Gardasil Administration

March 5, 2018 updated by: Sarah Hostetter, MD, St. Louis University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Patients will be screened in center for history of Gardasil vaccination. If the patient has not received the vaccination series they will be counseled/educated (standard of care [SOC }) and offered the vaccine series. If the patient agrees to the vaccination, they will then be offered participation in this study, (consent will be reviewed and signed) and they will receive the first vaccination at this visit, administered according to standard protocol. The patient will then be scheduled for two follow up vaccination appointments. The second vaccination will be given 2 months after the first vaccine and the third will be given 4 months after the second vaccination in accordance with the Gardasil vaccine guidelines. -SOC

The patients will receive a total of two texts during the study entirety. The two texts will be appointment reminders for the second and third vaccination, sent 1 week prior to the next appointment. This is study related.

Data collection Data will be collected using a data collection sheet. The investigators will record date of first vaccine administration and adherence to follow up.vaccinations.

Study Type

Interventional

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
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • St. Mary's Health Center

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

9 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria

  • 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.

Exclusion criteria

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

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vaccine
All patients who consent to be in the study will receive Appointment reminders.
Behavioral: Appointment reminders
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase HPV-9 vaccine administration rates
Time Frame: through study completion, an average of 1 year
The text reminder messages will increase HPV-9 vaccine administration rates
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

St. Louis University

Investigators

  • Principal Investigator: Sarah Hostetter, MD, St. Louis University

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 (Anticipated)

February 1, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 27734

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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