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| ID | Type | Description | Link |
|---|---|---|---|
| K01CA296781 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Exp Condition 1 | Experimental | Research participant receives the Constant component + Expert video + Self-persuasion + Narrative storytelling + Motivational interviewing |
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| Experimental: Exp Condition 2 | Experimental | Research participant receives Constant + Expert video + Self-persuasion + Narrative storytelling. |
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| Experimental: Exp Condition 3 | Experimental | Research participant receives Constant + Expert video + Self-persuasion + Motivational interviewing |
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| Experimental: Exp Condition 4 | Experimental | Research participant receives Constant + Expert video + Self-persuasion |
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| Experimental: Exp Condition 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. (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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Milkie Vu | Contact | 312-503-6592 | milkie.vu@northwestern.edu | |
| Ninh Nguyen | Contact | ninh.nguyen@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Milkie Vu, PhD | Northwestern University | Principal Investigator |
| Namratha Kandula | Northwestern University | Study Director |
| Siobhan Phillips |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17466815 | Background | 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. | |
| 31298268 | 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. |
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Individual participant data will not be shared due to the risk of re-identification. We want to protect participant confidentiality.
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Experimental |
Research participant receives Constant + Expert video + Narrative storytelling + Motivational interviewing |
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| Experimental: Exp Condition 6 | Experimental | Research participant receives Constant + Expert video + Narrative storytelling |
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| Experimental: Exp Condition 7 | Experimental | Research participant receives Constant + Expert video + Motivational interviewing |
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| Experimental: Exp Condition 8 | Experimental | Research participant receives Constant + Expert video |
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| Experimental: Exp Condition 9 | Experimental | Research participant receives Constant + Self-persuasion + Narrative storytelling + Motivational interviewing |
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| Experimental: Exp Condition 10 | Experimental | Research participant receives Constant + Self-persuasion + Narrative storytelling |
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| Experimental: Exp Condition 11 | Experimental | Research participant receives Constant + Self-persuasion + Motivational interviewing |
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| Experimental: Exp Condition 12 | Experimental | Research participant receives Constant + Self-persuasion |
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| Experimental: Exp Condition 13 | Experimental | Research participant receives Constant + Narrative storytelling + Motivational interviewing |
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| Experimental: Exp Condition 14 | Experimental | Research participant receives Constant + Narrative storytelling |
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| Experimental: Exp Condition 15 | Experimental | Research participant receives Constant + Motivational interviewing |
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| Experimental: Exp Condition 16 | Experimental | Research participant receives the Constant component only |
|
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| 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). |
|
| 1, 3 and 6 months post-randomization |
| HPV vaccine intention | "How likely is it that [your adolescent] will receive HPV shots in the next 12 months?" | Baseline, 1-month, 3-month, and 6-month post-randomization |
| 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. | Baseline, 1-month, 3-month, and 6-month post randomization |
| 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. | Baseline, 1-month, 3-month, and 6-month post randomization |
| Northwestern University |
| Study Director |
| Juned Siddique | Northwestern University | Study Director |
| 25264465 | 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. |
| 37521956 | 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. |
| 26661680 | 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. |
| 34388178 | 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. |
| 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 |
| 28877746 | 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. |
| Background | Collins LM. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions. Springer International Publishing; 2018. doi:10.1007/978-3-319-72206-1 |
| 26685815 | 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. |
| 34232452 | 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. |
| 35314854 | 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. |
| 29579499 | 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. |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |