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Evaluating a Digital Health Information Tool (Chat/Text)

25 de outubro de 2022 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

5220

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

15 anos a 25 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Increasing clinic attendance
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Use of more effective birth control use
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de fevereiro de 2015

Conclusão Primária (Real)

1 de janeiro de 2016

Conclusão do estudo (Real)

1 de março de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

10 de setembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de setembro de 2015

Primeira postagem (Estimativa)

15 de setembro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de outubro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de outubro de 2022

Última verificação

1 de setembro de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Chat/Text Program

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Delayed Treatment

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