- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02549599
Evaluating a Digital Health Information Tool (Chat/Text)
Chat/Text Program: Digital Health Information Efficacy Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The present evaluation study engages digital technology to target young people to impact their use of sexual health services. The primary aim of the proposed project is to conduct a randomized controlled trial to evaluate the efficacy of an intervention tool that enables young people to correspond with trained staff via online chat or text messages about urgent questions related to sexual/reproductive health. Specifically, Chat/Text is a program designed to provide immediate answers to urgent sexual and reproductive health questions from a reliable and confidential source and to link young people to sexual and reproductive health services. Agents are trained on substantive topics, and on responding compassionately and appropriately. They are provided scripted responses to specific topics. Agent performance is monitored and evaluated to ensure high-quality responses that meet the goals of the program. The program targets groups experiencing sexual and reproductive health disparities, particularly Black and Latino/Hispanic teens and young adults. The Chat/Text program was launched in September 2010 by Planned Parenthood Federation of America (PPFA). The present project is evaluating the efficacy of the Chat/Text program. Specifically, the investigators will compare the effect of the Chat/Text program to the standard of care available from PPFA (website content) in the absence of the Chat/Text program.
Participants will be randomized into one of the three arms of the evaluative study (experimental, control, and passive control). Participants in the experimental arm will receive access to the digital Chat/Text program where they can ask questions and receive answers about sexual and reproductive health issues in real-time, immediately followed by a combined baseline and follow-up assessment. Participants in the control arm of the study will be routed to the Planned Parenthood website to content and information on sexual and reproductive health issues, also followed by the combined assessment. Participants in the passive control will receive a standalone baseline assessment and then be routed to the website. No additional contact will be made with the passive control group.
The experimental participants will receive booster sessions in the form of e-mail and SMS communications. The first (5 days post-intervention) and second (3 weeks post-intervention) booster sessions will focus on appointment adherence. The third (2 months post-intervention) and fourth (2.5 months post-intervention) booster sessions will focus on effective birth control methods in addition to appointment adherence.
The control condition will not receive booster sessions, but will receive communications that aim to obtain additional tracking information. These tracking communications will be sent at the same time points as the experimental booster sessions (i.e., 5 days-, 3 weeks-, 2 months-, and 2.5 months-post website exposure).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10001
- Planned Parenthood Federation of America
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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:
- Female
- Aged 15-25
- Had sex within the past 30 days prior to enrollment
- Never used the Planned Parenthood Chat/Text program
Exclusion Criteria:
- Males
- Females outside the ages of 15-25
- Female who report not having sex in the past 30 days
- Have used the Planned Parenthood Chat/Text program
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Delayed Treatment
Participants will receive a baseline survey and be routed to the Planned Parenthood website.
No subsequent survey will be administered.
|
Participants will receive a baseline survey and be routed to the Planned Parenthood website.
No subsequent survey will be administered
|
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Experimental: Chat/Text Program
Participants will receive real-time answers to questions they have about sexual and reproductive health topics from trained chat agents via the digital intervention program.
|
Participants will receive access to the Chat/Text program on the internet via computer or mobile device.
The Chat/Text program involves interactive, immediate, and tailored messages (with pre-determined content) delivered by Chat/Text agents via online chat or mobile phone text.
At the conclusion of the session, the participants will receive a combination-baseline and follow-up survey.
|
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Otro: Website Content
Participants will be routed to the Planned Parenthood website to information and content about issues regarding sexual and reproductive health.
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Participants will be directed to content and information on the Planned Parenthood website.
The website contains information on birth control methods, locations of Planned Parenthood health clinics, and on sexual and reproductive health more broadly.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Increasing clinic attendance
Periodo de tiempo: Measured at 10 days post-intervention
|
Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
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Measured at 10 days post-intervention
|
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Increasing clinic attendance
Periodo de tiempo: Measured at 30 days post-intervention
|
Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
|
Measured at 30 days post-intervention
|
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Increasing clinic attendance
Periodo de tiempo: Measured at 3 months post-intervention
|
Increasing clinic attendance is measured using a self-report item that indicates if a participant completed a clinic appointment.
|
Measured at 3 months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Use of more effective birth control use
Periodo de tiempo: Measured at 10 days post-intervention
|
The use of more effective birth control use is determined, through a self-report question asking if a participant changed her method of birth control to a more effective one.
For example, a participant may change from a barrier method (e.g., condom) to a hormonal method.
|
Measured at 10 days post-intervention
|
|
Use of more effective birth control use
Periodo de tiempo: Measured at 30 days post-intervention
|
The use of more effective birth control use is determined, through a self-report question asking if a participant changed her method of birth control to a more effective one.
For example, a participant may change from a barrier method (e.g., condom) to a hormonal method.
|
Measured at 30 days post-intervention
|
|
Use of more effective birth control use
Periodo de tiempo: Measured at 3 months post-intervention
|
The use of more effective birth control use is determined, through a self-report question asking if a participant changed her method of birth control to a more effective one.
For example, a participant may change from a barrier method (e.g., condom) to a hormonal method.
|
Measured at 3 months post-intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Vincent Guilamo-Ramos, PhD, MPH, LCSW, RN, New York University
- Investigador principal: Leslie Kantor, PhD, MPH, Planned Parenthood Federation of America
Publicaciones y enlaces útiles
Enlaces Útiles
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Chat/Text Program
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