Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental: Exp Condition 1
Research participant receives the Constant component + Expert video + Self-persuasion + Narrative storytelling + Motivational interviewing
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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).
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 2
Research participant receives Constant + Expert video + Self-persuasion + Narrative storytelling.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 3
Research participant receives Constant + Expert video + Self-persuasion + Motivational interviewing
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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).
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 4
Research participant receives Constant + Expert video + Self-persuasion
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 5
Research participant receives Constant + Expert video + Narrative storytelling + Motivational interviewing
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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).
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 6
Research participant receives Constant + Expert video + Narrative storytelling
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 7
Research participant receives Constant + Expert video + Motivational interviewing
  • Behavioral: 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.
  • Behavioral: 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).
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 8
Research participant receives Constant + Expert video
  • Behavioral: 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.
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 9
Research participant receives Constant + Self-persuasion + Narrative storytelling + Motivational interviewing
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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).
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 10
Research participant receives Constant + Self-persuasion + Narrative storytelling
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 11
Research participant receives Constant + Self-persuasion + Motivational interviewing
  • Behavioral: 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.
  • Behavioral: 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).
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 12
Research participant receives Constant + Self-persuasion
  • Behavioral: 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.
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 13
Research participant receives Constant + Narrative storytelling + Motivational interviewing
  • Behavioral: 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.
  • Behavioral: 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).
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 14
Research participant receives Constant + Narrative storytelling
  • Behavioral: 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.
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 15
Research participant receives Constant + Motivational interviewing
  • Behavioral: 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).
  • Behavioral: 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).
Experimental
Experimental: Exp Condition 16
Research participant receives the Constant component only
  • Behavioral: 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).

Recruiting Locations

Northwestern University
Chicago, Illinois 60611
Contact:
Milkie Vu
312-503-6592
milkie.vu@northwestern.edu

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact

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

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.