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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Johanna Morfesis, Planned Parenthood Federation of America
ClinicalTrials.gov Identifier:
NCT01343485
First received: April 26, 2011
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
GARDASIL Vaccination
Behavioral: Computer reminder system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool

Resource links provided by NLM:


Further study details as provided by Planned Parenthood Federation of America:

Primary Outcome Measures:
  • On-time Completion of the Human Papillomavirus Vaccine Series [ Time Frame: 32 weeks after receipt of initial vaccine ] [ Designated as safety issue: No ]

Enrollment: 365
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Computer reminder system
Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series

  Eligibility

Ages Eligible for Study:   19 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343485

Locations
United States, Arizona
Planned Parenthood of Arizona
Glendale, Arizona, United States, 85302
United States, Colorado
Planned Parenthood of Rocky Mountains
Arvada, Colorado, United States, 80003
Planned Parenthood of Rocky Mountains
Denver, Colorado, United States, 80218
United States, Illinois
Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, North Carolina
Planned Parenthood of Central North Carolina
Chapel Hill, North Carolina, United States, 27514
Planned Parenthood of North Carolina
Charlotte, North Carolina, United States, 28205
United States, Utah
Planned Parenthood Association of Utah
Ogden, Utah, United States, 84403
Planned Parenthood Association of Utah
South Jordan, Utah, United States, 84095
United States, Washington
Planned Parenthood of Greater Northwest
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Planned Parenthood Federation of America
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ashlesha Patel, MD, MPH Planned Parenthood Federation of America, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Johanna Morfesis, Director of Research, Planned Parenthood Federation of America
ClinicalTrials.gov Identifier: NCT01343485     History of Changes
Other Study ID Numbers: PPFA-Merck-38068
Study First Received: April 26, 2011
Results First Received: September 30, 2013
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Planned Parenthood Federation of America:
Human papillomavirus (HPV) vaccine
Gardasil vaccine

ClinicalTrials.gov processed this record on April 15, 2014