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Trial record 6 of 1289 for:    physician patient AND (relations OR communication) | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03267251
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
Klein Buendel, Inc.
Information provided by (Responsible Party):
University of New Mexico

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


Condition or disease Intervention/treatment Phase
Vaccine Decision Making Other: Vacteens Web app for mobile devices Other: Standard Usual and Customary HPV Information - CDC pamphlet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Engaging Patients and Providers in Collaborative Communication on HPV Vaccination (EPICC-HPV)
Estimated Study Start Date : August 28, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Active Comparator: Usual Clinic communication - HPV Vaccine
Standard Usual and Customary HPV Information - CDC pamphlet
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.

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




Primary Outcome Measures :
  1. Vaccine Adoption [ Time Frame: 9-month follow up ]
    Shot records of initial and second HPV vaccination


Secondary Outcome Measures :
  1. Parental HPV vaccination knowledge - questionnaire [ Time Frame: Baseline, 3-month and 9-month follow-up ]
    Assessment of HPV-related knowledge among parents, developed by Perez, et al.

  2. Shared decision-making (SDM-Q9) questionnaire [ Time Frame: 3-month and 9-month follow-up ]
    Assessment of Shared Decision Making, developed by Kriston, et al.

  3. Physician-Patient Communication questionnaire [ Time Frame: 3-month and 9-month follow-up ]
    Satisfaction of communication between healthcare provider and parent, developed by Street, et al.



Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • adolescent girl has received HPV vaccination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267251


Contacts
Contact: William G Woodall, Ph.D. 505-925-2316 gwoodall@unm.edu
Contact: Marita Brooks, BS 505-925-2312 maritab@unm.edu

Sponsors and Collaborators
University of New Mexico
Klein Buendel, Inc.
Investigators
Study Chair: William Lawrence, MD Patient Centered Outcomes Research Organization

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT03267251     History of Changes
Other Study ID Numbers: UNewMexico
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan at this time.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of New Mexico:
Vaccine Decision Making
Public Health
Health Communication
Digital Interventions

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs