Clinical trial NCT03000998: Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake
Official title: Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Virus
HPV
Keywords: HPV
Cancer
Lead sponsor: Klein Buendel, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of New Mexico
name: Indiana University
name: National Cancer Institute (NCI)
First posted: 2016-12-22
Enrollment: 432
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

Adolescent boys:

1. being male
2. being 11-13 years old
3. being a patient at a participating University of New Mexico (UNM) Hospital's Envision pediatric practice
4. parental consent for testing, and
5. child assent for testing

Parents/Guardians:

1. being a parent/guardian of an eligible and participating 11-13 year old boy
2. demonstrated ability to comprehend study requirements, and
3. providing informed consent for oneself and assent for their youth's participation

Exclusion Criteria:

Adolescent boys:

1. another immediate family member is participating in the project (i.e., a sibling)
2. the participant has already received any or all doses for the HPV vaccine, or
3. the participant refuses to assent.

Parents/Guardians:

1. under the age of 18, or
2. another immediate family member is participating in the project (i.e., another parent).

Primary outcomes:
measure: Vaccine Initiation
timeFrame: 1 Month
measure: Vaccine Adherence
timeFrame: 2 Months
measure: Vaccine Adherence
timeFrame: 4 months
Secondary outcomes:
measure: Attitudes towards vaccination in general
timeFrame: Baseline, 3-month follow-up, and 9-month follow-up
measure: Attitudes towards the HPV vaccine
timeFrame: Baseline, 3-month follow-up, and 9-month follow-up
measure: Perception of risk due to HPV and not being vaccinated
timeFrame: Baseline, 3-month follow-up, and 9-month follow-up
measure: Perception of negative and positive consequences associated with HPV vaccination
timeFrame: Baseline, 3-month follow-up, and 9-month follow-up
measure: Self-efficacy to make informed decisions about HPV vaccination
timeFrame: Baseline, 3-month follow-up, and 9-month follow-up
measure: HPV knowledge
timeFrame: Baseline, 3-month follow-up, and 9-month follow-up
measure: Spousal support and social normative and cultural perceptions of receiving the HPV vaccination
timeFrame: Baseline, 3-month follow-up, and 9-month follow-up
Other outcomes:
Locations:
city: Golden
country: United States
facility: Klein Buendel, Inc.
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: Klein Buendel, Inc.
name: Gill Woodall, PhD
role: PRINCIPAL_INVESTIGATOR
References: