Clinical trial NCT06738355: PREVENT HPV-Related Cancers Trial
Official title: PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV Vaccination
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: 2024-12-17
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
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, 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. This study is a boot camp translation to tailor messaging based on patient and provider input 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.

Detailed description: The clinical trial in the PREVENT study is a patient-randomized control trial (RCT) of two human papillomavirus (HPV) vaccination patient reminder intervention arms that will take place in rural clinics operated by Sea Mar Community Health Centers. Results from the BootCamp Translation (BCT) activities will be conducted in English and Spanish and will inform the PREVENT RCT development and messaging strategies; BCT activities are not part of the RCT.

The PREVENT RCT will administer a three-arm patient randomized controlled trial that will assess completion of the next needed dose of HPV vaccination and on-time completion of the multi-dose HPV vaccine series. The study arms for each trial will consist of automated reminders, automated plus live reminders, and usual care. Parents/caregivers of children and adolescents selected for the trial will be chosen using established study criteria applied to the electronic health records linked to state immunization registries. As a minimal-risk study, for the intervention only, the investigators will apply for a waiver of informed consent. The RCT will be delivered as part of standard care, and patients will be unaware they are in the trial. Delivered vaccination messages will include opt-out choices as directed by BCT activities and local policies.

Depending on the specific interventions defined during BCT, parents/caregivers (P/C) of children and adolescents (C/A) will be sent any number of reminders to encourage parents to obtain an HPV vaccine for their age-eligible C/A. Reminders may include text messages, automated phone calls, mailed letters, live calls, or patient navigation. Reminders will be delivered by a vendor (automated reminders) or clinic staff (live reminders). Reminders will be delivered in English and Spanish, and interpreter services may be used for live reminders to the small proportion of patients who speak languages other than English or Spanish. The investigators will use electronic health record data to document HPV vaccination events as our primary outcome of interest. The investigators will also assess the reach for each intervention component, defined as the proportion of patients who receive a given intervention component. The investigators will also assess missed opportunities, defined as the proportion of patients who receive other recommended vaccines (e.g., Tdap or meningococcal) but not HPV, for each study arm, during the study. Aim 3 will gather patient- and provider-level qualitative data to assess reaction to the program, factors associated with implementation and long-term sustainability, and opportunities for additional clinic-based interventions. During active study recruitment, the investigators will convene a meeting of our data safety monitor board every six months. The investigators will disseminate study findings and research products in accordance with our dissemination plan. The study findings will serve as a basis for a larger multi-level trial of HPV vaccination in rural communities.

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: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)
timeFrame: 6 Months
Secondary outcomes:
measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion
timeFrame: 6 Months
measure: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)
timeFrame: 13 Months
measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion
timeFrame: 13 Months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Sea Mar Community Health Centers
state: Washington
Study officials:
affiliation: Study Principal Investigator
name: Deanna Kepka, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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