CClinicalTrials.gg
WithdrawnNCT03123419Updated Mar 7, 2018

Gardasil Administration

An interventional study of Appointment reminders in Vaccine Administration Rates, sponsored by St. Louis University. Withdrawn at 1 site in United States. Open to female participants aged 9 Years to 26 Years. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by St. Louis University · Not applicable, Interventional, and Other

Why this study was withdrawn
Departmental research hold
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
9 Years to 26 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Vaccine Administration Rates
03

In context

Lead sponsor

St. Louis University is the lead sponsor of 152 studies on the registry; 17 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 26 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Vaccine

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

    Behavioral: Appointment reminders

Interventions

  • BehavioralAppointment 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.

06

What researchers measure

Primary outcomes

  1. Increase HPV-9 vaccine administration rates

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

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • St. Mary's Health Center
    Saint Louis, Missouri 63117, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03123419
Lead sponsor
St. Louis University
Responsible party
Sarah Hostetter, MD (Principal Investigator, St. Louis University) — Principal investigator
First posted
Apr 21, 2017
Start date
Feb 1, 2018 (estimated)
Primary completion
Mar 1, 2019 (estimated)
Completion
Apr 1, 2019 (estimated)
Last update
Mar 7, 2018

Study contacts

Sarah Hostetter, MD
principal investigator · St. Louis University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion