Trial in HPV Prevention for the U.S. Vietnamese Community
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Expert Video
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralEach 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).
Treatment groups
96 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Experimental: Exp Condition 1Experimental treatment 5 interventions
Group B: Experimental: Exp Condition 2Experimental treatment 4 interventions
Group C: Experimental: Exp Condition 3Experimental treatment 4 interventions
Group D: Experimental: Exp Condition 4Experimental treatment 3 interventions
Group E: Experimental: Exp Condition 5Experimental treatment 4 interventions
Group F: Experimental: Exp Condition 6Experimental treatment 3 interventions
Group G: Experimental: Exp Condition 7Experimental treatment 3 interventions
Group H: Experimental: Exp Condition 8Experimental treatment 2 interventions
Group I: Experimental: Exp Condition 9Experimental treatment 4 interventions
Group J: Experimental: Exp Condition 10Experimental treatment 3 interventions
Group K: Experimental: Exp Condition 11Experimental treatment 3 interventions
Group L: Experimental: Exp Condition 12Experimental treatment 2 interventions
Group M: Experimental: Exp Condition 13Experimental treatment 3 interventions
Group N: Experimental: Exp Condition 14Experimental treatment 2 interventions
Group O: Experimental: Exp Condition 15Experimental treatment 2 interventions
Group P: Experimental: Exp Condition 16Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: Reach
Number of enrolled participants divided by number of eligible individuals
Time frame
Baseline2
Feasibility: Retention
Number of of participants who drop out divided by number of randomized participants
Time frame
1, 3, and 6 months post-randomization3
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
Time frame
1-month post randomization4
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
Time frame
1-month post randomizationSecondary outcomes
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. 1. No 2. Yes 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.
Time frame
1, 3 and 6 months post-randomization2
HPV vaccine intention
"How likely is it that \[your adolescent\] will receive HPV shots in the next 12 months?"
Time frame
Baseline, 1-month, 3-month, and 6-month post-randomization3
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.
Time frame
Baseline, 1-month, 3-month, and 6-month post randomization4
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.
Time frame
Baseline, 1-month, 3-month, and 6-month post randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov