Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Patient Compliance

Intervention / Treatment
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* Behavioral: HPV Vaccine Electronic Reminders


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV Vaccine Electronic Reminders<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV Vaccine Adherence, Electronic Reminders