Engaging Patients and Providers in Collaborative Communication on HPV Vaccination (EPICC-HPV)

NCT03267251 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-07-12

No results posted yet for this study

Summary

Vaccination against Human Papillomavirus is recommended for adolescent females by the Advisory Committee on Immunization Practices (ACIP), physicians, and many medical organizations, yet uptake of HPV vaccines remains very low. CDC data reveal that in 2013 only 44.3% of 13-17 year old females in New Mexico (and 37.6% nationwide) had completed the 3-dose HPV vaccine series. These data reveal the uptake of the HPV vaccines is unacceptably low, thereby diminishing its ability to provide population-level protection against the HPV types known to cause cervical, vaginal, and vulvar cancers in women, oropharyngeal and anal cancers in men and women, and penile cancers in men. The danger of very low vaccination rates is that adolescents of all ages will continue to be vulnerable to HPV and the associated cancer risks.

Despite recommendations for HPV, parents continue to have concerns about HPV vaccination. Clinicians often lack a clear frame for discussions about HPV vaccination with parents, so much so that recent research indicates that pediatricians' discussions with parents about vaccinations in general often take the form of bargaining, e.g., "since this may be too early for the vaccination, can we delay the vaccination schedule?" Effective messaging is needed to close a knowledge gap among parents around HPV and HPV vaccines, improve communication and shared decision-making about HPV vaccination between adolescent girls' parents and physicians, and ultimately prompt uptake of HPV vaccines.

This project will employ a web-based intervention on HPV as a way to improve knowledge, communication and shared decision-making about HPV vaccination for 11-13 year old girls and their parents. A clinic-based comparative effectiveness randomized trial will be used to examine the impact of the website on vaccine-related outcomes and vaccine uptake. New Mexico pediatric clinics will be randomly assigned to either the usual care clinic-based communication about HPV vaccination or to usual care plus web-based dissemination. Assessments of vaccine-related outcomes, including shared decision-making between girls, parents and physicians, will be assessed at baseline, 3 months, and 9 months and vaccine uptake and dose adherence will be abstracted from clinic vaccine records at 9 months. An effective web-based resource should increase parents' knowledge, intentions and motivations to vaccinate

Conditions

  • Vaccine Decision Making

Interventions

OTHER

Vacteens Web app for mobile devices

The Web app provides parents of young adolescent girls (ages 11-14) accurate information about HPV Vaccination, and a number of tools to aid informed decision making.

OTHER

Standard Usual and Customary HPV Information - CDC pamphlet

The usual communication about HPV Vaccination in clinics is for parents to be issued the CDC pamphlet on HPV Vaccination.

Sponsors & Collaborators

  • Klein Buendel, Inc.

    collaborator INDUSTRY
  • University of New Mexico

    lead OTHER

Principal Investigators

  • William Lawrence, MD · Patient Centered Outcomes Research Organization

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
26 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2017-08-28
Completion
2017-08-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03267251 on ClinicalTrials.gov