Educational Intervention to Improve HPV Vaccination Decision Quality

NCT02797054 | Completed Results

• 1 other identifier: 14-0402-1
• Study Type: interventional
• Target: 1,205
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.To measure the quality of the HPV vaccine decision among participants in different arms of the intervention
2. 2.To determine patterns of intervention utilization among participants in different arms of the intervention, and

Conditions

HPV Vaccination Decision Quality

Keywords

HPV vaccination; Vaccination decision-making; Tailored health messaging; Barriers to vaccination; Attitudes

Outcome Measures

Primary Outcomes (8)

• Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention

  1 day

• Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention

  1 day

• Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention

  1 day

• Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention

  1 day

• Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up

  2 Months

• Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up

  2 Months

• Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up

  2 Months

• Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up

  2 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: usual care as experienced during appointment with primary care provider. Participants in the usual care arm will not view any educational materials or complete the baseline survey.

Behavioral: Usual care

Interventions

Tailored educational materials BEHAVIORAL

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 materials BEHAVIORAL

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

Usual care BEHAVIORAL

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

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents of an adolescent between the ages of 9-17
• A young adult patient between the ages of 18-26
• Adolescent/young adult who has not yet received all three doses of the HPV vaccine.
• Parent/young adult who 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Michigan: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Behavior

Results Point of Contact

• Title: Julie A Maertens
• Organization: University of Colorado

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
• Restrictive Agreement: No

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 31, 2016
• First Posted: June 13, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: September 21, 2018
• Results First Posted: August 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)