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

Sponsor

Huong McLean, PhD (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05148559

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

2,500

Enrollment

Location

Arms

15.6

Anticipated Duration (Months)

159.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Papillomavirus Vaccines	Behavioral: Reminder Sent Via Preferred Method of Communication Behavioral: Reminder Sent Via Mailed Letter	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Aug 12, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marshfield Clinic Health System	Marshfield	Wisconsin	United States	54449

Sponsors and Collaborators

Huong McLean, PhD
Centers for Disease Control and Prevention

Investigators

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

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Apr 20, 2022

More Information

Publications

None provided.

Responsible Party:

Huong McLean, PhD, Research Scientist, Marshfield Clinic Research Foundation

ClinicalTrials.gov Identifier:

NCT05148559

Other Study ID Numbers:

MCL10517
U01IP001093

First Posted:

Dec 8, 2021

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 6, 2022