protocolSection identificationModule nctId: NCT06290206, orgStudyIdInfo id: UU_IRB_00161649, secondaryIdInfos id: 1R01CA279973-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01CA279973-01, secondaryIdInfos id: DSS_10065815, type: OTHER, domain: University of Utah, Document Summary Sheet (DSS) Number, briefTitle: PREVENT HPV-Related Cancers, acronym: PREVENT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, collaborators name: Kaiser Permanente, collaborators name: University of Arizona, collaborators name: Sea Mar Community Health Centers, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: 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, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States. The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. The proposed study includes the following: (1) boot camp translation to tailor messaging based on patient and provider input; (2) PREVENT randomized controlled trial (RCT) that will assign adult parent/caregiver participants to a timeline for receiving intervention; and (3) qualitative interviews with parents/caregivers, providers, and other healthcare team members and development of best practices, implementation guides and dissemination of findings for other clinics to implement the program on a broader scale. At the end of the trial, personal interviews with parents/caregivers, clinical staff, and providers will be conducted to understand reactions to the program and persistent barriers to initiating and completing HPV vaccination., conditionsModule conditions: Vaccine Hesitancy, conditions: HPV Vaccination, conditions: Vaccine; Uptake, conditions: Vaccination; Series Completion, conditions: Vaccine Refusal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The investigators will use intervention mapping (IM) to plan each intervention step. The investigators will apply IM to develop and test HPV vaccination reminders for parents/caregivers (P/C). Bootcamp Translation (BCT) will engage diverse stakeholders using an iterative schedule of meetings. The BCT process will define the format and content of vaccination messages.Intervention: The investigators propose a 3-arm RCT to compare rates of completing the next step in the HPV vaccination series at six months and completing the HPV vaccination series at 13 months between Auto, Auto-Plus, and UC arms. P/C of children/adolescents (C/A) who have not completed the series will be randomized 1:1:1 to study arms. Participants will be assessed for eligibility and enrolled, with a total participant time in the study of 13 months, for a total of 25 months of enrollment, participation, and follow-up., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Clinic analysts will create a real-time list of patients due for an initial HPV vaccine dose. P/C of remaining C/A patients will be individually randomized to either Auto or Auto-Plus intervention or usual care (UC) in a 1:1:1 ratio. The PREVENT study will only target one child/adolescent per parent/caregiver (siblings will be excluded from intervention assessments). The investigators will use automated codes to manage interventions so that eligible patients get initial HPV vaccines on time and P/C are prompted to repeat vaccination, as recommended. The investigators will select a cohort of approximately 1,038 P/C patients from the 4 clinics, randomized to intervention arms (UC, Auto, and Auto-Plus). Intervention activities largely mimic clinic processes, and clinicians and participants will be unaware of which intervention study arm the P/C has been assigned., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 519, type: ESTIMATED, armsInterventionsModule interventions name: PREVENT, outcomesModule primaryOutcomes measure: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion), primaryOutcomes measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion, secondaryOutcomes measure: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion), secondaryOutcomes measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sea Mar Community Health Centers, city: Seattle, state: Washington, zip: 98108, country: United States, contacts name: PREVENT Sea Mar CHC, Study Medical Coordinator, MsPH, MS, role: CONTACT, phone: 206-764-5504, email: LudyVillegas@seamarchc.org, contacts name: PREVENT Research Assistant, role: CONTACT, phone: 801-587-4565, email: Kepka-Research@hci.utah.edu, contacts name: Amanda Petrik, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False