Game-Based Intervention to Promote HPV Vaccination

Michigan State University

Status: Active, not recruiting

Conditions: Vaccine-Preventable Diseases; HPV Infection

Treatments: Behavioral: HPV game

Study type: Interventional

Funder types: Other

Identifiers

NCT06162676

STUDY00009385

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 estimated patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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131 participants in 2 patient groups

HPV game group

Experimental group

Description:

Parent-child dyads receive a HPV game intervention

Treatment:

Behavioral: HPV game

Usual care

No Intervention group

Description:

Parent-child dyads receive child's usual care