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

NCT03000998 | Completed

• 2 other identifiers: 03101R01CA210125-01A1
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 3

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.

Conditions

Human Papillomavirus Virus; HPV

Keywords

HPV; Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Attitudes towards vaccination in general

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

• 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

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

• 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

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

Study Arms (2)

Web App Intervention Group

EXPERIMENTAL

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

Usual Customary Care Group

ACTIVE COMPARATOR

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

Interventions

Web App Intervention Group BEHAVIORAL

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

Web App Intervention Group

Usual Customary Care Group BEHAVIORAL

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.

Also known as: UC

Usual Customary Care Group

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Klein Buendel, Inc.: lead
• University of New Mexico: collaborator
• Indiana University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

Indiana University

Indianapolis, Indiana, 46202-2915, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Gill Woodall, PhD

  Klein Buendel, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 22, 2016
• Study Start: January 31, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)