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NCT Number: NCT07637630

Trial in HPV Prevention for the U.S. Vietnamese Community

The purpose of the HERO study is to leverage the Multiphase Optimization Strategy (MOST) framework to conduct a pilot trial testing four different intervention components (expert video, self-persuasion, narrative storytelling, and motivational interviewing) targeting HPV vaccination among U.S. Vietnamese.

PRIMARY AIM To assess the feasibility and acceptability of each of the four digital HERO intervention components in a pilot optimization trial using the MOST framework. Using a highly efficient design, the study team will randomize 96 Vietnamese parents of unvaccinated adolescents to receive 0 to 4 HERO components. The study team will establish the feasibility (reach, retention, adherence) and acceptability (usability, satisfaction, usefulness, cultural relevance) of each component (expert video, self-persuasion, narrative storytelling, and motivational interviewing).

SECONDARY AIM To investigate effects of each component on HPV vaccination outcomes and psychosocial mediators. The study team will examine the effects on HPV vaccination (initiation and intention) and psychosocial mediators.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The purpose of the HERO study is to leverage the Multiphase Optimization Strategy (MOST) framework to conduct a pilot trial testing four different intervention components (expert video, self-persuasion, narrative storytelling, and motivational interviewing) targeting HPV vaccination among U.S. Vietnamese.

PRIMARY AIM To assess the feasibility and acceptability of each of the four digital HERO intervention components in a pilot optimization trial using the MOST framework. Using a highly efficient design, the study team will randomize 96 Vietnamese parents of unvaccinated adolescents to receive 0 to 4 HERO components. The study team will establish the feasibility (reach, retention, adherence) and acceptability (usability, satisfaction, usefulness, cultural relevance) of each component (expert video, self-persuasion, narrative storytelling, and motivational interviewing).

SECONDARY AIM To investigate effects of each component on HPV vaccination outcomes and psychosocial mediators. The study team will examine the effects on HPV vaccination (initiation and intention) and psychosocial mediators.

Research participants will be identified and recruited through online recruitment, community organizations, social media, research team social networks and personal contacts, and in-person events targeting U.S. Vietnamese parents of adolescents. Interested potential participants will answer an online screener for eligibility. When appropriate, potential participants can also be screened via a brief Zoom, telephone, or in-person interview. Once a participant is determined to be eligible for study participation, the study team will communicate via telephone or send a follow up email to them to invite them to participate in the research. Participants will provide eConsent via a form hosted on REDCap, including accepting that the interviews will be audio and/or video recorded. After consent is received, all additional study procedures will be handled by the study team.

Assessments. Participants will also fill out a short survey that captures sociodemographic information and vaccine beliefs and attitudes. This short survey cannot be completed until after participants have consented to participate. Participants will complete follow-up assessments at 1, 3, and 6 months post-baseline, including a survey and interview at Month 1 and surveys at Months 3 and 6.

Randomization and Study Orientation. Following the completion of the baseline assessment, participants will be randomized using computer-generated randomly permuted blocks, stratified by the sex of the adolescent (to acknowledge historical differences in HPV uptake among male and female adolescents). All participants will receive the constant component through the study website. Depending on the intervention condition, participants will receive 0 to 4 intervention components and complete them within 4 weeks from the baseline assessment.

Intervention Components

Constant component: Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Expert video: Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Self-persuasion: Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Narrative storytelling: Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Motivational interviewing: Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Participants will be followed for a maximum of 6 months from the baseline assessment and will complete up to 3 additional assessments (1-month, 3-month, and 4-month post-randomization).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identify as U.S. Vietnamese.
  • Are the parent of a youth ages 9-18 who have not initiated the HPV vaccine series. Only one parent per household will be able to participate.
  • Have lived in the U.S. for 12 months or more.

Exclusion criteria

  • Planning to move out of the U.S. within the next 6 months.
  • Not fluent in either spoken and written Vietnamese or spoken and written English.
  • Inability to provide informed consent.

Treatment and study plan

Expert Video

Behavioral

Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Self-persuasion

Behavioral

Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Narrative Storytelling

Behavioral

Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Motivational Interviewing

Behavioral

Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Constant Component

Behavioral

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Primary outcomes

  1. Feasibility: Reach

    Time frame: Baseline

    Number of enrolled participants divided by number of eligible individuals

  2. Feasibility: Retention

    Time frame: 1, 3, and 6 months post-randomization

    Number of of participants who drop out divided by number of randomized participants

  3. Feasibility: Adherence

    Time frame: 1-month post randomization

    Self-persuasion task: number of web launches and length of time spent completing task;

    Expert video and narrative storytelling: number of views and length of engagement time;

    Motivational interviewing: number of completed motivational interviewing calls and length of each call

  4. Acceptability

    Time frame: 1-month post randomization

    Survey questions and semi-structured interviews exploring cultural relevance; reason for use/lack of use; aspects participants liked the most/least; ideas for improvement

Secondary outcomes

  1. HPV vaccine initiation (adolescents)

    Time frame: 1, 3 and 6 months post-randomization

    Adolescent's receipt (yes or no) of ≥1 vaccine doses; uploads of adolescent vaccination cards (preferred) or self-reported if vaccination card is unavailable.

    Questions used:

    • You previously indicated in the baseline survey that you have a <sex - link from baseline> child aged <age - link from baseline>. Since our last survey, please indicate whether your child has gotten any HPV vaccine shot.
    • No
    • Yes
    • (if Yes to 1) If your child has received an HPV vaccine shot, you may upload a photo of your child's vaccination card or record here. This will help us confirm the information you shared. Your information will be kept confidential.
  2. HPV vaccine intention

    Time frame: Baseline, 1-month, 3-month, and 6-month post-randomization

    "How likely is it that [your adolescent] will receive HPV shots in the next 12 months?"

  3. Beliefs, attitudes, and trust in HPV vaccine

    Time frame: Baseline, 1-month, 3-month, and 6-month post randomization

    Measuring beliefs, attitudes, and trust in HPV vaccine

    Questions are adapted from the Carolina HPV Immunization Attitudes and Beliefs Scale (McRee et al., 2010). There are 16 questions, each scored on a 4-point Likert scale with 1=Strongly disagree and 4=Strongly agree. Higher scores indicate more favorable or positive beliefs, attitudes, and trust in HPV vaccine.

  4. Beliefs, attitudes, and trust in other childhood/adolescent vaccines

    Time frame: Baseline, 1-month, 3-month, and 6-month post randomization

    Measuring beliefs, attitudes, and trust in other childhood and adolescent vaccines

    Questions are adapted from the World Health Organization (Strategic Advisory Group of Experts on Immunization) Vaccine Hesitancy Scale. There are 10 questions, each scored on a 4-point Likert scale with 1=Strongly disagree and 4=Strongly agree. Higher scores indicated more favorable or positive beliefs, attitudes, and trusts in other childhood and adolescent vaccines.

Study contacts

Contact information is provided by the study sponsor or research team.

Milkie Vu

CONTACT

[email protected]

312-503-6592

Ninh Nguyen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Applying the Multiphase Optimization Strategy to Develop and Test a Culturally-Relevant Digital Health Intervention Targeting HPV Vaccination Among U.S. Vietnamese

Acronym: HERO

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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