Clinical trial NCT06162676: Game-Based Intervention to Promote HPV Vaccination
Official title: Pilot Testing of a Game-Based Intervention to Promote HPV Vaccination in Families With Unvaccinated Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV Infection
Vaccine-Preventable Diseases
Keywords: adolescent, parent, game intervention, HPV prevention
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2023-12-08
Enrollment: 131
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention vs. usual care (control)
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of eligible individuals agreeing to participate
timeFrame: 2 years
measure: Percentage of eligible individuals who complete the intervention (intervention arm only) and assessments (all participants)
timeFrame: 2 years
measure: Ease of use (intervention arm only)
timeFrame: 2 years
measure: Parent and child acceptability of the intervention (intervention arm only)
timeFrame: 2 years
measure: Intention to vaccinate the child against HPV
timeFrame: 2 years
measure: Child vaccination status (1st & 2nd doses).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: ANGELA CHEN, PhD
role: PRINCIPAL_INVESTIGATOR
References: