Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake

Study Overview
=================
Brief Summary
-----------------
The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended levels, particularly for adolescent boys and especially among minority families. Proposed here is a mobile web application (mobile web app) for personal computers, smart phones, and tablet computers that will accurately inform parents and adolescent boys about the HPV vaccination and address unique concerns about its safety and effectiveness for boys. The BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a randomized efficacy trial with parents and adolescent boys aged 11-13 years.

Detailed Description
-----------------
The President's Cancer Advisory Board and the Centers for Disease Control have called for renewed efforts in promoting vaccination for Human Papillomavirus (HPV), including vaccination for adolescent boys, because the uptake of this new vaccine remains alarmingly low. Currently, less than 15% of adolescent boys have received the HPV vaccine; thus, most of this population remains at risk for oropharyngeal, anal, and penile cancers. Many parents remain unconvinced of the safety and effectiveness of HPV vaccines, so effective and accessible messaging to improve decision-making on this vaccine is needed. Parents of adolescent boys also have different concerns about HPV vaccination than for adolescent girls, creating a need for unique health communication interventions to promote vaccine uptake among boys. Interventions also need to address the unique challenges of minority populations and populations for whom English is not the first language. A novel digital intervention will be produced and evaluated for its ability to improve HPV vaccine outcomes. Specifically, a mobile responsive web application (mobile web app) will be created that performs similar to a mobile app but runs on a variety of computing platforms from personal desktop and laptop computers to the latest smart phones and tablet computers. Mobile web app content will be targeted to parents and adolescent boys aged 11-13 years. The specific aims are to: 1) carefully and systematically develop a mobile web app (BoyVac) for smart phones, tablet computers, and personal computers that will utilize Diffusion of Innovations principles to provide targeted information concerning HPV vaccine adoption to adolescent males and their parents, particularly minority adolescents and parents; 2) implement a comprehensive and rigorous test of the impact of the BoyVac mobile web app intervention on HPV vaccine adoption outcomes via a randomized efficacy trial (BoyVac v. usual and customary care); and 3) examine the dose-response relationships between mobile web app usage and vaccine outcomes within a components analysis. A group-randomized pretest-posttest controlled design will be implemented, recruiting 1800 pairs of parents and adolescent boys from 30 pediatric clinics (n=60 parents and boys per clinic). Parents will be surveyed at baseline, a 3-month follow-up, and a 9-month follow-up and records HPV vaccination adoption for the boys will be obtained from the clinics' medical records at the 9-month follow-up. Analyses will test the hypotheses that 1) more 11-13 year old boys in the intervention group (BoyVac mobile web app) will adopt the HPV vaccine than boys in the usual and customary care comparison group and 2) adoption of HPV vaccine will be mediated by improvements in theoretical mediators among parents in the intervention compared to the usual and customary care comparison group.

Official Title
-----------------
Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake

Conditions
-----------------
Human Papillomavirus Virus, HPV

Intervention / Treatment
-----------------
* Behavioral: Web App Intervention Group
* Behavioral: Usual Customary Care Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent boys: being male being 11-13 years old being a patient at a participating University of New Mexico (UNM) Hospital's Envision pediatric practice parental consent for testing, and child assent for testing Parents/Guardians: being a parent/guardian of an eligible and participating 11-13 year old boy demonstrated ability to comprehend study requirements, and providing informed consent for oneself and assent for their youth's participation Exclusion Criteria: Adolescent boys: another immediate family member is participating in the project (i.e., a sibling) the participant has already received any or all doses for the HPV vaccine, or the participant refuses to assent. Parents/Guardians: under the age of 18, or another immediate family member is participating in the project (i.e., another parent).

Ages Eligible for Study
-----------------
Minimum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web App Intervention Group<br>The BoyVac mobile web app will be evaluated in a pair-matched group-randomized pretest-posttest controlled design. In Year 2, 30 clinics in New Mexico will be pair-matched and one member of each pair will be randomized to the intervention (mobile web app) or a usual and customary (UC) HPV vaccine adoption procedures comparison group. Clinics will be paired based on similarities in patient demographic (ethnicity and % Medicaid patients) and location (urban and rural). | Behavioral: Web App Intervention Group<br>* All baseline and follow-up data collection will be conducted via online surveys and a customized web portal and include parent self-reports and clinic records of vaccination of boys<br>|
| Active Comparator: Usual Customary Care Group<br>Currently in pediatric clinics in New Mexico, the HPV vaccines are offered to parents and adolescents as part of annual well-child checkups. Typically for boys aged 11-13, parents initiate this checkup as part of a back-to-school activity. As part of the well-child checkup, clinic staff (physician, physician assistant and/or nurse) talk with parents and adolescents about the recommendation that their sons or daughters receive the HPV vaccination. Well-child pediatric visits to promote good health and development are recommended for all children from infancy through adolescence by the American Academy of Pediatrics. | Behavioral: Usual Customary Care Group<br>* Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on HPV vaccination from the Centers for Disease Control and Prevention (CDC) in Portable Document Format (PDF) format.<br>* Other names: UC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine Initiation | Vaccine initiation - whether or not each boy received the HPV vaccine and the date of administration. Number of participants who received at least 1 dose. | 1 Month | 
| Vaccine Adherence | Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 2nd dose and date received. Number of participants who received at least 2 doses. | 2 Months | 
| Vaccine Adherence | Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 3rd dose and date received. Number of participants who received the 3 doses. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes towards vaccination in general | Quantitative research in the form of an online survey will be conducted to examine attitudes towards vaccinations in general | Baseline, 3-month follow-up, and 9-month follow-up | 
| Attitudes towards the HPV vaccine | Quantitative research in the form of an online survey will be conducted to examine attitudes towards the HPV vaccine | Baseline, 3-month follow-up, and 9-month follow-up | 
| Perception of risk due to HPV and not being vaccinated | Quantitative research in the form of an online survey will be conducted to examine the perception of risk due to HPV and not being vaccinated. | Baseline, 3-month follow-up, and 9-month follow-up | 
| Perception of negative and positive consequences associated with HPV vaccination | Quantitative research in the form of an online survey will be conducted to examine the perception of negative and positive consequences associated with HPV vaccination. | Baseline, 3-month follow-up, and 9-month follow-up | 
| Self-efficacy to make informed decisions about HPV vaccination | Quantitative research in the form of an online survey will be conducted to examine the self-efficacy to make informed decisions about HPV vaccination | Baseline, 3-month follow-up, and 9-month follow-up | 
| HPV knowledge | Quantitative research in the form of an online survey will be conducted to examine the participant's knowledge about HPV | Baseline, 3-month follow-up, and 9-month follow-up | 
| Spousal support and social normative and cultural perceptions of receiving the HPV vaccination | Quantitative research in the form of an online survey will be conducted to examine the spousal support and social normative and cultural perceptions of receiving the HPV vaccination. | Baseline, 3-month follow-up, and 9-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, Cancer