- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05846178
Digital Storytelling Intervention to Promote HPV Vaccination in Korean American Youths
Development and Feasibility Testing of a Culture-Centric Digital Storytelling Intervention to Promote HPV Vaccination in Korean American Youths
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The high morbidity, mortality, and economic burden attributed to cancer-causing HPV call for researchers to address this public health concern through vigorous prevention efforts, including HPV vaccination for boys and girls at age 11 or 12 years. Disparities of HPV-associated cancers in Korean Americans (KA) exist, yet vaccination rates remain low in this at-risk population. Mothers' lower English proficiency and lack of knowledge about HPV vaccine, or their concerns about vaccination would encourage children's premarital sex, have significantly contributed to their low rate of HPV vaccination. As evidence points to the importance of developing culturally and linguistically congruent interventions to improve HPV vaccination in the KA population, very few interventions have been designed to address this health issue. Since KA mothers usually make decisions for their children's vaccination, the proposed study will target 1st generation (defined as individuals who are born outside of United States) KA immigrant mothers who have children aged 11-14.
Storytelling (a specific form of cultural narrative) shows promise as an effective method to facilitate healthy behaviors through promoting a sense of identification with the stories and characters, and engagement of recipients. We propose to (1) identify collaborators and build capacity to engage stakeholders in the research process to address low rates of HPV vaccination; (2) develop six brief culturally and linguistically congruent first-person audiovisual digital stories (each 2-3 minutes long) about HPV and vaccination with KA mothers of vaccinated children aged 11-14, and (3) examine the feasibility and preliminary effectiveness of the digital storytelling intervention for our target population. Aim 1: In collaboration with our community partners, we will identify and recruit stakeholders to form a Community Advisory Board (CAB) to guide the research process, including data interpretation and dissemination activities. Aim 2: Six immigrant mothers who have >=1 vaccinated child aged 11-14 will be invited to develop their own stories via a digital storytelling workshop. Mothers will develop 6 stories (three stories for each for both boys and girls) to document personal experiences about their children's HPV vaccination. Stories will be reviewed by RAC and PAC as intervention content. Aim 3: We will examine the feasibility (response rate, retention, involvement, satisfaction) of delivering the digital storytelling intervention and the preliminary effectiveness of the intervention among 50 KA mothers of unvaccinated boys and girls aged 11-14.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
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Phoenix, Arizona, United States, 85004
- Arizona State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(a) self-identified as Korean American or Korean immigrant, (b) were 18 years old or older, and (c) had one or more children aged 11-14 years old who had not been vaccinated against HPV.
Exclusion Criteria:
(a) do not meet inclusion criteria or are unable/ unwilling to provide consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Baseline and Digital Storytelling (DST) intervention
Consented participants received an online link consisting of informed consent and a baseline (T0) assessment.
Once they consented and filled out T0 assessment online, they were led to view the digital stories.
After reviewing the four stories, participants were invited to complete a post-intervention survey (T1) immediately.
Given the safety concerns during the COVID-19 pandemic, we implemented the intervention and data collection online via the web-based data collection platform, Research Electronic Data Capture (REDCap)
|
Baseline surveys contained sociodemographic characteristics and health-related questions included mother's age, birthplace, immigration- and language-related questions, education, employment, if child receives free or reduced-price lunch at school, health insurance coverage, family cancer history, prior HPV education, and communication with healthcare providers about HPV and the vaccine.
Additionally, the baseline survey contained a series of scaled questions, including mother's attitudes toward HPV and the HPV vaccine.
Other Names:
The digital storytelling intervention includes four digital stories (each about 3 minutes long) that reflect the mothers' rich personal and cultural experiences, attitudes, and perceptions about their child HPV vaccination.
The content of stories represents a number of perceived barriers that an immigrant might face, including language barriers, complex healthcare system, competing family values, cultural perceptions about HPV, and lack of culturally-relevant information and resources, as well as strategies for overcoming these barriers.
The content also includes reasons and factors for choosing HPV vaccination for their children, such as protection for both sons and daughters, the importance of having children vaccinated against HPV-related cancers while they're young, the importance of provider's recommendation, and family history of cervical cancer.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intention to Vaccinate Child against HPV at post-intervention
Time Frame: Immediately post-intervention (T1)
|
Intention to vaccinate child against HPV was measured by a binary (yes/no) question to assess mothers' intention to vaccinate their children.
Higher scores indicating higher intention to vaccinate child against HPV.
|
Immediately post-intervention (T1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from Baseline Mother's Attitudes toward HPV and the HPV Vaccine at post-intervention
Time Frame: Baseline (T0) and Immediately post-intervention (T1)
|
Mother's attitudes toward HPV and the vaccine were assessed by a 6-item measure, with item response options ranging from 1 (strongly disagree) to 5 (strongly agree).
A composite score was computed as a mean of the item scores, with a potential range of 1 to 5. Lower scores indicating more positive attitudes toward HPV vaccination.
|
Baseline (T0) and Immediately post-intervention (T1)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sunny W Kim, Ph.D, Arizona State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00011733
- U54MD002316-11 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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