Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study

Patient Compliance Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908517
• Other study ID #: Merck-50915
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: May 23, 2016
• Start date: August 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Papilloma
• Patient Compliance

Intervention

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.

Locations

Country	Name	City	State
United States	East Carolina University's General Pediatric Outpatient Clinic	Greenville	North Carolina
United States	Kate B. Reynolds Medical Center	Snow Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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