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

NCT03267251 | Withdrawn DMC

• 1 other identifier: UNewMexico
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Vaccine Decision Making; Public Health; Health Communication; Digital Interventions

Outcome Measures

Primary Outcomes (1)

• Vaccine Adoption

  Shot records of initial and second HPV vaccination

  9-month follow up

Secondary Outcomes (3)

• Parental HPV vaccination knowledge - questionnaire

  Baseline, 3-month and 9-month follow-up

• Shared decision-making (SDM-Q9) questionnaire

  3-month and 9-month follow-up

• Physician-Patient Communication questionnaire

  3-month and 9-month follow-up

Study Arms (2)

Usual Clinic communication - HPV Vaccine

ACTIVE COMPARATOR

Standard Usual and Customary HPV Information - CDC pamphlet

Other: Standard Usual and Customary HPV Information - CDC pamphlet

Usual Care and Web App on HPV Vaccine

EXPERIMENTAL

Usual Care and Web app on HPV Vaccine: Vacteens Web app for mobile devices

Other: Vacteens Web app for mobile devices

Interventions

Vacteens Web app for mobile devices OTHER

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.

Usual Care and Web App on HPV Vaccine

Standard Usual and Customary HPV Information - CDC pamphlet OTHER

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

Usual Clinic communication - HPV Vaccine

Eligibility Criteria

• Age: 26 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent of an adolescent girl ages 11-14, adolescent girl has not yet received HPV vaccination

You may not qualify if:

• adolescent girl has received HPV vaccination

Sponsors & Collaborators

• University of New Mexico: lead
• Klein Buendel, Inc.: collaborator

Study Officials

• William Lawrence, MD

  Patient Centered Outcomes Research Organization

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This research project will compare usual care clinic-based communication about HPV vaccination (UC) to usual care plus web-based dissemination (UC+GHG) of information on HPV vaccination to parents and adolescent girls using a pair-matched group-randomized pretest-posttest design protocol. Pediatric/family practice clinics in New Mexico (n=30 clinics) will be pair-mated and one clinic per pair will be randomized to UC+GHG condition via the website, GoHealthyGirls.org. The remaining clinic will continue to receive UC only. Assessment protocols will be conducted at pretest, 3-month follow-up, and 9-month follow-up points, measuring knowledge, compatibility and relative advantage principles in DI, shared decision making, and vaccine adoption by girls. Thus, the proposed trial design will be a 2 (UC v. UC+GHG) intervention x 3 (level of time - pretest vs. 3-month follow-up vs. 9-month follow-up) mixed factorial design with participants nested within clinics.

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 30, 2017
• Study Start: August 28, 2017
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: July 12, 2023

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share