PREVENT HPV -Related Cancers Trial

Not Applicable

Recruiting

• Conditions: Uptake Vaccination; Series Completion; HPV Vaccination
• Interventions: Biological: PREVENT

• Registration Number: NCT07217145
• Lead Sponsor: University of Utah

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. 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.

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.

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.

Study Timeline

• Study First Submitted: 2025-09-25
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-13
• Last Update Submitted: 2025-10-13
• Study First Posted: 2025-10-15
• Last Update Posted: 2025-10-15
• Study Start: 2025-11-01
• Primary Completion: 2026-02
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 519

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Automated Intervention (Auto)	PREVENT	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.
Automated Intervention Plus (Auto-Plus)	PREVENT	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.

Primary Outcome Measures

Name	Time	Method
Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)	6 Months	The investigators will track intervention reach using the Proctor Implementation and RE-AIM frameworks. The primary outcome is whether patients initiate the next step in the HPV vaccination series at 6 months, which will be captured via the EHR and the state vaccine registry. Completing the next step in the vaccine series outcome will be compared via logistic generalized estimating equations (GEE) models, with bias-reduced robust sandwich variance estimators clustered by the clinic. These logistic GEEs will be adjusted for P/C and patient features that may influence the HPV vaccination series next step and completion, including age, sex, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment. Pre-defined subgroup analyses will be performed by P/C and/or patient sex, age group, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment, and each of these characteristics will be assessed for effect moderation.

Secondary Outcome Measures

Name	Time	Method
RCT Arm Effectiveness: Next HPV Vaccination Step Completion	13 Months	The investigators will track intervention effectiveness using the Proctor Implementation and RE-AIM frameworks. The primary comparisons are the rates of completing the next step in the HPV vaccination series at 13 months (N C/A complete next HPV vaccine dose/ N anticipated) between the Auto, Auto-Plus, and UC arms. The investigators anticipate little missing data for these outcomes. Completing the next step in the vaccine series outcome will be compared via logistic generalized estimating equations (GEE) models. These GEEs will be adjusted for P/C and patient features that may influence the HPV vaccination series next step and completion, including age, sex, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment. Pairwise differences between arms will be assessed with a Bonferroni correction to achieve type I error control at 0.05, with p\<0.017=0.05/3 needed for statistical significance.
Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)	13 Months	Using the Proctor Implementation and RE-AIM frameworks, the investigators will track intervention reach. The primary outcome is whether patients initiate the next step in the HPV vaccination series at 13 months, which will be captured via the EHR and the state vaccine registry. Completing the next step in the vaccine series outcome will be compared via logistic generalized estimating equations (GEE) models, with bias-reduced robust sandwich variance estimators clustered by the clinic. These logistic GEEs will be adjusted for P/C and patient features that may influence the HPV vaccination series next step and completion, including age, sex, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment. Pre-defined subgroup analyses will be performed by P/C and/or patient sex, age group, race/ethnicity, rurality, and HPV vaccination initiation status at study enrollment, and each of these characteristics will be assessed for effect moderation.

Trial Locations

Locations (1)

Sea Mar Community Health Centers; 🇺🇸 Seattle, Washington, United States