- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731496
The Efficacy of Reminders to Complete HPV Series (ICHAT)
February 5, 2015 updated by: Cynthia Rand, University of Rochester
Improving Communication and Health for Adolescents With Technology - Implementation of Immunization Strategy
The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and boys starting at age 11, although it can be offered as young as 9 years of age.
This is a 3-dose series and many adolescents do not complete it after getting the first dose.
This study will study how effective it will be to send reminders to parents to schedule an appointment when their child is due for the next dose of HPV.
Parents can chose whether they would like a phone call or text message reminder.
This study will determine if the reminders work, and if one method is better than another (phone message vs. text message).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
749
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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Rochester, New York, United States, 14620
- Highland Family Medicine
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Rochester, New York, United States, 14609
- Culver Medical Group
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Rochester, New York, United States, 14642
- Strong Pediatric Practice
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parents of adolescents aged 10 - 17 who have had at least 1 dose of HPV
- Patients aged 18 - 21 who have had at least 1 dose of HPV
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telephone reminder
Telephone message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine.
|
One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a telephone reminder to call to make an appointment to receive their next dose.
A total of 3 reminders will be sent.
|
Experimental: Text Message reminder
Text message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine.
|
One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a text message reminder to call to make an appointment to receive their next dose.
A total of 3 reminders will be sent.
|
No Intervention: Control: Telephone
|
|
No Intervention: Control: Text Message
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HPV completion rate
Time Frame: One Year
|
Post intervention HPV vaccination rates will be summarized by intervention group with frequencies and proportions, and will be compared between groups using chi square or Fisher's exact test as appropriate
|
One Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HPV Dosing Intervals
Time Frame: One Year
|
Dosing intervals will be summarized by group with mean, median, standard deviation and will be compared between groups using a two sample t-test.
|
One Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cynthia Rand, MD, MPH, University of Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
November 15, 2012
First Submitted That Met QC Criteria
November 15, 2012
First Posted (Estimate)
November 21, 2012
Study Record Updates
Last Update Posted (Estimate)
February 6, 2015
Last Update Submitted That Met QC Criteria
February 5, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5K08HS017951-03 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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