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Evaluating a Digital Health Information Tool (Chat/Text)

25 de octubre de 2022 actualizado por: New York University

Chat/Text Program: Digital Health Information Efficacy Trial

The primary aim of the proposed project is to conduct a randomized controlled trial to evaluate the efficacy of a digital 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.

Descripción general del estudio

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

Intervencionista

Inscripción (Actual)

5220

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10001
        • Planned Parenthood Federation of America

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

15 años a 25 años (Niño, Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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.
Otro: Website Content
Participants will be routed to the Planned Parenthood website to information and content about issues regarding sexual and reproductive health.
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.
Measured at 10 days post-intervention
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
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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2015

Finalización primaria (Actual)

1 de enero de 2016

Finalización del estudio (Actual)

1 de marzo de 2016

Fechas de registro del estudio

Enviado por primera vez

10 de septiembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

13 de septiembre de 2015

Publicado por primera vez (Estimar)

15 de septiembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de octubre de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

25 de octubre de 2022

Última verificación

1 de septiembre de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Chat/Text Program

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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