Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study

NCT01908517 | Completed DMC

• 1 other identifier: Merck-50915
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 2

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.

Conditions

Patient Compliance

Keywords

HPV Vaccine Adherence; Electronic Reminders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  7 months after the first initial HPV vaccine shot

Study Arms (1)

HPV Vaccine Electronic Reminders

EXPERIMENTAL

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

Interventions

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.

HPV Vaccine Electronic Reminders

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (2)

East Carolina University's General Pediatric Outpatient Clinic

Greenville, North Carolina, 27858, United States

Location

Kate B. Reynolds Medical Center

Snow Hill, North Carolina, 28580, United States

Location

Related Publications (1)

• 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.

  PMID: 31680111 DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

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

Study Officials

• Essie Torres, PhD, MPH

  East Carolina University

  PRINCIPAL INVESTIGATOR

• Alice Richman, PhD, MPH

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 25, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

US (2)