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OpenTrials
Active, Not Recruiting

NCT Number: NCT07217145

PREVENT HPV -Related Cancers Trial

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 a clinic-based behavioral outreach intervention to increase HPV vaccination rates at community clinics in rural counties. The intervention consists of communication and engagement strategies delivered within routine care settings and is designed to pose no more than minimal risk to participants.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HPV VACCINATION Behavior Communicable Diseases Communication DNA Virus Infections Disease Attributes Genital Diseases Health Behavior Infections Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Series Completion Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Treatment Adherence and Compliance Tumor Virus Infections Uptake Vaccination Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sea Mar Community Health Centers

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prevent

Behavioral

The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at community clinics in rural counties.

Primary outcomes

  1. Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)

    Time frame: 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 outcomes

  1. RCT Arm Effectiveness: Next HPV Vaccination Step Completion

    Time frame: 6 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 6 months (N C/A complete next HPV vaccine dose/ N anticipated) between the Auto, Auto-Plus, and UC arms. Little missing data is expected for these outcomes. 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. The 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.

  2. Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion)

    Time frame: 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.

  3. RCT Arm Effectiveness: Next HPV Vaccination Step Completion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Kaiser Permanente
  • National Cancer Institute (NCI)
  • Sea Mar Community Health Centers
  • University of Arizona

Registry information

Official study title

PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - Randomized Controlled Trial (RCT)

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 15, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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