Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study

A Randomized Longitudinal Intervention Study to Assess Whether Electronic Messaging Can Increase Human Papilloma Viruses (HPV) Vaccine Utilization and Adherence Among Adolescents in Eastern North Carolina.

There has been very limited research that has looked at electronic reminders (text messages) and its effectiveness in adherence to vaccination among low-income minority populations. Results have shown that text messages, among low-income parents and adolescents who were identified as having a cellphone, is an effective strategy to increase the likelihood of adolescent vaccination adherence. Hard copy and electronic messaging reminders have also been proven to be effective when coupled with other prevention strategies for immunizations for influenza and pneumococcal pneumonia and screening for colon, breast, and cervical cancer in adults. Additionally, Merck and Co. recommend electronic reminders in their patient compliance program as a key strategy for adherence. To our knowledge, this community-based pilot intervention study will be the first to assess electronic reminders and HPV vaccine initiation and adherence among rural uninsured and Medicaid populations. The investigators hypothesize that adolescent whose parents who receive the intervention will be more likely to initiate HPV vaccination and be compliant at 3 months and at 7 months as compared to the control group.

Study Overview

• Status: Completed
• Conditions: Patient Compliance
• Intervention / Treatment: Behavioral: HPV Vaccine Electronic Reminders

• Study Type: Interventional
• Enrollment (Actual): 522
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • East Carolina University's General Pediatric Outpatient Clinic
    • Snow Hill, North Carolina, United States, 28580
      • Kate B. Reynolds Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parent/Caretaker has Medicaid or is Uninsured
• Parent/Caretaker has a child between 11- 18 y/o
• Parent/Caretaker should be able to read English or Spanish
• Parent/Caretaker should have a phone and/or email address to provide for the study

Exclusion Criteria:

• Parents who have children younger than 11 or older than 18 years of age
• Parents who are not currently uninsured or enrolled in Medicaid/Medicare.
• Parent/Caretaker's child who received the 1st dose of HPV vaccine before enrolling in study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HPV Vaccine Electronic Reminders; Parents in the intervention group will receive 1 electronic message per month in addition to the baseline and final assessments which equates to 8 contacts over a 7 month period. Specifically, intervention group participants will receive 4 education messages, 2 reminder/education messages, as well as 1 baseline and 1 final assessment survey.

Behavioral: HPV Vaccine Electronic Reminders; The intervention group will receive 4 education messages, 2 reminder/education messages, as well as 1 baseline and 1 final assessment survey. Control group participants will receive 2 contacts throughout the study, 1 at baseline and 1 at their final assessment survey. Up to two reminder contacts will be used if surveys are not completed for both intervention and control group participants. Preference for receipt of reminders will be obtained from the information study card parents complete at study enrollment. Enrollment card content, educational messages and patient- reminders will all be developed with community input.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine Adherence, as measure by receiving the 3 recommended doses withing a 6 month time period.	Vaccine adherence will be measured using the CDC's guidelines which state that the second dose be given one to two months after the first, and the third dose be given six months after the first dose.	7 months after initial HPV Vaccince shot

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Knowledge, as measured by a 20% increase in knowledge about HPV and HPV vaccine among the intervention group.	Parents in the intervention group will receive 4 tailored education messages and 2 tailored reminder/education messages within the 6 month window period for the recommended HPV vaccine adherence guidelines. In order to assess a 20% increase in knowledge about HPV and the HPV vaccine, parents will take a baseline assessment survey and then a final assessment survey at the 7-month point once the vaccine series is completed.	7 months after the first initial HPV vaccine shot

Collaborators and Investigators

• Sponsor: East Carolina University
• Investigators: Principal Investigator: Alice Richman, PhD, MPH, East Carolina University

Publications and helpful links

General Publications

• Richman AR, Torres E, Wu Q, Carlston L, O'Rorke S, Moreno C, Olsson J. Text and Email Messaging for Increasing Human Papillomavirus Vaccine Completion among Uninsured or Medicaid-insured Adolescents in Rural Eastern North Carolina. J Health Care Poor Underserved. 2019;30(4):1499-1517. doi: 10.1353/hpu.2019.0090.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 15, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: HPV Vaccine Adherence; Electronic Reminders
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: Merck-50915