NCT01806714

Brief Summary

The purpose of the study is to evaluate the effectiveness of a managed care-based HPV vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse practices and patient populations. The trial will measure the effectiveness of text messaging reminder/recall on (a) improving initiation and (b) completion rate of the HPV vaccine series; (c) decreasing the time between vaccine doses; and (d) improving rates of preventive visits for adolescents The hypotheses are that text-messaged reminders to parents of adolescents will result in improved rates of HPV vaccine series initiation, HPV vaccine series completion, will decrease the intervals between vaccine doses and will improve rates of preventive care among adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV vaccination, well child care visits) for which their adolescent is due will be compared to a control group of parents receiving general health tips through text messages.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,812

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 26, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

March 5, 2013

Results QC Date

December 30, 2015

Last Update Submit

June 5, 2017

Conditions

Keywords

HPV vaccinationAdolescent well careAdolescent HPV immunizationHPV

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Receiving HPV Vaccination (Dose 1)

    Participants who received HPV vaccine dose 1 Kaplan-Meier failure function

    9 months

Secondary Outcomes (2)

  • Percentage of Participants Receiving HPV Vaccination (Dose 2)

    9 months

  • Percentage of Participants Receiving HPV Vaccination (Dose 3)

    9 months

Study Arms (2)

Text-based reminder for HPV vaccine/WCC

EXPERIMENTAL

Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit

Other: Text-based reminder for recommended HPV vaccine or WCC

Control arm

ACTIVE COMPARATOR

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Other: Non-specific text-based reminder (general health tip)

Interventions

Patients due for a well visit or HPV vaccine received a text reminder

Text-based reminder for HPV vaccine/WCC

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Control arm

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \<18 years
  • Member of MCO for \>6 months
  • Opted in to receive texted reminders from MCO

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Results Point of Contact

Title
Dr. Cynthia Rand
Organization
University of Rochester

Study Officials

  • Cynthia M Rand, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 7, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 26, 2017

Results First Posted

June 26, 2017

Record last verified: 2017-06

Locations