NCT03123419

Brief Summary

The purpose of the Gardasil study is to increase the rates of Gardasil vaccination at a maternal fetal Care Center. This will be done by reminding patients via text to come for follow up vaccine appointments.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

April 10, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

April 10, 2017

Last Update Submit

March 5, 2018

Conditions

Vaccine Administration Rates

Outcome Measures

Primary Outcomes (1)

  • Increase HPV-9 vaccine administration rates

    The text reminder messages will increase HPV-9 vaccine administration rates

    through study completion, an average of 1 year

Study Arms (1)

Vaccine

OTHER

All patients who consent to be in the study will receive Appointment reminders.

Behavioral: Appointment reminders

Interventions

Appointment remindersBEHAVIORAL

The purpose of the Gardasil study is to increase the rates of Gardasil vaccination in the Maternal Fetal Care Center. This will be done by reminding patients via text to come for their follow up vaccine appointments.

Vaccine

Eligibility Criteria

Age9 Years - 26 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient receiving gynecological or postpartum care at the Maternal Fetal Care Center
  • Females age 9-26 years per manufacturer's recommendation
  • Having a cell phone that will allow texting
  • Willing to accept any texting charges that may occur for receiving the reminder text.

You may not qualify if:

  • Allergy to HPV-4 or HPV-9 vaccine
  • Prior completion of the HPV-4/9 series,
  • Pregnancy
  • Patients older than 26 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

Study Officials

  • Sarah Hostetter, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 21, 2017

Study Start

February 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)