Human Papilloma Viruses (HPV) Vaccine Adherence Community Clinic Study

NCT ID: NCT01908517

Last Updated: 2016-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-05-31

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.

Detailed Description

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Conditions

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Patient Compliance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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HPV Vaccine Electronic Reminders

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.

Group Type EXPERIMENTAL

HPV Vaccine Electronic Reminders

Intervention Type 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.

Interventions

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HPV Vaccine Electronic Reminders

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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East Carolina University

OTHER

Sponsor Role lead

Responsible Party

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Essie Torres

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Essie Torres, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Alice Richman, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Locations

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East Carolina University's General Pediatric Outpatient Clinic

Greenville, North Carolina, United States

Site Status

Kate B. Reynolds Medical Center

Snow Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31680111 (View on PubMed)

Other Identifiers

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Merck-50915

Identifier Type: -

Identifier Source: org_study_id

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