Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series

April 3, 2018 updated by: Johanna Morfesis, Planned Parenthood Federation of America

Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool

Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a prospective, cluster randomized trial to determine which factors influence the acquisition of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to 26. This descriptive and interventional study will provide data to assess impact of a computerized tool upon HPV vaccine series completion. The interventional aspect of this study includes determination of patient assistance and provider support programs applicable to each woman's situation as well as the implementation of a computer software system for customized patient reminders.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

365

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

    • Arizona
      • Glendale, Arizona, United States, 85302
        • Planned Parenthood of Arizona
    • Colorado
      • Arvada, Colorado, United States, 80003
        • Planned Parenthood of Rocky Mountains
      • Denver, Colorado, United States, 80218
        • Planned Parenthood of Rocky Mountains
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Planned Parenthood of Central North Carolina
      • Charlotte, North Carolina, United States, 28205
        • Planned Parenthood of North Carolina
    • Utah
      • Ogden, Utah, United States, 84403
        • Planned Parenthood Association of Utah
      • South Jordan, Utah, United States, 84095
        • Planned Parenthood Association of Utah
    • Washington
      • Seattle, Washington, United States, 98105
        • Planned Parenthood of Greater Northwest

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

19 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female;
  • Age 19-26;
  • Fluent in English;
  • Seeking services for anything except pregnancy or abortion on the day of the visit
  • No previous vaccinations for HPV
  • No contraindication for HPV vaccine (includes a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, and polysorbate 80.)
  • Access to phone, text, mail, email, or facebook
  • Not wanting to become pregnant in the next 8 months;
  • Not planning on moving from the area in the next 8 months
  • Willing to be contacted for follow-up over the next 8 months.

Exclusion Criteria:

  • Women below 19 or above 26.
  • Male
  • Women who have one or more of HPV vaccination.
  • Women who have a contraindication for HPV vaccine.
  • Women who do not have access by phone, mail, email, Twitter or Facebook for follow up.
  • Women who are not fluent in English
  • Pregnant women or those intending on becoming pregnant during the study period.
  • Women who will be moving from the area and unable to return for follow up over the course of the study (approximately 8 months).
  • Severe mental impairment and unable to give Informed Consent.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control, standard care for HPV vaccine
Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
Experimental: Intervention, computer reminder system
Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.
Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
On-time Completion of the Human Papillomavirus Vaccine Series
Time Frame: 32 weeks after receipt of initial vaccine
32 weeks after receipt of initial vaccine

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Ashlesha Patel, MD, MPH, Planned Parenthood Federation of America, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 28, 2011

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PPFA-Merck-38068

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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