Game-Based Intervention to Promote HPV Vaccination

N/AActive Not RecruitingNCT06162676

Michigan State University131 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

131

Conditions

HPV Infection Vaccine-Preventable Diseases

Interventions

HPV gameBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 11 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Michigan State University

East Lansing, Michigan, United States

Outcomes

Primary Outcomes

Percentage of eligible individuals agreeing to participate

Assessed by the % of eligible individuals agreeing to participate

Time frame: 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

Time frame: 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

Time frame: 2 years

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

Assessed by a 12-item Likert scale.

Time frame: 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

Time frame: 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.

Time frame: 2 years

Data from ClinicalTrials.gov

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