Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series
Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool
1 other identifier
interventional
365
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
December 2, 2013
CompletedJune 26, 2018
April 1, 2018
1.1 years
April 26, 2011
September 30, 2013
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
On-time Completion of the Human Papillomavirus Vaccine Series
32 weeks after receipt of initial vaccine
Study Arms (2)
Control, standard care for HPV vaccine
NO INTERVENTIONStudy participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
Intervention, computer reminder system
EXPERIMENTALStudy 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.
Interventions
Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Planned Parenthood Federation of Americalead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (9)
Planned Parenthood of Arizona
Glendale, Arizona, 85302, United States
Planned Parenthood of Rocky Mountains
Arvada, Colorado, 80003, United States
Planned Parenthood of Rocky Mountains
Denver, Colorado, 80218, United States
Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
Planned Parenthood of Central North Carolina
Chapel Hill, North Carolina, 27514, United States
Planned Parenthood of North Carolina
Charlotte, North Carolina, 28205, United States
Planned Parenthood Association of Utah
Ogden, Utah, 84403, United States
Planned Parenthood Association of Utah
South Jordan, Utah, 84095, United States
Planned Parenthood of Greater Northwest
Seattle, Washington, 98105, United States
Related Publications (8)
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.
PMID: 21381442BACKGROUNDChao 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. doi: 10.4065/84.10.864.
PMID: 19797775BACKGROUNDDempsey 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. doi: 10.1016/j.vaccine.2009.10.133. Epub 2009 Nov 17.
PMID: 19925899BACKGROUNDJain 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. doi: 10.1016/j.ypmed.2008.11.010. Epub 2008 Dec 6.
PMID: 19100762BACKGROUNDNeubrand 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. doi: 10.1177/0009922809337534. Epub 2009 May 29. No abstract available.
PMID: 19483128BACKGROUNDOrenstein WA, Mootrey GT, Pazol K, Hinman AR. Financing immunization of adults in the United States. Clin Pharmacol Ther. 2007 Dec;82(6):764-8. doi: 10.1038/sj.clpt.6100401. Epub 2007 Oct 31.
PMID: 17971821BACKGROUNDSandfort 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. doi: 10.1080/07448480903221368.
PMID: 19892651BACKGROUNDPatel A, Stern L, Unger Z, Debevec E, Roston A, Hanover R, Morfesis J. Staying on track: a cluster randomized controlled trial of automated reminders aimed at increasing human papillomavirus vaccine completion. Vaccine. 2014 May 1;32(21):2428-33. doi: 10.1016/j.vaccine.2014.02.095. Epub 2014 Mar 13.
PMID: 24631099DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Zoe Unger, Research Program Coordinator
- Organization
- Planned Parenthood Federation of America
Study Officials
- PRINCIPAL INVESTIGATOR
Ashlesha Patel, MD, MPH
Planned Parenthood Federation of America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research
Study Record Dates
First Submitted
April 26, 2011
First Posted
April 28, 2011
Study Start
September 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 26, 2018
Results First Posted
December 2, 2013
Record last verified: 2018-04