Northwestern University
Chicago, Illinois, 60611, United States
Location status: Recruiting
NCT Number: NCT07637630
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Location status: Recruiting
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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).
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).
Time frame: Baseline
Number of enrolled participants divided by number of eligible individuals
Time frame: 1, 3, and 6 months post-randomization
Number of of participants who drop out divided by number of randomized participants
Time frame: 1-month post randomization
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 randomization
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, 3 and 6 months post-randomization
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:
Time frame: Baseline, 1-month, 3-month, and 6-month post-randomization
"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 randomization
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 randomization
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.
Contact information is provided by the study sponsor or research team.
Northwestern University
Other
Applying the Multiphase Optimization Strategy to Develop and Test a Culturally-Relevant Digital Health Intervention Targeting HPV Vaccination Among U.S. Vietnamese
Acronym: HERO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07648953
HPV VACCINATION
Salt Lake City, Utah, United States
View Trial DetailsNCT07164391
Cancer Prevention, HPV VACCINATION
Lansing, Michigan, United States
View Trial DetailsNCT07301905
HPV VACCINATION
Flint, Michigan, United States
View Trial DetailsNCT06997705
Adolescent, HPV VACCINATION
Abidjan, Côte d’Ivoire
View Trial Details