Clinical trial NCT01343485: Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GARDASIL Vaccination
Keywords: Human papillomavirus (HPV) vaccine
Gardasil vaccine
Lead sponsor: Planned Parenthood Federation of America
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-04-28
Enrollment: 365
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: On-time Completion of the Human Papillomavirus Vaccine Series
timeFrame: 32 weeks after receipt of initial vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Planned Parenthood of Arizona
state: Arizona
city: Arvada
country: United States
facility: Planned Parenthood of Rocky Mountains
state: Colorado
city: Denver
country: United States
facility: Planned Parenthood of Rocky Mountains
state: Colorado
city: Chicago
country: United States
facility: Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County
state: Illinois
city: Chapel Hill
country: United States
facility: Planned Parenthood of Central North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Planned Parenthood of North Carolina
state: North Carolina
city: Ogden
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: South Jordan
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: Seattle
country: United States
facility: Planned Parenthood of Greater Northwest
state: Washington
Study officials:
affiliation: Planned Parenthood Federation of America, Inc.
name: Ashlesha Patel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.