A Pilot Randomized Controlled Study to Examine Feasibility and Preliminary Effectiveness of a Game-based Intervention in Promoting HPV Vaccination Among Vulnerable Youth to Prevent Cancers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Michigan State University
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Percentage of eligible individuals agreeing to participate
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This proposed study aims to conduct timely research that promotes vaccine confidence and vaccination of one strongly recommended vaccine with suboptimal uptake rates: Human papillomavirus (HPV) in vulnerable and underserved youth aged 11-14.
Detailed Description
The study objectives are: Objective 1: Assess feasibility (participation rate, retention, involvement, satisfaction) of one game-based interventions targeting HPV vaccination. Objective 2: Conduct a pilot RCT with three conditions (Arm 1: HPV game-based intervention; Arm 2: usual care). The investigators will explore patterns of pre- to post-intervention change in theoretical mediators and vaccine intent, and explore levels of vaccine intent and uptake in 90 parent-child dyads of unvaccinated youth aged 11-14.
Investigators
Angela Chia-Chen Chen
Professor
Michigan State University
Eligibility Criteria
Inclusion Criteria
- •Child sample: (1) 11-14 years old, (2) speaks and reads English, (3) has never received any doses of the HPV vaccine, (4) is not currently enrolled in another project that involves HPV-related education, and (5) agrees and provides assent to participate in research activities.
- •Parent sample: (1) parent or legal guardian of the participating child, (2) speak and read English, (3) own a smartphone, (4) agree to receive email and text messages, (5) is not currently enrolled in another project that involves HPV-related education, and (6) agree and provide consent to participate in research activities.
Exclusion Criteria
- •Individuals who do not meet inclusion criteria or refuse to provide consent/assent.
Outcomes
Primary Outcomes
Percentage of eligible individuals agreeing to participate
Time Frame: T0 (occurs after consenting and before assigning to different study conditions)
Assessed by the % of eligible individuals agreeing to participate
Proportion of participants who are retained through follow-up
Time Frame: T2 (occurs two months after completion of the intervention)
Assessed by the % of participants who are retained through follow-up
Percentage of participants who complete the intervention and assessments
Time Frame: T2 (occurs two months after completion of the intervention)
Assessed by the % of participants who complete the intervention and assessments
Intention to vaccinate the children against HPV
Time Frame: T0 (occurs after consenting and before assigning to different study conditions); T1 (occurs immediately post intervention);T2 (occurs two months after completion of the intervention)
Assessed by a Likert scale question: How likely will you (parent) vaccinate your child against HPV? Responses: (0) no; (1) maybe; (2) yes
Participant satisfaction with the project
Time Frame: T2 (occurs two months after completion of the intervention)
Assessed by two Likert scale questions: (1) are you satisfied with the program? (2) Will you recommend this program to others? Responses: from (1) very dissatisfied/definitely not to (5) very satisfied/definitely yes)
Secondary Outcomes
- Children receives the first dose of HPV vaccine(T2 (occurs two months after completion of the intervention))