Engaging Patients and Providers in Collaborative Communication on HPV Vaccination (EPICC-HPV) (EPICC-HPV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03267251|
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
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|
|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)|
|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|
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.
- Vaccine Adoption [ Time Frame: 9-month follow up ]Shot records of initial and second HPV vaccination
- 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.
- 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.
- 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.
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
|Contact: William G Woodall, Ph.D.||email@example.com|
|Contact: Marita Brooks, BSfirstname.lastname@example.org|
|Study Chair:||William Lawrence, MD||Patient Centered Outcomes Research Organization|