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Clinical Trials/NCT06162676
NCT06162676
Active, not recruiting
Not Applicable

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

Michigan State University1 site in 1 country131 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HPV Infection
Sponsor
Michigan State University
Enrollment
131
Locations
1
Primary Endpoint
Parent and child acceptability of the intervention (intervention arm only)
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
February 28, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angela Chia-Chen Chen

Professor

Michigan State University

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

Outcomes

Primary Outcomes

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

Time Frame: 2 years

Assessed by a 12-item Likert scale.

Ease of use (intervention arm only)

Time Frame: 2 years

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

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

Time Frame: 2 years

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

Intention to vaccinate the child against HPV

Time Frame: 2 years

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

Percentage of eligible individuals agreeing to participate

Time Frame: 2 years

Assessed by the % of eligible individuals agreeing to participate

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

Time Frame: 2 years

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

Study Sites (1)

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