PREVENT HPV -Related Cancers Trial

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: HPV Vaccination; Series Completion; Uptake Vaccination

Treatments: Biological: PREVENT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07217145

DSS_10065815 (Other Identifier)

1R01CA279973-01 (U.S. NIH Grant/Contract)

HCI161649-3

Details and patient eligibility

About

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 a randomized controlled trial (RCT) that will assign adult parent/caregiver participants to a timeline for receiving intervention. This study will develop best practices, implementation guides, and dissemination of findings for other clinics to implement the program on a broader scale.

Full 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.

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.

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.

Enrollment: 519 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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519 participants in 3 patient groups

Automated Intervention (Auto)

Experimental group

Description:

Auto intervention participants will be eligible for outreach delivered using automated phone calls, text, or email messages with the mode, frequency, timing of reminders, and message content. Automated outreach may also include innovative communication strategies, such as text-linked videos, P/C, or patient narratives. Auto outreach to P/C will invite P/Cs to attend free HPV vaccination visits and emphasize family-friendly hours.

Treatment:

Biological: PREVENT

Automated Intervention Plus (Auto-Plus)

Experimental group

Description:

Auto-Plus intervention participants will be eligible for automated reminders, plus additional P/C prompts for patients who do not undergo vaccination within three weeks. These prompts may be delivered via live phone call outreach or patient navigation. Working with clinic leadership and previous research, activities will be selected from a list of possible options from the National HPV Vaccination Roundtable (previously chaired by Dr. Brewer) and our ranking of the effectiveness of language- and culturally- tailored intervention materials.

Treatment:

Biological: PREVENT

Usual Care (UC)

No Intervention group

Description:

The UC group will not receive tailored reminders but will only receive opportunistic vaccine reminders that are delivered during clinic visits or MyChart EHR-based patient portal reminders.