Clinical trial NCT06290206: PREVENT HPV-Related Cancers - BootCamp Translation
Official title: PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - BootCamp Translation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: University of Arizona
name: Sea Mar Community Health Centers
name: National Cancer Institute (NCI)
First posted: 2024-03-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Parents Participating in BCT
timeFrame: 1 day after study enrollment
Secondary outcomes:
measure: Likelihood of Parents to Get the HPV Vaccination for Their Child(Ren) This Year
timeFrame: After the in-person session (1 day)
measure: Satisfaction With BCT Session
timeFrame: After the in-person session (1 day)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Sea Mar Community Health Centers
state: Washington
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Deanna Kepka, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Sea Mar
name: Medical Director, MD
role: STUDY_CHAIR
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