Gardasil Administration

Vaccine Administration Rates Clinical Trial

Official title:

Gardasil Administration

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03123419
• Other study ID #: 27734
• Status: Withdrawn
• Phase: N/A
• First received: April 10, 2017
• Last updated: March 5, 2018
• Start date: February 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: March 2018
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 9 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaccine Administration Rates

Intervention

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.

Locations

Country	Name	City	State
United States	St. Mary's Health Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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