Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine

NCT02546752 | Completed Early Phase 1

• 1 other identifier: Merck - 20
• Study Type: interventional
• Target: 1,306
• Locations: 1 country
• Sites: 5

Brief Summary

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

Human Papilloma Virus Infection Type 11; Human Papilloma Virus Infection Type 16; Human Papilloma Virus Infection Type 18; Human Papilloma Virus Infection Type 6; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Outcome Measure 1: Difference Between Average HPV Vaccine Series Initiation and Completion Rates

  Difference between average HPV vaccine series initiation and completion rates (as recorded in the CHIRP immunization registry) between sites using THEO integrated technology product compared to HPV Vaccination rates at Eskenazi sites not using THEO integrated technology product. Note that CHICA operates in 5 clinics in the Eskenazi Health Network. These clinics have been matched into two groups, each with 2 clinics, based on race and ethnicity of their patients. We will randomly assign one of these two groups to use THEO. The other group plus an additional CHICA clinic will continue to use CHICA without THEO.

  Seven Months

Secondary Outcomes (1)

• Outcome Measure 1: Relative Difference in Time of Appointment

  Seven Months

Study Arms (2)

THEO Video Arm

EXPERIMENTAL

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.

Other: THEO

Usual Care Arm

NO INTERVENTION

This arm will receive usual care.

Interventions

THEO OTHER

THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). THEO is the intervention in this study.

THEO Video Arm

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regenstrief Institute, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

Eskenazi Health Outpatient Care Center

Indianapolis, Indiana, 46202, United States

Location

Eskenazi Health Center Blackburn

Indianapolis, Indiana, 46208, United States

Location

Eskenazi Health Center Forest Manor

Indianapolis, Indiana, 46226, United States

Location

Eskenazi Health West 38th Street

Indianapolis, Indiana, 46254, United States

Location

Eskenazi Health Pecar

Indianapolis, Indiana, 46268, United States

Location

Related Publications (33)

• Parkin 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 BACKGROUND

• Giuliano 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 BACKGROUND

• Chaturvedi 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 BACKGROUND

• Haupt 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 BACKGROUND

• Arnheim-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 BACKGROUND

• Scheller 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 BACKGROUND

• Ojha 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 BACKGROUND

• Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, Lewis N, Deosaransingh K, Sy L, Ackerson B, Cheetham TC, Liaw KL, Takhar H, Jacobsen SJ. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1140-8. doi: 10.1001/archpediatrics.2012.1451.

  PMID: 23027469 BACKGROUND

• Pedersen C, Petaja T, Strauss G, Rumke HC, Poder A, Richardus JH, Spiessens B, Descamps D, Hardt K, Lehtinen M, Dubin G; HPV Vaccine Adolescent Study Investigators Network. Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. J Adolesc Health. 2007 Jun;40(6):564-71. doi: 10.1016/j.jadohealth.2007.02.015.

  PMID: 17531764 BACKGROUND

• Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, Puchalski D, Giacoletti KE, Sings HL, Lukac S, Alvarez FB, Barr E. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201-9. doi: 10.1097/01.inf.0000253970.29190.5a.

  PMID: 17484215 BACKGROUND

• Baandrup L, Blomberg M, Dehlendorff C, Sand C, Andersen KK, Kjaer SK. Significant decrease in the incidence of genital warts in young Danish women after implementation of a national human papillomavirus vaccination program. Sex Transm Dis. 2013 Feb;40(2):130-5. doi: 10.1097/OLQ.0b013e31827bd66b.

  PMID: 23324976 BACKGROUND

• Ali H, Donovan B, Wand H, Read TR, Regan DG, Grulich AE, Fairley CK, Guy RJ. Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ. 2013 Apr 18;346:f2032. doi: 10.1136/bmj.f2032.

  PMID: 23599298 BACKGROUND

• Ali H, Guy RJ, Wand H, Read TR, Regan DG, Grulich AE, Fairley CK, Donovan B. Decline in in-patient treatments of genital warts among young Australians following the national HPV vaccination program. BMC Infect Dis. 2013 Mar 18;13:140. doi: 10.1186/1471-2334-13-140.

  PMID: 23506489 BACKGROUND

• Elam-Evans LD, Yankey D, Jeyarajah J, Singleton JA, Curtis RC, MacNeil J, Hariri S; Immunization Services Division, National Center for Immunization and Respiratory Diseases; Centers for Disease Control and Prevention (CDC). National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years--United States, 2013. MMWR Morb Mortal Wkly Rep. 2014 Jul 25;63(29):625-33.

  PMID: 25055186 BACKGROUND

• Brewer NT, Gottlieb SL, Reiter PL, McRee AL, Liddon N, Markowitz L, Smith JS. Longitudinal predictors of human papillomavirus vaccine initiation among adolescent girls in a high-risk geographic area. Sex Transm Dis. 2011 Mar;38(3):197-204. doi: 10.1097/OLQ.0b013e3181f12dbf.

  PMID: 20838362 BACKGROUND

• Donahue KL, Stupiansky NW, Alexander AB, Zimet GD. Acceptability of the human papillomavirus vaccine and reasons for non-vaccination among parents of adolescent sons. Vaccine. 2014 Jun 30;32(31):3883-5. doi: 10.1016/j.vaccine.2014.05.035. Epub 2014 May 18.

  PMID: 24844150 BACKGROUND

• Kester LM, Zimet GD, Fortenberry JD, Kahn JA, Shew ML. A national study of HPV vaccination of adolescent girls: rates, predictors, and reasons for non-vaccination. Matern Child Health J. 2013 Jul;17(5):879-85. doi: 10.1007/s10995-012-1066-z.

  PMID: 22729660 BACKGROUND

• Holman DM, Benard V, Roland KB, Watson M, Liddon N, Stokley S. Barriers to human papillomavirus vaccination among US adolescents: a systematic review of the literature. JAMA Pediatr. 2014 Jan;168(1):76-82. doi: 10.1001/jamapediatrics.2013.2752.

  PMID: 24276343 BACKGROUND

• Guerry SL, De Rosa CJ, Markowitz LE, Walker S, Liddon N, Kerndt PR, Gottlieb SL. Human papillomavirus vaccine initiation among adolescent girls in high-risk communities. Vaccine. 2011 Mar 9;29(12):2235-41. doi: 10.1016/j.vaccine.2011.01.052. Epub 2011 Feb 1.

  PMID: 21288799 BACKGROUND

• Fu LY, Bonhomme LA, Cooper SC, Joseph JG, Zimet GD. Educational interventions to increase HPV vaccination acceptance: a systematic review. Vaccine. 2014 Apr 7;32(17):1901-20. doi: 10.1016/j.vaccine.2014.01.091. Epub 2014 Feb 14.

  PMID: 24530401 BACKGROUND

• Kreuter MW, Strecher VJ, Glassman B. One size does not fit all: the case for tailoring print materials. Ann Behav Med. 1999 Fall;21(4):276-83. doi: 10.1007/BF02895958.

  PMID: 10721433 BACKGROUND

• Lustria ML, Noar SM, Cortese J, Van Stee SK, Glueckauf RL, Lee J. A meta-analysis of web-delivered tailored health behavior change interventions. J Health Commun. 2013;18(9):1039-69. doi: 10.1080/10810730.2013.768727. Epub 2013 Jun 10.

  PMID: 23750972 BACKGROUND

• Noar SM, Benac CN, Harris MS. Does tailoring matter? Meta-analytic review of tailored print health behavior change interventions. Psychol Bull. 2007 Jul;133(4):673-93. doi: 10.1037/0033-2909.133.4.673.

  PMID: 17592961 BACKGROUND

• Gerend MA, Shepherd MA, Lustria ML. Increasing human papillomavirus vaccine acceptability by tailoring messages to young adult women's perceived barriers. Sex Transm Dis. 2013 May;40(5):401-5. doi: 10.1097/OLQ.0b013e318283c8a8.

  PMID: 23588130 BACKGROUND

• Petty RE, Wegener DT, Fabrigar LR. Attitudes and attitude change. Annu Rev Psychol. 1997;48:609-47. doi: 10.1146/annurev.psych.48.1.609.

  PMID: 9046570 BACKGROUND

• Carroll AE, Bauer NS, Dugan TM, Anand V, Saha C, Downs SM. Use of a computerized decision aid for ADHD diagnosis: a randomized controlled trial. Pediatrics. 2013 Sep;132(3):e623-9. doi: 10.1542/peds.2013-0933. Epub 2013 Aug 19.

  PMID: 23958768 BACKGROUND

• Carroll AE, Biondich P, Anand V, Dugan TM, Downs SM. A randomized controlled trial of screening for maternal depression with a clinical decision support system. J Am Med Inform Assoc. 2013 Mar-Apr;20(2):311-6. doi: 10.1136/amiajnl-2011-000682. Epub 2012 Jun 28.

  PMID: 22744960 BACKGROUND

• Carroll AE, Biondich PG, Anand V, Dugan TM, Sheley ME, Xu SZ, Downs SM. Targeted screening for pediatric conditions with the CHICA system. J Am Med Inform Assoc. 2011 Jul-Aug;18(4):485-90. doi: 10.1136/amiajnl-2011-000088.

  PMID: 21672910 BACKGROUND

• Anand V, Carroll AE, Downs SM. Automated primary care screening in pediatric waiting rooms. Pediatrics. 2012 May;129(5):e1275-81. doi: 10.1542/peds.2011-2875. Epub 2012 Apr 16.

  PMID: 22508925 BACKGROUND

• Biondich PG, Downs SM, Anand V, Carroll AE. Automating the recognition and prioritization of needed preventive services: early results from the CHICA system. AMIA Annu Symp Proc. 2005;2005:51-5.

  PMID: 16779000 BACKGROUND

• Downs SM, Uner H. Expected value prioritization of prompts and reminders. Proc AMIA Symp. 2002:215-9.

  PMID: 12463818 BACKGROUND

• Downs SM, Zhu V, Anand V, Biondich PG, Carroll AE. The CHICA smoking cessation system. AMIA Annu Symp Proc. 2008 Nov 6;2008:166-70.

  PMID: 18998823 BACKGROUND

• Dixon BE, Zimet GD, Xiao S, Tu W, Lindsay B, Church A, Downs SM. An Educational Intervention to Improve HPV Vaccination: A Cluster Randomized Trial. Pediatrics. 2019 Jan;143(1):e20181457. doi: 10.1542/peds.2018-1457. Epub 2018 Dec 10.

  PMID: 30530637 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Gregory D Zimet, PhD

  317-274-8812

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)