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

NCT07637630 | Recruiting

• 2 other identifiers: STU00223028K01CA296781
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HPV-related Cancers; HPV Vaccination

Keywords

HPV vaccination; digital health intervention; U.S. Vietnamese; MOST framework; behavioral intervention; adolescent vaccination

Outcome Measures

Primary Outcomes (4)

• Feasibility: Reach

  Number of enrolled participants divided by number of eligible individuals

  Baseline

• Feasibility: Retention

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

  1, 3, and 6 months post-randomization

• 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

  1-month post randomization

• 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

  1-month post randomization

Secondary Outcomes (4)

• HPV vaccine initiation (adolescents)

  1, 3 and 6 months post-randomization

• HPV vaccine intention

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

• Beliefs, attitudes, and trust in HPV vaccine

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

• Beliefs, attitudes, and trust in other childhood/adolescent vaccines

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

Study Arms (16)

Experimental: Exp Condition 1

EXPERIMENTAL

Research participant receives the Constant component + Expert video + Self-persuasion + Narrative storytelling + Motivational interviewing

Behavioral: Expert Video; Behavioral: Self-persuasion; Behavioral: Narrative Storytelling; Behavioral: Motivational Interviewing; Behavioral: Constant Component

Experimental: Exp Condition 2

EXPERIMENTAL

Research participant receives Constant + Expert video + Self-persuasion + Narrative storytelling.

Behavioral: Expert Video; Behavioral: Self-persuasion; Behavioral: Narrative Storytelling; Behavioral: Constant Component

Experimental: Exp Condition 3

EXPERIMENTAL

Research participant receives Constant + Expert video + Self-persuasion + Motivational interviewing

Behavioral: Expert Video; Behavioral: Self-persuasion; Behavioral: Motivational Interviewing; Behavioral: Constant Component

Experimental: Exp Condition 4

EXPERIMENTAL

Research participant receives Constant + Expert video + Self-persuasion

Behavioral: Expert Video; Behavioral: Self-persuasion; Behavioral: Constant Component

Experimental: Exp Condition 5

EXPERIMENTAL

Research participant receives Constant + Expert video + Narrative storytelling + Motivational interviewing

Behavioral: Expert Video; Behavioral: Narrative Storytelling; Behavioral: Motivational Interviewing; Behavioral: Constant Component

Experimental: Exp Condition 6

EXPERIMENTAL

Research participant receives Constant + Expert video + Narrative storytelling

Behavioral: Expert Video; Behavioral: Narrative Storytelling; Behavioral: Constant Component

Experimental: Exp Condition 7

EXPERIMENTAL

Research participant receives Constant + Expert video + Motivational interviewing

Behavioral: Expert Video; Behavioral: Motivational Interviewing; Behavioral: Constant Component

Experimental: Exp Condition 8

EXPERIMENTAL

Research participant receives Constant + Expert video

Behavioral: Expert Video; Behavioral: Constant Component

Experimental: Exp Condition 9

EXPERIMENTAL

Research participant receives Constant + Self-persuasion + Narrative storytelling + Motivational interviewing

Behavioral: Self-persuasion; Behavioral: Narrative Storytelling; Behavioral: Motivational Interviewing; Behavioral: Constant Component

Experimental: Exp Condition 10

EXPERIMENTAL

Research participant receives Constant + Self-persuasion + Narrative storytelling

Behavioral: Self-persuasion; Behavioral: Narrative Storytelling; Behavioral: Constant Component

Experimental: Exp Condition 11

EXPERIMENTAL

Research participant receives Constant + Self-persuasion + Motivational interviewing

Behavioral: Self-persuasion; Behavioral: Motivational Interviewing; Behavioral: Constant Component

Experimental: Exp Condition 12

EXPERIMENTAL

Research participant receives Constant + Self-persuasion

Behavioral: Self-persuasion; Behavioral: Constant Component

Experimental: Exp Condition 13

EXPERIMENTAL

Research participant receives Constant + Narrative storytelling + Motivational interviewing

Behavioral: Narrative Storytelling; Behavioral: Motivational Interviewing; Behavioral: Constant Component

Experimental: Exp Condition 14

EXPERIMENTAL

Research participant receives Constant + Narrative storytelling

Behavioral: Narrative Storytelling; Behavioral: Constant Component

Experimental: Exp Condition 15

EXPERIMENTAL

Research participant receives Constant + Motivational interviewing

Behavioral: Motivational Interviewing; Behavioral: Constant Component

Experimental: Exp Condition 16

EXPERIMENTAL

Research participant receives the Constant component only

Behavioral: Constant Component

Interventions

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.

Experimental: Exp Condition 1; Experimental: Exp Condition 2; Experimental: Exp Condition 3; Experimental: Exp Condition 4; Experimental: Exp Condition 5; Experimental: Exp Condition 6; Experimental: Exp Condition 7; Experimental: Exp Condition 8

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.

Experimental: Exp Condition 1; Experimental: Exp Condition 10; Experimental: Exp Condition 11; Experimental: Exp Condition 12; Experimental: Exp Condition 2; Experimental: Exp Condition 3; Experimental: Exp Condition 4; Experimental: Exp Condition 9

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.

Experimental: Exp Condition 1; Experimental: Exp Condition 10; Experimental: Exp Condition 13; Experimental: Exp Condition 14; Experimental: Exp Condition 2; Experimental: Exp Condition 5; Experimental: Exp Condition 6; Experimental: Exp Condition 9

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).

Experimental: Exp Condition 1; Experimental: Exp Condition 11; Experimental: Exp Condition 13; Experimental: Exp Condition 15; Experimental: Exp Condition 3; Experimental: Exp Condition 5; Experimental: Exp Condition 7; Experimental: Exp Condition 9

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).

Experimental: Exp Condition 1; Experimental: Exp Condition 10; Experimental: Exp Condition 11; Experimental: Exp Condition 12; Experimental: Exp Condition 13; Experimental: Exp Condition 14; Experimental: Exp Condition 15; Experimental: Exp Condition 16; Experimental: Exp Condition 2; Experimental: Exp Condition 3; Experimental: Exp Condition 4; Experimental: Exp Condition 5; Experimental: Exp Condition 6; Experimental: Exp Condition 7; Experimental: Exp Condition 8; Experimental: Exp Condition 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (27)

• 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.

  PMID: 17466815 BACKGROUND

• 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.

  PMID: 31298268 BACKGROUND

• 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.

  PMID: 25264465 BACKGROUND

• 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.

  PMID: 37521956 BACKGROUND

• 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.

  PMID: 26661680 BACKGROUND

• 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.

  PMID: 34388178 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28877746 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26685815 BACKGROUND

• 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.

  PMID: 34232452 BACKGROUND

• 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.

  PMID: 35314854 BACKGROUND

• 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.

  PMID: 29579499 BACKGROUND

• Kim M, Lee H, Kiang P, Aronowitz T, Sheldon LK, Shi L, Allison JJ. A Storytelling Intervention in a Mobile, Web-Based Platform: A Pilot Randomized Controlled Trial to Evaluate the Preliminary Effectiveness to Promote Human Papillomavirus Vaccination in Korean American College Women. Health Educ Behav. 2020 Apr;47(2):258-263. doi: 10.1177/1090198119894589. Epub 2020 Jan 20.

  PMID: 31958991 BACKGROUND

• Lee G, Chang A, Pal A, Tran TA, Cui X, Quach T. Understanding and Addressing the Digital Health Literacy Needs of Low-Income Limited English Proficient Asian American Patients. Health Equity. 2022 Jul 4;6(1):494-499. doi: 10.1089/heq.2022.0045. eCollection 2022.

  PMID: 36186613 BACKGROUND

• Adia AC, Nazareno J, Operario D, Ponce NA. Health Conditions, Outcomes, and Service Access Among Filipino, Vietnamese, Chinese, Japanese, and Korean Adults in California, 2011-2017. Am J Public Health. 2020 Apr;110(4):520-526. doi: 10.2105/AJPH.2019.305523. Epub 2020 Feb 20.

  PMID: 32078359 BACKGROUND

• Hopfer S, Dyda A, Brandt HM. Editorial: Digital solutions to HPV vaccination. Front Digit Health. 2022 Aug 9;4:972234. doi: 10.3389/fdgth.2022.972234. eCollection 2022. No abstract available.

  PMID: 36743721 BACKGROUND

• Vu M, Ta D, Berg CJ, Bednarczyk RA, Huynh VN, King AR, Escoffery C. U.S. Vietnamese Mothers' HPV Vaccine Decision-Making for Their Adolescents: A Qualitative Study. J Health Care Poor Underserved. 2022;33(4):1985-2006. doi: 10.1353/hpu.2022.0149.

  PMID: 36341674 BACKGROUND

• Zimet GD, Silverman RD, Bednarczyk RA, English A. Adolescent Consent for Human Papillomavirus Vaccine: Ethical, Legal, and Practical Considerations. J Pediatr. 2021 Apr;231:24-30. doi: 10.1016/j.jpeds.2021.01.026. Epub 2021 Jan 20.

  PMID: 33484694 BACKGROUND

• Falcaro M, Castanon A, Ndlela B, Checchi M, Soldan K, Lopez-Bernal J, Elliss-Brookes L, Sasieni P. The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study. Lancet. 2021 Dec 4;398(10316):2084-2092. doi: 10.1016/S0140-6736(21)02178-4. Epub 2021 Nov 3.

  PMID: 34741816 BACKGROUND

• Pedersen C, Petaja T, Strauss G, Rumke HC, Poder A, Richardus JH, Spiessens B, Descamps D, Hardt K, Lehtinen M, Dubin G; HPV Vaccine Adolescent Study Investigators Network. Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. J Adolesc Health. 2007 Jun;40(6):564-71. doi: 10.1016/j.jadohealth.2007.02.015.

  PMID: 17531764 BACKGROUND

• Centers for Disease Control and Prevention. HPV Vaccine Recommendations. Published 2021. Accessed May 4, 2022. https://www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html

  BACKGROUND

• Pingali C, Yankey D, Elam-Evans LD, Trahan A, Markowitz LE, DeSisto CL, Hughes M, Valier MR, Stokley S, Singleton JA. Vaccination Coverage Among Adolescents Aged 13-17 Years - National Immunization Survey-Teen, United States, 2024. MMWR Morb Mortal Wkly Rep. 2025 Aug 14;74(30):466-472. doi: 10.15585/mmwr.mm7430a1.

  PMID: 40811113 BACKGROUND

• Vu M, Bednarczyk RA, Escoffery C, Ta D, Huynh VN, Berg CJ. U.S. Vietnamese parents' HPV vaccine decision-making for their adolescents: an exploration of practice-, provider-, and patient-level influences. J Behav Med. 2022 Apr;45(2):197-210. doi: 10.1007/s10865-021-00265-3. Epub 2021 Nov 18.

  PMID: 34792723 BACKGROUND

• United States Census Bureau. 2021 American Community Survey 1-Year Estimates Total Population, Vietnamese Alone or in Any Combination. Published 2021. Accessed September 28, 2022. http://data.census.gov

  BACKGROUND

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Milkie Vu, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Namratha Kandula

  Northwestern University

  STUDY DIRECTOR

• Siobhan Phillips

  Northwestern University

  STUDY DIRECTOR

• Juned Siddique

  Northwestern University

  STUDY DIRECTOR

Central Study Contacts

Milkie Vu

CONTACT

312-503-6592; milkie.vu@northwestern.edu

Ninh Nguyen

CONTACT

ninh.nguyen@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 10, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)