NCT01731496

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
749

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

2.1 years

First QC Date

November 15, 2012

Last Update Submit

February 5, 2015

Conditions

Keywords

Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

  • HPV completion rate

    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 Outcomes (1)

  • HPV Dosing Intervals

    One Year

Study Arms (4)

Telephone reminder

EXPERIMENTAL

Telephone message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine.

Other: Telephone reminder

Text Message reminder

EXPERIMENTAL

Text message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine.

Other: Text Message reminder

Control: Telephone

NO INTERVENTION

Control: Text Message

NO INTERVENTION

Interventions

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.

Telephone 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.

Text Message reminder

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Culver Medical Group

Rochester, New York, 14609, United States

Location

Highland Family Medicine

Rochester, New York, 14620, United States

Location

Strong Pediatric Practice

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Rand CM, Vincelli P, Goldstein NPN, Blumkin A, Szilagyi PG. Effects of Phone and Text Message Reminders on Completion of the Human Papillomavirus Vaccine Series. J Adolesc Health. 2017 Jan;60(1):113-119. doi: 10.1016/j.jadohealth.2016.09.011. Epub 2016 Nov 8.

Study Officials

  • Cynthia Rand, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatrics

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2014

Study Completion

October 1, 2014

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations