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Completed

NCT Number: NCT06162676

Game-Based Intervention to Promote HPV Vaccination

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.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Vaccine-Preventable Diseases Virus Diseases

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan State University

East Lansing, Michigan, 48824, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV game

Behavioral

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

Primary outcomes

  1. Percentage of eligible individuals agreeing to participate

    Time frame: 2 years

    Assessed by the % of eligible individuals agreeing to participate

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

    Time frame: 2 years

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

  3. Ease of use (intervention arm only)

    Time frame: 2 years

    (1) device-recorded time to complete interactive modules and the full game; (2) self reported easy of use

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

    Time frame: 2 years

    Assessed by a 12-item Likert scale.

  5. Intention to vaccinate the child against HPV

    Time frame: 2 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

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

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Arizona State University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 8, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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