NCT02145156

Brief Summary

The purpose of this study is to evaluate an innovative approach to improving HPV vaccination among the Hispanic population. The clinical objectives/aims of this HPV educational intervention project are to determine:

  1. 1.The number of young adults and adolescents in each arm who received any dose of the HPV vaccine during the study period,
  2. 2.The number of young adults and adolescents in each arm who initiated the HPV vaccine series during the study period,
  3. 3.The number of young adults and adolescents in each arm who initiated but did not complete the HPV vaccine series during the study period,
  4. 4.The number of young adults and adolescents in each arm, among all eligible, who completed the HPV vaccine series during the study period,
  5. 5.The number of young adults and adolescents in each arm who completed the HPV vaccine series during the study period, among those who initiated the series at study start, and
  6. 6.The number of young adults and adolescents in each arm who completed the HPV vaccine series among those who initiated the series during the study period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 26, 2016

Completed
Last Updated

June 26, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 20, 2014

Results QC Date

June 2, 2016

Last Update Submit

May 30, 2017

Conditions

HPV Vaccination Status

Keywords

HPV vaccinationTailored health messaging

Outcome Measures

Primary Outcomes (12)

  • Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period

    This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.

    16 months

  • Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period

    This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.

    16 months

  • Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period

    This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.

    16 months

  • Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period

    This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

    16 months

  • Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start

    This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

    16 months

  • Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period

    This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

    16 months

  • Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period

    This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.

    16 months

  • Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period

    This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.

    16 months

  • Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period

    This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.

    16 months

  • Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period

    This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

    16 months

  • Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start

    This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

    16 months

  • Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period

    This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.

    16 months

Study Arms (3)

Tailored intervention

EXPERIMENTAL

Intervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.

Behavioral: Tailored educational materials

Untailored Intervention

OTHER

Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.

Behavioral: Untailored educational materials

Usual Care

OTHER

Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.

Behavioral: Survey-only

Interventions

Tailored educational materialsBEHAVIORAL

The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.

Tailored intervention
Untailored educational materialsBEHAVIORAL

The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.

Untailored Intervention
Survey-onlyBEHAVIORAL

Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.

Usual Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26;
  • Adolescent/young adult has not yet received all three doses of the HPV vaccine.
  • Parent/young adult can read and converse in either English or Spanish

You may not qualify if:

  • Age \<18,
  • Prisoners
  • Decisionally challenged subjects
  • Those who cannot read and converse in either English or Spanish
  • Those who have received all 3 doses of the HPV vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Dempsey AF, Maertens J, Sevick C, Jimenez-Zambrano A, Juarez-Colunga E. A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos. Hum Vaccin Immunother. 2019;15(7-8):1577-1584. doi: 10.1080/21645515.2018.1559685. Epub 2019 Feb 20.

    PMID: 30689494DERIVED

Results Point of Contact

Title
Julie A. Maertens
Organization
University of Colorado Denver
julie.maertens@ucdenver.edu
303-724-7319

Study Officials

  • Amanda F Dempsey, MD, PhD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
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

May 20, 2014

First Posted

May 22, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

June 26, 2017

Results First Posted

August 26, 2016

Record last verified: 2017-05

Locations

US(1)