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HPV-related CancersHERONCT07637630

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

A study testing Expert Video, Self-persuasion and Narrative Storytelling in people with HPV-related Cancers and HPV Vaccination, run by Northwestern University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HPV-related Cancers, HPV Vaccination
What is being tested?
Expert Video, Self-persuasion and Narrative Storytelling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteUnited States
Study dates
1 May 2026to 30 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Milkie Vu contact

312-503-6592

milkie.vu@northwestern.edu

Ninh Nguyen contact

ninh.nguyen@northwestern.edu

United States1 site, 1 recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Milkie Vu, 312-503-6592, milkie.vu@northwestern.edu

    Ninh Nguyen, ninh.nguyen@northwestern.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

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).

Being tested
Expert Video, Self-persuasion, Narrative Storytelling, Motivational Interviewing, Constant Component
Keywords
HPV vaccination, digital health intervention, U.S. Vietnamese, MOST framework, behavioral intervention, adolescent vaccination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expert VideoBehavioural

    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-persuasionBehavioural

    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 StorytellingBehavioural

    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 InterviewingBehavioural

    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 ComponentBehavioural

    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).

Study groups in NCT07637630
Study groupRoleWhat they receive
Experimental: Exp Condition 1ExperimentalResearch participant receives the Constant component + Expert video + Self-persuasion + Narrative storytelling + Motivational interviewing
Receives: Behavioral: Expert Video; Behavioral: Self-persuasion; Behavioral: Narrative Storytelling; Behavioral: Motivational Interviewing; Behavioral: Constant Component
Experimental: Exp Condition 2ExperimentalResearch participant receives Constant + Expert video + Self-persuasion + Narrative storytelling.
Receives: Behavioral: Expert Video; Behavioral: Self-persuasion; Behavioral: Narrative Storytelling; Behavioral: Constant Component
Experimental: Exp Condition 3ExperimentalResearch participant receives Constant + Expert video + Self-persuasion + Motivational interviewing
Receives: Behavioral: Expert Video; Behavioral: Self-persuasion; Behavioral: Motivational Interviewing; Behavioral: Constant Component
Experimental: Exp Condition 4ExperimentalResearch participant receives Constant + Expert video + Self-persuasion
Receives: Behavioral: Expert Video; Behavioral: Self-persuasion; Behavioral: Constant Component
Experimental: Exp Condition 5ExperimentalResearch participant receives Constant + Expert video + Narrative storytelling + Motivational interviewing
Receives: Behavioral: Expert Video; Behavioral: Narrative Storytelling; Behavioral: Motivational Interviewing; Behavioral: Constant Component
Experimental: Exp Condition 6ExperimentalResearch participant receives Constant + Expert video + Narrative storytelling
Receives: Behavioral: Expert Video; Behavioral: Narrative Storytelling; Behavioral: Constant Component
Experimental: Exp Condition 7ExperimentalResearch participant receives Constant + Expert video + Motivational interviewing
Receives: Behavioral: Expert Video; Behavioral: Motivational Interviewing; Behavioral: Constant Component
Experimental: Exp Condition 8ExperimentalResearch participant receives Constant + Expert video
Receives: Behavioral: Expert Video; Behavioral: Constant Component
Experimental: Exp Condition 9ExperimentalResearch participant receives Constant + Self-persuasion + Narrative storytelling + Motivational interviewing
Receives: Behavioral: Self-persuasion; Behavioral: Narrative Storytelling; Behavioral: Motivational Interviewing; Behavioral: Constant Component
Experimental: Exp Condition 10ExperimentalResearch participant receives Constant + Self-persuasion + Narrative storytelling
Receives: Behavioral: Self-persuasion; Behavioral: Narrative Storytelling; Behavioral: Constant Component
Experimental: Exp Condition 11ExperimentalResearch participant receives Constant + Self-persuasion + Motivational interviewing
Receives: Behavioral: Self-persuasion; Behavioral: Motivational Interviewing; Behavioral: Constant Component
Experimental: Exp Condition 12ExperimentalResearch participant receives Constant + Self-persuasion
Receives: Behavioral: Self-persuasion; Behavioral: Constant Component
Experimental: Exp Condition 13ExperimentalResearch participant receives Constant + Narrative storytelling + Motivational interviewing
Receives: Behavioral: Narrative Storytelling; Behavioral: Motivational Interviewing; Behavioral: Constant Component
Experimental: Exp Condition 14ExperimentalResearch participant receives Constant + Narrative storytelling
Receives: Behavioral: Narrative Storytelling; Behavioral: Constant Component
Experimental: Exp Condition 15ExperimentalResearch participant receives Constant + Motivational interviewing
Receives: Behavioral: Motivational Interviewing; Behavioral: Constant Component
Experimental: Exp Condition 16ExperimentalResearch participant receives the Constant component only
Receives: Behavioral: Constant Component

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Reach

    Number of enrolled participants divided by number of eligible individuals

    Measured: Baseline

  2. Feasibility: Retention

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

    Measured: 1, 3, and 6 months post-randomization

  3. Feasibility: Adherence

    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

    Measured: 1-month post randomization

  4. Acceptability

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

    Measured: 1-month post randomization

Secondary outcomes (4)

  1. HPV vaccine initiation (adolescents)

    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:

    1. 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.
    2. No
    3. Yes
    4. (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.

    Measured: 1, 3 and 6 months post-randomization

  2. HPV vaccine intention

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

    Measured: Baseline, 1-month, 3-month, and 6-month post-randomization

  3. Beliefs, attitudes, and trust in HPV vaccine

    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.

    Measured: Baseline, 1-month, 3-month, and 6-month post randomization

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

    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.

    Measured: Baseline, 1-month, 3-month, and 6-month post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start1 May 2026
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637630
Sponsor's protocol ID
STU00223028
Other IDs
K01CA296781
Acronym
HERO
Status last verified
Jun 2026
First submitted
26 May 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to the risk of re-identification. We want to protect participant confidentiality.

Publications

  • Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.

    PubMed 17466815

  • Kim M, Lee H, Kiang P, Allison J. Development and acceptability of a peer-paired, cross-cultural and cross-generational storytelling HPV intervention for Korean American college women. Health Educ Res. 2019 Oct 1;34(5):483-494. doi: 10.1093/her/cyz022.

    PubMed 31298268

  • Wyrick DL, Rulison KL, Fearnow-Kenney M, Milroy JJ, Collins LM. Moving beyond the treatment package approach to developing behavioral interventions: addressing questions that arose during an application of the Multiphase Optimization Strategy (MOST). Transl Behav Med. 2014 Sep;4(3):252-9. doi: 10.1007/s13142-013-0247-7.

    PubMed 25264465

  • Vu M, Berg CJ, Pham NT, Tiro JA, Escoffery C, Spring B, Bednarczyk RA, Ta D, Kandula NR. U.S. Vietnamese parents' trusted sources of information and preferences for intervention messaging about HPV vaccination: A mixed methods study. PEC Innov. 2023 Jul 6;3:100189. doi: 10.1016/j.pecinn.2023.100189. eCollection 2023 Dec 15.

    PubMed 37521956

  • Jin H, Pinheiro PS, Xu J, Amei A. Cancer incidence among Asian American populations in the United States, 2009-2011. Int J Cancer. 2016 May 1;138(9):2136-45. doi: 10.1002/ijc.29958. Epub 2016 Jan 29.

    PubMed 26661680

  • Vu M, Huynh VN, Bednarczyk RA, Escoffery C, Ta D, Nguyen TT, Berg CJ. Experience and lessons learned from multi-modal internet-based recruitment of U.S. Vietnamese into research. PLoS One. 2021 Aug 13;16(8):e0256074. doi: 10.1371/journal.pone.0256074. eCollection 2021.

    PubMed 34388178

  • National Cancer Institute. Future Directions - Division of Cancer Control & Population Sciences. Published 2023. Accessed January 12, 2024. https://cancercontrol.cancer.gov/research-emphasis/future-directions

  • National Cancer Institute. Cancer Health Disparities Research. Published 2021. Accessed September 29, 2022. https://www.cancer.gov/research/areas/disparities

  • National Cancer Institute. Notice of Special Interest: National Cancer Institute Supports Applications for the Mentored Research Scientist Development Awards (K01) Within the Mission of the Division of Cancer Control and Population Sciences. Published 2023. https://grants.nih.gov/grants/guide/notice-files/NOTCA- 24-022.html

  • Aarons GA, Sklar M, Mustanski B, Benbow N, Brown CH. "Scaling-out" evidence-based interventions to new populations or new health care delivery systems. Implement Sci. 2017 Sep 6;12(1):111. doi: 10.1186/s13012-017-0640-6.

    PubMed 28877746

  • Collins LM. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions. Springer International Publishing; 2018. doi:10.1007/978-3-319-72206-1

  • Lee HY, Koopmeiners JS, McHugh J, Raveis VH, Ahluwalia JS. mHealth Pilot Study: Text Messaging Intervention to Promote HPV Vaccination. Am J Health Behav. 2016 Jan;40(1):67-76. doi: 10.5993/AJHB.40.1.8.

    PubMed 26685815

  • Ma GX, Zhu L, Tan Y, Zhai S, Lin TR, Zambrano C, Siu P, Lai S, Wang MQ. A Multilevel Intervention to Increase HPV Vaccination among Asian American Adolescents. J Community Health. 2022 Feb;47(1):9-16. doi: 10.1007/s10900-021-01013-z. Epub 2021 Jul 7.

    PubMed 34232452

  • Chen AC, Kim WS, Todd M, Larkey L. A Digital Storytelling Intervention for Vietnamese American Mothers to Promote Their Children's HPV Vaccination. Cancer Prev Res (Phila). 2022 Jul 5;15(7):465-472. doi: 10.1158/1940-6207.CAPR-21-0618.

    PubMed 35314854

  • Lee H, Kim M, Cooley ME, Kiang PN, Kim D, Tang S, Shi L, Thiem L, Kan P, Peou S, Touch C, Chea P, Allison J. Using narrative intervention for HPV vaccine behavior change among Khmer mothers and daughters: A pilot RCT to examine feasibility, acceptability, and preliminary effectiveness. Appl Nurs Res. 2018 Apr;40:51-60. doi: 10.1016/j.apnr.2017.12.008. Epub 2017 Dec 18.

    PubMed 29579499

Questions about this trial

What is this clinical trial studying?

A study testing Expert Video, Self-persuasion and Narrative Storytelling in people with HPV-related Cancers and HPV Vaccination, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Milkie Vu (312-503-6592, milkie.vu@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Reach (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07637630, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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