Gardasil Administration

NCT ID: NCT03123419

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-04-01

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.

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.

Conditions

Vaccine Administration Rates

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Vaccine

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

Group Type: OTHER

Appointment reminders

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Hostetter, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Hostetter, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

St. Mary's Health Center

St Louis, Missouri, United States

Countries

United States

Other Identifiers

27734

Identifier Type: -

Identifier Source: org_study_id