Evaluating a Digital Health Information Tool (Chat/Text)

October 25, 2022 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

5220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10001
        • Planned Parenthood Federation of America

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Delayed Treatment
Participants will receive a baseline survey and be routed to the Planned Parenthood website. No subsequent survey will be administered.
Other: Delayed Treatment
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.
Behavioral: Chat/Text 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.
Other: Website Content
Participants will be routed to the Planned Parenthood website to information and content about issues regarding sexual and reproductive health.
Behavioral: Website Content
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increasing clinic attendance
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of more effective birth control use
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University

Collaborators

Planned Parenthood Federation of America

Investigators

  • Principal Investigator: Vincent Guilamo-Ramos, PhD, MPH, LCSW, RN, New York University
  • Principal Investigator: Leslie Kantor, PhD, MPH, Planned Parenthood Federation of America

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 13, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Chat/Text Program

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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