Game-Based Intervention to Promote HPV Vaccination

NCT06162676 | Active Not Recruiting DMC

• 1 other identifier: STUDY00009385
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV Infection; Vaccine-Preventable Diseases

Keywords

adolescent, parent, game intervention, HPV prevention

Outcome Measures

Primary Outcomes (6)

• Percentage of eligible individuals agreeing to participate

  Assessed by the % of eligible individuals agreeing to participate

  2 years

• Percentage of eligible individuals who complete the intervention (intervention arm only) and assessments (all participants)

  Assessed by the % of eligible individuals who complete the intervention and assessments

  2 years

• Ease of use (intervention arm only)

  (1) device-recorded time to complete interactive modules and the full game; (2) self reported easy of use

  2 years

• Parent and child acceptability of the intervention (intervention arm only)

  Assessed by a 12-item Likert scale.

  2 years

• Intention to vaccinate the child against HPV

  Assessed by a Likert scale question: how likely will you (parent) vaccinate your child against HPV? Responses: (1) Very unlikely to (5) Very likely

  2 years

• Child vaccination status (1st & 2nd doses).

  Assessed by one binary (yes/no) question regarding whether or not the child has received the 1st \& 2nd dose of HPV vaccine.

  2 years

Study Arms (2)

HPV game group

EXPERIMENTAL

Parent-child dyads receive a HPV game intervention

Behavioral: HPV game

Usual care

NO INTERVENTION

Parent-child dyads receive child's usual care

Interventions

HPV game BEHAVIORAL

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

HPV game group

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Michigan State University: lead
• Arizona State University: collaborator

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections; Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ANGELA CHEN, PhD

  Michigan State University

  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: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: intervention vs. usual care (control)

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: April 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: February 28, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The data will be available when the award ends and following acceptance for publication of the main findings derived from the final data set. It will be available for 10 years.
• Access Criteria: The data will remain the property of the provider; the recipient shall show proof of appropriate training in the responsible conduct of research; any publication resulting from use of the data will acknowledge the provider and NIH of the original project from which the data were derived; the data will not be used for commercial or for-profit purposes; the data will not be further distributed to others; the provider makes no representations and extends no warranties of any kind, either expressed or implied; the recipient shall assume all liability for claims for damages against it by third parties that may arise from the use of the data; the recipient agrees to pay the cost of preparation and distribution of the data. Availability and use of the data may be limited by additional local institutional review board policies or by local, state, and federal laws and regulations.

Locations

US (1)