Clinical trial · Interventional
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
NCT01343485CI-TRIAL-00033450completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GARDASIL Vaccination | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computer reminder system | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control, standard care for HPV vaccine
- description
- Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
- type
- EXPERIMENTAL
- label
- Intervention, computer reminder system
- description
- 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.
- interventionNames
- Behavioral: Computer reminder system
Primary outcomes (1)
- measure
- On-time Completion of the Human Papillomavirus Vaccine Series
- timeFrame
- 32 weeks after receipt of initial vaccine
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 26 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDCenters 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 21381442
- BACKGROUNDChao 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 19797775
- BACKGROUNDDempsey 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 19925899
- BACKGROUNDJain 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 19100762
- BACKGROUNDNeubrand 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 19483128
- BACKGROUNDOrenstein 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 17971821
- BACKGROUNDSandfort 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.