Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study

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.

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Key information

Conditions

Patient Compliance Behavior Health Behavior Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University's General Pediatric Outpatient Clinic, Greenville, North Carolina, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV Vaccine Electronic Reminders

Behavioral

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.

Primary outcomes

Vaccine Adherence, as measure by receiving the 3 recommended doses withing a 6 month time period.

Time frame: 7 months after initial HPV Vaccince shot

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.

Secondary outcomes

HPV Knowledge, as measured by a 20% increase in knowledge about HPV and HPV vaccine among the intervention group.

Time frame: 7 months after the first initial HPV vaccine shot

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.

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Official study 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.

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Jul 25, 2013
Registry last updated: May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed