The Efficacy of Reminders to Complete HPV Series (ICHAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cynthia Rand, University of Rochester
ClinicalTrials.gov Identifier:
NCT01731496
First received: November 15, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Completion of Three Dose Series of HPV
Improvement in Vaccine Intervals Between HPV Doses
Other: Telephone reminder
Other: Text Message reminder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Improving Communication and Health for Adolescents With Technology - Implementation of Immunization Strategy

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • HPV completion rate [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • HPV Dosing Intervals [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Dosing intervals will be summarized by group with mean, median, standard deviation and will be compared between groups using a two sample t-test.


Estimated Enrollment: 1640
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone reminder
Telephone message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine.
Other: Telephone reminder
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.
Other: Text Message reminder
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

  Eligibility

Ages Eligible for Study:   10 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731496

Locations
United States, New York
Strong Pediatric Practice
Rochester, New York, United States, 14642
Culver Medical Group
Rochester, New York, United States, 14609
Highland Family Medicine
Rochester, New York, United States, 14620
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Cynthia Rand, MD, MPH University of Rochester
  More Information

No publications provided

Responsible Party: Cynthia Rand, Associate Professor, Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01731496     History of Changes
Other Study ID Numbers: 5 K08 HS017951-03
Study First Received: November 15, 2012
Last Updated: July 8, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
Human Papillomavirus

ClinicalTrials.gov processed this record on September 14, 2014