- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01343485
Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series
April 3, 2018 updated by: Johanna Morfesis, Planned Parenthood Federation of America
Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
365
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Glendale, Arizona, United States, 85302
- Planned Parenthood of Arizona
-
-
Colorado
-
Arvada, Colorado, United States, 80003
- Planned Parenthood of Rocky Mountains
-
Denver, Colorado, United States, 80218
- Planned Parenthood of Rocky Mountains
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Planned Parenthood of Central North Carolina
-
Charlotte, North Carolina, United States, 28205
- Planned Parenthood of North Carolina
-
-
Utah
-
Ogden, Utah, United States, 84403
- Planned Parenthood Association of Utah
-
South Jordan, Utah, United States, 84095
- Planned Parenthood Association of Utah
-
-
Washington
-
Seattle, Washington, United States, 98105
- Planned Parenthood of Greater Northwest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 26 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
On-time Completion of the Human Papillomavirus Vaccine Series
Time Frame: 32 weeks after receipt of initial vaccine
|
32 weeks after receipt of initial vaccine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ashlesha Patel, MD, MPH, Planned Parenthood Federation of America, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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: 10.1016/S0025-6196(11)60503-X.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
April 26, 2011
First Submitted That Met QC Criteria
April 27, 2011
First Posted (Estimate)
April 28, 2011
Study Record Updates
Last Update Posted (Actual)
June 26, 2018
Last Update Submitted That Met QC Criteria
April 3, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- PPFA-Merck-38068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on GARDASIL Vaccination
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedStem Cell Transplant | Immunogenicity | Gardasil VaccineUnited States
-
University of Roma La SapienzaCompletedVaccination Failure | Vaccination Adverse Events | Specific Antibody ResponseItaly
-
University of PennsylvaniaCompletedVaccine Refusal | Vaccination Hesitancy | Human Papillomavirus VaccinationUnited States
-
National Cancer Institute (NCI)CompletedHPV16 Anitbody Levels Post Vaccination | HPV18 Antibody Levels Post VaccinationUganda
-
Université de Reims Champagne-ArdenneRecruiting
-
China National Biotec Group Company LimitedPeking University; Beijing Institute of Biological Products Co Ltd.; Sichuan... and other collaboratorsCompleted
-
China National Biotec Group Company LimitedSichuan Center for Disease Control and PreventionCompleted
-
Emory UniversityMerck Sharp & Dohme LLCCompletedVaccinationUnited States
-
Columbia UniversityCompleted
-
University of TorontoPublic Health Agency of Canada (PHAC); Wholehealth Pharmacy PartnersNot yet recruitingVaccination Reaction | Vaccination Pain | Community PharmacyCanada
Clinical Trials on Computer reminder system
-
Institut de Recherche pour le DeveloppementChiang Mai University; Expertise FranceCompletedHIV, Hepatitis B, Hepatitis C and Syphilis InfectionsThailand
-
Blekinge Institute of TechnologyKristianstad UniversityCompletedPeriodontal Diseases | Gingivitis | Mild Cognitive ImpairmentSweden
-
University of AlbertaAlberta Health servicesCompletedKnowledge Translation | Sustainability of InnovationsCanada
-
ThinkWellUniversity of Oxford; Queen's University, Belfast; The BMJCompleted
-
Mahsa UniversityCompleted
-
Chinese University of Hong KongCompleted
-
Interactive Research and DevelopmentCompletedSMS | Immunization; Infection
-
Sarah HufCompletedCervical Carcinoma | Cervical DysplasiaUnited Kingdom
-
Lions Club International FoundationCompleted
-
Chinese University of Hong KongCompletedUltilization of Out-patient Colonoscopy ServiceHong Kong