PREVENT Pilot HPV - Related Cancers Trial

Not Applicable

Completed

• Conditions: HPV Vaccination; Uptake Vaccination; Series Completion

• Registration Number: NCT06738355
• 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 feasibility of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington.

Detailed Description

This is a randomized, pilot study 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 PILOT study will administer a three-arm, patient-randomized controlled trial that will assess the feasibility of clinic-based outreach to increase vaccination rates. The study arms 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 PILOT study 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 primary objective of this pilot study is the feasibility of the trial, which will be assessed by the number of patients randomized to the study intervention. Other secondary outcome measures include the correctness of the randomization, successful receipt of a text message intervention, the proportion of participants who responded to the text intervention, and the proportion of participants who were successfully contacted.

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: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Study Start: 2025-05-20
• Primary Completion: 2025-08-12
• Study Completion: 2025-08-12
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-18
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Number of Participants Correctly Randomized	up to 1 day after randomization	To assess the feasibility of the study intervention. This outcome measure will report the count of participants who were correctly randomized according to the study protocol.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Responded to the Text Intervention	up to 1 month after randomization	To assess the feasibility of the study intervention. This outcome measure will report the number of participants who responded to the text-based intervention, as defined by the study protocol.
Proportion of Participants Successfully Contacted	up to 1 day	To assess the feasibility of the study intervention. This outcome measure will report the proportion of participants who were successfully contacted out of the total number of attempted contacts.

Trial Locations

Locations (1)

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