- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00140296
Using the Healthcare Visit to Improve Contraceptive Use
Consistent and correct use of an effective contraceptive method is a primary determinant in preventing pregnancy. Unfortunately, only a minority of healthcare providers adequately address women's contraceptive needs. We have developed a standardized behavioral-based contraceptive counseling model that can be used by providers and other clinic staff to address this limitation. The model, ESP, is an adaptation of motivational interviewing and involves: Exploring discrepancies between pregnancy intention and contraceptive use and between risk of STDs and condom use; Sharing information; and Promoting behaviors to reduce risk.
Study question: Does ESP counseling lead to an increase in consistency and effectiveness of contraceptive use among women at risk of unintended pregnancy?
Methods: Randomized controlled trial of 747 women, ages 16-44, at self-identified risk of unintended pregnancy enrolled from March 2003 to September 2004 at healthcare settings in North Carolina. Intervention participants received individualized ESP counseling from a health educator to address barriers to effective and consistent contraceptive use. Risk reduction steps were negotiated. Pregnancy, Chlamydia infection and contraceptive use were assessed at baseline and follow-up. "Highly effective" contraceptive use was defined as a combination of effectiveness and consistency. Women in the control arm received general preventive health counseling (e.g., smoking and exercise). Differences between the study arms at 12-months may illustrate the longer term influence of the intervention.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Consistent and correct use of an effective contraceptive method is a primary determinant in preventing pregnancy. Unfortunately, only a minority of healthcare providers adequately address women's contraceptive needs. We have developed a standardized behavioral-based contraceptive counseling model that can be used by providers and other clinic staff to address this limitation. The model, ESP, is an adaptation of motivational interviewing and involves: Exploring discrepancies between pregnancy intention and contraceptive use and between risk of STDs and condom use; Sharing information; and Promoting behaviors to reduce risk.
Study question: Does ESP counseling lead to an increase in consistency and effectiveness of contraceptive use among women at risk of unintended pregnancy?
Methods: Randomized controlled trial of 747 women, ages 16-44, at self-identified risk of unintended pregnancy enrolled from March 2003 to September 2004 at healthcare settings in North Carolina. Intervention participants received individualized ESP counseling from a health educator to address barriers to effective and consistent contraceptive use. Risk reduction steps were negotiated. Pregnancy, Chlamydia infection and contraceptive use were assessed at baseline and follow-up. "Highly effective" contraceptive use was defined as a combination of effectiveness and consistency. Women in the control arm received general preventive health counseling (e.g., smoking and exercise). Differences between the study arms at 12-months may illustrate the longer term influence of the intervention.
Tipo de estudio
Inscripción
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7521
- Center for Women's Health Research, Universoty of North Carolina
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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:
- Women aged 16-44
- English-speaking
- Do not wish to be pregnant or unsure of pregnancy intention
- Have an appointment for non-acute care
- Currently using no method of contraception, inconsistent use of methods, pills, condoms, diaphragms, periodic abstinence, or methods associated with higher pregnancy rates
- Ability to read at least at 8th grade level
- Willing to participate in follow-up visits at 2, 8, and 12 months
- Able to be contacted by telephone
Exclusion Criteria:
- Women less than 16 or greater than 44 years
- Women who are sterilized, or whose partners are sterilized or who use the IUD for contraception
- Appointments for acute care
- Non-English speaking
- Inability to read at or above 8th grade level
- Pregnant at time of enrollment
- Lack of ability for telephone contact
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Educativo/Consejería/Entrenamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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El embarazo
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Contraceptive use
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Chlamydia infection
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ruth Petersen, MD, MPH, University of North Carolina
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
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
Términos MeSH relevantes adicionales
- Infecciones
- Enfermedades contagiosas
- Enfermedades de transmisión sexual
- Infecciones por bacterias gramnegativas
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por clamidias
- Enfermedades De Transmisión Sexual Bacterianas
- Infecciones por clamidia
- Efectos fisiológicos de las drogas
- Agentes de control reproductivo
- Agentes anticonceptivos
Otros números de identificación del estudio
- CDC-NCCDPHP-TS-0768
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