Impact of Adolescent Vaccine Reminder Notices Sent Via Preferred Method of Communication on HPV Vaccination

November 18, 2025 updated by: Huong Nguyen, PhD

Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas

Vaccine uptake in the United States is lower in rural areas, especially for HPV vaccine. Reminder/recall has been identified as an effective strategy to increase vaccination rates. This study will assess the impact by rurality of vaccine reminder notices sent via the parent's preferred method of communication on HPV vaccination among 12 year-old patients in a regional healthcare system.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5451

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Marshfield Clinic Health System patient aged 12 years with at least one preventive visit or two evaluation & management visits with a Marshfield Clinic Health System provider in the last 36 months
  • Due for at least one adolescent vaccine (HPV, MenACWY, Tdap)

Exclusion Criteria:

  • Primary care provider is not affiliated with Marshfield Clinic Health System
  • Opted out of Marshfield Clinic Health System vaccine reminder notifications
  • Missing or invalid contact information
  • Deceased

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Reminder
Behavioral: Reminder Sent Via Preferred Method of Communication
Parents of 12 year-old patients due for ≥1 adolescent vaccine will receive a vaccine reminder notice every other month via their preferred method of communication (text message, email, mailed letter) until the adolescent receives all recommended vaccines, opts out of reminders, or turns 13.
Other: Standard of Care
Behavioral: Reminder Sent Via Mailed Letter
Parents of 12 year-old patients due for ≥1 adolescent vaccine will receive a mailed vaccine reminder letter every other month until the adolescent receives all recommended vaccines, opts out of reminders, or turns 13.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients that received 1 dose of HPV vaccine during follow-up based on electronic health data
Time Frame: 90 days
Receipt of 1 dose of HPV vaccine within 90 days of receipt of reminder (yes/no) will be assessed using vaccination data available from the Marshfield Clinic Health System electronic health record, which includes vaccinations administered outside of MCHS through data exchanges with the Wisconsin Immunization Registry. Specifically patients will be classified as having received 1 dose of HPV vaccine if they have record of receipt of HPV vaccine with a vaccination date during the 90-day follow-up period.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huong Nguyen, PhD

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Huong McLean, PhD, Marshfield Clinic Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2021

Primary Completion (Actual)

November 2, 2022

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • MCL10517
  • U01IP001093 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Papillomavirus Vaccines

Clinical Trials on Reminder Sent Via Preferred Method of Communication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe