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

Papillomavirus Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05148559
• Other study ID #: MCL10517
• Secondary ID: U01IP001093
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Marshfield Clinic Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5451
• Est. completion date: December 2023
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Papillomavirus Vaccines

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Marshfield Clinic Health System	Marshfield	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Huong McLean, PhD	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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