10.1363/psrh.36.248.04.
PubMed 15687083Langston AM, Rosario L, Westhoff CL. Structured contraceptive counseling--a randomized controlled trial. Patient Educ Couns. 2010 Dec;81(3):362-7. doi: 10.1016/j.pec.2010.08.006.
PubMed 20869187Speizer IS, Santelli JS, Afable-Munsuz A, Kendall C. Measuring factors underlying intendedness of women's first and later pregnancies. Perspect Sex Reprod Health. 2004 Sep-Oct;36(5):198-205. doi: 10.1363/psrh.36.198.04.
PubMed 15519962Kavanaugh 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. doi: 10.1363/4123809.
PubMed 20444179Santelli J, Rochat R, Hatfield-Timajchy K, Gilbert BC, Curtis K, Cabral R, Hirsch JS, Schieve L; Unintended Pregnancy Working Group. The measurement and meaning of unintended pregnancy. Perspect Sex Reprod Health. 2003 Mar-Apr;35(2):94-101. doi: 10.1363/3509403. No abstract available.
PubMed 12729139Zabin LS, Astone NM, Emerson MR. Do adolescents want babies? The relationship between attitudes and behavior. J Res Adolesc. 1993;3(1):67-86. doi: 10.1207/s15327795jra0301_4.
PubMed 12318551Cowley C, Farley T. Adolescent girls' attitudes toward pregnancy: the importance of asking what the boyfriend wants. J Fam Pract. 2001 Jul;50(7):603-7.
PubMed 11485709Miller BC. Family influences on adolescent sexual and contraceptive behavior. J Sex Res. 2002 Feb;39(1):22-6. doi: 10.1080/00224490209552115.
PubMed 12476252Gold J, Lim MS, Hellard ME, Hocking JS, Keogh L. What's in a message? Delivering sexual health promotion to young people in Australia via text messaging. BMC Public Health. 2010 Dec 29;10:792. doi: 10.1186/1471-2458-10-792.
PubMed 21190584Adams BN, McAnarney ER, Panzarine S, Tuttle JI. Successful contraceptive behavior among adolescent mothers: are there predictors? J Adolesc Health Care. 1990 Jul;11(4):319-25. doi: 10.1016/0197-0070(90)90042-z.
PubMed 2365606Barnet B, Liu J, DeVoe M, Duggan AK, Gold MA, Pecukonis E. Motivational intervention to reduce rapid subsequent births to adolescent mothers: a community-based randomized trial. Ann Fam Med. 2009 Sep-Oct;7(5):436-45. doi: 10.1370/afm.1014.
PubMed 19752472Hall KS, Castano PM, Stone PW, Westhoff C. Measuring oral contraceptive knowledge: a review of research findings and limitations. Patient Educ Couns. 2010 Dec;81(3):388-94. doi: 10.1016/j.pec.2010.10.016. Epub 2010 Nov 16.
PubMed 21084170
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Text Message Support System for Effective Continuation of a Birth Control Method in Female Adolescents: 'BC 2U'
- ClinicalTrials.gov ID
- NCT01545609
- Acronym / sponsor ID
- BC 2U / GCO 11-1385
- Conditions
- Initiation of a Birth Control Method
- Keywords
- Text messaging, birth control, adolescents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text messaging | Experimental | Other: Text messagingText messaging |
| No intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text messagingText messages to cell phone with education messages about the specific birth control they are using | Other | Text messaging |
Primary outcome
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.
2 secondary outcomes
Change in birth control method being used.
Time frame: at 4 months
Pregnancy
Time frame: at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Background: PubMed 15105065Gilliam M, Knight S, McCarthy M Jr. Success with oral contraceptives: a pilot study. Contraception. 2004 May;69(5):413-8. doi: 10.1016/j.contraception.2003.12.006.
- Background: PubMed 16919800Woods JL, Shew ML, Tu W, Ofner S, Ott MA, Fortenberry JD. Patterns of oral contraceptive pill-taking and condom use among adolescent contraceptive pill users. J Adolesc Health. 2006 Sep;39(3):381-7. doi: 10.1016/j.jadohealth.2005.12.014. Epub 2006 Jul 10.
- Background: PubMed 12586322Moos MK, Bartholomew NE, Lohr KN. Counseling in the clinical setting to prevent unintended pregnancy: an evidence-based research agenda. Contraception. 2003 Feb;67(2):115-32. doi: 10.1016/s0010-7824(02)00472-9.
- Background: PubMed 15687083Bruckner H, Martin A, Bearman PS. Ambivalence and pregnancy: adolescents' attitudes, contraceptive use and pregnancy. Perspect Sex Reprod Health. 2004 Nov-Dec;36(6):248-57. doi: 10.1363/psrh.36.248.04.
- Background: PubMed 20869187Langston AM, Rosario L, Westhoff CL. Structured contraceptive counseling--a randomized controlled trial. Patient Educ Couns. 2010 Dec;81(3):362-7. doi: 10.1016/j.pec.2010.08.006.
- Background: PubMed 15519962Speizer IS, Santelli JS, Afable-Munsuz A, Kendall C. Measuring factors underlying intendedness of women's first and later pregnancies. Perspect Sex Reprod Health. 2004 Sep-Oct;36(5):198-205. doi: 10.1363/psrh.36.198.04.
- Background: PubMed 20444179Kavanaugh 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. doi: 10.1363/4123809.
- Background: PubMed 12729139Santelli J, Rochat R, Hatfield-Timajchy K, Gilbert BC, Curtis K, Cabral R, Hirsch JS, Schieve L; Unintended Pregnancy Working Group. The measurement and meaning of unintended pregnancy. Perspect Sex Reprod Health. 2003 Mar-Apr;35(2):94-101. doi: 10.1363/3509403. No abstract available.
- Background: PubMed 12318551Zabin LS, Astone NM, Emerson MR. Do adolescents want babies? The relationship between attitudes and behavior. J Res Adolesc. 1993;3(1):67-86. doi: 10.1207/s15327795jra0301_4.
- Background: PubMed 11485709Cowley C, Farley T. Adolescent girls' attitudes toward pregnancy: the importance of asking what the boyfriend wants. J Fam Pract. 2001 Jul;50(7):603-7.
- Background: PubMed 12476252Miller BC. Family influences on adolescent sexual and contraceptive behavior. J Sex Res. 2002 Feb;39(1):22-6. doi: 10.1080/00224490209552115.
- Background: PubMed 21190584Gold J, Lim MS, Hellard ME, Hocking JS, Keogh L. What's in a message? Delivering sexual health promotion to young people in Australia via text messaging. BMC Public Health. 2010 Dec 29;10:792. doi: 10.1186/1471-2458-10-792.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Francis, MD principal investigator
Mount Sinai Adolescent Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Text messaging in people with Initiation of a Birth Control Method, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuation of a birth control method (time frame: at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01545609, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.