Empowering Vietnamese Americans

NCT ID: NCT07164391

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to learn whether short videos can help Vietnamese American mothers decide to vaccinate their children against HPV (human papillomavirus). The study will explore: (1) which type of video is most effective in encouraging mothers to vaccinate their children; (2) how mothers perceive and engage with the videos; and (3) how many children receive the HPV vaccine after their mothers watch the videos.

Participants will be randomly assigned to one of three groups: (a) watch four short digital stories about the HPV vaccine created by Vietnamese mothers; (b) watch four short informational videos about HPV and the vaccine; or (c) watch four short videos on general teen health topics such as mental health and social media use. Participants will complete brief surveys and their child's HPV vaccination status will be checked two months after the intervention.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study focuses on increasing HPV vaccination rates among Vietnamese American (VA) youth by engaging their mothers-who are key decision-makers-in culturally relevant video interventions. VA females experience disproportionately high rates of HPV-related cervical cancer and low vaccine uptake. Contributing factors include limited HPV knowledge, low English proficiency, and culturally influenced health beliefs. There is a critical need for tailored, community-driven interventions to address these disparities.

Researchers will evaluate three different 4-week video-based interventions: a digital storytelling (DST) intervention featuring personal stories created by Vietnamese mothers, an informational HPV video series, and a general teen health video series. Each mother will view one 3-minute video per week over four weeks. The study uses a randomized, 3-arm design with 60 VA mothers of unvaccinated children ages 11-14 assigned to one of the three groups.

The study draws on the Theory of Planned Behavior and a culture-centric health promotion framework. It aims to measure feasibility, acceptability, and changes in vaccination intention and behavior. Follow-up assessments will occur two months post-intervention to evaluate vaccine uptake. Additionally, a subset of participants will complete interviews to explore engagement and refine future trial design.

Data will be collected at baseline, post-intervention, and 2-month follow-up using online surveys and secure platforms. To ensure equitable participation, the study incorporates bilingual staff, culturally tailored outreach, community partnerships, and graduated incentives. Findings will inform future large-scale trials and may help scale culturally grounded HPV prevention strategies for other underserved populations.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HPV Vaccination Cancer Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Story group

This group will receive the digital Intervention for Vietnamese-American Storytelling (VIDAS)

Group Type ACTIVE_COMPARATOR

Digital Intervention for Vietnamese-American Storytelling (VIDAS)

Intervention Type BEHAVIORAL

The intervention consists of 4 brief stories about HPV vaccine, created by Vietnamese mothers

Video group

This group will receive the HPV Educational Video Intervention.

Group Type ACTIVE_COMPARATOR

HPV Educational Video Intervention

Intervention Type BEHAVIORAL

The intervention consists of 4 brief informational videos about HPV and the vaccine

Teen General Health group

This group will receive the Teen General Health intervention.

Group Type PLACEBO_COMPARATOR

Teen General Health

Intervention Type BEHAVIORAL

This intervention consists of 4 brief videos on general teen health topics, such as mental health, social media usage.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Intervention for Vietnamese-American Storytelling (VIDAS)

The intervention consists of 4 brief stories about HPV vaccine, created by Vietnamese mothers

Intervention Type BEHAVIORAL

HPV Educational Video Intervention

The intervention consists of 4 brief informational videos about HPV and the vaccine

Intervention Type BEHAVIORAL

Teen General Health

This intervention consists of 4 brief videos on general teen health topics, such as mental health, social media usage.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Self-identify as a Vietnamese American or immigrant woman aged 18 years or older
* Are the primary caregiver of at least one unvaccinated child aged 11-14 years
* Can speak and read English
* Agree to receive text messages and/or emails related to project activities during the study period

Exclusion Criteria

* inability/unwillingness to provide consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Angela Chia-Chen Chen

Professor & Endowed Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IP00769244

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gardasil Knowledge
NCT03083249 COMPLETED