An interventional study of PREVENT in HPV Vaccination, Uptake Vaccination and Series Completion, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by University of Utah · Not applicable, Interventional, and Prevention
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.
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.
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 335 is above the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: 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. Activities selected from a list of possible options from the National HPV Vaccination Roundtable and our ranking of the effectiveness of language- and culturally-tailored intervention materials.
Behavioral: PREVENT
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.
The proposed study will assess the feasibility of an RCT for clinic-based outreach to increase vaccination rates for HPV at community clinics in rural counties. The study is a pilot trial that will assign adult parent/caregiver participants to a timeline for receiving the vaccination messaging intervention. Auto and Auto-Plus intervention arms may use some of the same components (automated calls, live calls, text messages, emails, and mailings).
Number of Participants Correctly Randomized
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.
Time frame: up to 1 day after randomization
Number of Participants Who Responded to the Text Intervention
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.
Time frame: up to 1 month after randomization
Proportion of Participants Successfully Contacted
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.
Time frame: up to 1 day
Plan to share: Undecided — A plan for sharing IDP that maintains participant anonymity has not yet been developed.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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