Game-Based Intervention to Promote HPV Vaccination

HPV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06162676
• Other study ID #: STUDY00009385
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Michigan State University
• Contact: ANGELA CHEN, PhD
• Phone: 3135361937
• Email: HPVgame[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 131
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• HPV Infection
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of eligible individuals agreeing to participate	Assessed by the % of eligible individuals agreeing to participate	2 years
Primary	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
Primary	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
Primary	Parent and child acceptability of the intervention (intervention arm only)	Assessed by a 12-item Likert scale.	2 years
Primary	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
Primary	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