Contraceptives, OralNCT00677703
Txt Now 2 Decrease Pregnancies L8r: A Study to Evaluate the Effect of Daily Text Message Reminders on Pill Continuation
A study testing Daily Text Messages in people with Contraceptives, Oral, run by Columbia University at 1 site in United States.
Trial summary
Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. Read more about this study
- Who is it for?
- Ages Up to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptives, Oral
- What is being tested?
- Daily Text Messages
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 968 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2012
- Phase
- Interventional
- 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 Up to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged <25 years requesting OC as their primary method of contraception
- currently sexually active or anticipating sexual activity within the next 30 days
- owns cell phone with text messaging capability
Who cannot join
- contraindications to combined hormonal contraception per clinic protocol (e.g., hypertension)
- previous participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Boro Hall
Brooklyn, New York, 11201
About this study
Official title: The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. We will test whether contraceptive continuation is affected after six months of daily text message reminders.
Read the detailed description
In 2000, there were 84 pregnancies for every 1,000 women aged 15 to 19 in the US (4). More than 90% of the resulting 900,000 teen pregnancies were unintended (6). Nationwide, teen pregnancy rates have dropped 28% since their peak in 1990 but dropped only 15% in Hispanic teens (4). New York state ranks 38th in the nation with 91 teen pregnancies per 1,000 teens. For Whites the teen pregnancy rate is only 52. Teen pregnancy rates are two to three times higher in Hispanics (130 pregnancies) and African Americans (167 pregnancies)(4). In New York City, the teen pregnancy rate is 99, even higher than the NY state and US rates (8).
Unintended pregnancy has long-term consequences that can disproportionately affect teens. Teen pregnancy negatively affects a teen's socioeconomic status. Pregnant teens are less likely to finish their education, more likely to be single parents and less likely to acquire work experience (9). Teen pregnancies are more likely to be medically complicated, with higher maternal and infant morbidity and mortality rates than in older pregnant women (10). Over one third of teen pregnancies end in abortion. Once a teen has one delivery, she is at increased risk to have another. Furthermore, a daughter of a teen pregnancy is more likely to have a teen pregnancy herself (11). Consistent contraceptive use is the only way to prevent pregnancy (and all of its consequences) in sexually-active teens. In a study of OC use in our population, 99% of the pregnancies that did occur were in women who had discontinued their OC during the study period (1).
The National Survey of Family Growth, a nationwide study examining contraceptive use in 2,271 teenagers, showed that 98% of sexually-active teenagers had used a contraceptive method at some time (12). Among teen contraceptors, 53% use oral contraceptives (OC) - the highest percentage among all age groups (12). The percentage of African American and Hispanic teens using contraception is lower than white teens (12). The World Health Organization estimates that half of patients take their medication improperly (13). One million of the United States' unintended pregnancies result from improper OC use, failure or discontinuation (14). Teens discontinue OCs because they experience side effects, misunderstand instructions for use and do not establish a pill-taking routine (3). In a study of OC use in inner city family planning clinics, we found discontinuation rates of 40% and 61% at three and six months, respectively (1). For the 595 teens in that study, discontinuation rates were 53% and 75% at three and six months, respectively. High discontinuation rates are also reported elsewhere (15-19). Improving OC continuation in the U.S. by just 10% can lead to a 7% reduction in unintended pregnancies and an annual savings of $280 million (1995 dollars) (14). Nationally, that could mean a reduction of unintended teen pregnancies by 63,000.
Wireless text messaging is a technology that was effective in improving medication adherence in clinical trials of vaccines and smoking cessation in Spain and South Africa (20,21). Text messaging has also been found to be more effective than telephone call-backs and scheduled clinic revisits in providing patients in London with lab results and decreasing the time for them to return to clinic for treatment (22). Cell phones have more recently become widespread in America and cell phone use continues to increase. A 2005 survey of wireless providers revealed that there were nearly 208 million wireless subscribers in the US, nearly 26 million more than in 2004 (23). Americans use cell phones for more than talking; they can use the text message function to share photos, to vote for reality television programming contestants, to receive daily jokes or to receive ring tones. Sixty-four percent of teens with cell phones use text messaging (24). Urban teen girls are more likely to use text messaging than boys or adults (24).
To assess cell phone use in our own population we carried out a survey of 2,521 racially-diverse reproductive-aged women, including 473 teens, attending family planning clinics in NYC. Cell phone usage was 77% among teens, and 81% of them read and send text messages (5). One-third of the participants in this feasibility survey worry about forgetting to take their medications and 30% would like to receive text message reminders for this (5). There are no studies of the effectiveness of text message reminders on contraceptive continuation rates.
Successful teen pregnancy prevention programs use varied, multifactorial approaches (2). We propose a study using an existing technology, text messaging, in an innovative way to improve OC continuation rates. Daily text messages will provide information regarding side effects, their management and instructions for troubleshooting common pill-taking mistakes. They may also help teens and young women establish a dosing routine.
- Conditions
- Contraceptives, Oral
- Being tested
- Daily Text Messages
- Keywords
- birth control pills, contraception, continuation, text messaging, contraceptive continuation, contraceptive knowledge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Text MessagesOther
Also called Text Messaging
Text message reminders to take oral contraception daily:
Each text message will be a short educational message listing the benefits of contraceptive use and providing instructions for avoiding common medication errors.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Participants will receive standard care without daily reminders. |
| Text Messages | Experimental | Participants will receive a daily text message reminder for 6 months Receives: Other: Daily Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
contraceptive continuation
Measured: 6 months
Secondary outcomes (1)
change in contraceptive knowledge scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Contraceptives, OralStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 968 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Castano, Columbia University
- Investigators
- Paula M Castano, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677703
- Sponsor's protocol ID
- AAAC1600
- Status last verified
- Nov 2012
- First submitted
- 12 May 2008
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Castano PM, Martinez RA. Harnessing technology for adolescent health promotion. Adolesc Med State Art Rev. 2007 Aug;18(2):400-6, xiii.
PubMed 18605654Castano PM, Westhoff C, Andres Martinez R, Lara M. The effect of daily text message reminders on adolescent oral contraceptive pill continuation. Journal of Adolescent Health 44(2): S17, 2009.
Hall KS, Westhoff CL, Castano PM. The impact of an educational text message intervention on young urban women's knowledge of oral contraception. Contraception. 2013 Apr;87(4):449-54. doi: 10.1016/j.contraception.2012.09.004. Epub 2012 Oct 10.
PubMed 23062523Castano PM, Bynum JY, Andres R, Lara M, Westhoff C. Effect of daily text messages on oral contraceptive continuation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):14-20. doi: 10.1097/AOG.0b013e31823d4167.
PubMed 22143257
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00677703
- Acronym / sponsor ID
- AAAC1600
- Conditions
- Contraceptives, Oral
- Keywords
- birth control pills, contraception, continuation, text messaging, contraceptive continuation, contraceptive knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 May 2008 (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.
Teen girls and young women taking birth control pills may forget to take their pills or may stop taking them altogether. This places them at risk for unintended pregnancies. Most young women own cell phones and use them for text messaging. We will test whether contraceptive continuation is affected after six months of daily text message reminders.
Detailed description
In 2000, there were 84 pregnancies for every 1,000 women aged 15 to 19 in the US (4). More than 90% of the resulting 900,000 teen pregnancies were unintended (6). Nationwide, teen pregnancy rates have dropped 28% since their peak in 1990 but dropped only 15% in Hispanic teens (4). New York state ranks 38th in the nation with 91 teen pregnancies per 1,000 teens. For Whites the teen pregnancy rate is only 52. Teen pregnancy rates are two to three times higher in Hispanics (130 pregnancies) and African Americans (167 pregnancies)(4). In New York City, the teen pregnancy rate is 99, even higher than the NY state and US rates (8).
Unintended pregnancy has long-term consequences that can disproportionately affect teens. Teen pregnancy negatively affects a teen's socioeconomic status. Pregnant teens are less likely to finish their education, more likely to be single parents and less likely to acquire work experience (9). Teen pregnancies are more likely to be medically complicated, with higher maternal and infant morbidity and mortality rates than in older pregnant women (10). Over one third of teen pregnancies end in abortion. Once a teen has one delivery, she is at increased risk to have another. Furthermore, a daughter of a teen pregnancy is more likely to have a teen pregnancy herself (11). Consistent contraceptive use is the only way to prevent pregnancy (and all of its consequences) in sexually-active teens. In a study of OC use in our population, 99% of the pregnancies that did occur were in women who had discontinued their OC during the study period (1).
The National Survey of Family Growth, a nationwide study examining contraceptive use in 2,271 teenagers, showed that 98% of sexually-active teenagers had used a contraceptive method at some time (12). Among teen contraceptors, 53% use oral contraceptives (OC) - the highest percentage among all age groups (12). The percentage of African American and Hispanic teens using contraception is lower than white teens (12). The World Health Organization estimates that half of patients take their medication improperly (13). One million of the United States' unintended pregnancies result from improper OC use, failure or discontinuation (14). Teens discontinue OCs because they experience side effects, misunderstand instructions for use and do not establish a pill-taking routine (3). In a study of OC use in inner city family planning clinics, we found discontinuation rates of 40% and 61% at three and six months, respectively (1). For the 595 teens in that study, discontinuation rates were 53% and 75% at three and six months, respectively. High discontinuation rates are also reported elsewhere (15-19). Improving OC continuation in the U.S. by just 10% can lead to a 7% reduction in unintended pregnancies and an annual savings of $280 million (1995 dollars) (14). Nationally, that could mean a reduction of unintended teen pregnancies by 63,000.
Wireless text messaging is a technology that was effective in improving medication adherence in clinical trials of vaccines and smoking cessation in Spain and South Africa (20,21). Text messaging has also been found to be more effective than telephone call-backs and scheduled clinic revisits in providing patients in London with lab results and decreasing the time for them to return to clinic for treatment (22). Cell phones have more recently become widespread in America and cell phone use continues to increase. A 2005 survey of wireless providers revealed that there were nearly 208 million wireless subscribers in the US, nearly 26 million more than in 2004 (23). Americans use cell phones for more than talking; they can use the text message function to share photos, to vote for reality television programming contestants, to receive daily jokes or to receive ring tones. Sixty-four percent of teens with cell phones use text messaging (24). Urban teen girls are more likely to use text messaging than boys or adults (24).
To assess cell phone use in our own population we carried out a survey of 2,521 racially-diverse reproductive-aged women, including 473 teens, attending family planning clinics in NYC. Cell phone usage was 77% among teens, and 81% of them read and send text messages (5). One-third of the participants in this feasibility survey worry about forgetting to take their medications and 30% would like to receive text message reminders for this (5). There are no studies of the effectiveness of text message reminders on contraceptive continuation rates.
Successful teen pregnancy prevention programs use varied, multifactorial approaches (2). We propose a study using an existing technology, text messaging, in an innovative way to improve OC continuation rates. Daily text messages will provide information regarding side effects, their management and instructions for troubleshooting common pill-taking mistakes. They may also help teens and young women establish a dosing routine.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants will receive standard care without daily reminders. |
| Text Messages | Experimental | Other: Daily Text MessagesParticipants will receive a daily text message reminder for 6 months |
Who may qualify
- Ages
- Up to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- aged <25 years requesting OC as their primary method of contraception
- currently sexually active or anticipating sexual activity within the next 30 days
- owns cell phone with text messaging capability
Key exclusion criteria (2 listed)
- contraindications to combined hormonal contraception per clinic protocol (e.g., hypertension)
- previous participation in this study
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 |
|---|---|---|
| Daily Text MessagesAlso: Text MessagingText message reminders to take oral contraception daily: Each text message will be a short educational message listing the benefits of contraceptive use and providing instructions for avoiding common medication errors. | Other | Text Messages |
Primary outcome
contraceptive continuation
Time frame: 6 months
1 secondary outcome
change in contraceptive knowledge scores
Time frame: 6 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 19 Nov 2012.
- Background: PubMed 18605654Castano PM, Martinez RA. Harnessing technology for adolescent health promotion. Adolesc Med State Art Rev. 2007 Aug;18(2):400-6, xiii.
- Results publicationCastano PM, Westhoff C, Andres Martinez R, Lara M. The effect of daily text message reminders on adolescent oral contraceptive pill continuation. Journal of Adolescent Health 44(2): S17, 2009.
- Results publication: PubMed 23062523Hall KS, Westhoff CL, Castano PM. The impact of an educational text message intervention on young urban women's knowledge of oral contraception. Contraception. 2013 Apr;87(4):449-54. doi: 10.1016/j.contraception.2012.09.004. Epub 2012 Oct 10.
- Results publication: PubMed 22143257Castano PM, Bynum JY, Andres R, Lara M, Westhoff C. Effect of daily text messages on oral contraceptive continuation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):14-20. doi: 10.1097/AOG.0b013e31823d4167.
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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.
Paula M Castano, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Text Messages in people with Contraceptives, Oral, run by Columbia University 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 3 inclusion and 2 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 19 Nov 2012. 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.
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?
contraceptive continuation (time frame: 6 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 NCT00677703, which also lists 4 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 19 Nov 2012.