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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Planned Parenthood Federation of America.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Merck

Information provided by:

Planned Parenthood Federation of America

ClinicalTrials.gov Identifier:

NCT01343485

First received: April 26, 2011

Last updated: April 27, 2011

Last verified: April 2011

History of Changes

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:

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

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

Primary Outcome Measures:

Intervention sites will have an increase of 30% of study participants completing the HPV vaccine series compare to the control sites [ Time Frame: 12 months post site randomization ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	July 2011
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	February 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

Contacts

Contact: Ashlesha Patel, MD, MPH	212-261-4760	ashlesha.patel@ppfa.org
Contact: Johanna Morfesis, MSN, WHNP-BC	212-261-4703	johanna.morfesis@ppfa.org

Locations

United States, Arizona
Planned Parenthood of Arizona	Not yet recruiting
Glendale, Arizona, United States, 85302
United States, Colorado
Planned Parenthood of Rocky Mountains	Not yet recruiting
Arvada, Colorado, United States, 80003
Planned Parenthood of Rocky Mountains	Not yet recruiting
Denver, Colorado, United States, 80218
United States, Illinois
Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County	Not yet recruiting
Chicago, Illinois, United States, 60612
United States, North Carolina
Planned Parenthood of Central North Carolina	Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
Planned Parenthood of North Carolina	Not yet recruiting
Charlotte, North Carolina, United States, 28205
United States, Utah
Planned Parenthood Association of Utah	Not yet recruiting
Ogden, Utah, United States, 84403
Planned Parenthood Association of Utah	Not yet recruiting
South Jordan, Utah, United States, 84095
United States, Washington
Planned Parenthood of Greater Northwest	Not yet recruiting
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Planned Parenthood Federation of America

Merck

Investigators

Principal Investigator:

Ashlesha Patel, MD, MPH

Planned Parenthood Federation of America, Inc.

More Information

Additional Information:

Planned Parenthood Federation of America This link exits the ClinicalTrials.gov site

Publications:

Centers for Disease Control and Prevention (CDC). Recommended adult immunization schedule--United States, 2011. MMWR Morb Mortal Wkly Rep. 2011 Feb 4;60(4):1-4. No abstract available.

Chao C, Velicer C, Slezak JM, Jacobsen SJ. Correlates for completion of 3-dose regimen of HPV vaccine in female members of a managed care organization. Mayo Clin Proc. 2009 Oct;84(10):864-70.

Dempsey A, Cohn L, Dalton V, Ruffin M. Patient and clinic factors associated with adolescent human papillomavirus vaccine utilization within a university-based health system. Vaccine. 2010 Jan 22;28(4):989-95. Epub 2009 Nov 17.

Jain N, Euler GL, Shefer A, Lu P, Yankey D, Markowitz L. Human papillomavirus (HPV) awareness and vaccination initiation among women in the United States, National Immunization Survey-Adult 2007. Prev Med. 2009 May;48(5):426-31. Epub 2008 Dec 6.

Neubrand TP, Breitkopf CR, Rupp R, Breitkopf D, Rosenthal SL. Factors associated with completion of the human papillomavirus vaccine series. Clin Pediatr (Phila). 2009 Nov;48(9):966-9. Epub 2009 May 29. No abstract available.

Orenstein WA, Mootrey GT, Pazol K, Hinman AR. Financing immunization of adults in the United States. Clin Pharmacol Ther. 2007 Dec;82(6):764-8. Epub 2007 Oct 31. Review.

Sandfort JR, Pleasant A. Knowledge, attitudes, and informational behaviors of college students in regard to the human papillomavirus. J Am Coll Health. 2009 Sep-Oct;58(2):141-9.

Responsible Party:	Ashlesha Patel, M.D., MPH, Planned Parenthood Federation of America, Inc.
ClinicalTrials.gov Identifier:	NCT01343485 History of Changes
Other Study ID Numbers:	PPFA-Merck-38068
Study First Received:	April 26, 2011
Last Updated:	April 27, 2011
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 May 23, 2013

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