NCT02549599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 27, 2022

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

September 10, 2015

Last Update Submit

October 25, 2022

Conditions

Behavior and Behavior Mechanisms

Keywords

Digital and mobile healthSexual and reproductive healthAdolescents and young adults

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Use of more effective birth control use

    Measured at 10 days post-intervention

  • Use of more effective birth control use

    Measured at 30 days post-intervention

  • Use of more effective birth control use

    Measured at 3 months post-intervention

Study Arms (3)

Delayed Treatment

OTHER

Participants will receive a baseline survey and be routed to the Planned Parenthood website. No subsequent survey will be administered.

Other: Delayed Treatment

Chat/Text Program

EXPERIMENTAL

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

Website Content

OTHER

Participants will be routed to the Planned Parenthood website to information and content about issues regarding sexual and reproductive health.

Behavioral: Website Content

Interventions

Chat/Text ProgramBEHAVIORAL

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.

Chat/Text Program
Website ContentBEHAVIORAL

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.

Website Content
Delayed TreatmentOTHER

Participants will receive a baseline survey and be routed to the Planned Parenthood website. No subsequent survey will be administered

Delayed Treatment

Eligibility Criteria

Age15 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female
  • Aged 15-25
  • Had sex within the past 30 days prior to enrollment
  • Never used the Planned Parenthood Chat/Text program

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood Federation of America

New York, New York, 10001, United States

Location

Related Links

MeSH Terms

Conditions

BehaviorCoitus

Interventions

Treatment Delay

Condition Hierarchy (Ancestors)

Sexual Behavior

Intervention Hierarchy (Ancestors)

Time-to-TreatmentPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Vincent Guilamo-Ramos, PhD, MPH, LCSW, RN

    New York University

    PRINCIPAL INVESTIGATOR

  • Leslie Kantor, PhD, MPH

    Planned Parenthood Federation of America

    PRINCIPAL INVESTIGATOR

  • James Jaccard, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 15, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

October 27, 2022

Record last verified: 2017-09

Locations

US(1)