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Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study

Primary Purpose

Patient Compliance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HPV Vaccine Electronic Reminders
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Compliance focused on measuring HPV Vaccine Adherence, Electronic Reminders

Eligibility Criteria

9 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • East Carolina University's General Pediatric Outpatient Clinic
  • Kate B. Reynolds Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HPV Vaccine Electronic Reminders

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 15, 2013
Last Updated
May 23, 2016
Sponsor
East Carolina University
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1. Study Identification

Unique Protocol Identification Number
NCT01908517
Brief Title
Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Carolina University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Compliance
Keywords
HPV Vaccine Adherence, Electronic Reminders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
522 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HPV Vaccine Electronic Reminders
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HPV Vaccine Electronic Reminders
Intervention Description
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 Outcome Measure Information:
Title
Vaccine Adherence, as measure by receiving the 3 recommended doses withing a 6 month time period.
Description
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.
Time Frame
7 months after initial HPV Vaccince shot
Secondary Outcome Measure Information:
Title
HPV Knowledge, as measured by a 20% increase in knowledge about HPV and HPV vaccine among the intervention group.
Description
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.
Time Frame
7 months after the first initial HPV vaccine shot

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Essie Torres, PhD, MPH
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alice Richman, PhD, MPH
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Carolina University's General Pediatric Outpatient Clinic
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Kate B. Reynolds Medical Center
City
Snow Hill
State/Province
North Carolina
ZIP/Postal Code
28580
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31680111
Citation
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.
Results Reference
derived

Learn more about this trial

Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study

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