PREVENT HPV-Related Cancers - BootCamp Translation (PREVENT)

May 1, 2025 updated by: University of Utah

PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - BootCamp Translation

This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, this intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States.

The proposed study will determine the components of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. This study is a boot camp translation to tailor messaging based on patient and provider input.

This study will refine intervention components and messages to increase HPV vaccination among rural children and adolescents (C/A). The research team will use a validated patient-engaged approach for parents/caregivers (P/Cs), Bootcamp Translation (BCT), with separate sessions conducted in English and Spanish.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The PREVENT BootCamp Translation (BCT) study will determine the components and messages of reminders to encourage parents to obtain an HPV vaccine for their age-eligible children and adolescents (C/A)

This study will design format and content of an intervention to promote adolescent HPV vaccine coverage that will consider unique information needs of diverse rural parents/caregivers. The study team will use BCT to develop locally relevant intervention materials (e.g., reminder phone scripts for automated calls, text messages, and patient portal messages for P/C). Targeted promotional materials for HPV vaccination are available in Spanish and could be translated into other languages, as needed. Newly designed messages and materials will seek to counter anti-vaccination sentiment by leveraging cancer prevention, vaccine effectiveness, and vaccine safety messages. BCT methods will provide the framework to tailor HPV vaccination messages for rural and Hispanic IMW P/C.

Bootcamp Translation (BCT), a method for engaging diverse stakeholders in a consensus-building process, has been used by this research team to actively develop and adapt study interventions. It uses an iterative, flexible schedule of face-to-face meetings combined with short, focused teleconferences in a process that addresses 2 questions: "What do we need to say in our message to the community (newly HPV vaccine-eligible adolescents and adolescents who have not completed the HPV vaccination series)?" and "How do we deliver that message to our community?" BCT emphasizes no wrong answers and no hierarchy of expertise. The process requires up to nine (9) hours of participant time over 3-6 months. Participants will be surveyed before and after the in-person session to assess learning outcomes and capture basic sociodemographic information.

With Sea Mar's project manager and/or Sea Mar's designated team member(s), this study will recruit P/C (i.e., participants) for BCT sessions by generating a list of potential P/C of patients across 4 clinics. This study will recruit 6 participants from each clinic (24 total): 12 whose preferred language is English and 12 whose preferred language is Spanish. About two Sea Mar staff members will participate in BCT.

Two parallel sessions will be conducted, one in English and one in Spanish, with approximately 12 study participants per session. The in-person or live Zoom presentation will consist of an expert presentation, and/or subject matter experts. They will share research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. They will educate participants about the six different types of cancers that are prevented by the HPV vaccine among women and men in the United States. The study Investigators and/or subject matter experts to whom they delegate this responsibility will also present up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) as well as novel formats for educational messages (e.g., digital videos, narratives).

Participants will be assigned to a Spanish-language or English-language text message group, as appropriate, to provide iterative feedback to the research team on HPV vaccination messages over a 3-month period. Clinical partners in rural communities emphasized the high prevalence of mobile phone use among the parents/caregivers in their communities for seeking and sharing health information, and nationally 95% of adults ages 18-49 have a smartphone, including the majority of Hispanics (85%) and rural residents (80%). Further, obtaining feedback from P/C about the suitability of HPV vaccine messages through text messaging will facilitate more specific and tailored feedback from participants, increase accessibility for individuals who may have limited access to meet in person, and provide an opportunity where individuals may feel more comfortable sharing their opinions and perceptions than they would during a face-to-face or synchronous online experience. Text messages will emphasize individual involvement and personal meaning to enhance retention and promote engagement. Text messages between study staff and BCT participants will occur through the text messaging Twillio, which the research team has previously used to pilot HPV vaccine reminders. Text messages will be designed to elicit feedback on the HPV vaccination messages (which are suitable for girls vs. boys, English vs. Spanish speaking parents/caregivers) that are developed during the Bootcamp sessions, on reminder scripts (i.e., automated call scripts, text messages, patient portal messages), and on key intervention components (e.g., reminder type, number, sequence). The text messages will occur two times per week. This process can be automated using the text-messaging tool Twillio. Each text will ask participants to provide their feedback via text response. Messages will be pilot tested.

Because the BCT process is interactive and iterative, recording and transcribing sessions is often impractical. Instead, field notes will be taken by the study team in English and/or Spanish during each session and shared during weekly meetings of the project team. Reminder materials tailored through BCT and proposed protocols for the intervention will be reviewed by members of the IMW HPV Vaccination Coalition and tested in a later study. Following BCT, the research team will finalize the trial protocol, including procedures for the Auto and the Auto-Plus arms of the intervention, and the study team will finalize methods for data coordination, management, and ongoing monitoring. Because the goal of this study is to craft materials and messages that are motivating for English- and Spanish-speakers, this study does not anticipate directly translating materials from English to Spanish. Instead, the research team will rely on BCT and native speakers to craft messages from the ground up; this approach was successful in prior research. This study aims for a broad scale-up, all English and Spanish materials will be reviewed by the Sea Mar marketing and communications office for appropriateness and equivalency.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • Sea Mar Community Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Parents/Caregivers (P/C) of children/adolescents (C/A) ages 9-17 years of age (i.e., age-eligible for HPV vaccination);
  2. P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 months); and
  3. P/C who speak either English or Spanish.

Exclusion Criteria:

  1. P/C of C/A with previous excluding HPV vaccination history (e.g., completed vaccination, or not due);
  2. P/C of C/A with clinical conditions that influence the CDC HPV vaccination recommendations (e.g., pregnancy);
  3. P/C of C/A with other factors that would influence CDC HPV recommendations; and
  4. P/C that does not speak Spanish or English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: English Language Session and Messaging

The in-person or live Zoom presentation in English will consist of an expert presentation about the research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. In this session, participants will receive up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) in addition to novel formats for educational messages (e.g., digital videos, narratives).

Participants in the English-language text message group will provide iterative feedback to the research team on HPV vaccination messages over a 3-month period.
Behavioral: PREVENT - BCT

Bootcamp Translation (BCT), a method for engaging diverse stakeholders in a consensus-building process, has been used by this research team to actively develop and adapt study interventions. It uses an iterative, flexible schedule of face-to-face meetings combined with short, focused teleconferences. BCT emphasizes no wrong answers and no hierarchy of expertise. The process requires up to nine (9) hours of participant time over 3-6 months. Participants will be surveyed before and after the in-person session to assess learning outcomes and capture basic sociodemographic information.

The BCT process will define the format (mode and frequency) and content of messages to promote vaccine series completion. Auto and Auto-Plus intervention arms may use some of the same components (automated calls, live calls, text messages, emails, and mailings).
Experimental: Spanish Language Session and Messaging

The in-person or live Zoom presentation in Spanish will consist of an expert presentation about the research on the safety and effectiveness of the HPV vaccine and social norms about vaccination. In this session, participants will receive up-to-date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine recommendations with recommendations for other vaccines) in addition to novel formats for educational messages (e.g., digital videos, narratives).

Participants in the Spanish-language text message group will provide iterative feedback to the research team on HPV vaccination messages over a 3-month period.
Behavioral: PREVENT - BCT

Bootcamp Translation (BCT), a method for engaging diverse stakeholders in a consensus-building process, has been used by this research team to actively develop and adapt study interventions. It uses an iterative, flexible schedule of face-to-face meetings combined with short, focused teleconferences. BCT emphasizes no wrong answers and no hierarchy of expertise. The process requires up to nine (9) hours of participant time over 3-6 months. Participants will be surveyed before and after the in-person session to assess learning outcomes and capture basic sociodemographic information.

The BCT process will define the format (mode and frequency) and content of messages to promote vaccine series completion. Auto and Auto-Plus intervention arms may use some of the same components (automated calls, live calls, text messages, emails, and mailings).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Parents Participating in BCT
Time Frame: 1 day after study enrollment

This outcome measure will report the number of participants who participant in the BCT English sessions and number of participants who participant in the BCT Spanish sessions.

BCT is a community-based research approach to develop and evaluate messaging for health related issues. This study will employ BCT to determine the frequency and content of HPV messaging for future research.
1 day after study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This Year
Time Frame: After the in-person session (1 day)

Participants will be surveyed before and after the in-person session to assess learning outcomes.

This outcome measure is a single-item self-report of the intention of parents to get the HPV vaccination for their children this year. A low score (Minimum: 1 Extremely Unlikely) is an unfavorable outcome and a high score (Maximum: 5 Extremely Likely) is a favorable outcome. This outcome measure will report the number of patients per response for the BCT English sessions and the BCT Spanish sessions.
After the in-person session (1 day)
Satisfaction With BCT Session
Time Frame: After the in-person session (1 day)

Participants will be surveyed before and after the in-person session to assess learning outcomes.

This outcome measure is a single-item self-report of the participants satisfaction with the BCT session. A low score (Minimum: 1 Not at all satisfied) is an unfavorable outcome and a high score (Maximum: 10 Extremely satisfied) is a favorable outcome. This outcome measure will report the mean score of participants for the BCT English sessions and the BCT Spanish sessions.
After the in-person session (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Cancer Institute (NCI)
Kaiser Permanente
University of Arizona
Sea Mar Community Health Centers

Investigators

  • Principal Investigator: Deanna Kepka, PhD, MPH, Huntsman Cancer Institute/ University of Utah
  • Study Chair: Medical Director, MD, Sea Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

February 4, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HCI161649-1
  • 1R01CA279973-01 (U.S. NIH Grant/Contract)
  • DSS_10065815 (Other Identifier: University of Utah, Document Summary Sheet (DSS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A plan for sharing IDP that maintains participant anonymity has not yet been developed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HPV Vaccination

Clinical Trials on PREVENT - BCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe