NCT05148559

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,451

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Aug 2021Dec 2026

Study Start

First participant enrolled

August 12, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

November 16, 2021

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients that received 1 dose of HPV vaccine during follow-up based on electronic health data

    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

Study Arms (2)

Enhanced Reminder

EXPERIMENTAL
Behavioral: Reminder Sent Via Preferred Method of Communication

Standard of Care

OTHER
Behavioral: Reminder Sent Via Mailed Letter

Interventions

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.

Enhanced Reminder

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.

Standard of Care

Eligibility Criteria

Age12 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marshfield Clinic Health System

Marshfield, Wisconsin, 54449, United States

Location

Study Officials

  • Huong McLean, PhD

    Marshfield Clinic Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 8, 2021

Study Start

August 12, 2021

Primary Completion

November 2, 2022

Study Completion (Estimated)

December 1, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations