Game-Based Intervention to Promote HPV Vaccination

December 7, 2023 updated by: Angela Chia-Chen Chen, Michigan State University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of eligible individuals agreeing to participate
Time Frame: 2 years
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)
Time Frame: 2 years
Assessed by the % of eligible individuals who complete the intervention and assessments
2 years
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
2 years
Parent and child acceptability of the intervention (intervention arm only)
Time Frame: 2 years
Assessed by a 12-item Likert scale.
2 years
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
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

Arizona State University

Investigators

  • Principal Investigator: ANGELA CHEN, PhD, Michigan State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will provide de-identified survey data stored in an encrypted electronic database. They will be available free of identifiers to avoid the possibility of disclosing identify of research participants. Quantitative data collected from this study will be made available to qualified scientists for research purposes following acceptance for publication of the main findings derived from the final data set.

IPD Sharing Time Frame

The data will be available when the award ends and following acceptance for publication of the main findings derived from the final data set. It will be available for 10 years.

IPD Sharing Access Criteria

The data will remain the property of the provider; the recipient shall show proof of appropriate training in the responsible conduct of research; any publication resulting from use of the data will acknowledge the provider and NIH of the original project from which the data were derived; the data will not be used for commercial or for-profit purposes; the data will not be further distributed to others; the provider makes no representations and extends no warranties of any kind, either expressed or implied; the recipient shall assume all liability for claims for damages against it by third parties that may arise from the use of the data; the recipient agrees to pay the cost of preparation and distribution of the data. Availability and use of the data may be limited by additional local institutional review board policies or by local, state, and federal laws and regulations.

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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