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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05846178
Other study ID # STUDY00011733
Secondary ID U54MD002316-11
Status Completed
Phase N/A
First received
Last updated
Start date March 24, 2020
Est. completion date March 1, 2023

Study information

Verified date April 2023
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Asian American (AA) females are disproportionately affected by cervical cancer. Among AA subgroups, Korean American (KA) females had higher risks of developing cervical cancer and rates of cervical cancer mortality compared to white females (11.9, 7.1 per 100,000, respectively). Despite that HPV vaccines have shown to be efficacious in preventing cancers and are recommended for routine vaccinations for youth at age 11 or 12 years, AA females aged 9-17 years have significantly lower HPV vaccine initiation (12.4% vs 27.2%) and completion (1.9% vs 10.3%) rates compared with all other race/ethnicities combined. Using culturally grounded narratives/stories incorporating culture-specific beliefs and practices for health behavior change is effective to mitigate health disparities, specifically for Asian Americans. Storytelling, a specific form of cultural narrative, is showing promise as an effective method of facilitating healthy behaviors through promoting a sense of identification with stories and characters, and transportation (i.e., emotional engagement) as defined in the Model of Narrative as Culture-Centric Health Promotion. We propose to use a digital storytelling approach to gather in-person stories from KA immigrant mothers about HPV vaccination of their children for our intervention.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 1, 2023
Est. primary completion date October 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Baseline Surveys
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.
Digital Storytelling Intervention
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.

Locations

Country Name City State
United States Arizona State University Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Arizona State University National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intention to Vaccinate Child against HPV at post-intervention 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 Changes from Baseline Mother's Attitudes toward HPV and the HPV Vaccine at post-intervention 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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