Clinical trial · Interventional
Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine
- 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)
This primary goal of this study is to assess whether patient whose parents watch a standardized digital video using the integrated digital approach during a routine office visit are more likely to accept a dose of HPV vaccine (1st, 2nd, or 3rd dose) compared to those not completing the program. The study team anticipates eligible patients in the intervention clinics to have higher rates of HPV vaccine acceptance (1st, 2nd, or 3rd doses) than patients in the usual care comparison clinics. Additionally, the study team is interested in determining the impact of the integrated system on clinical workflow by measuring the number of minutes of each patient office visit when using the system compared to the number of minutes of each visit in offices where the system is not used. Although this is a descriptive/exploratory aim, our expectation is that the THEO system will have minimal impact on patient flow.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Human Papilloma Virus Infection Type 11 | — | UNRESOLVED | — |
| Human Papilloma Virus Infection Type 16 | — | UNRESOLVED | — |
| Human Papilloma Virus Infection Type 18 | — | UNRESOLVED | — |
| Human Papilloma Virus Infection Type 6 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| THEO | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- THEO Video Arm
- description
- THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). Two programs have been developed. Parents/guardians of children who have not received the first HPV vaccine, will first assess whether the family has already decided in favor of the HPV vaccine or if they would like more information. The parent/guardian will be shown a video specific to where they are in the decision-making process. After completion, the THEO system will then ask the parent/guardian a series of Post Video questions. Parents/guardians of children who have received the first or second vaccine in the series, will emphasize the need to make the first vaccine "count". Pre and post video questions have been developed.
- interventionNames
- Other: THEO
- type
- NO_INTERVENTION
- label
- Usual Care Arm
- description
- This arm will receive usual care.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 11 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Parents/legal guardians of 11-17 year old children. * Children receive their healthcare at one of the 5 CHICA clinics. * Parents are able to read either English or Spanish. * Children have received no more than 2 doses of HPV vaccine Exclusion Criteria: * Parents will be excluded if their child is outside of the designated age range of 11-17 years, if the child has completed the 3-dose HPV vaccine series, or if the parent does not read either English or Spanish.
References
Publications (33)
- BACKGROUNDParkin DM, Bray F. Chapter 2: The burden of HPV-related cancers. Vaccine. 2006 Aug 31;24 Suppl 3:S3/11-25. doi: 10.1016/j.vaccine.2006.05.111. PMID 16949997
- BACKGROUNDGiuliano AR, Anic G, Nyitray AG. Epidemiology and pathology of HPV disease in males. Gynecol Oncol. 2010 May;117(2 Suppl):S15-9. doi: 10.1016/j.ygyno.2010.01.026. Epub 2010 Feb 6. PMID 20138345
- BACKGROUNDChaturvedi AK. Beyond cervical cancer: burden of other HPV-related cancers among men and women. J Adolesc Health. 2010 Apr;46(4 Suppl):S20-6. doi: 10.1016/j.jadohealth.2010.01.016. PMID 20307840
- BACKGROUNDHaupt RM, Sings HL. The efficacy and safety of the quadrivalent human papillomavirus 6/11/16/18 vaccine gardasil. J Adolesc Health. 2011 Nov;49(5):467-75. doi: 10.1016/j.jadohealth.2011.07.003. Epub 2011 Sep 9. PMID 22018560
- BACKGROUNDArnheim-Dahlstrom L, Pasternak B, Svanstrom H, Sparen P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ. 2013 Oct 9;347:f5906. doi: 10.1136/bmj.f5906. PMID 24108159
- BACKGROUNDScheller NM, Svanstrom H, Pasternak B, Arnheim-Dahlstrom L, Sundstrom K, Fink K, Hviid A. Quadrivalent HPV vaccination and risk of multiple sclerosis and other demyelinating diseases of the central nervous system. JAMA. 2015 Jan 6;313(1):54-61. doi: 10.1001/jama.2014.16946. PMID 25562266
- BACKGROUNDOjha RP, Jackson BE, Tota JE, Offutt-Powell TN, Singh KP, Bae S. Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States. Hum Vaccin Immunother. 2014;10(1):232-7. doi: 10.4161/hv.26292. Epub 2013 Sep 6. PMID 24013368