Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series
NCT ID: NCT01343485
Last Updated: 2018-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
365 participants
INTERVENTIONAL
2011-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
No interventions assigned to this group
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.
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
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
26 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Planned Parenthood Federation of America
OTHER
Responsible Party
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Johanna Morfesis
Director of Research
Principal Investigators
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Ashlesha Patel, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Planned Parenthood Federation of America, Inc.
Locations
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Planned Parenthood of Arizona
Glendale, Arizona, United States
Planned Parenthood of Rocky Mountains
Arvada, Colorado, United States
Planned Parenthood of Rocky Mountains
Denver, Colorado, United States
Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
Planned Parenthood of Central North Carolina
Chapel Hill, North Carolina, United States
Planned Parenthood of North Carolina
Charlotte, North Carolina, United States
Planned Parenthood Association of Utah
Ogden, Utah, United States
Planned Parenthood Association of Utah
South Jordan, Utah, United States
Planned Parenthood of Greater Northwest
Seattle, Washington, United States
Countries
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References
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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. doi: 10.4065/84.10.864.
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. doi: 10.1016/j.vaccine.2009.10.133. 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. doi: 10.1016/j.ypmed.2008.11.010. 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. doi: 10.1177/0009922809337534. 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. doi: 10.1038/sj.clpt.6100401. Epub 2007 Oct 31.
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. doi: 10.1080/07448480903221368.
Patel 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.
Related Links
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Planned Parenthood Federation of America
Other Identifiers
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PPFA-Merck-38068
Identifier Type: -
Identifier Source: org_study_id
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