Clinical trial NCT01908517: 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
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Keywords: HPV Vaccine Adherence
Electronic Reminders
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 522
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Vaccine Adherence, as measure by receiving the 3 recommended doses withing a 6 month time period.
timeFrame: 7 months after initial HPV Vaccince shot
Secondary outcomes:
measure: HPV Knowledge, as measured by a 20% increase in knowledge about HPV and HPV vaccine among the intervention group.
timeFrame: 7 months after the first initial HPV vaccine shot
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University's General Pediatric Outpatient Clinic
state: North Carolina
city: Snow Hill
country: United States
facility: Kate B. Reynolds Medical Center
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Essie Torres, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: East Carolina University
name: Alice Richman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.