Evaluating a Digital Health Information Tool

Behavior and Behavior Mechanisms Clinical Trial

— Chat/Text  

Official title:

Chat/Text Program: Digital Health Information Efficacy Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549599
• Other study ID #: Chat/Text Program
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2017
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5220
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms

Intervention

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.
• 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.

Other:
• Delayed Treatment
Participants will receive a baseline survey and be routed to the Planned Parenthood website. No subsequent survey will be administered

Locations

Country	Name	City	State
United States	Planned Parenthood Federation of America	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	Planned Parenthood Federation of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increasing clinic attendance	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
Primary	Increasing clinic attendance	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
Primary	Increasing clinic attendance	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	Use of more effective birth control use	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
Secondary	Use of more effective birth control use	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
Secondary	Use of more effective birth control use	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

External Links

•   Intervention Information
•   Website Content Information