Game-Based Intervention to Promote HPV Vaccination

Study Overview
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Brief Summary
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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
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Guided by Social Cognitive Theory, we propose to examine the feasibility and acceptability of a new HPV preventive intervention, the HPV Detective video game, designed for youth and their parents; explore pre-post, intervention-related change in vaccine intent and uptake as well as change in theoretically posited intervention mediators; and 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.

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

Conditions
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HPV Infection, Vaccine-Preventable Diseases

Intervention / Treatment
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* Behavioral: HPV game


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intervention vs. usual care (control)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV game group<br>Parent-child dyads receive a HPV game intervention | Behavioral: HPV game<br>* A brief health game for parent-child dyads to promote child's HPV vaccination<br>|
| No Intervention: Usual care<br>Parent-child dyads receive child's usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent, parent, game intervention, HPV prevention