Clinical trial NCT02549599: Evaluating a Digital Health Information Tool
Official title: Chat/Text Program: Digital Health Information Efficacy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior and Behavior Mechanisms
Keywords: Digital and mobile health
Sexual and reproductive health
Adolescents and young adults
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation of America
First posted: 2015-09-15
Enrollment: 5220
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Increasing clinic attendance
timeFrame: Measured at 10 days post-intervention
measure: Increasing clinic attendance
timeFrame: Measured at 30 days post-intervention
measure: Increasing clinic attendance
timeFrame: Measured at 3 months post-intervention
Secondary outcomes:
measure: Use of more effective birth control use
timeFrame: Measured at 10 days post-intervention
measure: Use of more effective birth control use
timeFrame: Measured at 30 days post-intervention
measure: Use of more effective birth control use
timeFrame: Measured at 3 months post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Planned Parenthood Federation of America
state: New York
Study officials:
affiliation: New York University
name: Vincent Guilamo-Ramos, PhD, MPH, LCSW, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Planned Parenthood Federation of America
name: Leslie Kantor, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: James Jaccard, PhD
role: PRINCIPAL_INVESTIGATOR
References: