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- Ensayo clínico NCT00677703
Txt Now 2 Decrease Pregnancies L8r: A Study to Evaluate the Effect of Daily Text Message Reminders on Pill Continuation
The Effect of Text Message Reminders on Contraceptive Continuation, a Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Brooklyn, New York, Estados Unidos, 11201
- Planned Parenthood Boro Hall
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- contraindications to combined hormonal contraception per clinic protocol (e.g., hypertension)
- previous participation in this study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Standard Care
Participants will receive standard care without daily reminders.
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Experimental: Text Messages
Participants will receive a daily text message reminder for 6 months
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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contraceptive continuation
Periodo de tiempo: 6 months
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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change in contraceptive knowledge scores
Periodo de tiempo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Paula M Castano, MD, MPH, Columbia University
Publicaciones y enlaces útiles
Publicaciones Generales
- Castano PM, Martinez RA. Harnessing technology for adolescent health promotion. Adolesc Med State Art Rev. 2007 Aug;18(2):400-6, xiii.
- Castano 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.
- Castano 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- AAAC1600
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Ensayos clínicos sobre Anticonceptivos Orales
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University of HohenheimTerminadoSeguridad después de la ingesta oral | Farmacocinética después de la ingesta oralAlemania
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University of HohenheimTerminadoSeguridad después de la ingesta oral | Farmacocinética después de la ingesta oralAlemania
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University of HohenheimGerman Federal Ministry of Economics and TechnologyTerminadoSeguridad después de la ingesta oral | Farmacocinética después de la ingesta oralAlemania
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Altinbas UniversityReclutamiento
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Medical University of GrazReclutamiento
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University of California, DavisRenew Life Formulas IncTerminadoMicrobioma oralEstados Unidos
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BayerTerminadoAnticoncepción oralFederación Rusa
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San Diego State UniversityVista Community ClinicTerminado
Ensayos clínicos sobre Daily Text Messages
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Birmingham Community Healthcare NHSNSA, LLCTerminado
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Bausch & Lomb IncorporatedTerminado
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Yale UniversityTerminadoCáncer de mama | Adherencia, Medicación | Efecto secundarioEstados Unidos
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Ankara City Hospital BilkentTerminado
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Alcon ResearchTerminadoError refractivo | MiopíaReino Unido
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Alcon ResearchTerminadoError refractivoReino Unido
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New York State Psychiatric InstituteCity University of New York, School of Public HealthRetiradoTrastorno de despersonalizaciónEstados Unidos
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Sunnybrook Health Sciences CentreCanadian Institutes of Health Research (CIHR); Ontario Neurotrauma FoundationTerminadoCaídas Accidentales | Equilibrio musculoesqueléticoCanadá
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TCI Co., Ltd.TerminadoCondición de pielTaiwán