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Game-Based Intervention to Promote HPV Vaccination

Not Applicable
Recruiting
Conditions
HPV Infection
Vaccine-Preventable Diseases
Interventions
Behavioral: HPV game
Registration Number
NCT06162676
Lead Sponsor
Michigan State University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
131
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
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Exclusion Criteria
  • Individuals are unable to comprehend the consent or assent forms due to cognitive issues
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
HPV game groupHPV gameParent-child dyads receive a HPV game intervention
Primary Outcome Measures
NameTimeMethod
Parent and child acceptability of the intervention (intervention arm only)2 years

Assessed by a 12-item Likert scale.

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

Percentage of eligible individuals who complete the intervention (intervention arm only) and assessments (all participants)2 years

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

Intention to vaccinate the child against HPV2 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 participate2 years

Assessed by the % of eligible individuals agreeing to participate

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

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Michigan State University

🇺🇸

East Lansing, Michigan, United States

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