Game-Based Intervention to Promote HPV Vaccination

NCT ID: NCT06162676

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-02-28

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.

Conditions

HPV Infection; Vaccine-Preventable Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

HPV game group

Parent-child dyads receive a HPV game intervention

Group Type: EXPERIMENTAL

HPV game

Intervention Type: BEHAVIORAL

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

Usual care

Parent-child dyads receive child's usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HPV game

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona State University

OTHER

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Angela Chia-Chen Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ANGELA CHEN, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

Michigan State University

East Lansing, Michigan, United States

Countries

United States

Other Identifiers

STUDY00009385

Identifier Type: -

Identifier Source: org_study_id