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Game-Based Intervention to Promote HPV Vaccination

Pilot Testing of a Game-Based Intervention to Promote HPV Vaccination in Families With Unvaccinated Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06162676
Enrollment
133
Registered
2023-12-08
Start date
2024-04-01
Completion date
2026-02-28
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Infection, Vaccine-Preventable Diseases

Keywords

adolescent, parent, game intervention, HPV prevention

Brief summary

This study will examine the feasibility and acceptability of an innovative game-based intervention designed for families of youth aged 11-14 to promote HPV vaccination; will explore changes in key outcomes and related measures; and will identify factors contributing to or impeding effective implementation in health clinic settings. The intervention and its approach have the potential to reduce health disparities in HPV-associated cancers in youth via low-cost technology and timely intervention.

Detailed description

Guided by Social Cognitive Theory, we propose to 1. examine the feasibility and acceptability of a new HPV preventive intervention, the HPV Detective video game, designed for youth and their parents; 2. explore pre-post, intervention-related change in vaccine intent and uptake as well as change in theoretically posited intervention mediators; and 3. assess the potential for broader intervention implementation. Using a sequential mixed-methods, 2-group (intervention vs usual care), longitudinal design, 64 parent-youth dyads (32/per study condition) will be recruited. Parent-youth dyads in the intervention will play HPV Detective (tablet format) at the clinic prior to the healthcare provider visits. The control dyads will receive standard clinic treatment.

Interventions

BEHAVIORALHPV game

A brief health game for parent-child dyads to promote child's HPV vaccination

Sponsors

Michigan State University
Lead SponsorOTHER
Arizona State University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

intervention vs. usual care (control)

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* Youth: (1) 11-14 years old; (2) have not received the 1st dose of HPV vaccine; (3) speak and read English * Parent: (1) are the parent/legal guardian of the participating child; (2) ≥ 18 years old; (3) speak English or Spanish; (4) own a smartphone; (5) agree to participate in the research activities at study sites; (6) agree to receive text messages. * Healthcare providers: (1) ≥ 20 years old; (2) speak English or Spanish); (3) work at study sites

Exclusion criteria

* Individuals are unable to comprehend the consent or assent forms due to cognitive issues

Design outcomes

Primary

MeasureTime frameDescription
Percentage of eligible individuals agreeing to participate2 yearsAssessed by the % of eligible individuals agreeing to participate
Percentage of eligible individuals who complete the intervention (intervention arm only) and assessments (all participants)2 yearsAssessed by the % of eligible individuals who complete the intervention and assessments
Ease of use (intervention arm only)2 years(1) device-recorded time to complete interactive modules and the full game; (2) self reported easy of use
Parent and child acceptability of the intervention (intervention arm only)2 yearsAssessed by a 12-item Likert scale.
Intention to vaccinate the child against HPV2 yearsAssessed by a Likert scale question: how likely will you (parent) vaccinate your child against HPV? Responses: (1) Very unlikely to (5) Very likely
Child vaccination status (1st & 2nd doses).2 yearsAssessed by one binary (yes/no) question regarding whether or not the child has received the 1st \& 2nd dose of HPV vaccine.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORANGELA CHEN, PhD

Michigan State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026