PREVENT HPV-Related Cancers - BootCamp Translation

NCT06290206 | Completed Results DMC

• 3 other identifiers: HCI161649-11R01CA279973-01DSS_10065815
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HPV Vaccination; Vaccine; Uptake; Vaccination; Series Completion

Keywords

Humans; Adolescent; Child; Male; Female; Caregivers; Parents; Hispanic or Latino; Rural Population; Health Personnel; United States; Vaccination; Papillomavirus Vaccines; Papillomavirus Vaccines / administration & dosage; Human Papillomavirus Viruses; Papillomavirus Infections; Papillomavirus Infections / prevention & control; Cancer / prevention & control; Incidence; Text Messaging; Reminder Systems / instrumentation; Social Norms; Vaccination Refusal; Health Knowledge, Attitudes, Practice; Health Promotion / methods; Motivation; Communication; Patient Acceptance of Health Care; Parents / education; Religion; Religiosity; Stakeholder Participation; Participatory Approach; Qualitative Research; Quantitative Research; Randomized Control Trial; Surveys and Questionnaires

Outcome Measures

Primary Outcomes (1)

• Number of Parents Participating in BCT

  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 Outcomes (2)

• Likelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This Year

  After the in-person session (1 day)

• Satisfaction With BCT Session

  After the in-person session (1 day)

Study Arms (2)

English Language Session and Messaging

EXPERIMENTAL

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

Spanish Language Session and Messaging

EXPERIMENTAL

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

Interventions

PREVENT - BCT BEHAVIORAL

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).

English Language Session and Messaging; Spanish Language Session and Messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead
• Kaiser Permanente: collaborator
• University of Arizona: collaborator
• Sea Mar Community Health Centers: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sea Mar Community Health Centers

Seattle, Washington, 98108, United States

Location

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Related Links

• PREVENT HPV Cancers study website hosted by Kaiser Permanente
• PREVENT HPV Cancers study website hosted by Kaiser Permanente

MeSH Terms

Conditions

Papillomavirus Infections; Neoplasms; Vaccination Refusal; Behavior; Communication; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Kaila Christini, MsPH, MS
• Organization: University of Utah

Kaila.Christini@hci.utah.edu

801-587-4565

Study Officials

• Deanna Kepka, PhD, MPH

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

• Medical Director, MD

  Sea Mar

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: March 4, 2024
• Study Start: February 2, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 31, 2024
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-05

Locations

US (1)